36C24623Q0302.docx
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- H166--Pharmaceutical Aseptic and Environmental Testing & Analysis Federal contract opportunity
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- 36C24623Q0302
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36C24623Q0302
PAGE 1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE DATE/LOCAL
TIME
9. ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a. PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
UEI:
EFT:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. NOV 2021)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
36C24623Q0302 Serina Black 757-315-3965 02-08-2023 15:00
EST
Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton
VA
23667 X 541380 $16.5 Million N/A X Department of Veterans Affairs W.G. "Bill" Hefner VAMC 1601 Brenner Avenue Salisbury
NC
28144 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton
VA
23667
Department of Veterans Affairs Financial Services Center
PO BOX 149971
Austin
TX
78714-9971 512-460-5049 512-460-5221 X See CONTINUATION Page The Contractor shall provide all materials, tools, specialized equipment, labor, supervision, and technical expertise for services covered in the scope of work.
Submit the quote, SF1449 and supporting information to the Contract Specialist, Serina Black at serina.black1@va.gov by the due date shown in block 8.
See CONTINUATION Page X X X Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 3 |
| B.1 CONTRACT ADMINISTRATION DATA | 3 |
| B.3 PRICE/COST SCHEDULE | 12 |
| ITEM INFORMATION | 12 |
| SECTION C - CONTRACT CLAUSES | 21 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) | 21 |
| C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 26 |
| C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) | 27 |
| C.4 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018) | 28 |
| ?.## VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (NOV 2022) | 29 |
| C.5 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 31 |
| C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 32 |
| C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION) | 32 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 40 |
| SECTION E - SOLICITATION PROVISIONS | 41 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) | 41 |
| E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 45 |
| E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION) | 46 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36C246
Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or |
| [] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [X] Monthly in arrears |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 PERFORMANCE WORK STATEMENT
Performance Work Statement Pharmaceutical Aseptic and Environmental Testing and Analysis
1. INTRODUCTION:
1.1 Under the authority of United States Pharmacopeia (USP) <797> and Veterans Affairs Acquisition Regulation (VAAR) 873, the Salisbury VA Health Care System (VAHCS) located at 1601 Brenner Avenue, Salisbury, NC, requires services of a medical laboratory scientist to perform incubation and analysis of gloved fingertip and media fill testing for all designated personnel and surface sampling of pharmacy IV hoods and spaces used in sterile compounding.
1.2. Medical laboratory scientists (also referred to as, and covered by the services in the scope of work, a clinical laboratory scientist or medical technologist) shall provide documentation of certification as a Medical Laboratory Scientist, (or equivalent) by the American Society for Clinical Pathology (ASCP). The contractor shall be licensed and insured to provide services in the geographic area covered in the scope of work.
Documentation of the aforementioned personnel qualifications must be submitted with offer and upon request of the Salisbury VAHCS.
2. SCOPE:
The Contractor agrees to provide all materials, tools, specialized equipment, labor, supervision, and technical expertise for services covered in the scope of work.
Salisbury VAHCS Pharmacy will serve as the focal point and the point of contact for this contract. Personnel can be reached at 704-638-9000 ext. 14362 during normal business hours.
The government requests a base + four (4) Option Year contract.
2.1 Glove-fingertip Testing: Glove fingertip (GFT) sampling shall be used to evaluate the competency of personnel in performing hand hygiene, garbing procedures, and aseptic technique, in addition to educating compounding personnel on proper work practices.
a. Salisbury VAHCS staff will collect the samples using appropriate agar plates or paddles containing trypticase soy agar (TSA) with lecithin and polysorbate 80. Salisbury VAHCS staff will label and ship the testing plates via overnight delivery to contractor location for incubation and reading of results.
b. GFT agar plates or paddles, shall be incubated by the contractor at contractor’s location in an incubator at a temperature of 30 to 35 degrees Celsius for 48 to 72 hours, then at 20 to 25 degrees Celsius for no less than 120 additional hours and not more than 168 hours, followed by examination for growth.
c. GFT agar plates or paddles, once incubated for the defined time, shall be read to determine if there are any colony forming units (CFUs). An analysis report for each sample shall be submitted to the Salisbury VAHCS Pharmacy via email within 5 calendar days of the reading. GFT analysis report shall include, at a minimum, the following:
| 1. Sample name or number (assigned by Salisbury VAHCS Pharmacy) |
| 2. Dates and times for each interval of incubation |
| 3. Starting temperature for each interval of incubation |
| 4. Date and time GFT sample was evaluated |
| 5. Number of CFUs in the sample (if any) |
| 6. Name and signature of the person who read and documented results of the sample. |
2.2. Media-fill Testing: Media-fill testing (MFT) is used to assess the quality of the aseptic skill of compounding personnel.
