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36C24923Q0010
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
621-23-1-168-0004 36C24923Q0010 10-12-2022 L. Kyle Love 615-225-6456 10-20-2022
08:00 AM
EDT
90C Department of Veterans Affairs Network Contracting Office 9 (90C) 1639 Medical Center Parkway Suite 400 Murfreesboro
TN
37129 X X Y 541990 $17.0 Million N/A X Department of Veterans Affairs James H. Quillen VA Medical Center 809 Lamont St & Veterans Way Pharmacy Service (119) Mountain Home
TN
37684 90C Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 400 Murfreesboro
TN
37129
90C FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically
Setup 1-877-489-6135 See CONTINUATION Page James H. Quillen VA Medical Center is requesting a vendor to perform on-site full-service testing and certification for the operation and performance of their sterile compounding room equipment, systems, and personnel. The prospective contractor shall provide certification of primary, secondary engineering controls, and testing of compounding personnel.
The facility testing must meet United States Pharmacopeia standards & competencies for sterile compounded preparations The Period of Performance is 11/01/2022 to 10/31/2023.
Questions regarding this RFQ must be in writing, via email (only). Send all questions NLT 10-17-2022 at 15:00 (EST) to L. Kyle Love, Email: loren.love@va.gov No further questions will be accepted after that time.
Quotes shall be submitted NLT 10-20-2022 at 08:00 (EST).
Wage determination 2015-4641 Rev 18 dated 8/26/2022 will be in effect for the contract. (Washington County, TN) See CONTINUATION Page 621-3630160-168-822400-2580 010022400 X x Lori L. Ellis 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 |
| STATEMENT OF WORK (SOW) | 4 |
| A - GENERAL INFORMATION | 4 |
| B – WORK REQUIREMENTS | 4 |
| D – SPECIAL CONSIDERATIONS: | 13 |
| B.2 PRICE/COST SCHEDULE | 15 |
| ITEM INFORMATION | 15 |
| SECTION C - CONTRACT CLAUSES | 17 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) | 17 |
| C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 23 |
| C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) | 23 |
| C.4 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018) | 25 |
| C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018) | 25 |
| C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 26 |
| 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) | 26 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 35 |
| SECTION E - SOLICITATION PROVISIONS | 36 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) | 36 |
| E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) | 40 |
| E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 43 |
| E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) | 43 |
| E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION) | 44 |
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 36C249 Department of Veterans Affairs Network Contracting Office 9 (90C) 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129
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 |
| [X] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [X] Monthly |
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 |
STATEMENT OF WORK (SOW)
A - GENERAL INFORMATION
A.1 INTRODUCTION – 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. The USP establishes standards for sterile compounding room design, environmental monitoring, and competencies for the preparation, handling, and storage of compounded sterile products (CSPs).
To meet regulatory requirements in accordance with USP <797> and USP <800>, the James H. Quillen VA Medical Center (JHQVAMC) requires certification of primary engineering controls (PECs), secondary engineering controls (SECs), and testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling, and media fill testing.
A.2 SCOPE OF WORK – The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed below. The effort on this project shall be a one-year contract base to properly support the hospital staff at James H. Quillen VA Medical Center. The Period of Performance shall be 11/01/2022 to 10/31/2023
B – WORK REQUIREMENTS
B.1 TASKS TO BE ACCOMPLISHED:
a. All work must be conducted, coordinated, and scheduled based on the needs of the Pharmacy Service. The testing of the Sterile Compounding Suites and equipment must be conducted during dynamic operating conditions to assure smooth even flow across the DCA and out to the returns. In the presence of the Medication Safety Program Manager.
b. The Contractor may be notified at a minimum of 2 business days to a maximum of 5 business days and must respond and be available on site to perform testing/retesting within the specified time frame.
c. The Contractor will provide a Qualified Tester and appropriate tools/test equipment to complete the work as covered in Section C.3.
d. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will maintain a clean work area at all times by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with 70% sterile isopropyl alcohol.
e. The Contractor will test each PEC and SEC according to Certification Guide for Sterile Compounding Facilities (CETA) and USP <797> regulations every six months.
f. The Contractor will provide JHQVAMC with the original certification documents that includes all measurements and results of each PEC and SEC. Certification should include identifying information of each PEC and SEC as well as all test equipment used for certification. See Section B for specific requirements.
g. The Contractor will immediately notify identified points of contact (POC) with any results indicating failure.
h. A formalized written report including all required aspects specified in this statement of work will be provided in a timely manner by email with receipt by identified POC no more than 10 business days from certification evaluation.
i. Any failure of engineering controls to meet required specifications shall be clearly marked with a sign that will notify pharmacy staff.
