36C25624Q0328.docx

36C25624Q0328

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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. SIGNAT

URE 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

586-24-2-143-0008 36C25624Q0328 Angela Kennedy angela.kennedy2@va.gov 228-523-5000 ext 40361 01-15-2024

12PM

CST

00586 Department of Veterans Affairs Gulf Coast Veterans Healthcare System 400 Veterans Avenue Biloxi MS 39531 X Y 541990 $19.5 Million N/A X 00586 Department of Veterans Affairs G.V. (Sonny) Montgomery VAMC 1500 E. Woodrow Wilson Drive Jackson MS 39216-5199 10N16 Department of Veterans Affairs Gulf Coast Veterans Healthcare System Veterans Avenue Biloxi MS 39531

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically 1-877-489-6135 See CONTINUATION Page The Network Contracting Office (NCO) 16 is seeking businesses capable of providing IV Room Certification for the G.V. (Sonny) Montgomery VAMC facility, as per the Performance Work Statement within. All questions are due by 12PM CT January 8, 2024 and all quotes are due by 12PM CT January 15, 2024 via email to angela.kennedy2@va.gov.

**PAY CLOSE ATTENTION TO SECTION E.1 INSTRUCTIONS TO OFFEROR

AND SECTION

E.7 EVALUATION FACTORS

This solicitation utilizes FAR 13.106 Comparative Analysis Evaluation.

$0.00 See CONTINUATION Page X Table of Contents

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 Angela Kennedy Department of Veterans Affairs Gulf Coast Veterans Healthcare System

400 Veterans Avenue Biloxi MS 39531

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.2 STATEMENT OF WORK

Personnel and Environmental Monitoring Certifications for G.V. (Sonny) Montgomery VAMC

1.0. Introduction

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 G.V. (Sonny) Montgomery VAMC (GVSMVAMC). This contract will be for a Base Year and Four 1 year Option Periods. The GVSMVAMC has both hazardous and non-hazardous sterile drug compounding areas with primary engineering controls (PECs) and containment primary engineering controls (C-PECs). The PECs include laminar airflow workbenches (LAFW) and compounding aseptic isolators (CAI) for all non-hazardous sterile drug compounding and the C-PECs include compounding aseptic containment isolators (CACIs) for hazardous sterile drug compounding. In addition, the Government requires personnel certification testing of gowning and garbing, gloved fingertip and thumb testing, and media fill testing. The testing and certification must be performed in accordance with USP <797>, USP <800>, CETA and FDA guidelines.

Floor Plan

2.0. Description/Scope/Objective

2.1. The Contractor must provide all labor, equipment, tools, materials, sampling supplies, replacement parts, transportation, and travel necessary to perform all inspections, testing, certifications, preventive maintenance, repairs and internal HEPA and other filter replacement, 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. Contractor must 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.

2.3. Contractor must provide unscheduled work or emergency requests within 7 days of a request from the COR, or designee. No additional funding will be provided to pay for travel for service.

2.4. The number and type of Primary Engineering Control (PEC) and Containment Primary Engineering Control (C-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 as well as the number of personnel that require certification testing of gloved fingertip and thumb testing, and media fill testing.

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. Gowning and Garbing Evaluation: The Vendor shall perform a gowning and garbing evaluation for each employee in conjunction with the gloved fingertip and thumb sampling and media-fill test. The vendor shall use the facility’s standard operating procedure as guidance for their evaluation.

4.1.2. Gloved fingertip and thumb sampling: The Vendor shall perform the gloved fingertip and thumb sampling for the expected number of employees. This should be done in conjunction with media-fill testing. The results should be reported by number of colony-forming units (CFU) per hand (left hand, right hand). If any agar plates demonstrate growth, the preliminary results will be reported to the Chief, Pharmacy Service, Associate Chief, Pharmacy Operations and Compounded Sterile Products Program Manager. Final results will be expeditiously reported after further antimicrobial testing is complete. The organism isolated for growth leading to non-compliance according to USP guidelines must additionally be reported.

4.1.3. Media-Fill Testing: The Vendor shall perform media-fill testing for the expected number of employees. This should be done in conjunction with gloved fingertip and thumb sampling. The results should include the name of the employee evaluated, the evaluation date/time, media and components used to include the expiration date and lot number, the results, and the signatures of the person evaluated and the observer. Failure of the test is indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container-closer units on or before the end of the incubation period. If any container-closer units demonstrate growth, 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 results are known, and final results will be expeditiously reported after further antimicrobial testing is complete.

4.1.4. Compounding area certification: 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, plan for up to two additional certifications a year. Certification must include but is not limited to the following:

4.1.4.1. 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.

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

4.1.4.3. 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 including the buffer room(s) and ante-room(s), should be taken at representative locations that reflect the quality of air in the room(s).

4.1.4.4. 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 DVD format to comply with VHA guidance for media. No .zip files, usb storage, flash drives, or downloadable files from vendor web sites.

4.1.4.5. 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.

4.1.4.6. 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.

4.1.5. 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.

4.1.6. 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 monthly. 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.

4.1.7. Environmental wipe sampling for hazardous drug (HD) surface residue should be performed every 6 months during certification or as outlined by USP <800>. Results will be reported to the Chief, Pharmacy Service, Associate Chief, Pharmacy Operations and Compounded Sterile Products Program Manager as soon as results are available.

4.1.8. 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.