a. A commercially available sterile fluid media consisting of Soybean-Casein Digest Medium will be used to assess aseptic skill. The Salisbury VAHCS Pharmacy will collect the samples then label and ship via overnight delivery to the contractor where they shall be incubated for 7 days at 20 to 25 degrees Celsius followed by 7 days at 30 to 35 degrees Celsius.
b. Once the incubation period for MFT samples is completed, the samples shall be analyzed using visual examination. Failure is indicated by visible turbidity or other visual manifestations of growth in any MFT sample on or before 14 days from the time incubation was initiated. An analysis report for each sample shall be submitted to the Salisbury VAHCS Pharmacy via email within 5 calendar days of the analysis. MFT analysis report shall include, at a minimum, the following:
| 1. Sample name or number (assigned by Salisbury VAHCS Pharmacy) |
| 2. Dates and times for each interval of incubation |
| 3. Starting temperature for each interval of incubation |
| 4. Date and time MFT sample was evaluated |
| 5. Results indicating the presence or lack of turbidity or other visual manifestations or growth |
| 6. Name and signature of the person who examined and documented results of the sample |
2.3. Surface Sampling: Surface sampling is an important component of the maintenance of a suitable microbial controlled environment for compounding sterile products, especially since transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination into CSPs.
a. Surface sampling shall be performed in all ISO classified areas, pass-through chambers connecting to classified areas, and on worksurfaces and frequently touched surfaces near primary engineering controls monthly and shall be initiated by the Salisbury VAHCS Pharmacy. Surface samples will be conducted on appropriate agar plates or paddles containing trypticase soy agar (TSA) with lecithin and polysorbate 80. All growth media used in sampling must have an associated certificate of analysis. Samples will be labeled and shipped to contractor via overnight delivery.
b. Surface samples shall be incubated by the contractor at contractor’s location in an incubator at a temperature of 30 to 35 degrees Celsius for 48 to 72 hours, then examined and any CFUs recorded. The same samples shall then be incubated at 20 to 25 degrees Celsius for no less than 120 additional hours and not more than 168 hours, followed by examination for growth.
c. Once incubated for required period, surface samples shall be read to determine if any CFU is visible. An analysis report for each sample shall be submitted to the Salisbury VAHCS Pharmacy via email within 5 calendar days of the reading and shall include, at a minimum, the following:
| 1. Sample number (assigned by Salisbury VAHCS Pharmacy) |
| 2. Dates and times for each interval of incubation |
| 3. Starting temperature for each interval of incubation |
4. Date and time surface sample was evaluated
| 5. Number of CFUs in the sample (if any) |
| 6. Name and signature of the staff member who read the sample. |
d. If CFU levels of a sample exceed the levels as specified in the action levels table below, the sample shall have microbial evaluation performed by the contractor to identify which organism(s) were grown on the respective surface sample. A microbial evaluation report identifying each organism to the genus level shall be provided to the Salisbury VAHCS Pharmacy via email within 10 calendar days.
Action Levels for Surface Sampling
| ISO class of space where sample taken |
| CFU levels triggering microbial identification |
| 5 |
| >3 CFU |
| 7 |
| >5 CFU |
| 8 |
| >50 CFU |
| No ISO class |
| >50 CFU |
3. CONTRACTOR’S QUALIFICATIONS: The contractor must be regularly established in the business called for, financially responsible, and have the necessary equipment and personnel to furnish service in the volume required for all items under this requirement. The successful Contractor shall meet all Federal, State and Local codes and requirements for the operation of this service and equipment provided. Medical laboratory scientists authorized by the Contractor to perform services under this specification and any resulting contract, shall be certified by the American Society for Clinical Pathology. Qualified personnel must be American citizens (or offer evidence of a green card).
Contractor’s employee(s) shall be technically proficient in the skills necessary to fulfill the Government's requirements, to include the ability to speak, understand, read & write English fluently.
The qualifications of employees authorized to complete services under this specification, shall also be subject to review by the Chief, Pharmacy Service, Chief of Staff, and/or the Medical Center Director of the Salisbury VAHCS.
