Combined Synopsis and Solicitation - Biological Cabinet and Hood.docx
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- Biological Cabinet Hood Inspection
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- 36C24725Q0957
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This document is a Combined Synopsis and Solicitation for Biological Cabinet Hood Inspection services for the Department of Veterans Affairs (VA) in Augusta, Georgia. The solicitation (Number 36C24725Q0957) seeks a contractor to provide certification, testing, and repairs for Biological Safety Cabinets, Pharmacy & Chemical Fume Hoods at the Charlie Norwood VA Medical Center. The contract is structured as a base year with four option years, running from October 1, 2025, to September 31, 2030, with a total potential contract period of five years.
The procurement is set aside for Service-Disabled Veteran-Owned Small Businesses (SDVOSB) under NAICS code 532490, with a small business size standard of $40 million. The scope of work includes bi-annual testing of 15 biological safety cabinets, annual testing of 21 chemical fume hoods, bi-annual pharmacy testing, and additional services such as equipment decontamination and surface wipe sampling. Contractors must have technicians with specific certifications, including NSF-49 for biological safety cabinet testing and CETA Registered Cleanroom Professional certification for pharmacy testing. Quotes are due by September 26, 2025, at 1:00 PM Eastern Time, with all responses to be submitted via email to the contract specialist.
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36C24725Q0957
| SUBJECT* |
| Biological Cabinet Hood Inspection |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 30901 |
| SOLICITATION NUMBER* |
| 36C24725Q0957 |
| RESPONSE DATE/TIME/ZONE |
| 09-26-2025 1:00pm EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 30 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| SET-ASIDE |
| SDVOSBC |
| PRODUCT SERVICE CODE* |
| H266 |
| NAICS CODE* |
| 532490 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901
POINT OF CONTACT*
Contract Specialist Steven Timmons steven.timmons@va.gov
PLACE OF PERFORMANCE
ADDRESS
POSTAL CODE
COUNTRY
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.
This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-05/05-22-2024.
The associated North American Industrial Classification System (NAICS) code for this procurement is 532490 with a small business size standard of $40 Mil.
The Network Contracting Office 7 is seeking Biological Cabinet Hood Inspection at the Charlie Norwood VAMC in Augusta, GA 30904.
All questions regarding this RFQ must be in writing and may be sent by e‐mail to steven.timmons@va.gov. Questions must be received no later than September 23, 2025 at 1:00 PM ET. No further questions will be accepted after that date and time.
You are reminded that representatives from your company SHALL NOT contact any VA Medical Center employees to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to the Contracting Officer (CO).
This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-01. The associated North American Industrial Classification System (NAICS) code for this procurement is 532490– Other Commercial and Industrial Machinery and Equipment Rental and Leasing, with a small business size standard of $40M.
The Engineering-Safety Department at the Charlie Norwood VAMC, Augusta, GA. This requirement is for a base plus 4 option year contract for Biological Cabinet Hood Inspection.
All interested companies shall provide offer(s) for the base plus 4 option year period of performance in accordance with the attached Statement of Work NLT.9/26/2025 1:00PM. closing date.
All responses must be sent to Steven Timmons steven.timmons@va.gov email address.
Please sign and send back SF1449 along with Capability Statement.
Base Year: October 1, 2025 to September 30, 2026 1st Option Year: October 1, 2026 to September 31, 2027 2nd Option Year: October 1, 2027 to September 31, 2028 3rd Option Year: October 1, 2028 to September 31, 2029 4th Option Year: October 1, 2029 to September 31, 2030 Combined Synopsis/Solicitation Notice
| *= Required Field |
| Combined Synopsis/Solicitation Notice |
Combined Synopsis/Solicitation Notice
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
509-26-1-5295-0002
09-18-2025 Steven Timmons N/A 09-26-2025 1:00pm
EDT
Department of Veterans Affairs VISN 7 Network Contracting Activity 501 Greene Street
X
532490 $40 Million
N/A
Department of Veterans Affairs VISN 7 Network Contracting Activity 501 Greene Street
Augusta GA 30901
Department of Veterans Affairs VISN 7 Network Contracting Activity 501 Greene Street
FMS-VA-2 (101)
Financial Services Center P.O. Box 149971 Austin TX 78714-9971
See CONTINUATION Page Biological Cabinet Hood Inspection for the Charlie Norwood VAMC, 1 Freedom Way, Augusta, GA 30904.
