36C24724Q0071 Final.pdf

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

36C24724Q0071

Janet Smith 803-776-4000 ext 56610 11-22-2023

1300 EST

Department of Veterans Affairs W.J.B. Dorn VA Medical Center 6439 Garners Ferry Road Columbia SC 29209-1639

X 100

X

541990

$19.5 Million

N/A

X

See Delivery Schedule

Department of Veterans Affairs W.J.B. Dorn VA Medical Center 6439 Garners Ferry Road Columbia SC 29209-1639

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

The Contractor shall provide all labor, equipment, materials, supervision, test equipment, travel, and transportation necessary to provide semi-annual CETA USP 797 certifications for the facility's sterile compounding areas, bio-safety cabinets, and fume hoods.

Period of Performance Base Year: 12/23/2023-12/22/2024 Option Year 1: 12/23/2024-12/22/2025 Option Year 2: 12/23/2025-12/22/2026 Option Year 3: 12/23/2026-12/22/2027 Option Year 4: 12/23/2027-12/22/2028 COR: Khalid Chaudhry CO: Terrence McMillan CS: Janet Smith

ADD PROPOSAL PRICING TO PRICE/COST SCHEDULE BEGINNING

ON PAGE 15 AND RETURN TO JANET.SMITH@VA.GOV NLT 1PM EST

ON 11/22/2023

See CONTINUATION Page x X x 1

Terrence McMillan Contract Officer

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...35

C.3 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.4 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

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 Terrence McMillan

Atlanta VAMC

2008 Weems Rd.

Tucker, GA 30084

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] Monthly in arrears

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

B.2 STATEMENT OF WORK

Inspect / Certify BSCs, LFHs, Pharmacy Cleanroom for Birmingham VA Medical Center 700 S.

19th Street Birmingham, AL 35233

1. INTRODUCTION AND SCOPE OF WORK:

Contractor shall furnish service as specified to ensure that the equipment functions in accordance with NCI Specification “General Purpose, Clean Air, Biological Safety Cabinet, revised August 19, 1975”, NIH specification NIH-03-11ZC dated Sept 17, 1974; National

Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49

[NSF 49]; Federal Standard No. 209E-April 24, 1973, “Clean Room And Work Station

Requirements, Controlled Environment”; SAMA Standard LF10-1980 Laboratory Fume

Hoods, USP 797 and 800. Furnished all labor, equipment, tools, materials and travel necessary to test, certify andmeasure Government – owned Biological Safety Cabinets (BSCs), Laminar

Flow Hoods (LFHs), and Pharmacy clean rooms.

2. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

a. Each respondent must have an established business, with an office and full-time staff.

b. The contractor must meet Joint Commission requirements by providing competency of the service technician. All certifying technicians who perform work under this contract will have a current Controlled Environment Testing Association (CETA) certification.

Contractor will provide a copy of CETA certification to COR.

c. If subcontractor(s) are under consideration for use, they must be approved by the

COR and meet the CETA certification requirements noted in 2.b.

d. Prior to each certification event/visit, the Contractor shall provide the BVAHCS with the current calibration of all test equipment which is used on BVAHCS’s equipment. This certification shall also be provided on a periodic basis when requested by the

BVAHCS. Test equipment calibration shall be traceable to the national standard.

3. REFERENCES:

Contract service shall ensure that the equipment functions in accordance with the following standards/guidelines:

National Safety Foundation (NSF) 49-2019: Biosafety Cabinetry: Design, Construction, Performance and Field Certification.

American Society of Heating, Refrigeration and Air Conditioning Engineers (ASHRAE)

110-2016: Method of Testing Performance of Laboratory Fume Hoods.

International Organization for Standardization (ISO), 14644-1 Part 1: Classification of air cleanliness.

The Science Equipment and Furniture Association (SEFA) 1.2-1996: Laboratory Fume

Hoods Recommended Practices.

American Conference of Governmental Industrial Hygienist (ACGIH).

The United States Pharmacopeial Convention (USP) 2020, Chapters 797 (USP 42 –

NF 37) and 800 (USP 40 – NF 35).

American Society Health-System Pharmacists (ASHP) – Minimum Standards for

Pharmacies in Hospitals (2013).

CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2012).

