36C25625Q0677_1.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

A.1 COMBINED SYNOPSIS/SOLICITATION

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, in conjunction with FAR Part 13, Simplified Acquisition Procedures for Certain Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

2. The combined synopsis/solicitation number is 36C25625Q0677. It is issued as a Request for Quote. The Government anticipates awarding one firm-fixed price purchase order resulting from this solicitation.

3. Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2025-03 (eff. 01/17/2025)

4. This requirement is Total Small Business Set Aside. The North American Industry Classification System number is 541990 with a size standard of $19.5 Mil.

5. Place of Performance:

Alexandria VA Medical Center 2495 Shreveport Hwy 71 North, Pineville, LA, 71360

6. Delivery Schedule/Installation: All services shall be performed and completed no less than 30 days and no more than 60 calendars days from the date of award.

7. All questions regarding this solicitation shall be submitted via email to the Contract Specialist, Rhonda Gibson at Rhonda.gibson2@va.gov no later than 10:00A.M. Central Time on 16 April 2025.

8. Quotes are due no later than 18 Apr 2025 at 10:00A.M. Central Time and shall be submitted electronically via e-mail to the Contract Specialist, Rhonda Gibson at rhonda.gibson2@va.gov

APPLICABLE Provisions and Clauses:

The provision at 52.212-1 Introduction to Offerors – Commercial, applies to this acquisition.

The provision at 52.212-2 EVALUATION – COMMERCIAL ITEMS (JAN 1999) applies to this acquisition.

All offers shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications –Commercial Items.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition and all additional FAR clauses cited in the clause are applicable to the acquisition.

Addendum to FAR 52.212-4 Show FAR clauses followed by VAAR clauses in numeric order.

Solicitation contains a list of all clauses incorporated by reference in numeric order under 52.252-2 (see below), starting first with FAR and followed by VAAR.

Table of Contents

A.1 COMBINED SYNOPSIS/SOLICITATION ……………………………………….……

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 36C256 Peter Wren Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.4 PERFORMANCE WORK STATEMENT (PWS)

PERFORMANCE WORK STATEMENT (PWS)

FOR

ALEXANDRIA VA HEALTH CARE SYSTEM

IV Room (SCA) Certification Semi Annual Service

Environmental Monitoring Certifications for Alexandria VAHCS

1.0. Description of Service

1.1. This is a non-personnel services contract to provide environmental testing and certification of all primary engineering controls (PECs) and secondary engineering controls (SECs) used for the preparation of compounded sterile preparations (CSPs) and hazardous drugs (HDs) for Alexandria VAHCS (AVAHCS). This contract will be for a Base Year plus Four 1-year Option Periods for Workbench 1-310A Segregated Compounding Area Laminar Airflow, Workbench 2 -264 - Contingency IV Room Laminar Airflow and 308B Chemo Storage Closet. The AVAHCS has two non-hazardous sterile drug compounding areas with primary engineering controls (PECs). The PECs include laminar airflow workbenches (LAFW) for all non-hazardous sterile drug compounding. The AVAHCS has a Chemotherapy Storage Closet that stores hazardous medications. The testing and certification shall be performed in accordance with USP <797>, USP <800>, CETA and FDA guidelines.

Floor Plan

2.0. Basic Service

2.1. The Contractor shall provide all labor, equipment, tools, materials, sampling supplies, replacement parts, transportation, and travel necessary to perform all inspections, testing, certifications as required throughout the contract period, supervision and other items and services necessary to perform the work as defined in this Performance Work Statement.

2.2. The Contractor shall be certified Controlled Environmental Testing Association (CETA-CAG) and comply with all USP, FDA and CETA standards.

2.3. Contractor shall perform routine work detailed in this Performance Work Statement (PWS) on a regular schedule mutually agreed upon by the Contractor and Contracting Officer Representative (COR), or designee.