See SOW & section B.2 for specific information.
See CONTINUATION Page
James E. Boles Jr
Page 1 of Table of Contents
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 8 |
| B.1 CONTRACT ADMINISTRATION DATA | 8 |
| STATEMENT OF WORK | 9 |
| This template has been developed to assist you in creating a Quality Assurance Surveillance Plan (QASP). The purpose of the QASP is to provide the Government and contractor with evaluation criteria that determines whether or not the performance standards for a specific contract have been met. | Error! Bookmark not defined. |
| This template should be TAILORED to meet your specific requirements. The performance standards included in this QASP should match the performance standards proposed in the “Performance Requirements Summary Matrix” in your PWS. | Error! Bookmark not defined. |
| B.2 PRICE/COST SCHEDULE ITEM INFORMATION | 28 |
| B.3 DELIVERY SCHEDULE | 29 |
| SECTION C - CONTRACT CLAUSES | 30 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023) | 30 |
| C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 35 |
| C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 36 |
| C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION) | 36 |
| C.5 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023) (DEVIATION) | 39 |
| C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 41 |
| C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 42 |
| C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 42 |
| C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025) | 43 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 52 |
| SECTION E - SOLICITATION PROVISIONS | 53 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) | 53 |
| E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) | 58 |
| E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023) | 61 |
| E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 62 |
| E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION FEB 2025) | 63 |
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 36C247
VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901
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] Invoice upon completion |
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 |
Page 1 of Page 1 of Page 1 of
STATEMENT OF WORK
VA Augusta Health Care System (VAAHCS) Augusta, Georgia Biological Safety Cabinets, Pharmacy & Chemical Fume Hoods (Testing & Certification)
1. General
1.1. Services:
The contractor shall provide certification, testing and as needed repairs for Bio Safety Cabinets, Pharmacy & Chemical Fume Hoods for both divisions of the Augusta VA Health Care System (VAAHCS). The testing and certification of all Biosafety cabinets is required bi-annually, Chemical Fume Hoods is required annually, and Pharmacy is required bi-annually. The VAAHCS is seeking services of contractors that can provide all labor, equipment, tools, material, supervision and other items and services necessary to perform the work as defined in this Statement of Work.
1.2 Place Performance: Service shall be performed at Charlie Norwood VA Health Care System and locations listed below.
a. 1 Freedom Way, Augusta GA 30904; Buildings 110
b. 950 15th St. Augusta, GA 30904; Building 801
1.3 Background: The Government requires certifications, testing and as needed repairs for Chemical Fume Hoods, Laminar Flow Hoods (LAFW) and Biological Safety Cabinets (BSC’s). The testing and certification of all hoods is required bi-annually, in support of the VA Augusta Health Care System. The certifications must meet ASHRAE 110
1.4 Acronyms and Definition
1.4.1.1. VAAHCS – VA Augusta Health Care System
1.4.1.2. VHA – Veteran Health Administration
1.4.1.5. SOW – Statement of Work
1.4.1.6. VA – Veterans Administration
1.4.2. Publications
1.4.2.1. VA Handbook 6500.6
1.4.2.2. VA Handbook 6500.2
Period of Performance: One Base Year and 4 Option Years:
| Base Year |
| 1 October 2025 – 30 September 2026 |
| Option 1 |
| 1 October 2026 – 30 September 2027 |
| Option 2 |
| 1 October 2027 – 30 September 2028 |
| Option 3 |
| 1 October 2028 – 30 September 2029 |
| Option 4 |
| 1 October 2029 – 30 September 2030 |
2. Hours of Operation
2.1. Business Hours
8:00am – 4:30pm, Monday – Friday, excluding Federal Holidays.
Federal Holidays
| New Year’s Day | January 1st | |||
| Martin Luther King’s Birthday | 3rd Monday in January | |||
| President’s Day | 3rd Monday in February | |||
| Memorial Day | Last Monday in May | |||
| Juneteenth | June 19th | |||
| Independence Day | July 4th | |||
| Labor Day | 1st Monday in September | |||
| Columbus Day | 2nd Monday in October | |||
| Veteran’s Day | November 11th | |||
| Thanksgiving Day | Last Thursday in November | |||
| Christmas Day | December 25th |
2.2. Work Schedule
The Contractor shall be available during normal business hours of 8:00am – 4:30pm, Monday – Friday, excluding Federal Holidays.