The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully; including knowledge and skills required to provide care for certain patient populations, as appropriate.); a current performance evaluation supporting ability of the Contractor employee to successfully perform the work required in this requirement; and listing of relevant continuing education for the last two (2) years. The Contractor shall provide current copies of these records at the time of contract award and annually on the anniversary date of contract award to the Salisbury VAHCS COR or Pharmacy management designee; or upon request, for each Contractor employee working on the contract.
4. CONTRACT REQUIREMENTS:
a. All work shall commence within twenty-four (24) hours after receipt of sample and will proceed progressively without undue delay. All work shall be performed by competent personnel, experienced and qualified to work on the specific equipment.
b. Hours of Operation: The normal duty hours for these services will be Monday through Friday from 8:00am until 4:30pm (Eastern Standard Time). No operations will be required to perform on federal holidays or after the normal duty hours.
5. CONTRACTOR’S FURNISHED EQUIPMENT:
1. Incubators used for GFT, MFT, and surface sample testing must meet the following minimum requirements:
1. Designed for incubating general growth media at a consistent temperature of 30 to 35 degrees Celsius and 20 to 25 degrees Celsius;
2. Equipped with a continuous temperature monitor;
3. Not located in an area where drugs are stored, handled, prepared, or where clinical microbiology samples are cultured, or where they would pose a threat to patient and employee health; and
4. Connected to an emergency power supply or have an internal battery emergency power supply.
1. Any equipment or materials used to detect, analyze, or identify microorganisms as deemed acceptable per industry standards.
6. SUPPLIES: Contractor shall be solely responsible for the procurement, receipt, and safekeeping, of all supplies required in the performance of the services defined herein and authorized by the COR/ACOR. Additionally, the Contractor shall be responsible for providing the Salisbury VAHCS with necessary supplies to complete work of services defined herein, including but not limited to, sampling plates or paddles. Contractor shall also be responsible for the waste management, removal and proper disposal of all samples provided for testing by the Salisbury VAHCS. The cost for proper disposal of materials furnished under this contract shall be part of any line item pricing listed in the Schedule of Supplies/Services and should not be separately priced for this requirement.
7. DOCUMENTATION/REPORTS:
The Contractor shall provide all documentation and analysis reports to the Chief, Pharmacy Service of the Salisbury VAHCS during the duration of the contract. All documentation and reports shall be submitted as defined herein via e-mail to: Tyler.Billings@va.gov.
All analysis reports shall be read by a certified Medical Laboratory Scientist.
Documentation required by the successful Contractor prior to the commencement of services:
a. Certificate of Insurance not limited to but, includes: Professional Liability, Worker’s Compensation, liability and property insurance of Contractor’s furnished equipment which shall be submitted to the Contracting Officer within ten (10) calendar days of receipt of notification of award. It is agreed upon and understood that the VISN 6 shall not be held responsible for any damage or vandalism, which may be caused to the Contractor’s equipment while on Salisbury VAHCS premises.
b. Required Federal, State and local licenses.
c. Employee(s) Certifications/Registrations, Competency Check List and Training Certificates.
8. BILLING AND PAYMENT:
a. The contractor shall submit payment requests in electronic form via VA’s Electronic Presentment and Payment System: http://www.fsc.va.gov/einvoice.asp.
b. Invoices shall be submitted monthly for services rendered. The following information must be included all submitted invoices. Invoices submitted without the following information may be rejected for payment. Invoices shall include, at a minimum:
1. Date services performed
2. Contract number
3. Sample Number
4. Contractor's charge per sample
5. Valid purchase order number
c. Contractor shall provide scheduled services throughout the contract period. Other necessary personnel for the operation of the services contracted for services for the VA will be provided by the Contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.
d. No charge services: The Contractor shall not charge the Salisbury VAHCS if the quality of the testing performed is unacceptable as determined by Salisbury VAHCS personnel. Contractor shall be notified if the above should occur and monthly billing shall be adjusted accordingly. Nonconforming products or services will be rejected. Unless otherwise agreed by the parties, deficiencies shall be corrected within seven (7) days of the rejection notice. If the deficiencies cannot be corrected within seven (7) days, the Contractor shall immediately notify the COR and the Contracting Officer of the reason for the delay and provide a proposed corrective action plan within seven (7) working days.
9. CONTRACT ADMINISTRATION:
Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, the administration of the contact will require maximum coordination between the Government and the Contractor.
The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contacting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity, or quality of this contract.
The COR shall the responsible for the overall technical administration of this contract as outlined in the COR Delegation Authority.
