Minneapolis VAMC Pharmacy Clean Room Solicitation 36C26322Q0423.docx

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S201--Clean/Decontaminate Rooms & Pharmacy - MPLS Full and Open
Solicitation number
36C26322Q0423
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This solicitation is for pharmacy clean room decontamination and cleaning services at the VA Minneapolis Medical Center. The contractor shall provide monthly cleaning of specified ISO-classified clean room areas in accordance with USP Chapters 797 and 800 standards. The contract term is for a minimum of 12 months with a maximum of 5 years. Offerors must hold ISSO 9001:2015 certification and certification to clean ISO 7/8 clean rooms. The contractor must submit a quality control plan detailing clean room maintenance procedures. Offers are due by April 21, 2022 and shall include technical and pricing proposals as well as past performance references. Pricing shall be provided for line items of monthly cleaning services by area. The Department of Veterans Affairs Veterans Health Administration VISN 23 is the contracting agency.

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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.

DUNS:

DUNS+4:

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

36C26322Q0423 04-07-2022 Jeffrey Brown Jeffrey.Brown8@va.gov

04-21-2022

5:00 PM

CDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

X

561720 $19.5 Million

N/A

Department of Veterans Affairs Minneapolis VA Medical Center One Veterans Drive, Building 70

Minneapolis MN 55417

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page This acquisition is for providing Pharmaceutical Clean Room Cleaning in accordance with the Statement of Work below.

Prior to submitting a quote, please review all documentation within.

Review and follow INSTRUTIONS TO OFFERORS in Provision 52.212-1 Addendum.

$0.00

See CONTINUATION Page

Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES1
SECTION B - CONTINUATION OF SF 1449 BLOCKS3
B.1 CONTRACT ADMINISTRATION DATA3
B.2 PRICE/COST SCHEDULE4
B.3 STATEMENT OF WORK5
B.4 CONTRACTOR QUALITY CONTROL AND ASSURANCE REQUIREMENTS:10
VHA Supplemental Contract Requirements for Combatting COVID-1911
SECTION C - CONTRACT CLAUSES13
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)13
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)19
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)19
C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)19
C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)21
C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)21
C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION)22
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS30
See attached document: P07 DOL WD 2015-4945 R18 12.27.2021.30
SECTION E - SOLICITATION PROVISIONS31
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)31
ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS35
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)37
E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)39
52.212-2 EVALUATION—SIMPLIFIED ACQUISITION PROCEDURES40
E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)41

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 36C263

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

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
[X]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[]

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.

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

B.2 PRICE/COST SCHEDULE

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12.00
MO
_______________
__________________

Pharmacy Clean Room Decontamination/Cleaning Services in Accordance with the Statement of Work PRINCIPAL NAICS CODE: 561720 - Janitorial Services PRODUCT/SERVICE CODE: S201 - Housekeeping - Custodial Janitorial

12.00
MO
_________________
__________________

Pharmacy Clean Room Decontamination/Cleaning Services in Accordance with the Statement of Work

12.00
MO
_______________
__________________

Pharmacy Clean Room Decontamination/Cleaning Services in Accordance with the Statement of Work

12.00
MO
_______________
__________________

Pharmacy Clean Room Decontamination/Cleaning Services in Accordance with the Statement of Work

12.00
MO
________________
__________________

Pharmacy Clean Room Decontamination/Cleaning Services in Accordance with the Statement of Work

GRAND TOTAL
__________________

36C26322Q0299 (End of Clause) Page 1 of Page 1 of

B.3 STATEMENT OF WORK

General Contractor shall provide pharmacy clean room decontamination and cleaning services in support of the VA Minneapolis Pharmaceutical Compounding Areas to meet cleaning requirements of USP 797 and USP 800 at the VA Minneapolis Minnesota campus, Building 70. The Minneapolis VA Medical Center shall provide all chemicals, equipment and garb (other than respiratory PPE). All services shall be performed in accordance with the terms and conditions specified in this solicitation and in compliance with the statement of work. The contract will cover a minimum of twelve (12) months from start date, with a maximum of 5 years.

The company must be regularly established in the business of Pharmaceutical Clean Room Cleaning, be ISSO 9001:2015 certified, be able to provide primary services under the condition and scope of work, in the judgment of the Contracting Officer, are financially responsible, and show evidence of their reliability, ability, experience, facilities and personnel directly employed or supervised by them to render prompt, detailed service in accordance with USP Chapters 797 & 800, and satisfactory standards. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required. The contractor shall have a robust training program to include classroom training, cleanroom cleaning protocols, cross-contamination procedures, and an on-going education for all employees.