B.2 PRIMARY ENGINEERING CONTROLS (PECs) TO CERTIFY
a. PEC tested and certified according to CETA and IEST guidelines, and to manufacturer’s specifications.
b. Within DCA with a NIST traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POC.
c. The Contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration ready of the HEPA filter leak test and the results of the induction leak test and backstreaming test.
d. The Contractor will provide and label with a certification sticker that contains the following: company name, phone number, PEC model and serial number, service number, certification date, recertification date, certifiers signature.
e. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each PEC during testing.
f. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.
g. Viable Surface Sampling reports to indicate site locations, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.
h. Documentation of the smoke study results shall include the number of personnel present in the PEC during the dynamic airflow smoke pattern test.
| Line Item |
| Description |
| Qty |
| Frequency per Year |
| Qty per Year |
| 1 |
| Restricted Access Barrier- Nu-Aire CAI IV Hood ISO Class 5, Building 77 Room FA126A |
| 1 |
| 2 |
| 2 |
| 2 |
| 8’ BVBI-8SSRX Laminar Vertical Flow Workstation ISO Class 5, Building 77 Room FA126A |
| 1 |
| 2 |
| 2 |
| 3 |
| 6’ BBF-6SS Biological Safety Cabinet Class II Type A ISO Class 5, Building 77 Room J140A |
| 1 |
| 2 |
| 2 |
B.2A SERVICES TO BE PERFORMED FOR PECs
| Line Item |
| Description |
| Qty |
| Frequency per Year |
| Qty per Year |
| 1 |
| Total particle count testing under dynamic operating conditions using calibrated electronic equipment for each of the listed PECs. |
| 7 or more |
| 2 |
| varies |
| 2 |
| Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples) |
| 8 or more |
| 2 |
| varies |
| 3 |
| Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) |
| 12 or more |
| 2 |
| varies |
| 4 |
| Both static and dynamic smoke studies verifying a continuous flow of HEPA filtered air void of turbulence, dead air zones, and refluxing from the HEPA filters to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s). Contractor to leave video of smoke test on site prior to completion of certification process for each of the listed PECs. |
| 3 |
| 2 |
| 2 |
| 5 |
| HEPA filter leak test |
| 3 |
| 2 |
| 6 |
| 6 |
| Cabinet leak test |
| 3 |
| 2 |
| 6 |
| 7 |
| Inflow velocity test to include exhaust airflow volume rate |
| 3 |
| 2 |
| 6 |
| 8 |
| Electrical leakage and ground circuit resistance and polarity tests |
| 3 |
| 2 |
| 6 |
| 9 |
| Lighting intensity test |
| 3 |
| 2 |
| 6 |
| 10 |
| Vibration test |
| 3 |
| 2 |
| 6 |
| 11 |
| Noise level test |
| 3 |
| 2 |
| 6 |
| 12 |
| Ultraviolet (UV) lamp test |
| 3 |
| 2 |
| 6 |
| 13 |
| Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate. |
| 2 |
| 2 |
| 6 |
| 14 |
| Hazardous drug contamination to include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested. |
| 4 |
| 2 |
| 8 |
B.3 SECONDARY ENGINEERING CONTROLS (SECs) TO CERTIFY
a. The Contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room.
b. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report.
c. The report provided will specify flow rates detailing returns and supply that were obtained during the testing.
d. The contractor shall calculate air changes per hours (ACPH) from HVAC, ACPH contributed from the PEC, and the total ACPH for each buffer, ante room, and storage room shall be documented on the certification report.
e. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each SEC during testing.
f. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.
g. Viable Surface Sampling reports to indicate site locations, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU’s with locations, identification of CFU’s, date & time of sample results.
h. Hazardous drug contamination sampling report to include manufacturer, lot #, and expiration date of sampling kit, sample site locations, name of products tested for, and results.