3. Contractors Responsibilities
3.1 The contractor shall perform bi-annual and annual testing & certification of all listed hoods, BSC’s, rooms and other items listed in the attached equipment list, to ensure equipment performance in accordance with the equipment’s intended purpose. This facility has 15 biological safety cabinets (BSCs) that require NSF 49 certification, 2 BSCs that require USP <797> & <800> certification, 2 laminar flow hoods that require USP<797> certification, 1 Anteroom that requires USP <797> & <800> certification, 1 Hazardous buffer room that requires USP <797> & <800> certification, 1 Non-hazardous buffer room that requires <797> certification, 1 Negative pressure hazardous storage room that requires USP <800> certification, 3 pass-thrus that requires USP <797> certification, 21 chemical fume hoods that require certification per ASHRAE 110, and 3 Grossing tables that require certification per manufacturers specification.
The contract shall include 3 BSC decontaminations using chlorine dioxide.
During the inspection, the contractor shall perform maintenance to correct any equipment malfunctions and assure that the equipment meets manufacturer's factory specifications if achievable. Any calibration procedures or adjustments necessary to assure accurate and reliable equipment operation will be performed at this time. Contractor shall maintain a sufficient stock of all parts meeting or exceeding the original manufacturer's design and specification needed for repair and maintenance of the equipment or be able to secure needed parts within one calendar day.
The Contractor shall furnish all labor, equipment, transportation, permits, testing and incidentals necessary for the performance of the work specified in this Statement of Work.
3.1.1 Contractor Qualifications
3.1.1.1 The VA Augusta Health Care Center is seeking a qualified contractor that meets the following specifications:
3.1.1.1.1 Certifications must be performed by a trained service representative/service technician. These service individuals must be trained on all equipment listed in the statement of work (SOW). Documentation shall be provided to the VA with the bid certifying that the service representative or service technicians have been trained and certified in the performance of this work by appropriate training courses/certifications etc. The certification technician(s) performing the testing of the BSCs must have an NSF-49 field certification. The technician(s) performing the testing of the pharmacy clean rooms and equipment must have passed the CETA CNBT exam and have a current CETA certification. A copy of these certifications must be included with the bid and the technicians holding the certification must be a full-time employee of the contractor submitting the bid. Sub-contracting the testing services is not allowed as this is the primary subject of the contract.
3.1.1.1.2 Certifications will be accomplished using laboratory calibrated equipment provided by the Certification contractor.
3.1.1.1.3 Contractor is required to have a Certified Industrial Hygienist (CIH) on staff to review and sign all reports submitted. CIH certification must be submitted with the bid as well as documentation showing that this is not subcontracted to an outside firm.
3.1.1.1.4 Contractor must submit at least 3 past performance summaries for projects of similar scope and size at VA facilities.
3.1.2 Testing & Certification shall be performed every 6 months.
3.1.2.1 Dates and times of service performance shall be coordinated with COR/POC.
3.1.2.2 The contractor will supply every unit that passes required certification specifications with a certification sticker with the following information:
3.1.2.1.1 BSC/LAFW/Grossing Tables: Company name and address, unit make, model and serial number, report number, location (room number), certification date, recertification date, and technician signature.
3.1.2.1.2 Fume Hood: Company name and address, certification date, recertification date, report number, average face velocity, sash height, and technician signature.
Any unit that does not pass required certification specifications will be marked as such with clear signage that states this unit is out of service until further notice.
3.1.3 Repairs shall be performed as needed, after confirmation with COR that funds are available, and services are approved to be performed.
3.1.3.1 All equipment shall be maintained in proper operating condition as specified by the Manufacturer. Vendor is to have proven access to original equipment manufacturers (OEM) parts, manuals, and schematics, which must be available on site to perform the services.
3.1.3.2 All parts shall be new and conform to the original manufacturer’s specifications. Vendor shall have access to all manufacturer parts and must provide within a reasonable timeframe when needed.
3.1.4 The certification technician(s) performing the testing of the BSCs must have an NSF-49 field certification. The technician(s) performing the testing of the pharmacy clean rooms and equipment must have passed the CETA CNBT exam and have a current CETA certification.