Certified contractor personnel shall be required for performance of work under this contract. Each servicemen designated by the Contractor to perform work under this contract shall be cleared for access through restricted areas of customer’s facilities. The Contractor shall conform to all Federal, State, Health Authority and local regulations governing the servicing and compliance to meet USP Chapters 797 & 800 as well as use of chemicals and equipment used. The company must furnish a copy of state certification to perform said service contracted. The company must provide documentation to the Contracting Officer prior to performing any work under the contract. Certification shall mean a current certificate of competency in compliance with industry standards including ASTM E2042 –and USP 797 & USP 800. Company servicemen must be certified to clean ISO 7/8 clean rooms.

All company servicemen shall have their name and their company’s name indicated on their uniform or a name badge at all times, so they are easily recognizable as a contractor employee. In cases when contractor has two or more employees reporting to work, under this contract one of these employees’ shall be designated as a supervisor/foreman. The supervisor shall be fully certified and knowledgeable of the location and work site to perform USP sterile room cleaning. On each visit the company servicemen shall report to the Contracting Officer Representative or the Contracting Officer’s designated representative prior to performing services.

Description of Services:

Clean Room Cleaning (Sterile Maintenance) Cleanroom Cleaning Services must comply with industry standards ASTM E2042 and USP Chapters 797 USP 800. Cleaning will be performed in BR-118 Ante Room, 195.2 sq. ft. (ISO 7), BR-118B Buffer Room, 292.2 sq. ft. (ISO 7), BR-118C Hazardous Drug (HD) Buffer Room, 260 sq. ft. (ISO 7), BR-119 HD Storage Room, 206.8 sq. ft. (unclassified), 2R-103a OR Satellite Buffer Room, 50.5 sq. ft., 2R-103b OR Satellite Buffer Room, 101.3 sq. ft. and 3F-117a Containment Segregated Compounding Area (C-SCA), 187.5 sq. ft. (unclassified).

The below areas are all expected to be cleaned on monthly basis:

BR-118 – Time and day of the week TBD BR-118B – Time and day of the week TBD BR-118C Saturday & Sunday anytime, Monday-Friday 0001-6am and 5pm BR-119 Sunday-Saturday any hours 2R-103a & b Mon – Fri 7:30am to 3:00pm (or Mon-Fri 3pm-11pm if arranged ahead of time and works for both parties) excluding federal holidays 3F-117a Mon – Fri 7:30am to 3:00pm (or Mon-Fri 3pm-11pm if arranged ahead of time and works for both parties) excluding federal holidays Schedule Needs to be approximately 1 month apart for monthly cleaning (give or take 7 days). Need prior notice for when they are coming.

Will need fit testing and wear full face respirator or PAPR with organic vapor/acid gas cartridge/P100 filter, in areas where Acetic Acid levels are exceeded.

Contractor must check in with IV room staff prior to starting any cleaning and check out after service is completed. All personal servicing MVAHCS must complete appropriate clearance through MVAHCS security process. Contracted workers must be on MVAHCS access roster prior to entering Pharmacy Compounding space.

The cleaning of all cleanroom areas will be accomplished in accordance with USP 797, USP 800 and ASTM E2042.

The work and services include the following:

1. Monthly: Cleaning will be performed with a sporicidal detergent cleaner chosen by the MVAHCS. After proper dwell time, select items (generally metal and glass surfaces) will be cleaned with sterile isopropyl alcohol (sIPA)

2. Cleaning must be done per procedures outlined in facility SOPs (SOPs will be provided to vendor)

a. General cleaning procedure

i. Non-HD areas: sporicidal cleaning agent applied once with 3 minute dwell

ii. HD areas: sporicidal cleaning agent applied twice with 3 minute dwell on second pass

iii. Non-HD and HD area: sIPA applied after sporicidal dwell time on all metal and glass to remove sporicidal residue.

3. Cleaning Tools must be cleaned with sporicidal cleaner (with proper dwell time) followed by sIPA both before beginning cleaning and after cleaning is complete.

4. Cleaning Solutions: Currently, MVAHCS uses Ready to Use (RTU) cleaning solutions. MVAHCS reserves the right to change to a concentrated cleaning product(s). If mixing is required, the contractor will mix all chemicals fresh on site and document preparation in accordance with facility SOP.