2.4. The number and type of Primary Engineering Control (PEC) may change throughout the contract period. The number and types of devices are the Governments best estimate of the number and type expected to be serviced by the contract. The Government reserves the right to delete or add units as required. Table A provides the best estimate of the number and type of control expected to be tested, sampled, serviced, and certified by the contractor.

2.5. If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this PWS, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this PWS. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO.

3.0. Applicable Documents

3.1. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

3.1.1. United States Pharmacopeia (USP) at http://www.usp.org/

3.1.2. Controlled Environmental Testing Association (CETA) at https://www.cetainternational.org/

3.1.3. U.S. Food and Drug Administration (FDA) at https://www.fda.gov/

4.0. Performance Requirements

4.1. The vendor shall refer to the most current versions of standards including but not limited to USP, FDA and CETA when conducting the requested monitoring and reporting. The frequencies of testing and specific procedure should be determined by the most updated version of CETA, USP <797> and <800>, and per specific facility requirements and/or requests. The vendor shall be responsible for complying with the most updated versions of this guidance and will conduct all sampling per the procedures outlined within the official chapters.

4.1.1. Compounding area certification: The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification shall be performed at least every 6 months and as needed depending on facility requirements or requests, plan for up to two additional certifications a year. Certification shall include but is not limited to the following:

4.1.1.1. Airflow testing: The air changes per hour (ACPH) from the HVAC, ACPH contributed from the PEC, and the total ACPH shall be documented on the certification report.

4.1.1.2. HEPA filter integrity testing: HEPA filters shall be leak tested at the factory and then leak tested again after installation and as part of recertification.

4.1.1.3. 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 shall be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles should be taken at representative locations that reflect the quality of air in the room(s).

4.1.1.4. Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). 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 USB format to comply with VHA guidance for media. No .zip files or downloadable files from vendor web sites.

4.1.1.5. 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.

4.1.1.6. 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 minimum 0.010” w.c. negative relative to adjacent spaces.

4.1.2. 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, the Associate Chief, Pharmacy Operations and Compounded Sterile Products Program Manager as soon as the initial result is known, and final results will be expeditiously reported after further antimicrobial testing is complete.

4.1.3. Viable Surface Monitoring: Each classified area including the interior of the PEC (including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass through chambers must be sampled at least every 6 months. Sampling should be performed at the end of the compounding activities, but before the area has been cleaned and disinfected. The media should be examined, and the report should detail the total number of discrete colonies of microorganisms on each device as CFU per sample 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 3 for ISO Class 5, greater than 5 for ISO class 7, and greater than 50 for ISO class 8. If any device demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service, Associate Chief, Pharmacy Operations, and Compounded Sterile Products Program Manager as soon as the initial result is known, and final results will be expeditiously reported after further antimicrobial testing is complete.

4.1.4. The contracting officer representative or designee will schedule testing with the vendor. The vendor shall provide the corresponding Pharmacy Service with all service reports and certification of the job performed. After completion of work, the vendor shall notify the contracting officer representative for signature and verification of work performed.

4.1.5. All equipment shall be maintained in proper operating condition as specified by the Manufacturer, USP, CETA and FDA standards. The vendor is to have required supplies, manuals, and schematics, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by state and local ordinances with manufacturer’s manual and quality control manual, and with all terms, conditions, provisions, schedules, and specifications provided herein.

4.2. In the event that the facility recertification or testing due to actionable results, the vendor must be able to provide retesting. If vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

4.3. In the event that the samples obtained during testing are damaged during transport or processing, the vendor shall annotate the damage in the report and provide retesting within 7 calendar days of the request at no additional cost to the facility. If the vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

5.0. Additional Requirements

5.1. Scheduling of Work. Contractor shall provide current documentation of required technician qualifications. Contractor shall also submit a current copy of their most recent standard operating procedures (SOPs) for testing, troubleshooting, repair and certification including documentation of certification equipment calibration to National Institute of Standards and Technology (NIST)-traceable primary standards, a safety plan to include job hazard analysis, respiratory protection program, hazard communication and safety data sheets (SDS) for all chemical products that will be used during the course of this contract prior to scheduling work. Contractor shall contact the COR, or designee to schedule work, prior to beginning work, and at the conclusion of all work. For services performed during normal working hours, the contractor's technician is to report to the COR, or designee to report/sign-in and obtain an identification badge, which shall be worn at all times while the technician is on station.

