36C24724Q0024.pdf

PDF 759 KB Posted Oct 11, 2023

Attached to: PHARMACEUTICAL COMPOUNDED STERILE PREPARATIONS USP 797 Certification Federal contract opportunity
Solicitation number: 36C24724Q0024
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 7

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Written by GovTribe AI · Dec 21, 2023

This is a solicitation for pharmaceutical compounded sterile preparations USP 797 certification services. The Department of Veterans Affairs VISN 7 Network Contracting Office is seeking a contractor to test and certify sterile compounding areas at the Atlanta VA Health Care System to ensure sterilization of drugs used in compounding sterile preparations. Services include biannual and monthly certification testing, recertification in response to issues, and emergency maintenance. The base period of performance is November 1, 2023 to October 31, 2024 with four one-year option periods. Pricing is fixed price by CLIN for certification tests, controls, repairs and replacement parts.

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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

36C24724Q0024

Terrence McMillan terrence.mcmillan@va.gov 10-16-2023

15:00 EDT

36C247 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

541380

$19 Million

N/A

See Delivery Address

36C247

Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Inpatient Pharmacy USP 797 Certification

The contractor shall furnish labor, parts, supplies and equipment necessary to test and certify USP 797 797 (Pharmaceutical Compounding-Sterile Preparations) compliant sterile compounding areas to ensure the sterilization of drugs that are used in compounding sterile preparations. Environmental sampling of viable and non-viable particle testing is included in the compliance testing. Per USP 797 standard, certification testing must be performed by a certified CETA (Controlled Environment Testing Association Contractor.

Base Year: 11/1/2023-10/31/2024 Option Year 1: 11/1/2024-10/31/2025 Option Year 2: 11/1/2025-10/31/2026 Option Year 3: 11/1/2026-10/31/2027 Option Year 4: 11/1/2027-10/31/2028

See CONTINUATION Page

X X

X 1

Terrence McMillan Contracting 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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

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

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

52.212-1 Instructions to Quoters – Commercial Products and Commercial Services (Nov 2021) 50

52.212-2 EVALUATION—SIMPLIFIED ACQUISITION PROCEDURES

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.216-1 TYPE OF CONTRACT (APR 1984)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C247 Terrence McMillan

VISN 7 Network Contracting Office

LaVista Business Park - Bldg A

2008 Weems Road

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 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

DESCRIPTION OF

SUPPLIES/SERVIC

QUANTIT

UNI

T UNIT PRICE AMOUNT

2.00 EA ________________

Biannual Certification (Every 6 months):

Contract Period: Base POP Begin: 11-01-2023 POP End: 10-31-2024

LOCAL STOCK NUMBER: CLIN0001

10.00 EA ________________

Each month excluding the months for Biannual testing will be surface tested along with the necessary sample control. Provide Viable Sampling, Surface; with Colony ID = Qty 9 Provide Viable Sample - Control = Qty 1 Contract Period: Base POP Begin: 11-01-2023

LOCAL STOCK NUMBER: CLIN0002

Tests appropriate to certify a cleanroom used in sterile compounding.

USP requires all environmental controls to be certified at least every 6 months or whenever PECs or compounding devices within PECs are relocated/altered or when major service to the facility is performed. An additional Qty (2) Biannual Certification's will be provided per annual obligation in the likelihood that PECs are relocated/altered or when major service to the facility is performed and/or the first certification fails.

Contract Period: Base POP Begin: 11-01-2023

LOCAL STOCK NUMBER: CLIN0003

An additional Qty (2) Monthly Certification's will be provided per annual obligation in the likelihood that there is a failure upon initial testing.

Contract Period: Base POP Begin: 11-01-2023

LOCAL STOCK NUMBER: CLIN0004

1.00 EA ________________

An additional Qty (1) Recertification will be provided in response to identified problems with end products or staff technique or issues with compounded sterile products (CSPs), observed compounding personnel work practices or patient -related infections (where the CSP is considered as a potential source of the infection).

Contract Period: Base POP Begin: 11-01-2023

LOCAL STOCK NUMBER: CLIN0005

Contractor to provide emergency labor and materials needed to make repairs to hoods and/or replacement of HEPA and BAG filters to include cleaning of systems to keep the Pharmaceutical Compounding-Sterile Preparations operational. The mechanical equipment that is affixed to the building such as HVAC, reheat systems, sensors and controls are not covered under this contract line-item number.

Contract Period: Base POP Begin: 11-01-2023

LOCAL STOCK NUMBER: CLIN0006

Biannual Certification (Every 6 months):

Contract Period: Option 1 POP Begin: 11-01-2024 POP End: 10-31-2025

Tests appropriate to certify a cleanroom used in sterile compounding.

Contract Period: Option 1

POP Begin: 11-01-2024

An additional Qty (2) Monthly Certification's will be provided per annual obligation in the likelihood that there is a failure upon initial testing.