4.1.9. 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 or personnel require recertification or testing due to actionable results, the vendor must be able to provide retesting within 7 calendar days of the request. 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 must provide current documentation of required technician qualifications. Contractor must 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 must 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. Work must be 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 must receive approval from the COR, or designee for irregular work hours testing.

5.2. Service Reports. Contractor must 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 must 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 must 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 must 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 must 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 must 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 must:

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 must furnish services for the GVSMVAMC located at 1500 East Woodrow Wilson Avenue, Jackson MS 39216.

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 must 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 must 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 must be responsible to physically ensure such accesses are secured to prevent unauthorized entry.

5.15. Contractor Personnel Badges and Parking: Contractor technician must acquire an access badge upon entrance into the GVSMVAMC buildings. Contractor must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the facility COR, or designee. Contractor must 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 must ensure technician parks in the appropriate designated parking areas. Parking information shall be coordinated with the COR, or designee. Contractor must be aware that GVSMVAMC 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 GVSMVAMC 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

6.1. GVSMVAMC, 1500 East Woodrow Wilson Avenue, Jackson MS 39216

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

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 must 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

Fingertip testing, media fill testing, viable air and surface sampling, hazardous drug environmental wipe 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: BZ-4SS Serial#20032 Model: BZ-6SS Serial#20033 IV Buffer Room

Model: LFGI-3USP Serial#20048 Model: LFGI-3USP Serial#20049 Hazardous Storage Buffer Room

Model: LFGI-3USP Serial#20050 (positive pressure) Contingency SCA

Personnel

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Gowning/Garbing Evaluation, IAW PWS Contract Period: Base POP Begin: 01-01-2024 POP End: 09-30-2024 PRINCIPAL NAICS CODE: 541990 - All Other Professional, Scientific, and Technical Services PRODUCT/SERVICE CODE: H999 - Other Quality Control, Testing, and Inspection - Miscellaneous

Gloved Fingertip/Thumb Test, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Low risk/medium risk Media Fill, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Airflow testing in each classified area, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

HEPA Filter integrity testing, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Total particle count testing in each classified area, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Smoke visualization study in each primary engineering control, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Smoke visualization study in rooms with low wall return, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Primary engineering control certification, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Differential pressure certification, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Viable Air Sampling and specification, IAW PWS

POP Begin: 01-01-2024 POP End: 09-30-2024

Viable surface sampling and specification in 5 PECs and 4 SECs

POP Begin: 01-01-2024 POP End: 09-30-2024

Wipe sampling for Hazardous Drugs for PECs and SECs

POP Begin: 01-01-2024 POP End: 09-30-2024

Gowning/Garbing Evaluation, IAW PWS Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025

Gloved Fingertip/Thumb Test, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Low risk/medium risk Media Fill, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Airflow testing in each classified area, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

HEPA Filter integrity testing, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Total particle count testing in each classified area, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Smoke visualization study in each primary engineering control, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Smoke visualization study in rooms with low wall return, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Primary engineering control certification, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Differential pressure certification, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Viable Air Sampling and specification, IAW PWS

POP Begin: 10-01-2024 POP End: 09-30-2025

Viable surface sampling and specification in 5 PECs and 4 SECs

POP Begin: 10-01-2024 POP End: 09-30-2025

Wipe sampling for Hazardous Drugs for PECs and SECs

POP Begin: 10-01-2024 POP End: 09-30-2025

Gowning/Garbing Evaluation, IAW PWS Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026

Gloved Fingertip/Thumb Test, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Low risk/medium risk Media Fill, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Airflow testing in each classified area, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

HEPA Filter integrity testing, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Total particle count testing in each classified area, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Smoke visualization study in each primary engineering control, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Smoke visualization study in rooms with low wall return, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Primary engineering control certification, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Differential pressure certification, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Viable Air Sampling and specification, IAW PWS

POP Begin: 10-01-2025 POP End: 09-30-2026

Viable surface sampling and specification in 5 PECs and 4 SECs

POP Begin: 10-01-2025 POP End: 09-30-2026

Wipe sampling for Hazardous Drugs for PECs and SECs

POP Begin: 10-01-2025 POP End: 09-30-2026

Gowning/Garbing Evaluation, IAW PWS Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027

Gloved Fingertip/Thumb Test, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Low risk/medium risk Media Fill, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Airflow testing in each classified area, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

HEPA Filter integrity testing, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Total particle count testing in each classified area, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Smoke visualization study in each primary engineering control, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Smoke visualization study in rooms with low wall return, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Primary engineering control certification, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Differential pressure certification, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Viable Air Sampling and specification, IAW PWS

POP Begin: 10-01-2026 POP End: 09-30-2027

Viable surface sampling and specification in 5 PECs and 4 SECs

POP Begin: 10-01-2026 POP End: 09-30-2027

Wipe sampling for Hazardous Drugs for PECs and SECs

POP Begin: 10-01-2026 POP End: 09-30-2027

Gowning/Garbing Evaluation, IAW PWS Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028

Gloved Fingertip/Thumb Test, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

Low risk/medium risk Media Fill, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

Airflow testing in each classified area, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

HEPA Filter integrity testing, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

Total particle count testing in each classified area, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

Smoke visualization study in each primary engineering control, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

Smoke visualization study in rooms with low wall return, IAW PWS

POP Begin: 10-01-2027 POP End: 09-30-2028

Pri…