Period of Perfromance All work must be completed 30 Days within time of award. Working hours are performed during the facilities regular administrative working hours, Monday through Friday, 8:00 a.m. - 4:30 p.m. excluding- weekends and Federal holidays.

Exception to this will be given when deemed necessary to accommodate evening, night, and weekend staff. Contractor shall receive approval from the COR, or designee for irregular work hours testing.

VA follows all Federal holidays that are sent by law (USC Title 5 Section 6103). The Government hereby provided notice and Contractor hereby acknowledges receipt that Government personnel observe the listed days as holidays:

New Year’s Day January 1 Martin Luther King Jr.’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 14 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by the US government agencies.

In addition to the days designated as holidays, the Government observes the following days:

- Any other day designated by Executive Order

- Any other day designated by the President’s Proclamation; and

- Any other day designated by Federal Statute

5.2. Service Reports. Contractor shall provide a certificate sticker for each unit that passes certification before the technician leaves the facility. Any unit that does not pass certification will be marked as such with clear signage that the unit is out of service until further notice. A complete report of services for each unit serviced and must include a listing of replacement parts, when applicable. Contractor shall also contact the COR, or designeee upon completion of work to verbally report the status of the unit and any deficiencies identified. The COR, or designee, must sign the service report before the technician(s) leave the facility. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included on a per test basis where applicable. Larger formal reports as required for the pharmacy clean rooms that include viable sampling and surface sampling kits for hazardous drug detection must be submitted to the COR, or designee within fifteen (15) business days following the collection of the viable sampling and /or surface sampling kit. Results of viable samples and/or surface sampling kit must be submitted to the COR, or designee within one (1) business day of the receipt of the results from an accredited laboratory. The service reports from the contractor shall contain, at a minimum, the following information:

5.2.1. Room number and/or location

5.2.2. Room type (e.g. cleanroom)

5.2.3. Date and time of the contractor's arrival on station

5.2.4. Certified technician(s) name

5.2.5. Date of testing

5.2.6. Standards used to test PEC and/or SEC

5.2.7. Diagram of room showing the location of supply/exhaust diffusers, equipment, room dimensions, etc

5.2.8. Total room area and volume

5.2.9. Room humidity and temperature

5.2.10. Air changes per hour

5.2.11. Pressure differential

5.2.12. Particle counts

5.2.13. Diagram with labeling of nonviable particle count locations

5.2.14. Viable particle sampling certificate of analysis for growth and sterility controls analysis and interpretation

5.2.15. Diagram with labeling of viable particle sampling and environmental wipe sampling test locations in room

5.2.16. Report of actions performed

5.2.17. Notes or recommendations

5.2.18. Date of next required certification

5.2.19. Service reports must also include the following as applicable to type of PEC/SEC certification or personnel assessment and testing:

5.2.19.1. List of vendor equipment used; to include manufacturer make, model, serial number, date calibrated, and date of next calibration.

5.2.19.2. SDS forms for all agents used during the certification procedures.

5.2.19.3. Certificate of analysis

5.2.19.4. Growth Control

5.2.19.5. Sterile Control

5.3. Excluded services. Contractor shall not be obligated to provide services under this agreement for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by:

5.3.1. Fire or explosion of any origin, riot, civil commotion, aircraft, war

5.3.2. Act of God or other force majure including but not limited to lightning, windstorm, hail, flood, earthquake

5.3.3. VAMC misuse or abuse of such instrument

5.3.4. Decontamination due to spillage by VA personnel due to their own negligence

5.3.5. Installation of unauthorized field modifications.

5.4. Schedule of Insurance. Contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability Insurance. Prior to contract award, the Contractor shall provide proof of insurance for the entire contract period. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the contractor.