3.2 Chemical Fume Hood Testing
3.2.1 Testing shall be performed annually. The Contractor shall test the face velocity of each fume hood and establish the safe working height in accordance with the sections of ANSI/ASHRAE 110 (2016) which describe face velocity testing. The report shall include the size of the sampled grid used to obtain the overall average face velocity. Both individual grid readings shall be recorded as well as the overall average. A visible smoke test shall also be performed to ensure adequate draw of air into the hood and that no room air currents disrupt the flow of air into the hood or create cross drafts which could result in gases escaping out the face of the hood.
3.2.2 If the chemical fume hood has an airflow monitor or controller, the Contractor shall verify the performance of the monitor against a calibrated anemometer and document any discrepancies (i.e. outside of a +/-10% tolerance). The Contractor shall recalibrate the monitor if outside of tolerance. Additionally, the airflow alarm shall be tested and recalibrated if not alarming at the correct airflow.
3.3 Grossing Station Testing
3.3.1 These are exhaust units with no HEPA filtration in the system and shall be tested to the manufacturer’s specifications. Testing shall be performed annually and shall include inflow (FPM/CFM), smoke inflow, smoke clearance time, and inspection of installation and use. A visible smoke test shall also be performed to ensure adequate draw of air into the grossing station and that no room air currents disrupt the flow of air into the unit or create cross drafts which could result in gases escaping out of the work area.
3.4 Biological Safety Cabinets (BSC) Testing
3.4.1 The facility BSCs shall be certified bi-annually. Any testing performed on BSCs shall be performed by NSF 49 accredited technicians onsite and physically performing the testing. Copies of NSF 49 certifications must be provided with the bid documents. Certification shall be performed in accordance with NSF 49 (2018) and shall consist of the following:
| • | Down flow velocity test |
| • | Inflow velocity test |
| • | Airflow smoke pattern test |
| • | HEPA filter leak test |
| • | Alarm function test |
| • | Blower interlock test (Class II, type B cabinets) |
| • | Electrical leakage on the main cabinet (those that aren’t UL listed) |
| • | A visual inspection to identify defects, damage, misuse or missing parts |
| • | Documentation of the certification and inspection results |
| • | A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification (see NSF 49 for full decal requirements. |
| • | Rebalancing/adjusting of the BSC if testing indicates the airflows are out of tolerance. |
| • | Minor repair and adjustments to include adjustments of sashes, stuck switches, loose hinges, etc. All broken items will be covered by repair outside of the contract. |
· Posting an “Out of Service” sign on cabinets that fail certification.
• Notifying the cabinet user and the COR of cabinets that fail certification.
3.5 Laminar Airflow Workstations (LAFWs)
3.5.1 LAFWs shall be tested using the protocol described in IEST RP-CC002.3. The test report shall document the testing method used, the grid spacing, face velocity data, induction leak test and back streaming test, HEPA filter leak testing and any changes made to the system.
3.6 Pharmacy Testing
3.6.1 Compounding area certification: Pharmacy testing shall comply with USP <797> (2022), USP <800> (2019). The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification must be performed at least every 6 months and as needed depending on facility requirements or requests. Technicians conducting the testing must have a CETA Registered Cleanroom Professional certificate. The certified technician must be onsite performing the testing. The Contractor shall not send non-certified technicians and have ‘remote’ oversight with a certified technician. Copies of these certifications shall be provided with the bid documents.
Certification must include the following:
3.6.1.1 Airflow testing: The air changes per hour (ACPH) from the HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.
3.6.1.2 HEPA filter integrity testing: 13 HEPA filters (5 HD buffer, 6 ante, 2 non-HD buffer) and 3 Passthroughs with HEPA must be leak tested at the factory and then leak tested again after installation and as part of recertification. The report shall document the total airflow through the filter, the PAO concentration, the test method, any patches found, the size and location of any patches made in the field and the results of the leak test. The Contractor shall attempt to patch any leaks found using DOW 732, DOW 734 or equivalent patching product.
3.6.1.3 Total particle count testing: Must be performed under dynamic operating conditions using current, state-of-the-art electronic equipment. Air sampling sites must be selected in all classified areas. Measurements must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles in other classified areas shall not be taken underneath the ceiling HEPA filters.
3.6.1.4 Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to ensure it is properly placed into the facility and compounders understand how to utilize the unidirectional airflow to maintain first air in the DCA. Additional smoke tests will need to be performed in rooms without low air returns. A video of the smoke test must accompany the report. Any media files must be provided in DVD format to comply with VHA guidance for media. No .zip files, usb storage, flash drives, or downloadable files from vendor web sites.
