S02 36C26324Q0953.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

438-25-1-1115-0001

36C26324Q0953 07-18-2024

Marie Weathers 605-347-2511 x16673 08-01-2024

10:00AM CDT

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St Sioux Falls, SD 57105

X 100

X

541380

$19 Million

N/A

X

DEPARTMENT OF VETERAN AFFAIRS

SIOUX FALLS VA HEALTHCARE SYSTEM

2501 W. 22nd St.

04-S

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Y

Tungsten Electronic Invoicing VA Tungsten Number: AAA544240062 va.registration@tungsten-network.com Refer to VAAR 852.232-72

See CONTINUATION Page

Biological Safety Cabinet, Laboratory, Clean Room, Primary Engineering Controls, and Pharmacy Compounding Fume Hood, Cabinet, and Closet Inspection and Certification Services in support of the Sioux Falls VA Health Care System.

See Statement of Work and Price/Cost Schedule for specific requirements.

Period of Performance 11-01-2024 to 10-31-2025 and includes four (4), one-year option periods.

This is a 100% SDVOSB set-aside; offerors shall be registered and verified as SDVOSB at the time of submission of offer and prior to award.

Offerors shall have an active System for Award Management (SAM.gov) registration at the time of offer and prior to award. Subcontracting limitations apply; see VAAR 852.219-10 DOL Wage Determination 2015-5369 applies to all services performed under this requirement.

Technical Questions due 07/24/2024 by 10:00AM CST by Marie.weathers@va.gov Quotes due 08/01/2024 by 10:00AM CST by marie.weathers@va.gov

See CONTINUATION Page

438-3650162-1115-850100-2514-0100501X3 438-25-1-1115-0001

X X

X 1(one)

John Milroy

VA-VHA-RPOC-2023-0067

36C26324Q0953

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.2 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...20

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.6 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.7 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

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: BUSINESS NAME: ________________________________

DUNS: ________________________________

CONTACT NAME: ________________________________

CONTACT PHONE: ________________________________

CONTACT EMAIL: ________________________________

b. GOVERNMENT: Contracting Officer 36C263

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St

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 or within 30 days after completion of service

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

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

The Contractor shall furnish all labor, equipment, transportation, permits, testing and incidentals necessary for the performance of the work specified in this Statement of Work.

I: Background- The Sioux Falls VA Medical Center (SFVAMC) in Sioux Falls, SD is seeking services to test, repair and certify a variety of pharmacy equipment, pharmacy clean rooms, and laboratory equipment on an annual and semiannual basis.

Annual Inspection and Certification Research Laboratory:

2 - Biological Safety Cabinets 7 - Fume Hoods 1 - Animal Bedding Disposal Station 1 - Animal Cage Changing Station 3 - Animal Cage Rack Blowers

Podiatry:

1 - Fume Hood

Semiannual (every 6 months +/- 20 days) Inspection and Certification Pharmacy:

4 - Biological Safety Cabinets 3 - Classified Compounding Rooms 1 - ISO 8 Ante room 1 - ISO 7 Ante room 2 - Containment-Segregated Compounding Area Room 1 - Containment Ventilated Enclosure (CVE) for Nonsterile Compounding 1 - Hazardous Drug (HD) Storage/Nonsterile HD Compounding Room

Clinical Laboratory:

4 - Biological Safety Cabinets 1 - Grossing Station

II: Contractor Qualifications Contractor that meets the following specifications:

All Biological Safety Cabinet (BSC) certifications must be signed by a National Sanitation Foundation (NSF) 49 certified technician.

All United States Pharmacopeia (USP) certification work must be performed by a Controlled Environment Testing Association (CETA) National Board of Testing Registered Cleanroom Certification Professional for Sterile Compounding Facility.

III: Testing and certifying standards Biological Safety Cabinet and Laminar Airflow Workstation Testing and Certification.

BSC’s must be tested to NSF 49 (2106), CAG-003-2006, USP <797>/<800> and manufacturer testing protocols. The contractor shall certify all Class II biosafety cabinets using NSF/American National Standards Institute (ANSI) 49, Annex F and manufacturer testing protocols. The contractor shall provide NSF 49 (2106), USP <797>/<800> and NSF/ANSI 49, Annex F documents. All equipment used to certify biological safety cabinets shall have National Institute of Standards and Technology (NIST) traceable or comparable calibration certification. Any unit that fails to meet NSF 49 criteria shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. Additionally, all BSC’s used for pharmaceutical compounding must be certified to USP <797> and USP <800> testing requirements to include viable and non-viable particle testing.