The most recent revision of each standard takes precedence.

4. REPORTING REQUIREMENTS:

The Contractor shall be required to check in by calling (see below) the Contracting Officer’s

Representative (COR) prior to entering the facility. This check in is mandatory. When the service is completed, the Field Service Representative (FSR) shall document services rendered on a legible Engineering Service Reports (ESRs). The FSR shall be required to log out with the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed copy of the ESR will be sent to the COR after the work is performed.

VA Contact Person(s): Safety Manager/COR

Location (Building/Room Number): BVAHCS 2706-D & 2710

Telephone Number & Extension(s): (205) 933-8101, extension 8063/5795

5. BIOSAFETY CABINET CERTIFICATION(BSCs)

The Pharmacy BSCs shall be certified twice per year (see ATTACHMENT 1). All other BSCs will be certified once per year (see ATTACHMENT 2). Certification shall consist of the following:

a. Down flow velocity test

b. Direct inflow method velocity test

c. Airflow smoke pattern test

d. HEPA filter leak test

e. Alarm function test

f. Blower interlock test (Class II, type B cabinets)

g. Electrical leakage on the main cabinet (those that are not UL listed)

h. Ground Fault Circuit Interrupter (GFCI) outlet trip test.

i. A visual inspection to identify defects, damage, misuse, or missing parts

j. Documentation of the certification and inspection results

k. A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification

l. Posting an “Out of Service” sign on cabinets that fail certification.

m. Notifying the cabinet user and the COR of cabinets that fail certification.

6. LAMINAR FLOW HOOD CERTIFICATION(LFHs)

Laminar Flow Hoods (LFHs) shall be certified twice per year (see ATTACHMENT 1).

Certification shall consist of the following:

a. Measurement of sash face velocity according to the current version of ASHRAE 110.

b. Comparison of the sash face velocity to the current ACGIH recommendation.

c. Airflow smoke pattern test.

d. HEPA filter leak test.

e. GFCI outlet trip test.

f. A visual inspection to identify defects, damage, misuse or missing parts.

g. Documentation of the certification and inspection results (e.g., a decal or label affixed in a visible location that indicates the sash certification height, the face velocity and the date of certification).

h. Posting an “Out of Service” sign hoods that fail certification.

i. Notifying the hood user and the COR of hoods that fail certification.

7. PHARMACY TESTING AND CERTIFICATION

Testing and certification (under CAG-003-2006-11 and to USP 797 and 800 Standards) of the

Pharmacy Ante Room(s), Buffer (IV) Room and Chemo Buffer Room as well as viable air sampling for mold and bacteria will be twice per year (see ATTACHMENTS 3, 4 & 5).

Certification and testing shall consist of the following:

a. Smoke Pattern Test (with Digital Recording) – USP 797, First Air Direct Compounding

Area. Dynamic airflow smoke pattern test conducted in situ to ensue unidirectional air flow and sweeping action over and away from product. All air flow visualization testing will be performed using simulations that mimic the most complex processes performed. Simulated dynamic smoke pattern test in the Primary Engineering Controls

(PEC) and BSCs as required by USP 797. Smoke testing will be video recorded & provided on a USB drive of the date of service.

b. USP 797 Air Viable Sampling per location – dual analysis. Air samples shall be taken in: the IV (non-hazard) buffer room, two (2) each; the chemo (hazardous drug) buffer room, two (2) each; the airlock leading to the chemo (HD) room, one (1) each; the anteroom, one (1) each; the LFHs, two (2) each; the BSCs, two (2) each; Colony forming units (CFU) results from the cultures shall be calculated in CFU per cubic meter (m3) of air.

c. USP 797 surface viable sampling per location – dual analysis. Surface samples shall be taken in: the IV (non-hazard) buffer room, one (1) each; the chemo (HD) buffer room, one (1) each; the airlock leading to the chemo (HD) buffer room, one (1) each;

the anteroom, one (1) each; the LFHs, two (2) each; the BSCs, two (2) each; the passthrough boxes, three (3) each. Colony forming units (CFU) results from the cultures shall be calculated in CFU per device or swab).

d. Cleanroom certification per room will include:

1) Room air change calculations (air changes per hour).

2) Room-to-room differential pressures/room pressurization (this includes the and

Chemo Storage Room)

3) Airborne particle count survey.