5.5. Price Schedule. The contract rate is an all-inclusive rate. No separate fees will be allowed for such incidental costs of malpractice insurance coverage, supplies, equipment, etc.

5.6. Environment of Care. Contractor shall maintain a clean and safe environment always.

5.7. Contracting with Parties Listed on the OIG List of Excluded Individuals/Entities. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs. The list of excluded individuals/entities can be found on the OIG web site at www.hhs.gov/oig. With submittal of proposal, the contractor shall provide evidence than none of the contractor’s employees are on the Excluded Parties list.

5.8. Invoices/Payments. This provision shall survive the termination or ending of the contract. Payment for services rendered by the Contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen (14) workdays following completion of the Contractors rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt of sampling reports. Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Contractor shall:

5.8.1. Be electronically prepared and submitted in accordance with FAR 52.212-4(g)

5.8.2. Clearly state the terms of any discounts offered.

5.8.3. Include the current fiscal year and purchase order number.

5.8.4. Include the period of performance covered by the invoice.

5.8.5. Accept payment for services rendered under this contract as payment in full. This provision shall survive the termination or ending of the contract.

5.9. Place of Performance. Contractor shall furnish services for the AVACHS located at 2495 Shreveport Hwy 71 North, Pineville, LA 71360.

5.10. Authority: This procurement is executed under FAR Part 12 – Simplified Acquisitions

5.11. Information Security Officer, Information Protection: The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

5.12. Privacy Officer: The contractor will not have access to Patient Health Information (PHI) and they will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

5.13. Records Officer: The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

5.13.1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

5.13.2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

5.13.3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

5.13.4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5.13.5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

5.13.6. The Government Agency owns the rights to all data/records produced as part of this contract.

5.13.7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor shall deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

5.13.8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

5.13.9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

5.13.10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

5.14. Security: Contractor shall be liable for security of all areas accessed by the technician(s). All doors, passageways, windows and accesses to equipment and service areas, must be locked and/or secured after passage. In no instance will any door, window or access be rendered unlocked, propped open, mechanism taped open or rendered to prevent securing. Contractor shall be responsible to physically ensure such accesses are secured to prevent unauthorized entry.

5.15. Contractor Personnel Badges and Parking: Contractor technician shall acquire an access badge upon entrance into the AVAHCS buildings. Contractor shall safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the facility COR, or designee. Contractor shall ensure technicians properly display their access badges. Access badges must be worn at or above the waist (facing forward). Access badges must be returned to the COR, or designee at the end of each site visit. Contractor shall ensure technician parks in the appropriate designated parking areas. Parking information shall be coordinated with the COR, or designee. Contractor shall be aware that AVAHCS does not validate or make reimbursement for parking violations of the contractor technician under any circumstance.

5.16. Interference to Normal Function: Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection (detection and suppression) systems, passage of facility patients, personnel, equipment and carts and patient care activities (e.g., preparing sterile compounds). In the event of an emergency, contractor services may be stopped by the AVAHCS and rescheduled at no additional cost to the government. Contractor personnel shall inform the COR or the designee of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with the COR, or designee.

6.0. Performance Location and Hours

Alexandria HCS(AVAHCS,) POC: Christy Smith Phone #:318-483-5013 Address: 2495 Shreveport Hwy 71 North, Pineville, LA 71360

Hours are from 0730 to 1600, Monday through Friday, excluding Federal holidays.

INVOICE AND PAYMENT: Offeror shall submit quotes upon completion. See VAAR Clause 852.232-72, Electronic Submission of Payment Requests for invoicing procedures. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer’s Representative (COR). A properly prepared invoice will contain:

a) Invoice Number and Date

b) Contractor’s Name and Address

c) Accurate Purchase Order Number

d) Supply or Service provided

e) Total Amount Due

Payments shall be made in accordance with the Prompt Payment Act out of the Government annual appropriated funds obligated in a task order which will be issued after the contract is awarded.