Contract Period: Option 1 POP Begin: 11-01-2024

Biannual Certification (Every 6 months):

Contract Period: Option 2 POP Begin: 11-01-2025 POP End: 10-31-2026

Each month excluding the months for Biannual testing will be surface tested along with the necessary sample control. Provide Viable Sampling, Surface; with Colony ID = Qty 9 Provide Viable

Sample - Control = Qty 1 Contract Period: Option 2 POP Begin: 11-01-2025

Tests appropriate to certify a cleanroom used in sterile compounding.

Contract Period: Option 2 POP Begin: 11-01-2025

An additional Qty (2) Monthly Certification's will be provided per annual obligation in the likelihood that there is a failure upon initial testing.

Contract Period: Option 2 POP Begin: 11-01-2025

Contract Period: Option 2

POP Begin: 11-01-2025

Biannual Certification (Every 6 months):

Contract Period: Option 3 POP Begin: 11-01-2026 POP End: 10-31-2027

Tests appropriate to certify a cleanroom used in sterile compounding.

Contract Period: Option 3 POP Begin: 11-01-2026

An additional Qty (2) Monthly Certification's will be provided per annual obligation in the likelihood that there is a failure upon initial testing.

Contract Period: Option 3 POP Begin: 11-01-2026

Biannual Certification (Every 6 months):

Contract Period: Option 4 POP Begin: 11-01-2027 POP End: 10-31-2028

Tests appropriate to certify a cleanroom used in sterile compounding.

Contract Period: Option 4 POP Begin: 11-01-2027

An additional Qty (2) Monthly Certification's will be provided per annual obligation in the likelihood that there is a failure upon initial testing.

Contract Period: Option 4 POP Begin: 11-01-2027

GRAND TOTAL ________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: 1670 Clairmont Rd Decatur, GA 30033

USA

2.00 11/1/2023- 10/31/2028

MARK

FOR:

Edouard Lemay

(404) 321-6111 ext. 204960 Edouard.Lemay@va.gov

A. GENERAL INFORMATION

1. Title of Project: Inpatient Pharmacy USP 797 Certification

2. Scope of Work:

The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. Furnish labor, parts, supplies and equipment necessary to test and certify USP 797 (Pharmaceutical Compounding-Sterile Preparations) compliant sterile compounding areas to ensure the sterilization of drugs that are used in compounding sterile preparations. Environmental sampling of viable and non-viable particle testing is included in the compliance testing. Per USP 797 standard, certification testing must be performed by a certified CETA (Controlled Environment Testing Association) Contractor. The Inpatient Pharmacy Pharmaceutical Compounding-Sterile Preparation area is located at the Atlanta VA Health Care System, 1670 Clairmont Road, Decatur, GA 30033

- Biannual Certification (Every 6 months):

Provide TAF – Airflow Only = Qty 11 Provide Room Pressure Readings = Qty 4 Provide Room Air Exchange Rate Calculations = Qty 4 Provide Particle Count (per location) = Qty 20 Provide HD Storage Room – Test (Airflow, RAER, and DP) = Qty 1 Provide Biosafety Cabinet (A2) – Test = Qty 3 Provide Biosafety Cabinet – Particle Count = Qty 3 Provide Biosafety Cabinet – Airflow Visualization Study = Qty 3 Provide Laminar Flow Unit – Test = Qty 2 Provide Laminar Flow Unit – Particle Count = Qty 2 Provide Laminar flow Unit – Air Visualization Study = Qty 2 Provide Viable Sampling, Airborne; with Colony ID = Qty 9 Provide Viable Sampling, Surface; with Colony ID = Qty 9 Provide Viable Sample – Control = Qty 2

- Monthly Certification:

Each month excluding the months for Biannual testing will be surface tested along with the necessary sample control.

Provide Viable Sampling, Surface; with Colony ID = Qty 9 Provide Viable Sample – Control = Qty 1

- Biannual Certification (Out of Cycle – Maintenance, Construction and/or Failure) Tests appropriate to certify a cleanroom used in sterile compounding. USP requires all environmental controls to be certified at least every 6 months or whenever PECs or compounding devices within PECs are relocated/altered or when major service to the facility is performed.

An additional Qty (2) Biannual Certification’s will be provided per annual obligation in the likelihood that PECs are relocated/altered or when major service to the facility is performed and/or the first certification fails.

- Monthly Certification (Out of Cycle – Failure of Initial Test) An additional Qty (2) Monthly Certification’s will be provided per annual obligation in the likelihood that there is a failure upon initial testing.

- Recertification (Out of Cycle) An additional Qty (1) Recertification will be provided in response to identified problems with end products or staff technique or issues with compounded sterile products (CSPs), observed compounding personnel work practices or patient -related infections (where the CSP is considered as a potential source of the infection).