4) Work height velocity (unidirectional).

5) Airflow parallelism.

6) Airflow uniformity

7) Airflow smoke pattern tests.

8) Room recovery.

9) Enclosure integrity leak test.

10) Temperature and humidity (this includes the Chemo Storage Room).

11) Particle count statistical analysis.

12) Lighting and noise level test.

e. Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air.

f. Inspect HVAC filter assembly for air bypass issues.

g. Test and calibrate the existing air balancing monitors (Chemo and Ante Rooms).

8. RE-TESTING

Testing and certification will include up to two (2) additional air samples and two (2) additional surface samples (i.e.., re-testing) if any sample results are out of compliance

(OOC) for the base year and any subsequent option years. Re-testing will be included in the contract as a separate line item (CLIN) and travel cost should be included (not a separate line item) in this expense.

9. MAINTENANCE AND REPAIR

The main purpose of this Contract is to eliminate unscheduled shutdowns and contribute significantly to the continuous operating economy and integrity of the system. All work is to follow NSF-49 and ASHRAE 110.

The following items shall be provided as part service to the BVAHCS:

a. Biological safety cabinet and laminar flow hood filters shall be replaced when they fail a leak test and cannot be repaired. This should be a separate line item (CLIN).

b. When applicable, cabinets will be marked inside to indicate the safe capture air zone to prevent contamination of the outside work area.

c. Cabinet dampers shall be adjusted to provide required flow and marked to indicate correct position.

d. The Contractor’s equipment shall be calibrated according to the manufacturer’s specifications.

e. Consult with end user and COR regarding unit performance.

10. DOCUMENTATION/REPORTS:

At the conclusion of each certification visit, documentation shall be submitted and include detailed descriptions of the scheduled certifications required to maintain the equipment in accordance with the manufacturer’s specifications. Such documentation shall meet the guidelines as set forth in paragraph 3, References. In addition, each FSR must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor.

b. Name of FSR who performed services.

c. Contractor service FSR number/log number.

d. Date, time (starting and ending), equipment downtime, and hours on-site for the service call.

e. BVAHCS purchase order numbers(s) covering the call if outside normal working hours.

f. Description of problem reported by COR (If applicable).

g. Identification of the equipment to be serviced:

1. Inventory ID number

2. Manufacturer’s name

3. Device name

4. Model number

5. Serial Number

6. Any other manufacturer’s identification numbers

h. Itemized Description of Service Performed (including Costs associated with after normal working hour services) including:

1. Materials and Circuit

2. Location of problem/corrective action.

i. Total Cost to be billed for service(s) rendered. Invoices to be input to Tungsten system and will include Contract Line Item Numbers (CLINs) for each service performed and the applicable purchase order number from the contract.

j. Signatures:

1. FSE performing services described.

2. VA Employee who witnessed service described.

NOTE: Failure to provide this information in the service report may result in non-payment of invoice.

11. NOTES AND OTHER INFORMATION:

a. ADDITIONAL CHARGES: There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional

FSE.

b. Security Issues: There are security issues associated with this Statement of Work

Both Pharmacy and Medical Research are controlled access areas and a VA employee escort is required to enter these areas.

c. The C&A requirements do not apply; a Security Accreditation Package is not required.

12. DEFINITIONS:

a. Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR

b. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

13. PARKING:

Contractors are responsible for finding their own parking.

14. ARRIVAL AT THE BVAHCS:

Contractors are required to report their arrival to the Safety Office, room 2710, 700 19th

Street South, Birmingham, AL 35233. While on BVAHCS property, contractors will be escorted by the COR, a Safety Office employee, or the Service they are certifying (e.g., Path & Lab, Medical Research, Or Pharmacy).

15. RECORDS MANAGEMENT:

a. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. Chapters. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA)

(5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for

Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. Birmingham VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Birmingham VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18

U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Birmingham VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the

Government’s behalf, without the express written permission of the Head of the Contracting

Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Birmingham VA Medical Center control or the

Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY

PROHIBITED unless in accordance with Paragraph (4).

f. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Birmingham VA Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Birmingham VA Medical Center policy.

h. The Contractor shall not create or maintain any records containing any non-public

Birmingham VA Medical Center information that are not specifically tied to or authorized by the contract.

i. The 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 from public disclosure by an exemption to the Freedom of Information Act.

j. The Birmingham VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S.