Note: Invoices that are not in compliance with the aforementioned requirements under this paragraph will be rejected for payments and required to be resubmitted.

7.0. Deliverables

7.1. Report will include all components specified in 4.1.1 through 4.1.8. The structure of the report should follow specifications outlined in the CETA application guides.

7.2. Report of all testing results shall be sent via e-mail with a hard copy sent by mail to the Chief, Pharmacy Service/Contracting Officer Representative.

8.0. Contractor Personnel and Management

8.1. Contractor Personnel: The Contractor shall be responsible for employing technically qualified personnel to perform the work specified in this PWS. The Contractor shall maintain the personnel, organization, and administrative control necessary to ensure that the work delivered meets the contract specifications and requirements.

8.2. Key Personnel: All work shall be completed by CETA (CNBT) and NSF Certified technicians in accordance with all applicable Federal, State, Local, and industry: standards, laws, policies, procedures, codes, and any other applicable governing body for the proper performance of all equipment per manufactures specifications/calibrations. Personnel performing all certifications must have current CETA National Board of Testing (CNBT) accreditation and hold classification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities (RCCP-SCF). Proof of certification must be provided prior to the start of the contract. The contractor shall provide written notification to the Contracting Officer & Contracting Officer Representative (COR) if RCCP-SCF certification lapses or is terminated.

8.3. Contractor Badges. Contractor personnel shall wear a laminated contractor identification badge at all times when performing services under this Contract, including when on Government directed travel. The badge will contain a personal picture, name of employee, and Contractor's name. Badges shall be worn on the outer garment attached to the outer shirt or jacket pocket by a button or clip or worn around the neck secured by an appropriate identification card lanyard. They must also ensure that all documents or reports produced by Contractor personnel are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

8.4. Standards of conduct:

8.4.1. Conduct of Personnel. Contractor personnel shall conduct themselves in a professional manner (i.e., timeliness, communication; spoken and written etc.). The Contracting Officer may require the Contractor to remove from the job site any employee working under this contract for reasons of suspected misconduct, a suspected security breach, or suspected to be under the influence of alcohol, drugs, or any other incapacitating agent. Contractor employees shall be subject to dismissal from the premises upon determination by the Contracting Officer that such action is necessary in the interests of the Government. The medical center director or designated representative has the authority to bar individuals from the Government facility. The removal from the job site or dismissal from the premises shall not relieve the Contractor of the requirement to provide sufficient personnel to perform the services as required by this performance work statement. The Government shall not reimburse the Contractor for travel and other expenses associated with the removal of personnel.

8.4.2. Contractor personnel are not authorized to carry or possess personal weapons to include, but not limited to, firearms and knives with a blade length in excess of three inches, while assigned under this contract.

8.4.3. Working Attire and Appearance: Contractor personnel shall present a professional appearance commensurate with standards delineated for Government civilian personnel acting in similar capacities.

9.0. Travel: N/A

10.0. Non-Personal Service Statement

10.1. Contractor employees performing services under this order will be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the PWS. Contractor employees will perform their duties independent of, and without the supervision of any Government official. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

11.0. Performance Standards and Quality Measurement

11.1. Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets, or does not meet these standards. The Government shall use these standards to determine Contractor performance and shall compare Contractor performance to the Acceptable Quality Level (AQL).

Performance Standards Requirements Summary Matrix

Viable air and surface sampling, non-viable testing, and hood/room certification testing completed All testing is completed prior to due date 99% acceptable level Random inspection conducted by the COR Favorable Contractor Performance Evaluations Below AQL, non-acceptance of services. A Contract Discrepancy Report (CDR) will be issued for performance below the AQL. The Contractor will have five workdays to provide a response that includes an improvement strategy for addressing the issues. 30 days after issuing the CDR, the Contractor will be re-rated. If performance does not comply with PWS, the CO will be notified, the performance record will be documented, and CO may pursue contract action.

action report.