- Emergency Maintenance and Replacement of Filters Contractor to provide emergency labor and materials needed to make repairs to hoods and/or replacement of HEPA and BAG filters to include cleaning of systems to keep the Pharmaceutical Compounding-Sterile Preparations operational. The mechanical equipment that is affixed to the building such as HVAC, reheat systems, sensors and controls are not covered under this contract line-item number.

All testing and certifications conducted will include but not limited to the most recent CETA CAG 003 standards, VHA Directive 1108.12, and Joint Commission Accreditation Standards.

3. Background:

Sterile compounding facilities must maintain a specific minimum standard of quality within their facilities and compounding equipment. The certification of sterile compounding facilities and equipment is a complex process that requires communication and planning between the Designated Person of the pharmacy and a representative of the certification company. USP 797 and 800 standards have are currently being amended with additional regulations and requirements for primary and secondary engineering controls for compounding.

4. Performance Period:

[November 1st, 2023, to October 31st, 2028)

5. Type of Contract:

[Firm-Fixed-Price]

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kickoff meeting or has advised the contractor that a kickoff meeting is waived.

C. GENERAL REQUIREMENTS

Testing Guidelines:

The certification of sterile compounding facilities consists of several elements to accomplish the process. The first being cleanroom (SEC) certification and airflow visualization studies followed by certification of primary engineering controls (e.g., BSCs, Laminar airflow workbenches). All testing instrumentation used must be calibrated in accordance with IEST- RP-CC013 or manufacturer’s recommendation and be NIST traceable where possible.

All testing and certifications must be compliant with the most recent Controlled Environment Testing Association CETA guidelines and recommendations for the certification of sterile compounding facilities for USP compliance CETA CAG 003 standards.

Certifications included within this Statement of Work:

a. Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The Air Changes Per Hour (ACPH) from Heating, Ventilation, and Air Conditioning (HVAC), ACPH contributed from the Primary engineering Control (PEC), and the total ACPH must be documented on the certification report. Calibration of the room pressure gauges is an important component of air flow testing.

b. High Efficiency Particulate Air (HEPA) filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

c. Total particle count testing: Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment.

d. Total airborne particle count testing must be conducted in all classified areas during dynamic operating conditions to measure the performance of the engineering controls that are being used to provide the specified levels of air cleanliness (e.g., in the ISO Class 5 PEC and ISO Class 7 and 8 rooms).

e. Air Sampling: Evaluation of airborne microorganisms in the controlled air environments is performed for all compounding risk levels.

f. Total airborne particle sampling sites must be selected in all classified areas.

g. Surface sampling: Surface sampling is an important tool used to assist in maintenance of a suitably controlled environment for compounding CSPs.

h. ACPH from HVAC, ACPH from PEC, and total ACPH must be documented on the certification report.

i. Number of personnel present in each PEC and SEC during total particle-count tests and dynamic airflow smoke-pattern tests must be documented.

j. Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each

Primary engineering control (PEC) during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). A video must be provided with the test results.

1. The contractor shall develop detailed environmental monitoring for viable air and surface, sampling for the Atlanta VA Health Care System Pharmacy Sterile Compounding area, to determine potential existence of bacteria, and fungi.

2. The Compounding area includes a minimum of 9 locations: two (2) anterooms, one chemo room, 3 biological safety cabinets (BSCs), one buffer room, and two (2) laminar hoods. The current size of the rooms is Chemo Buffer Room=98.25ft2 (5), IV Buffer Room= 138.75 ft2 (5), Chemo Ante Room= 49.5ft2 (6).

3. A written report detailing the findings shall be provided to document sampling. A video must be provided with the test results of the dynamic airflow smoke pattern test.

4. If sample results/readings are outside (failed) the recommended levels, testing must be repeated.

5. All primary and secondary engineering controls are recommended to be certified to USP

797/800 and CETA CAG 003 standards.

6. All work must be scheduled and coordinated with the facility Associate Chief of Pharmacy, 404-321-6111 ext. 202750 prior to visiting the Atlanta VA Health Care System, 1670 Clairmont Rd., Decatur, GA 30033.

For All visits by Contractor:

Contractor will be required to sign in at the location designated by the Chief of Pharmacy and/or the designated POC after contract award before performing the necessary work described in the SOW. Upon completion of the testing and sampling, the contractor shall sign out of the designated area and leave a copy of any reports generated the day of with the designated POC/Chief of Pharmacy.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Description of Tasks and Associated Deliverables:

The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW. All tasks and deliverables will be provided to the Chief of Pharmacy, Sterile Compounding Facility Program Manager, Quality Assurance Pharmacist and the COTR. Some of the results from sampling take up to two weeks for the specific types of tests being conducted.