Government for which Birmingham VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by

FAR 52.227-11 through FAR 52.227-20.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training.

The Contractor is responsible for confirming training has been completed according to agency policies, including initial.

ATTACHMENT 1 - PHARMACY EQUIPMENT

Pharmacy

Equip. Make Model Serial No. Location Work Performed

LFH NuAire 301-530 165343092514 1101D IV Buffer Rm Annual Cert./Inspection

LFH NuAire 301-530 165342092514 1101D IV Buffer Rm Annual Cert./Inspection

BSC NuAire 540-300 203893020121 1101D Chemo Buffer Rm Annual Cert./Inspection

BSC NuAire 540-300 198819052720 1101D Chemo Buffer Rm Annual Cert./Inspection

ATTACHMENT 2 – PATHOLOGY & LABORATORY AND RESEARCH EQUIPMENT

Medical Research Equipment

Equip. Make Model Serial No. Location Work Performed

BSC NuAire 425-400 165290092414 5713 Annual Certification/Inspection

BSC NuAire 425-400 165289092414 5718 Annual Certification/Inspection

BSC NuAire 425-400 165288092414 5708 Annual Certification/Inspection

BSC NuAire 425-400 165282092314 5720 Annual Certification/Inspection

BSC NuAire 425-400 165280092314 5714 Annual Certification/Inspection

BSC ThermoFisher TSF 1377 1540488-1046 5715 Annual Certification/Inspection

Pathology and Laboratory Equipment

Equip. Make Model Serial No. Location Work Performed

BSC NuAire 425-400 165285092414 3428 Annual Certification/Inspection

BSC NuAire 425-600 165287092414 3428 Annual Certification/Inspection

BSC NuAire 543-300 203540011821 3427F Annual Certification/Inspection

BSC NuAire 543-300 203541011821 Annex, 1A165 Annual Certification/Inspection

ATTACHMENT 3 – PHARMACY CLEANROOMS

Cleanrooms

Room Approximate Square Footage Location

Ante 83 1101D

Chemo 120 1101D

Buffer (IV) 113 1101D

Air lock 45 1101D

Chemo Storage 54 1101D

ATTACHMENT 4 - PHARMACY LAYOUT

ATTACHMENT 5 - PHARMACY CLEAN ROOM (7) FILTER LOCATIONS

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

20.00 JB _______________

USP 797 Viable Active Air Sampling Per Location-TSA Single Plate Method Contract Period: Base POP Begin: 12-23-2023 POP End: 12-22-2024

22.00 JB _______________

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method Contract Period: Base

10.00 JB _______________

Clean Room Certification Per Room Contract Period: Base

12.00 JB _______________

Cleanroom Certification Per Filter Contract Period: Base

14.00 JB _______________

Biological Safety Cabinet Certification Class II (Type A1, A2, or B1) Contract Period: Base

4.00 JB _______________

Laminar Flow Bench or Polymerase Chain Reaction Certification Contract Period: Base

8.00 JB _______________

Operational Particle Count (USP 797) - Devices Contract Period: Base

Smoke Pattern Test with Digital Recording - USP 797 (First Air Direct Compounding Area) Contract Period: Base

24.00 JB _______________

Travel Charges (CLINS 1-8) Contract Period: Base

Daily Expenses Per Person (CLINS 1-8) Contract Period: Base

USP 797 Viable Active Air Sampling Per Location -TSA Single Plate Method (Retesting as required- Paragraph 8 of

SOW)

Contract Period: Base

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method (Retesting as Required per Paragraph 8 of SOW).