5. Ceilings, Walls, Doors and Windows

a. Ceilings and walls are cleaned with sporicidal cleaning agent only. Windows, window trim, and doors are cleaned with sporicidal cleaning agent followed by sIPA as they are glass and/or metal.

b. Sporicidal cleaning agent will be applied to mop head. Ceilings and walls will be mopped in a unidirectional fashion utilizing overlapping strokes. Mop head will be rewetted as necessary to ensure surfaces remain sufficiently wet for the proper dwell time. See SOP for detailed procedures.

c. Mop head will be changed when visibly soiled >15%

d. Sprinkler heads are not to be cleaned or touched by vendor.

6. Carts, Counters, Shelves, Bins, Trash cans, Sharps Containers, HD Waste Containers Refrigerator, Freezer, Outside of LAFW/BSCs, etc.

a. Clean all surfaces of carts, counters, shelves, trash cans, outside of sharps containers, outside of HD waste containers, outside of refrigerator, freezer with sporicidal cleaning agent (2 passes of sporicidal in HD area) with proper dwell. Metal and glass will be cleaned with sIPA after sporicidal dwell time is met.

i. Items containing chemo or prescription drugs will be cleaned by MVAHCS employees

b. Clean all surfaces of bins and contents of bins which contain non-critical solutions and supplies with sporicidal cleaning agent (2 passes of sporicidal in HD area) with proper dwell. Metal and glass will be cleaned with sIPA after sporicidal dwell time is met.

i. Any bins containing chemo or prescription drugs will be cleaned by MVAHCS employees

7. Hoods: Laminar Airflow Workbenches (LAFWs) and Biological Safety Cabinets (BSCs)

a. Interior of hoods will be cleaned by MVAHCS pharmacy personnel

b. Exterior of hoods will be cleaned by vendor

8. Sink Drain in Anteroom

a. Sporicidal cleaning agent will be poured into sink drain and allowed to dwell for 10 minutes then flushed with water for 2 minutes.

9. Floors

a. Floors are cleaned with sporicidal cleaning agent from cleanest to dirtiest area following procedure outlined in SOP. Repeat a second pass with 3-minute dwell in HD areas.

10. All cleaning supplies must be disposed of properly.

a. Saturated and/or used wipers and mop heads may be required to be placed in ziplock bags prior to disposal to contain odors.

b. Cleaning supplies used in HD compounding areas are disposed in hazardous waste containers.

11. Documentation:

a. Record cleaning in Simplifi software, web based application.

b. Document cleaning agents used (product, manufacturer, lot number, expiration)

12. Emergency Provision – Up to 10 times a year.

a. Terminal cleaning is generally done in response to known contamination of an area with the intent to fully clean the entire space in one period in order to remove all contamination prior to use of the room.

b. This may be in place of monthly cleaning or in addition to monthly cleaning, depending on when the incident occurs. It would require that the cleaning be done from beginning to end with no compounding during cleaning session (in some rooms this may be done over consecutive days).

c. This will need to be arranged between the vendor and the MVAHCS pharmacy on an as-needed basis. Additional charges may be incurred if additional cleaning is required.

d. In areas open for compounding during the period of cleaning, there may occasionally be a need to compound an emergent compounded sterile product. When this occurs, cleaning will be halted so that the compounding can occur (compounding and cleaning cannot be done at the same time)

13. Monitoring: MVAHCS will do environmental monitoring to verify appropriate cleaning of cleanroom areas. If results are out of allowable limits per USP 797, MVAHCS will work with vendor to investigate the situation to identify the potential cause and implement corrective actions to remediate the issue.

Garb / Contracted Employee Conduct

1. Requirements for Contracted Cleaning Employees

a. Personal hygiene and garbing are essential to maintain microbial control of the environment. Contacted cleaning staff must maintain proper personal hygiene to minimize the risk of contaminating the sterile compounding environment.

b. Cleanroom garb that is required for entry into the cleanroom suite/SCA will be provided by MVAHCS (includes mask, beard cover, headcover, shoe covers, gown(s), gloves)

c. Hand hygiene and garbing will be done per facility SOP

d. Contracted cleaning employees will wear MVAMC supplied scrubs in the cleanroom

i. Contracted employee must change into scrubs at the start of shift and change out of scrubs before leaving facility

ii. Scrubs are not allowed to be worn outside

e. Contracted cleaning employees will wear socks that cover above the ankles

f. Personal outer garments such as sweaters, vests, scarves, or jackets must be removed prior to entering the cleanroom suite/C-SCA.