3.6.1.5 Primary engineering control (PEC) certification (laminar flow hoods, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators, pass through chambers etc.). The PEC must be certified to meet ISO class 5 at 0.5 μm and larger particles during dynamic operating conditions. PEC certification must include all specifications as outlined per CETA application guides and pertinent USP chapters. This must be performed at least every 6 months and as needed depending on facility requirements. Refer to the sections covering the testing of LAFWs, CAIs and CACIs for requirements on physical testing.
3.6.1.6 Differential pressure certification: Must be performed at least every 6 months and as needed depending on facility requirements for ante rooms and buffer rooms. Cleanrooms used for non-hazardous compounding must be positive pressure relative to the adjacent spaces. USP chapter <797> requires a minimum pressure differential of 0.020” w.c. relative to adjacent spaces. Cleanrooms used for hazardous applications should be a -0.01 to -0.03” w.c. negative relative to adjacent spaces. The requirements for segregated compounding area (C-SCA) is between -0.01 to -0.03 W.C.
3.6.1.7 Viable Air Sampling: Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions at least every 6 months and as needed depending on facility requirements. At least 1 cubic meter or 1000 liters of air should be sampled at each designated location. The media should be examined, and the report should detail the total number of discrete colonies of microorganisms on each plate as CFU per cubic meter of air based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 1 for ISO Class 5, greater than 10 for ISO class 7, and greater than 100 for ISO class 8. If any container demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact as soon as the initial result is known, and final results will be expeditiously reported after further antimicrobial testing is complete. Samples shall be collected according to USP <797>.
3.6.1.8 Environmental wipe sampling for hazardous drug (HD) surface residue should be performed routinely as outlined by USP <800>. The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually (e.g. every 6 months), or more frequently as needed to verify containment. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs. The drugs required for testing include:
| • | Cyclophosphamide |
| • | Ifosfamide |
| • | Methotrexate |
· Fluorouracil
· Platinum-containing drugs
| • | Additional Drugs |
| * | Additional drugs may be requested based upon identified need per site. |
| * | Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing. |
3.6.1.9 Surface sampling will include the following areas with a total of 40 samples for the year:
| • | Interior of PEC and equipment contained in it. |
| • | Pass-through chambers |
| • | Surfaces in staging or work areas near PEC |
| • | Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area) |
| • | Areas immediately outside the hazardous drug buffer room or C-SCA |
| • | Patient administration areas |
Results will be report to the Chief, Pharmacy Service, or corresponding Pharmacy Service point of contact (COR, etc) as soon as results are available.
3.7 Repair(s) Services any/all to include Retest, Certify and Decontamination.
3.7.1 The Contractor shall be responsible for any repairs and subsequent certification of any equipment listed in this contract. When items are found to be damaged or not functioning properly, the contractor shall provide a proposal for repairs within 24 hours of the discovery of the damage. The proposal shall include:
| • | All costs associated with the decontamination of the unit (if required) |
| • | All labor for installation of the new part(s) |
· All labor for the recertification of the piece of equipment
• All parts. The contractor must provide the original parts quote from the manufacturer or distributor so that the government can verify that an unreasonable mark-up has not been added to the cost of parts.
3.7.2 Proposals must be broken out to provide details of the labor costs, parts costs, travel costs, etc. Proposals found with exaggerated labor hours or unreasonable parts mark-up will be rejected and could result in failure to award future option year contracts.
3.7.2.1 Contractor shall include OEM parts costing $30.00 at/or below as part of the company’s service repairs.
3.7.3 Upon approval of the proposal, the contractor shall work with the COR to schedule the repairs. Assuming replacement parts are not on back order, repairs are expected to be made within 2-5 business days of the authorization to proceed. All repairs to biological safety cabinets shall be performed by an NSF 49-certified technician. All other equipment repairs must be provided by a technician with a minimum of 1 year of experience working on such equipment. Contractor shall provide evidence of these requirements upon request by the government.
3.8 Identification/Parking
3.8.1 The contractor’s employee(s) shall always wear visible identification while on the premises of the VAAHCC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the Police and Security Section.