Contract Period: Base

2.00 JB _______________

Labor - Replace HEPA Filters in Laminar Flow Bench as required per Paragraph 9A of SOW Contract Period: Base

Labor - Replace HEPA Filters in Biological Safety Cabinets 5ft to 6 ft (As Required per Paragraph 9A of SOW) Contract Period: Base

Labor - Replace HEPA Filters in Biological Safety Cabinet 2ft to 4ft (As required by Paragraph 9A of SOW) Contract Period: Base

Vaporized hydrogen peroxide (VHP) Biodecontamination for Biological Safety Cabinet (CLINS 14 or 15) Contract Period: Base

Biological Safety Cabinet (BSC) Biological Indicator Processing/Reporting (CLINS 14 or 15) Contract Period: Base

Travel Charges Per Job (CLINS 11-15) Contract Period: Base

Base year total ________

USP 797 Viable Active Air Sampling Per Location-TSA Single Plate Method Contract Period: Option 1 POP Begin: 12-23-2024 POP End: 12-22-2025

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method Contract Period: Option 1

Clean Room Certification Per Room Contract Period: Option 1

Cleanroom Certification Per Filter Contract Period: Option 1

Biological Safety Cabinet Certification Class II (Type A1, A2, or B1) Contract Period: Option 1

Laminar Flow Bench or Polymerase Chain Reaction Certification

Contract Period: Option 1

Operational Particle Count (USP 797) - Devices Contract Period: Option 1

Smoke Pattern Test with Digital Recording - USP 797 (First Air Direct Compounding Area) Contract Period: Option 1

Travel Charges (CLINS 1-8) Contract Period: Option 1

Daily Expenses Per Person (CLINS 1-8) Contract Period: Option 1

USP 797 Viable Active Air Sampling Per Location -TSA Single Plate Method (Retesting as required- Paragraph 8 of

SOW)

Contract Period: Option 1

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method (Retesting as Required per Paragraph 8 of SOW).

Contract Period: Option 1

Labor - Replace HEPA Filters in Laminar Flow Bench as required per Paragraph 9A of SOW Contract Period: Option 1

Labor - Replace HEPA Filters in Biological Safety Cabinets 5ft to 6 ft (As Required per Paragraph 9A of SOW) Contract Period: Option 1

Labor - Replace HEPA Filters in Biological Safety Cabinet 2ft to 4ft (As required by Paragraph 9A of SOW) Contract Period: Option 1

Vaporized hydrogen peroxide (VHP) Biodecontamination for Biological Safety Cabinet (CLINS 14 or 15) Contract Period: Option 1

Biological Safety Cabinet (BSC) Biological Indicator Processing/Reporting (CLINS 14 or 15) Contract Period: Option 1

Travel Charges Per Job (CLINS 11-15) Contract Period: Option 1

Option Year 1 Total ___________

USP 797 Viable Active Air Sampling Per Location-TSA Single Plate Method Contract Period: Option 2 POP Begin: 12-23-2025

POP End: 12-22-2026

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method Contract Period: Option 2

Clean Room Certification Per Room Contract Period: Option 2

Cleanroom Certification Per Filter Contract Period: Option 2

Biological Safety Cabinet Certification Class II (Type A1, A2, or B1) Contract Period: Option 2

Laminar Flow Bench or Polymerase Chain Reaction Certification Contract Period: Option 2

Operational Particle Count (USP 797) - Devices Contract Period: Option 2

Smoke Pattern Test with Digital Recording - USP 797 (First Air Direct Compounding Area) Contract Period: Option 2

Travel Charges (CLINS 1-8) Contract Period: Option 2

Daily Expenses Per Person (CLINS 1-8) Contract Period: Option 2

USP 797 Viable Active Air Sampling Per Location -TSA Single Plate Method (Retesting as required- Paragraph 8 of

SOW)

Contract Period: Option 2

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method (Retesting as Required per Paragraph 8 of SOW).

Contract Period: Option 2

Labor - Replace HEPA Filters in Laminar Flow Bench as required per Paragraph 9A of SOW Contract Period: Option 2

Labor - Replace HEPA Filters in Biological Safety Cabinets 5ft to 6 ft (As Required per Paragraph 9A of SOW) Contract Period: Option 2

Labor - Replace HEPA Filters in Biological Safety Cabinet 2ft to 4ft (As required by Paragraph 9A of SOW) Contract Period: Option 2

Vaporized hydrogen peroxide (VHP) Biodecontamination for Biological Safety Cabinet (CLINS 14 or 15) Contract Period: Option 2

Biological Safety Cabinet (BSC) Biological Indicator Processing/Reporting (CLINS 14 or 15) Contract Period: Option 2