Deliverables:

• A signed copy of each semi-annual report of what tests were conducted and the results with-in two weeks of being tested.

• A signed copy of the semi-annual certification immediately upon completion of sampled results.

• A signed copy of each monthly report of what surfaces were sampled and the results with-in two weeks of being tested.

• A signed copy of each monthly certification immediately upon completion of sampled results.

Safety and License Requirements:

1. Contractor shall furnish all labor, certifications, materials, equipment, insurance, and supervision required to perform this work. Contractor shall take all precautions necessary to protect persons and property from injury and/or damage during performance of this contract.

Contractor shall be responsible for any injury to their employees as well as for any damages to personnel or Government property that occurs during the performance of this contract that is caused by the Contractor’s fault or negligence. Contractor shall insure that all areas where equipment is serviced under this contract are left in a clean, neat, and orderly condition.

2. The contractor will be responsible for ensuring that each service technician or assistant providing services under this contract is fully trained and completely competent to perform the required services covered by this contract; must be CETA and NSF certified.

3. Contractor’s personnel shall follow all applicable hospital policies while on site, i.e., smoking, sexual harassment, etc. The Contracting Officer and/or the COTR reserve the right to remove any of the Contractor’s personnel and refuse them permission to work on VAMC- Atlanta equipment for serious violations of hospital policies.

4. Contractor’s service personnel shall wear all required PPE personal protective equipment where necessary and visible identification while on the premises of the VAMC-Atlanta. A picture ID is preferred.

E. SCHEDULE FOR DELIVERABLES

• Month of November = 1st Semi Annual testing and certification results

• Month of May = 2nd Semi Annual testing and certification results

• Month of December = Monthly testing and certification results

• Month of January = Monthly testing and certification results

• Month of February = Monthly testing and certification results

• Month of March = Monthly testing and certification results

• Month of April = Monthly testing and certification results

• Month of June = Monthly testing and certification results

• Month of July = Monthly testing and certification results

• Month of August = Monthly testing and certification results

• Month of September = Monthly testing and certification results

• Month of October = Monthly testing and certification results

F. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

G. REPORTING REQUIREMENTS

Contractor will provide an electronic record via email to the following staff and Chief of Pharmacy after each sampled result and test after the two-week time frame for each month of service to include both biannual services.

Chief of Pharmacy:

Jeff Denner, Pharm.D., MBA, MHA Chief, Pharmacy Service Atlanta VA Medical Center Jeffrey.Denner@va.gov

Facility Program Manager – Sterile Compounding:

Jordan Carroll, BS, PharmD Facility Program Manager – Sterile Compounding Atlanta VA Medical Center Jordan.Carroll@va.gov

Pharmacy Quality Assurance Manager:

Briana Reed, PharmD, MHSA Pharmacy Quality Assurance Manager Atlanta VA Medical Center Briana.Reed@va.gov

COTR:

Edouard LeMay Engineering Service Edouard.LeMay@va.gov

H. INVOICE FORMAT

mailto:Jeffrey.Denner@va.gov mailto:Jordan.Carroll@va.gov mailto:Briana.Reed@va.gov mailto:Edouard.LeMay@va.gov

An itemized statement is required. The invoice format for recurring charges will match the pricing schedule, to allow VA certification of invoice against the contract price. Non-recurring charges will be itemized individually.

Invoices will be submitted into Tungsten per the Contractor with an itemized statement that will include but is not limited to:

• Invoice From: Contractor Information and address

• Vendor Code

• Contract Number

• Purchase Order Number

• Invoice Number

• Contractor Point of Contact

• Contracting Officer Technical Representative (COTR)

• Itemized Services and Respective Cost for each item

• Dates of Service

• (CLIN) Contract Line-Item Number

• Type of Service (Biannual or Monthly)

I. GOVERNMENT RESPONSIBILITIES

• Provide necessary parking for contractors on-site.

• Provide necessary toiletries to contractors on-site.

• Provide necessary escorts for contractor access throughout the facility.

• Ensure contractors are signed into and out of designated areas.

• Manage Payment Schedules per CLIN

J. CONTRACTOR EXPERIENCE REQUIREMENTS (Standard mandatory language for all task orders) The contractor shall submit certified CETA (Controlled Environment Testing Association), NSF (National Sanitation Foundation) documentation to the COTR and Chief of Pharmacy listed within this document for their records prior to award.

If a key person becomes unavailable to complete the SR, proposed Substitutions of key personnel shall be made only if approved by the COTR and Project Manager.

The C&A requirements do not apply, and that a Security Accreditation Package is not required.

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.

(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.

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.

(D) Contractor points 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. 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 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

(End of Provision)

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 30 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.

(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 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

(a) Definitions. As used in this clause—

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

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

This office may be different from the office issuing the payment.

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause.

Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests.

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

(5) Payment…

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