3.8.2 The Contractor, at his/her own expense, shall provide all employees with a Contractor Identification Card (ID), prior to performing work under this contract. Contractor employees are required to display this card at all times when performing under this contract. The Contractors employee shall sign each card issued. Employees released from service by the Contractor shall have their card collected by the Contractor. All cards shall contain an expiration date and photograph of the employee. All cards shall be destroyed upon contract completion or termination of the contract. The contractor's onsite supervisor shall ensure that all employees carry and display their card when on duty and are prepared to present them upon request. The Contracting Officer Representative (COR) shall periodically verify cards of contract employees match their personal identification.
3.8.3 Permits and Responsibilities: The Contractor shall obtain and maintain all permits, licenses, and appointments required for the execution of work under this contract at no additional cost to the Government. The Contractor shall obtain these permits, licenses, and appointments in compliance with applicable host country laws. In addition, contract termination shall result if the required documents are subsequently denied or withdrawn by the local authorities. Application, justification, fees, and certifications for any licensure required are entirely the responsibility of the Contractor. The Contractor shall ensure that all employees receive the mandatory training, if applicable to this contract, as required by OSHA, Joint Commission, etc., and shall comply with all standards and/or requirements.
3.8.4 Conduct of Personnel: The Contractor shall be responsible for the performance and conduct of its employees. Personnel employed by the Contractor in the performance of this SOW or any representative of the Contractor entering the VA premises shall be subject to inspections by the Government as deemed necessary. The Contractor shall not employ for performance under this SOW any person whose employment would result in a conflict of interest with the Government’s standards of conduct.
3.8.5 Personnel Removal: Government rules, regulations, laws, directives, and requirements that are issued during the Contract term relating to law and order, and security shall be applicable to all employees or representatives who enter the VA premises. Violation of such rules, regulations, laws, directives, or requirements shall be grounds for removal (permanently or temporarily as the Government determines) from the work site. Removal of employee does not relieve the Contractor from the responsibility for the work defined in this SOW.
3.8.5.1 The Contracting Officer or designated representative (COR) may require the Contractor to remove any employee performing requirements under this SOW for reasons of misconduct, safety, or security risk posed. Contractor employees shall be subject to immediate dismissal from the premises upon determination by the COR that such action(s) is in the best interest of the Government
3.8.6 Personnel Courtesy: Contractor employees shall not exhibit rude behavior. Loudness, vulgarity, rudeness, or other similar offensive conduct by an employee of the Contractor will be ground for denying the employee further access to the VA premises.
3.8.7 Alcohol and Illegal Drug Use: Contractor employees shall not consume alcohol or illegal drugs during working hours or at any other time the employees are performing work under this contract. The contractor shall not allow any employee to perform work if the employee is under the influence of alcohol or illegal drugs. Contractor employees found to be under the influence of alcohol or illegal drugs during working hours will be immediately removed from duty. For the purpose of this provision, the threshold for being under the influence of alcohol or illegal drugs is the same as that established by current laws for vehicle operations. The Contractor is responsible for establishing the method(s) by which employees will be determined to be under the influence of alcohol or illegal drugs.
3.8.8 Vehicle Conditions and Markings: All Contractor-owned vehicles shall be maintained in a neat, presentable, and operational condition as determined by the Contracting Officer or COR. Contractor vehicles shall be clearly marked so as to be distinguishable from Government Equipment. Markings shall include, but not limited to, the Contractor's name and telephone number on all equipment and vehicles used to carry out the requirements of the contract. Contractor vehicles will follow parking rules while on US government property and is subject to tow if illegally parked.
3.8.9 Insurance: The Contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employers Public Liability Insurance in accordance with laws of the State of Florida. Before commencing work under this contract, the contractor shall certify to the Contracting Officer in writing that the required insurance has been obtained. See FAR 52.228-5, Clauses Section. Contractor shall provide the CO with an original signed copy of Insurance Certification with appropriate coverage, no later than ten (10) calendar days after notice of award. The contractor will notify the VA immediately of any changes in insurance coverage. Failure to submit documentation regarding the above insurance requirement shall be grounds to terminate the contract for default.
4. Government Responsibilities
4.1.1. The Government will designate a Contracting Officers Representative (COR) who will furnish technical guidance and advice or generally monitor the work to be performed under this contract.