g. Eyeglasses will be cleaned before entering the anteroom/C-SCA

h. Fingernails will be kept neat and trimmed as per SOP

i. Training and evaluation/competency for hand hygiene and donning and doffing of garb by contracted cleaning personnel will be done by MVAMC IV Room staff.

j. Contracted cleaning employees with rashes, oozing sores, conjunctivitis, respiratory infection, or recent tattoos are prohibited from entering the cleanroom suite/C-SCA.

k. Prohibited in cleanroom suite/C-SCA.:

i. Jewelry (including hand/wrist, neck, lip, eyebrow, ear, nose)

ii. Cosmetics (foundation, tinted moisturizer, eye shadow, mascara)

iii. Nail polish/gel and nail applique

iv. Eyelash extensions/artificial eyelashes

v. Food, drink, and gum are not allowed in cleanroom areas

vi. Electronic devices that are not used for compounding/VA assigned tasks cannot be taken into the anteroom or cleanroom. This includes cell phones, music players, earbuds, headphones, or other personal devices.

2. Personal Protective Equipment: The MVAMC requires use of respiratory protection when cleaning with agents that have OSHA/NIOSH limits. Not all spaces have been tested. Some spaces have exceeded limits. Testing is based on the number of personnel cleaning in a space at one time. If more personnel are cleaning in the space than when testing was done, respiratory PPE is required. Respiratory protection will be necessary in some areas/situations. The vendor will select, provide and fit test their employees with one of the following options:

i. An appropriate full face cartridge mask with organic vapor/acid gas cartridge/P100 filter full-facepiece chemical cartridge-type respirator

ii. An appropriate half face cartridge mask with organic vapor/acid gas cartridge/P100 filter in addition to goggles

iii. A powered air-purifying respirator (PAPR) mask with organic vapor/acid gas cartridge/P100 filter

Contractor Personnel Security Requirements:

Contractor employees who have access to the MVAMC, Minneapolis (Building 70) shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. The requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start of the contract, the Contractor will be responsible for the actions of the individuals who perform on the contract.

a. Position Sensitivity - The position sensitivity has been designated as low risk.

b. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.

c. Agency Responsibilities:

The Contracting Officer will initiate the Background Investigation request into the Security and Investigations Center (SIC).

d. Vendor Responsibilities:

The Contractor has two key responsibilities: getting all employees who will work in a VA facility electronically fingerprinted at a local VA hospital or police station and having those same employees fill out the E-QIP questionnaire that will be emailed to them once the contracting officer initiates the investigation.

When the request is submitted the Contractor Request Database will generate an "initial" email with the website link and instructions to all email addresses listed on the request worksheet. This email will indicate what level of investigation was requested and how to complete the process. This is not considered an initiated investigation at this point. A case is not initiated until we have received a complete security package from the contract employee and can forward that security package to OPM.

e. Time Frames:

Below is a breakdown by level of each investigation handled by the SIC. Times frames may vary due to OPM.

Low Risk (NACI) The case is only open for 30 days except in rare occasions when something in the person's background requires an extension. This investigation is done by mail and that is why we have to be so stringent with the paperwork. The average turn around on these cases is 45 days.

B.4 CONTRACTOR QUALITY CONTROL AND ASSURANCE REQUIREMENTS:

The Contractor will be required to provide their Quality Control and Assurance program. This program shall detail all steps required to maintain and continuously provide a clean room environment in accordance with published criteria for USP 797 Sterile Compounding areas.

The Government intends to take the Contractors Quality Control Plan and implement it in the Quality Assurance Surveillance Plan (QASP). Please see provision 52.212-1 for further instructions on how to submit to the Contracting Officer.

VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

1. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

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

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

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

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

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

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

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

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

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

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

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

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

(i) Payment.—

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

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

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

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 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 52.217-8 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 1 day of contract expiration.

(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 1 day of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 7 days 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 one (1) year.

(End of Clause) C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.] [] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[] 852.233–70, Protest Content/Alternative Dispute Resolution.

[] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[X] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

(End of Clause) C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

FAR Number
Title
Date
52.204-9
PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL
JAN 2011
52.204-13
SYSTEM FOR AWARD MANAGEMENT MAINTENANCE
OCT 2018
52.204-18
COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE
AUG 2020
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
NOV 2021
852.204-70
PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL
MAY 2020
852.242-71
ADMINISTRATIVE CONTRACTING OFFICER
OCT 2020

(End of Addendum to 52.212-4)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020) (DEVIATION)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209–6, Protecting the Government’s Interest When…

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