Receiving documents are accurate 98% of the time.

Random inspection conducted by the COR Favorable Contractor Performance Evaluations Below AQL, non-acceptance of service. A contract Discrepancy Report (CDR), will be issued. Contractor will have 5 workdays to provide a response that includes an improvement strategy for addressing the issues. 30 days after issuing CDR, the contractor will re-rated. If performance does not comply with PWS CO may deduct from invoice 2%, 3%, 4% progressive deduction.

proof of current CNBT certification.

All technicians performing work maintain current

CNBT

certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities

(RCCP-SCF)

Random inspection conducted by the COR Favorable Contractor Performance Evaluations Below AQL, non-acceptance of services. A Contract Discrepancy Report (CDR) will be issued for performance below the AQL. The Contractor will have five workdays to provide a response that includes an improvement strategy for addressing the issues. 30 days after issuing the CDR, the Contractor will be re-rated. If performance does not comply with PWS, the CO will be notified, the performance record will be documented, and CO may pursue contract action.

Table A.

Model: NU-301-530 Serial# 181959091417 IV Room

Model: NU- 340-530 Serial# 196931021920 Contingency SCA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Room Workbench 1- 310A Segregated Compounding Area Laminar Airflow

Contract Period: Base POP Begin: 04-25-2025 POP End: 04-24-2026 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services PRODUCT/SERVICE CODE: R428 - Support - Professional: Industrial Hygienics Cleanroom Suite Certification Semi Annual Service

Room Workbench 2- 264 - Contingency IV Room Laminar Airflow

POP Begin: 04-25-2025 POP End: 04-24-2026 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

308B Chemo Storage Closet

POP Begin: 04-25-2025 POP End: 04-24-2026 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 1- 310A Segregated Compounding Area Laminar Airflow Contract Period: Option 1 POP Begin: 04-25-2026 POP End: 04-24-2027 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 2- 264 - Contingency IV Room Laminar Airflow

POP Begin: 04-25-2026 POP End: 04-24-2027 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

308B Chemo Storage Closet

POP Begin: 04-25-2026 POP End: 04-24-2027 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 1- 310A Segregated Compounding Area Laminar Airflow Contract Period: Option 2 POP Begin: 04-25-2027 POP End: 04-24-2028 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 2- 264 - Contingency IV Room Laminar Airflow

POP Begin: 04-25-2027 POP End: 04-24-2028 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

308B Chemo Storage Closet

POP Begin: 04-25-2027 POP End: 04-24-2028 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 1- 310A Segregated Compounding Area Laminar Airflow Contract Period: Option 3 POP Begin: 04-25-2028 POP End: 04-24-2029 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 2- 264 - Contingency IV Room Laminar Airflow

POP Begin: 04-25-2028 POP End: 04-24-2029 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

308B Chemo Storage Closet

POP Begin: 04-25-2028 POP End: 04-24-2029 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 1- 310A Segregated Compounding Area Laminar Airflow Contract Period: Option 4 POP Begin: 04-25-2029 POP End: 04-24-2030 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

Room Workbench 2- 264 - Contingency IV Room Laminar Airflow

POP Begin: 04-25-2029 POP End: 04-24-2030 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

308B Chemo Storage Closet

POP Begin: 04-25-2029 POP End: 04-24-2030 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services

B.3 DELIVERY SCHEDULE

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

Christy.Smith3@va.gov 318 466-2547

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shrevport VAMC Pineville, LA 71360, LA 71360

USA

christy.smith3@va.gov

(318) 466-2575

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shreveport Hwy 71 North Pineville, LA 71360

USA

2495 Shrevport VAMC Pineville, LA 71360, LA 71360

USA

christy.smith3@va.gov

(318) 466-2575

36C25625Q0677

Page 1 of Page 1 of Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

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.1 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within ; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed six (6) years.

(End of Clause)

C.2 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.3 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)

C.4 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.