Laminar Airflow Workstation’s (LAFW’s) must be tested to IEST RP-CC-002.3 and manufacturer testing protocols. The contractor shall provide IEST RP-CC-002.3 documents. Any unit that fails to meet the testing criteria shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice.

Animal changing stations and grossing stations must be tested to the manufacturer’s requirements.

For each unit passing the required certification tests, the contractor shall supply each unit with a certification sticker with the following information:

BSC’s, Animal Cage Changing & Bedding Disposal Stations, Grossing Stations and LAFWs:

Company name and address Unit make, model and serial number Report number Location (room number) Certification date Recertification date Technician signature

Chemical Fume Hood Testing and Certification.

The contractor shall test and certify each fume hood to manufacturer’s specifications as well as The American Conference of Government Industrial Hygienists (ACGIH) or American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE) 110 testing requirements.

The contractor shall provide ACGIH and ASHRAE 110 documents. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an Air Flow Monitor (AFM) or Air Flow Controller (AFC), the contractor shall confirm the unit is calibrated. If it is not calibrated appropriately, the contractor shall calibrate the AFM or AFC.

The contractor shall use NIST traceable or comparable calibrated equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, pass/fail grade for the airflow smoke pattern test and low flow alarm test. Any failures shall be reported directly to the VA Technical Representative.

For each unit passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Chemical Fume Hoods:

Company name and address Average face velocity Report number Safe sash height Location (room number) Certification date Recertification date Technician signature

For any unit that fails to pass required certification tests, the VA Technical Representative shall be notified immediately so that arrangement for repairs can be made. The contractor shall mark each failing unit or room with signage that states this unit is out of service until further notice.

IV: USP<797> and USP <800> Testing for Pharmacy Clean Rooms

HEPA Filter Leak Test The contractor shall perform a proper High Efficiency Particulate Air (HEPA) filter leak test of the room air supply HEPA filters. An aerosol photometer with linear or expanded logarithmic scale shall be used. The instrument shall be capable of indicating 100% upstream concentration with a minimum aerosol concentration of 10µg/L of polyalphaolefin (PAO) particles, or an equivalent fluid that provides the same particle size distribution. It shall also be capable of detecting an aerosol concentration in the downstream equal to 10-5 of the upstream concentration of the same particles. The sampling rate of air shall be 1 ft3/min. Probe area shall have a maximum open area of 1.7 in2 and a minimum dimension of 0.50 in.

An aerosol generator of the Laskin nozzle type shall be used to create an aerosol by flowing air through liquid PAO or equivalent substitute. When a Laskin nozzle generator is used, the compressed air supplied to the generator should be adjusted to a minimum of 23 psi.

The contractor shall calculate the upstream concentration and locate a point to introduce aerosol that will allow for adequate mixing.

Air Changes per Hour The contractor shall calculate the total room volume for each buffer and ante room semi-annually. A sketch of the room with dimensions, exhaust/supply diffuser locations, particle count (both viable and non-viable) locations and equipment locations shall be included in the report.

The contractor shall calculate Air Changes Per Hour (ACPH) for each buffer and ante room and include the findings in the report. The negative pressure segregated compounding areas or drug storage areas shall all be tested for air changes per hour and shall be included in the report. In the event that a room does not meet USP<797> or USP <800> requirements for ACPH, the VA Technical Representative shall be informed immediately. The ACPH from HVAC, ACPH from the PEC and total ACPH must be documented on the report. Rooms at facility that require this to be reported include:

1. A93-5 Satellite C-SCA room

2. A94-5 HD Storage

3. A95-5 Satellite Ante room

4. A95A-5 HD Buffer

5. A95B-5 Satellite non-HD Buffer Room

6. B93-5 Pharmacy C-SCA

7. B93A-5 Pharmacy non-HD Buffer room

8. B93B-5 Pharmacy Ante room

Pressure Requirements The contractor shall include in their report differential pressure reading from each C-SCA, Buffer, Ante HD storage and HD receiving Rooms to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797>/<800>. The contractor shall report all pressures to an accuracy of four decimal places (i.e, “0.0001”). The pressure differential must be documented for the following spaces:

1. A93-5 Satellite C-SCA room

2. A94-5 HD Storage

3. A95-5 Satellite Ante room

4. A95A-5 HD Buffer

5. A95B-5 Satellite non-HD Buffer Room

6. B93-5 Pharmacy C-SCA

7. B93A-5 Pharmacy non-HD Buffer room

8. B93B-5 Pharmacy Ante room

Viable Environmental Sampling The contractor shall perform viable environmental air sampling semiannually (e.g. every 6 months) for fungi and bacteria using high volume sampling pumps capable of achieving and maintaining the required minimum flow rate of 28 liters per minute and impaction samplers to conduct the sampling. A minimum of 1,000 liters of air shall be tested at each location in order to maximize sensitivity.

The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates. Both bacteria and fungi surface samples will also be collected within each space. Any laboratory results equal to or greater than the action level will require notification of the VA Technical Representative immediately upon receipt of results. The contractor shall provide a means for the facility to complete monthly surface sample testing for the 10 months within the year that the contractor does not complete this as part of the semiannual certification visit. The contractor shall provide a means for the facility to complete initial and semiannual surface sampling in accordance with the media fill testing completed for all new employees and on a rolling semiannual basis for each employee. The contractor shall provide a means for the facility to complete initial and semiannual gloved fingertip and media fill testing on a rolling semiannual basis for each employee

The following spaces and equipment require surface and air sampling for fungus and bacteria:

1. A93-5 Satellite C-SCA room and BSCs (2)

2. A95-5 Satellite Ante room

3. A95A-5 Satellite HD Buffer Room and BSC (1)

4. A95B-5 Satellite non-HD Buffer Room and LAFW (1)

5. B93-5 Pharmacy C-SCA room and BSC (1)

6. B93A-5 Pharmacy non-HD Buffer room and LAFW (1)

7. B93B-5 Pharmacy Ante room

Smoke Pattern Testing Airflow smoke pattern testing will be completed in accordance with CAG-003-2006 for each pharmacy PEC and HD receiving room semiannually. The testing will be video-recorded, and the contractor must have experience in collecting these videos. The facility will provide a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC. This may mean that the contractor provides movement of the smoke source and/or multiple camera angles to ensure that each compounding task Is effectively shown to be completed within an area receiving first air. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and also the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2006.

The following PECs require smoke pattern testing:

1. A93-5 Satellite C-SCA BSCs (2)

2. A94-5 non-Sterile CVE (1)

3. A95B-5 Satellite non-HD LAFW (1)

4. A95A-5 Satellite HD BSC (1)

5. B93-5 Pharmacy C-SCA BSC (1)

6. B93A-5 Pharmacy non-HD BSC (1)

Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the International Standards Organization (ISO)/Draft International Standards (DIS) 14644-1.2 standard. The contractor shall be responsible for supplying Annex A in the ISO/DIS 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any LAFW and BSC.

ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or ante area providing access to negative pressure buffer room (setting found in satellite pharmacy)

ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any ante area providing access to positive pressure buffer room only (setting found in main pharmacy)

Particle counts are required in:

1. A93-5 Satellite C-SCA BSCs (2)

2. A95-5 Satellite Ante room

3. A95A-5 Satellite HD Buffer Room and BSC (1)

4. A95B-5 Satellite non-HD Buffer Room and LAFW (1)

5. B93-5 Pharmacy C-SCA BSC (1)

6. B93A-5 Pharmacy non-HD Buffer room and BSC (1)

7. B93B-5 Pharmacy Ante room

Report Requirements All of the following information shall be included in the report for clean room certification.

Pass/Fail notifications shall be included on a per test basis where applicable.

Room number and/or location Room type (e.g. oncology buffer room) Date of testing Date of next required certification Standards used to test room Notes Room sketch (location of supply/exhaust diffusers, equipment, room dimensions) Total room area and volume Room humidity and temp Air changes per hour Pressure differential Nonviable particle counts Viable particle count analysis Photo of viable particle test location in room (both surface and air sample locations) Video of smoke testing performed in area(s)

Copy of lab report Findings and recommendations

The contractor shall include 2 extra site visits each contract year in order to accommodate recertification requirements and/or repairs. Under no circumstance will repairs be accomplished by the contractor unless specifically covered under the contract.

Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semi-annually (e.g. every 6 months). The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs. Retesting, if required to mitigate any contamination found over a locally established action level, will be done by the Sioux Falls VAHCS.

The drugs required for testing include:

Cyclophosphamide Doxorubicin HCL Etoposide Irinotecan HCL Paclitaxel Cisplatin Carboplatin Oxaliplatin 5-Fluorouracil Gemcitabine Platinum-containing drugs Additional Drugs o Additional drugs may be requested based upon identified need per site.

o Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

Site will determine which areas will be tested each time but will include samples taken from the following locations:

Interior of PEC and equipment contained in it (i.e. camera).

Surfaces in staging or work areas near PEC Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area) Areas immediately outside the hazardous drug buffer room or C-SCA Patient administration areas

Repairs If equipment deficiencies are found during the certification process, the Contactor shall furnish the COTR with a written estimate of the cost to make necessary repairs. Contractor shall also provide a comparison quote to the COTR for what that item would have cost for commercial pricing so Government has basis for making price fair and reasonableness determination, or as alternative, Contractor shall provide a quote provided to another federal agency for similar item for determination purposes. The

Contracting Officer shall issue a bilateral contract modification to increase funding for this line item per coordination with COTR, that includes supporting documentation as cited above.

Required Services and Equipment List. See SIOUX FALLS VAHCS EQUIPMENT LISTING ATTACHMENT for a detailed list of equipment and tasks required.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVI

CES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

1.00 EA _______________

Base Year - Services to certify pharmacy spaces and pahrmacy, lab, and research equipment to maintain certifications.

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H266 - Equipment and Materials Testing - Instruments and Laboratory Equipment

Option Year 1 - Services to certify pharmacy spaces and pharmacy, lab, and research equipment to maintain certifications. POP 11/ 01/2025 to 10/31/2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Option Year 2 - Services to certify pharmacy spaces and pharmacy, lab, and research equipment to maintain certifications. POP 11/ 01/2026 to 10/31/2027 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Option Year 3 - Services to certify pharmacy spaces and pharmacy, lab, and research equipment to maintain certifications. POP 11/01/2027 to 10/31/2028 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

Option Year 4 - Services to certify pharmacy spaces and pharmacy, lab, and research equipment to maintain certifications. POP 11/01/2028 to 10/31/2029 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services

GRAND TOTAL _______________

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

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

(1) The schedule of supplies/services.

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

(3) The clause at 52.212-5.

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

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

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

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

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

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

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

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

(End of Clause)

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

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

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

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause)

C.5 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

(a) Definition. for the Department of Veterans Affairs, ‘‘Service-disabled Veteran-owned small business concern or SDVOSB’’:

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.201, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term ‘‘Service-disabled Veteran’’ means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(3) The term ‘‘small business concern’’ has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term ‘‘small business concern owned and controlled by Veterans with service-connected disabilities’’ has the meaning given the term ‘‘small business concern owned and controlled by service-disabled veterans’’ under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)).

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or ‘‘similarly situated’’ (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219–75 or 852.219–76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/ VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

(2) Supplies/products.

(i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted. Refer to 13 CFR 125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database.

(4) Special trade construction contractors. In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, may be paid to firms that are not certified SDVOSBs listed in the SBA certification database.

(5) Subcontracting. An SDVOSB subcontractor must meet the NAICS size standard assigned by the prime contractor and be certified and listed in the SBA certification database to count as similarly situated. Any work that a first tier SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, the cost of materials is excluded and not considered to be subcontracted. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the portion of the contract with the preponderance of the expenditure upon which the assigned NAICS is based. For information and more specific requirements, refer to 13

CFR 125.6.

(e) Required limitations on subcontracting compliance measurement period. An SDVOSB shall comply with the limitations on subcontracting as follows:

[] By the end of the base term of the contract or order, and then by the end of each subsequent option period; or

[] By the end of the performance period for each order issued under the contract.

(f) Joint ventures. A joint venture may be considered eligible as an SDVOSB if the joint venture complies with the requirements in…