The Government reserves the right to refuse acceptance of Contractor, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. The Contracting Officer and Contracting Officer's Technical Representative shall deal with issues raised concerning contract personnel's conduct. The final arbiter on questions of acceptability is the Contracting Officer.
If the Contractor is involved and named in a validated patient complaint the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.
Contractor rendering services is subject to professional or technical direction from the COR.
The Salisbury VAHCS shall provide the Contractor the name, title, and telephone number of the COR at the time of contract award.
Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.
The services to be performed by the contractor will be under the direction of the Chief, Pharmacy Service or his/her designee.
10. CONTRACT QUALITY MONITORS:
a. The following monitors will be implemented at the contract inception and be maintained indefinitely until it expires.
b. To ensure The Contractor remains compliant with the terms of this contract, Salisbury VAHCS Pharmacy will:
1. Review random samples at least quarterly to confirm that samples are incubated in timely manner in compliance with USP <797> standards and for completion of all required documentation related to sample receipt, storage, handling, and microbial evaluation.
| 2. Follow up on all complaints regarding issues with timeliness in processing and analysis submission. |
| 3. Review overall pass/fail rate of all personnel and environmental samples submitted. |
B.3 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 300.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Gloved Finger Sampling Contract Period: Base POP Begin: 02-17-2023 POP End: 02-16-2024 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H166 - Quality Control - Instruments and Laboratory Equipment
| 80.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Media Fill Test
POP Begin: 02-17-2023 POP End: 02-16-2024
| 400.00 |
| EA |
| __________________ |
| __________________ |
Surface sampling (dual incubation)
POP Begin: 02-17-2023 POP End: 02-16-2024
| 120.00 |
| EA |
| __________________ |
| __________________ |
Retest (media fill or fingertip)
POP Begin: 02-17-2023 POP End: 02-16-2024
| 80.00 |
| EA |
| __________________ |
| __________________ |
Retest (surface samples)
POP Begin: 02-17-2023 POP End: 02-16-2024
| 4.00 |
| EA |
| __________________ |
| __________________ |
Shipping Charge for USP 797 Supplies per Quarter as needed
POP Begin: 02-17-2023 POP End: 02-16-2024
| 300.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Gloved Finger Sampling Contract Period: Option 1 POP Begin: 02-17-2024 POP End: 02-16-2025
| 80.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Media Fill Test
POP Begin: 02-17-2024 POP End: 02-16-2025
| 475.00 |
| EA |
| __________________ |
| __________________ |
Surface sampling (dual incubation)
POP Begin: 02-17-2024 POP End: 02-16-2025
| 120.00 |
| EA |
| __________________ |
| __________________ |
Retest (media fill or fingertip)
POP Begin: 02-17-2024 POP End: 02-16-2025
| 80.00 |
| EA |
| __________________ |
| __________________ |
Retest (surface samples)
POP Begin: 02-17-2024 POP End: 02-16-2025
| 4.00 |
| EA |
| __________________ |
| __________________ |
Shipping Charge for USP 797 Supplies per Quarter as needed
POP Begin: 02-17-2024 POP End: 02-16-2025
| 300.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Gloved Finger Sampling Contract Period: Option 2 POP Begin: 02-17-2025 POP End: 02-16-2026
| 80.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Media Fill Test
POP Begin: 02-17-2025 POP End: 02-16-2026
| 475.00 |
| EA |
| __________________ |
| __________________ |
Surface sampling (dual incubation)
POP Begin: 02-17-2025 POP End: 02-16-2026
| 120.00 |
| EA |
| __________________ |
| __________________ |
Retest (media fill or fingertip)
POP Begin: 02-17-2025 POP End: 02-16-2026
| 80.00 |
| EA |
| __________________ |
| __________________ |
Retest (surface samples)
POP Begin: 02-17-2025 POP End: 02-16-2026
| 4.00 |
| EA |
| __________________ |
| __________________ |
Shipping Charge for USP 797 Supplies per Quarter as needed
POP Begin: 02-17-2025 POP End: 02-16-2026
| 300.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Gloved Finger Sampling Contract Period: Option 3 POP Begin: 02-17-2026 POP End: 02-16-2027
| 80.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Media Fill Test
POP Begin: 02-17-2026 POP End: 02-16-2027
| 475.00 |
| EA |
| __________________ |
| __________________ |
Surface sampling (dual incubation)
POP Begin: 02-17-2026 POP End: 02-16-2027
| 120.00 |
| EA |
| __________________ |
| __________________ |
Retest (media fill or fingertip)
POP Begin: 02-17-2026 POP End: 02-16-2027
| 80.00 |
| EA |
| __________________ |
| __________________ |
Retest (surface samples)
POP Begin: 02-17-2026 POP End: 02-16-2027
| 4.00 |
| EA |
| __________________ |
| __________________ |
Shipping Charge for USP 797 Supplies per Quarter as needed
POP Begin: 02-17-2026 POP End: 02-16-2027
| 300.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Gloved Finger Sampling Contract Period: Option 4 POP Begin: 02-17-2027 POP End: 02-16-2028
| 80.00 |
| EA |
| __________________ |
| __________________ |
USP 797 - Media Fill Test
POP Begin: 02-17-2027 POP End: 02-16-2028
| 475.00 |
| EA |
| __________________ |
| __________________ |
Surface sampling (dual incubation)
POP Begin: 02-17-2027 POP End: 02-16-2028
| 120.00 |
| EA |