| Line Item |
| Description |
| Qty |
| Frequency per Year (minimum) |
| Qty per Year (minimum) |
| 1 |
| Non-Hazardous IV Anteroom Certification ISO Class 8, Building 77 Room FA126 |
| 1 |
| 2 |
| 2 |
| 2 |
| Non-Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room FA126A |
| 1 |
| 2 |
| 2 |
| 3 |
| Hazardous IV Anteroom Certification ISO Class 7, Building 77 Room J140 |
| 1 |
| 2 |
| 2 |
| 4 |
| Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room J140A |
| 1 |
| 2 |
| 2 |
| 5 |
| Hazardous Drug Storage Room Building 77 Room J139 |
| 1 |
| 2 |
| 2 |
B.3A SERVICES TO BE PERFORMED FOR SECS
| Line Item |
| Description |
| Qty |
| Frequency per Year (minimum) |
| Qty per Year (minimum) |
| 1 |
| Total particle count testing under dynamic operating conditions using calibrated electronic equipment, for the SECs |
| 7 or more |
| 2 |
| varies |
| 2 |
| Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples) |
| 8 or more |
| 2 |
| varies |
| 3 |
| Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) |
| 12 or more |
| 2 |
| varies |
| 4 |
| HEPA filter integrity testing |
| 7 |
| 2 |
| 14 |
| 5 |
| Airflow profiling and uniformity testing |
| for listed SECs |
| 2 |
| 2 |
| 6 |
| Particulate monitoring |
| For listed SECs |
| 2 |
| 2 |
| 7 |
| Room pressurization monitoring |
| For listed SECs |
| 2 |
| 2 |
| 8 |
| Temperature and Humidity monitoring |
| For listed SECs |
| 2 |
| 2 |
| 9 |
| Air pattern analysis |
| For listed SECs |
| 2 |
| 2 |
| 10 |
| Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms. |
| For listed SECs |
| 2 |
| 2 |
| 11 |
| Hazardous drug sampling to include: |
cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested.
| 4 |
| 2 |
| 8 |
C – SUPPLEMENTAL TESTING
1. Media Fill Testing will occur in Laminar Vertical Flow Workstation in Building 77 Room FA126A and simulate 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.
2. A certificate of analysis (COA) must be provided if commercial sterile microbial growth media is used for the media fill testing.
3. Media Fill Testing will occur prior to gloved fingertip and thumb testing for recertification.
4. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP <797> guidance (and <800>).
5. Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.
6. The Contractor shall perform three separate gloved fingertip and thumb tests during initial testing (one sampling device per hand) for each designated employee. Subsequent sampling shall occur every 6 months.
7. Gloved fingertip and thumb samples shall be performed in controlled temperature environments and incubated in accordance with USP <797> and <800> guidance.
8. Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling.
9. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the number of colony forming units (CFU) for the left and right hand.
| Line Item |
| Description |
| Qty |
| Frequency per Year |
| Qty per Year (minimum) |
| 1 |
| Media Fill Testing |
| 25 or more |
| varies |
| 50 |
| 2 |
| Gloved Fingertip and thumb testing |
| 25 or more |
| varies |
| 50 |
D – SPECIAL CONSIDERATIONS:
D.1 Place of Performance: James H. Quillen VA Medical Center, 809 Lamont and Veterans Way, Johnson City, Tennessee 37601. Contractor shall perform services between the hours of 7:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The recognized Federal Government holidays are as follows: New Year’s Day, Dr. Martin Luther King’s Birthday, Washington’s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day.
D.2 Contractor Furnished Materials: All labor, materials, equipment to perform the job. When “furnish”, “provide”, “install”, or similar term is used it shall mean a complete installation, ready for use. The Contractor shall supply all parts that is currently not covered under warranty, equipment, material and labor to conduct work as listed in the Statement of Work above. The work will include all items as described in the Scope of Work listed above.
D.3 Government Furnished Materials and Services: Government furnished property, if any, will be identified and will only be used for the performance of this contract unless otherwise authorized by the Contracting Officer. The Contractor shall, at all times, take any and all steps necessary for maintenance and preservation of all Government-furnished property. The Contractor shall comply with all reasonable requests of the Contracting Officer to enclose, or specifically protect, Government-furnished property.
D.4 Qualifications of Key Personnel: The Contractor will provide three references for showing the completion of at least three jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center, in addition will also provide three references for each Qualified Tester that performs work at JHQVAMC. The Contractor’s Qualified Tester must possess current CETA, NSF and CNBT Certification for Sterile Compounding Facilities. The Contractor will provide copies of the Qualified Tester’s accreditation prior to conducting certification.