5. CONTRACT PERFORMANCE MONITORING
| Performance Indicators |
| PWS Ref |
| Performance Measure |
| Acceptable Level of Quality |
| Method of Assessment |
| Incentive |
| Dis-incentive |
All testing and certification were completed in February and August
Section 4.1.1 Performance requirements
| Delivered on time |
| 100% |
| Direct observation |
| Positive Past Performance |
| Negative Performance Report |
| All CFH’s certified annually |
| Section 4.2.1; Chemical fume hood testing |
| Delivered on time |
| 100% |
| Direct observation, 100% Inspection |
| Positive Past Performance |
| Negative Performance Report |
| All BSC’s certified bi-annually |
| Section 4.4.1 |
| Delivered on time |
| 100% |
| Direct observation, 100% Inspection |
| Positive Past Performance |
| Negative Performance Report |
| Pharmacy testing shall comply with USP <797> and USP <800> |
| Section 4.7.1; Pharmacy Testing |
| Technicians conducting the testing must have a CETA Registered Cleanroom Professional certificate |
| 100% |
| 100% Inspection |
| Positive Past Performance |
| Negative Performance Report |
6. Invoicing
6.1 INVOICES: Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer’s Representative (COR), and submitted electronically through OB-10.
https://portal.tungsten-network.com/
A properly prepared invoice will contain:
· Invoice Number and Date
· Contractor’s Name and Address
· Accurate Purchase Order Number
· Supply or Service provided
· Total amount due
7. Special Contract Requirements PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A- INFORMATION SECURITY AND PRIVACY CHECKLIST:
· “The C&A requirements do not apply, and a Security Accreditation Package is not required.”
· Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the vendor
· There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services.
Minimum Statutory Requirements Prohibition on unauthorized disclosure: Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). See VA Handbook 6500.6, Appendix C, paragraph 3.a.
Requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. The term ‘security incident’ means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a Requirement to pay liquidated damages in the event of a data breach: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text
(6) Amount of time the data has been out of VA control
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons)
(8) Known misuses of data containing sensitive personal information if any
(9) Assessment of the potential harm to the affected individuals
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports
(3) Data breach analysis
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs (see VA handbook 6500.6, appendix c, paragraph 7.a, 7.d)
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
QUANTITY
| 001 |
| Test and certify Biological Safety Cabinets |
(January/February)
| 002 |
| Test and certify Biological Safety Cabinets |
(July/August)
| 003 |
| Test and certify canopy/ custom fume hoods (July/August) |
| 4 |
| 004 |
| Test and certify chemical fume hoods (July/August) |
| 21 |
| 005 | |
| Test and certify Pathology workstation/Grossing Stations (July/August) | |
| 3 |
| 006 |
| Test and certify biosafety safety cabinets to include USP <797> & <800> (January/February) |
| 2 |
| 007 |
| Test and certify biosafety safety cabinets to include USP<797> & <800> (July/August) |
| 2 |
| 008 |
| Test and certify slot hoods (July/August) |
| 2 |
| 009 |
| Test and certify Laminar flow hoods that require USP <797> & <800> (January/February) |
| 2 |
| 010 |
| Test and certify Laminar flow hoods that require USP <797> & <800> (July/August) |
| 2 |
| 011 |
| Anteroom that requires USP <797> & <800> certification- 6 HEPA’s (January/February) |
| 1 |
| 012 |
| Anteroom that requires USP <797> & <800> certification- 6 HEPA’s (July/August) |
| 1 |
| 013 |
| Hazardous buffer room that requires USP <797> & <800> certification- 5 HEPA’s (January/February) |
| 1 |
| 014 |
| Hazardous buffer room that requires USP <797> & <800> certification- 5 HEPA’s (July/August) |
| 1 |
| 015 |
| Non-hazardous buffer room that requires <797> certification- 2 HEPA’s (January/February) |
| 1 |
| 016 |
| Non-hazardous buffer room that requires <797> certification- 2 HEPA’s (July/August) |
| 1 |
| 017 |
| Negative pressure hazardous storage room that requires USP <800> certification (January/February) |
| 1 |
| 018 |
| Negative pressure hazardous storage room that requires USP <800> certification (July/August) |
| 1 |
| 019 |
| Pass-thrus that requires USP <797> & < 800> certification (January/February) |
| 3 |
| 020 |
| Pass-thrus that requires USP <797> & < 800> certification (July/August) |
| 3 |
| 021 |
| Three (3) addition site visits for unscheduled recertification, troubleshooting/repair labor hours or maintenance. |
| 3 |
| 022 |
| Three (3) BSC decontaminations for any repairs or maintenance |
| 3 |
| 023 |
| Hazardous Surface Wipe Sampling (January/February) |
| 20 |
| 024 |
| Hazardous Surface Wipe Sampling (July/August) |
| 20 |
QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)
("FOR INFORMATIONAL PURPOSES ONLY")
Contract Number: Upon award, Government will enter contract number
Contract Description:
Contractor’s name: <Upon award, Government will enter name.>
1. PURPOSE
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:
· What will be monitored.