Travel Charges Per Job (CLINS 11-15) Contract Period: Option 2

Option year 2 total____________

USP 797 Viable Active Air Sampling Per Location-TSA Single Plate Method Contract Period: Option 3 POP Begin: 12-23-2026 POP End: 12-22-2027

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method Contract Period: Option 3

Clean Room Certification Per Room Contract Period: Option 3

Cleanroom Certification Per Filter Contract Period: Option 3

Biological Safety Cabinet Certification Class II (Type A1, A2, or B1) Contract Period: Option 3

Laminar Flow Bench or Polymerase Chain Reaction Certification Contract Period: Option 3

Operational Particle Count (USP 797) - Devices Contract Period: Option 3

Smoke Pattern Test with Digital Recording - USP 797 (First Air Direct Compounding Area) Contract Period: Option 3

Travel Charges (CLINS 1-8) Contract Period: Option 3

Daily Expenses Per Person (CLINS 1-8) Contract Period: Option 3

USP 797 Viable Active Air Sampling Per Location -TSA Single Plate Method (Retesting as required- Paragraph 8 of

SOW)

Contract Period: Option 3

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method (Retesting as Required per Paragraph 8 of SOW).

Contract Period: Option 3

Labor - Replace HEPA Filters in Laminar Flow Bench as required per Paragraph 9A of SOW Contract Period: Option 3

Labor - Replace HEPA Filters in Biological Safety Cabinets 5ft to 6 ft (As Required per Paragraph 9A of SOW) Contract Period: Option 3

Labor - Replace HEPA Filters in Biological Safety Cabinet 2ft to 4ft (As required by Paragraph 9A of SOW) Contract Period: Option 3

Vaporized hydrogen peroxide (VHP) Biodecontamination for Biological Safety Cabinet (CLINS 14 or 15) Contract Period: Option 3

Biological Safety Cabinet (BSC) Biological Indicator Processing/Reporting (CLINS 14 or 15) Contract Period: Option 3

Travel Charges Per Job (CLINS 11-15) Contract Period: Option 3

Option year 3 total___________

USP 797 Viable Active Air Sampling Per Location-TSA Single Plate Method Contract Period: Option 4 POP Begin: 12-23-2027 POP End: 12-22-2028

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method Contract Period: Option 4

Clean Room Certification Per Room Contract Period: Option 4

Cleanroom Certification Per Filter Contract Period: Option 4

Biological Safety Cabinet Certification Class II (Type A1, A2, or B1) Contract Period: Option 4

Laminar Flow Bench or Polymerase Chain Reaction Certification Contract Period: Option 4

Operational Particle Count (USP 797) - Devices Contract Period: Option 4

Smoke Pattern Test with Digital Recording - USP 797 (First Air Direct Compounding Area) Contract Period: Option 4

Travel Charges (CLINS 1-8) Contract Period: Option 4

Daily Expenses Per Person (CLINS 1-8) Contract Period: Option 4

USP 797 Viable Active Air Sampling Per Location -TSA Single Plate Method (Retesting as required- Paragraph 8 of

SOW)

Contract Period: Option 4

USP 797 Viable Surface Sampling Per Location - TSA Single Plate Method (Retesting as Required per Paragraph 8 of SOW).

Contract Period: Option 4

Labor - Replace HEPA Filters in Laminar Flow Bench as required per Paragraph 9A of SOW Contract Period: Option 4

Labor - Replace HEPA Filters in Biological Safety Cabinets 5ft to 6 ft (As Required per Paragraph 9A of SOW) Contract Period: Option 4

Labor - Replace HEPA Filters in Biological Safety Cabinet 2ft to 4ft (As required by Paragraph 9A of SOW) Contract Period: Option 4

Vaporized hydrogen peroxide (VHP) Biodecontamination for Biological Safety Cabinet (CLINS 14 or 15) Contract Period: Option 4

Biological Safety Cabinet (BSC) Biological Indicator Processing/Reporting (CLINS 14 or 15) Contract Period: Option 4

Travel Charges Per Job (CLINS 11-15) Contract Period: Option 4

Option year 4 total______________

GRAND TOTAL _______________

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

SHIP TO: Birmingham VA Medical Center 700 S. 19th St.

Birmingham, AL 35233

POP:

12/23/2023- 12/22/2028

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by

Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text.