D.5 Other Requirements: The Contract will provide sample reports of prior certification reports from other contracted Sterile Compounding Suites certifications include Primary and Secondary Engineering Controls. The sample reports should include the calibration reports of equipment used to certify the Sterile Compounding Suites.
D.6 Security Requirements: Contractor shall identify which employees will be working under the awarded contract. Contractor personnel shall include employees, sub-contractors, subcontractor employees, suppliers and delivery personnel entering the Medical Center. This does not apply to suppliers and delivery personnel making deliveries to the VA warehouse dock only. Those employees shall bring photo ID to obtain a VA Contractor identification badge that shall be worn above the belt at all times while on Medical Center property. Contractor’s employees shall return all I.D. badges to designated personnel at time designated in the task order.
D.7 Inspection of Work:
a. The COR is responsible for the inspection of the work called for in this job. The Contracting Officer’s Representative will be identified in the task order by name, telephone number and location. Inspections made by the COR are for the sole benefit of the Government and do not relieve the Contractor of any quality control responsibilities.
b. The Contractor will be notified by the Contractee of any updates to identified points of contact list on an as needed basis and in turn the Contractor will provide the Contractee with any updates.
D.8 Safety: The Safety Manger is responsible for safety inspections of all contract operations. The Safety Manager will be identified in the task order by name, phone number and location.
D.9 Drawings General: Contract drawings (if applicable) will indicate the extent and location of work. If any departure from the contract drawings are deemed necessary by the Contractor, the details of such departure and the reasons therefore shall be submitted to the Contracting Officer for approval as soon as practical. No such departure shall be made without proper written permission of the Contracting Officer. The Contractor is responsible for all information and requirements in drawings and specifications that pertain to the task order.
D.10 Verification of Dimensions: The Contractor shall visit the job site to thoroughly familiarize themselves with all the details of the work and working conditions. The Contractor shall also verify all dimensions in the field and shall advise the Contracting Officer of any discrepancy before performing any work. The Contractor shall be specifically responsible for the coordination and proper relation of their work to the building, structure, phasing and ensure the safety of employees and workmen.
D.11 Smoking Policy: The Contractor shall ensure employees do no smoke on the VA grounds as JHQVAMC is a smoke-free facility.
D.12 Parking/Traffic Regulations: The Contractor shall not park on grassy areas unless approved by the COR and the Contractor agrees to restore areas back to VA standards. Drivers should be particularly concerned with pedestrian traffic. Yield to pedestrians in crosswalks. Posted speed limits and all other traffic controls are to be observed by operators at all times. Seat belt use is mandatory on the VA grounds.
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 2.00 |
| JB |
| __________________ |
| __________________ |
Cleanroom certifications for two (2) ISO classified Anterooms, one (1) Non-Hazardous IV Buffer Room, one (1) Hazardous Drug Buffer Room, and airflow and room pressurization testing for one (1) non-classified hazardous drug storage room.
Contract Period: Base POP Begin: 11-01-2022 POP End: 10-31-2023 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services PRODUCT/SERVICE CODE: R428 - Support - Professional: Industrial Hygienics
| 2.00 |
| JB |
| __________________ |
| __________________ |
Hazardous Drug Wipe Testing
POP Begin: 11-01-2022 POP End: 10-31-2023
| 1.00 |
| JB |
| __________________ |
| __________________ |
Personell Testing
POP Begin: 11-01-2022 POP End: 10-31-2023
| 1.00 |
| JB |
| __________________ |
| __________________ |
Repairs
POP Begin: 11-01-2022 POP End: 10-31-2023
| 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) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/
(End of Clause)
| FAR Number |
| Title |
| Date |
| 52.204-13 |
| SYSTEM FOR AWARD MANAGEMENT MAINTENANCE |
| OCT 2018 |
| 52.204-18 |
| COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE |
| AUG 2020 |
| 52.232-40 |
| PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS |
| NOV 2021 |
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.
[X] 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.
[X] 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 .
(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) C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)
(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.
(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract 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 compliance with the subcontracting commitments.
(End of Clause)
C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)
The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.
(End of Clause) (End of Addendum to 52.212-4)
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)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or…
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