| __________________ |
| __________________ |
Retest (media fill or fingertip)
POP Begin: 02-17-2027 POP End: 02-16-2028
| 80.00 |
| EA |
| __________________ |
| __________________ |
Retest (surface samples)
POP Begin: 02-17-2027 POP End: 02-16-2028
| 4.00 |
| EA |
| __________________ |
| __________________ |
Shipping Charge for USP 797 Supplies per Quarter as needed
POP Begin: 02-17-2027 POP End: 02-16-2028
| GRAND TOTAL |
| __________________ |
Page 1 of Page 1 of
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—
(1) Within a reasonable time after the defect was discovered or should have been discovered; and
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—
(i) Name and address of the Contractor;
(ii) Invoice date and number;
(iii) Contract number, line item number and, if applicable, the order number;
(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent;
(viii) Name, title, and phone number of person to notify in event of defective invoice; and
(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.
(i) Payment.—
(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—
(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);
(B) Affected contract number and delivery order number, if applicable;
(C) Affected line item or subline item, if applicable; and
(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—
(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;
(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or
(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:
(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—
(A) The date on which the designated office receives payment from the Contractor;
(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or
(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or
(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:
(1) The schedule of supplies/services.
(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) The clause at 52.212-5.
(4) Addenda to this solicitation or contract, including any license agreements for computer software.
(5) Solicitation provisions if this is a solicitation.
(6) Other paragraphs of this clause.
(7) The Standard Form 1449.
(8) Other documents, exhibits, and attachments
(9) The specification.
(t) [Reserved]
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:
(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.
(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
(End of Clause)
C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.
(End of Clause) C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)
(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.
[X] 852.203–70, Commercial Advertising.
[] 852.209–70, Organizational Conflicts of Interest.
[] 852.211–70, Equipment Operation and Maintenance Manuals.
[] 852.214–71, Restrictions on Alternate Item(s).
[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.] [] 852.214–73, Alternate Packaging and Packing.
[] 852.214–74, Marking of Bid Samples.
[] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.
[X] 852.215–71, Evaluation Factor Commitments.
[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.
[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.
[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.
[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.
[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.
[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.
[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.
[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.
[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.
[] 852.228–70, Bond Premium Adjustment.
[] 852.228–71, Indemnification and Insurance.
[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.
[X] 852.232–72, Electronic Submission of Payment Requests.
[] 852.233–70, Protest Content/Alternative Dispute Resolution.
[] 852.233–71, Alternate Protest Procedure.
[] 852.237–70, Indemnification and Medical Liability Insurance.
[] 852.246–71, Rejected Goods.
[] 852.246–72, Frozen Processed Foods.
[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.
[] 852.270–1, Representatives of Contracting Officers.
[] 852.271–72, Time Spent by Counselee in Counseling Process.
[] 852.271–73, Use and Publication of Counseling Results.
[] 852.271–74, Inspection.
[] 852.271–75, Extension of Contract Period.
[] 852.273–70, Late Offers.
[] 852.273–71, Alternative Negotiation Techniques.
[] 852.273–72, Alternative Evaluation.
[] 852.273–73, Evaluation—Health-Care Resources.
[] 852.273–74, Award without Exchanges.
(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:
[] 852.237–74, Nondiscrimination in Service Delivery.
(End of Clause) C.4 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)
(a) This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns.
(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement.
(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.
(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.
(End of Clause)
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?.## VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (NOV 2022)
(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) □ 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 852.219-73 or VOSBs as set forth in 852.219-74. 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 852.219-73 or VOSBs as set forth in 852.219-74. 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 852.219-73 or VOSBs as set forth in 852.219-74. 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…
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