· How monitoring will take place.
· Who will conduct the monitoring.
· How monitoring efforts and results will be documented.
This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.
This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.
*Note. The QASP is not a part of the contract. Its sole use is to monitor contractor performance.
2. GOVERNMENT ROLES AND RESPONSIBILITIES
The following personnel shall oversee and coordinate surveillance activities.
a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.
Assigned CO: <Upon award, Government will enter name.> Organization or Agency:
b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.
Assigned COR: Upon award, Government will enter name Nicole Reynolds x6045
c. Other Key Government Personnel - Upon award, Government will enter name, if applicable. This may include Performance Monitors, Clinical Quality experts, etc. who act on behalf of the COR to monitor performance
3. CONTRACTOR REPRESENTATIVES
The following employees of the contractor serve as the contractor’s program manager for this contract.
a. Program Manager – Enter name(s) of the providers.
b. Other Contractor Personnel - Enter name(s) of the providers.
4. PERFORMANCE MEASURES
Performance measures are comprised of performance indicators (some characteristic of a deliverable that can be measured) and performance measures (a mark, measure or benchmark that government personnel use as a point of comparison when evaluating contractor performance). The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these measures.
The Performance Requirements Summary Matrix, paragraph <enter number> in the Performance Work Statement (PWS), includes performance measures. The Government shall use these measures to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).
| Performance Indicators |
| PWS Ref |
| Performance Measure |
| Acceptable Level of Quality |
| Method of Assessment |
| Incentive |
| Dis-incentive |
All testing and certification were completed in February and August
Section 4.1.1 Performance requirements
| Delivered on time |
| 100% |
| Direct observation |
| Positive Past Performance |
| Negative Performance Report |
| All CFH’s certified annually |
| Section 4.2.1; Chemical fume hood testing |
| Delivered on time |
| 100% |
| Direct observation, 100% Inspection |
| Positive Past Performance |
| Negative Performance Report |
| All BSC’s certified bi-annually |
| Section 4.4.1 |
| Delivered on time |
| 100% |
| Direct observation, 100% Inspection |
| Positive Past Performance |
| Negative Performance Report |
| Pharmacy testing shall comply with USP <797> and USP <800> |
| Section 4.7.1; Pharmacy Testing |
| Technicians conducting the testing must have a CETA Registered Cleanroom Professional certificate |
| 100% |
| 100% Inspection |
| Positive Past Performance |
| Negative Performance Report |
5. INCENTIVES AND DISINCENTIVES
There are no incentives or disincentives. The Government shall use the scoring methods above for continuing contract performance.
6. METHODS OF QUALITY ASSURANCE SURVEILLANCE
Various methods exist to monitor performance. The COR may use any surveillance methods listed below in the administration of this QASP.
a. DIRECT OBSERVATION: The COR can perform periodically or through 100% surveillance.
b. PERIODIC INSPECTION. The COR evaluates outcomes on a periodic basis. Inspections may be scheduled daily, weekly, monthly, quarterly, or annually or use unscheduled inspections.
c. USER SURVEY: This method combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. The COR may also generate inspections and sampling.
d. VALIDATED USER/CUSTOMER COMPLAINTS. This method relies on the patient to identify deficiencies. Complaints are then investigated and validated.
e.100% INSPECTION. The COR may evaluate all outcomes.
f. RANDOM SAMPLING. This is designed to evaluate performance by randomly selecting and inspecting a sample of cases.
g. Progress reports or status meetings. The COR will analyze contractor's progress reports. (Evaluate cost, schedule, etc.)
7. RATINGS
Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral or negative outcome. The following ratings shall be used: 100% is positive, 95% is neutral, and 90% is negative.
8. DOCUMENTING PERFORMANCE
a. ACCEPTABLE PERFORMANCE (100% RATING)
The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.
b. UNACCEPTABLE PERFORMANCE (90% RATING)
When unacceptable performance occurs, the COR shall inform the contractor.
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