36C24120Q0338_2.docx

36C24120Q0338

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 ATTA

CHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNAT

URE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

650-20-4-7058-0029 36C24120Q0338 08-19-2020 Cory Dionne 860-666-6951 X8341 08-28-2020

4:30 PM

Department of Veterans Affairs Network Contracting Office 1 Contracting Officer (90C) 555 Willard Avenue, Building 3 Newington CT 06111 X 561720 $19.5 Million N/A X Department of Veteran Affairs Providence VAMC 830 Chalkstone Avenue Providence RI 02908-4734 Department of Veterans Affairs Network Contracting Office 1 Contracting Officer (90C) 555 Willard Avenue, Building 3 Newington CT 06111

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page This solicitation is a Request for Quotation for Pharmacy Cleanroom Cleaning services. The government intends to award a firm fixed price contract for a minimum of one year with 4 possible option years to follow. Contractor shall provide all necessary personnel, supervision, labor,equipment materials and disposal necessary to provide Cleanroom Cleaning services at Providence VAMC pursuant to the Performance Work Statement described herein.

Quoters shall carefully follow instructio ns included in evaluation criteria specified in section E( 52.212-2 Addenda) Pricing shall be identified in B.3 Price/Cost Schedule attached to the RFQ.

Wage Determination Number: 2015-4083 Revision Numbers: 13 Date Of Last Revision:

04/13/2020 beta.sam.gov All quotes shall be emailed to cory.dionne@va.gov Any quote not complaint with RFQ requirements will not be considered. Questions will not be accepted after 8/24/2020.

See CONTINUATION Page X X X Mercedes Blanton Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C241

Network Contracting Office 1 Contracting Officer (90C) 555 Willard Avenue, Building 3 Newington CT 06111

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp P.O. Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT

Pharmacy Cleaning and Decontamination

PART A – GENERAL INFORMATION

INTRODUCTION: The Providence VA Medical Center currently prepares and compounds necessary intravenous medications (and other sterile products) to our patients. As a healthcare facility, the pharmacy is required to provide these compounded products according to all relevant USP compounding guidelines including USP 797/800. To accomplish this, a multidisciplinary approach has been adopted to provide safe compounded medications. Included in this multidisciplinary approach is the requirement for routine IV cleanroom cleaning, decontamination and other related services (procurement of cleanroom consumable supplies). These services must be carried out according to Industry Standards and applicable USP guidelines.

BACKGROUND: The Providence VAMC Pharmacy Service wishes to establish a contract for weekly cleaning and decontamination of our sterile intravenous (IV) compounding areas and monthly terminal cleans. The contract is for the cleaning of the primary engineering controls (PECs), secondary engineering controls (SECs) and the negative pressure storage room. These areas must conform to USP 797/800 standards of operation, this not a general cleaning or janitorial requirement.

The Contractor shall provide all necessary supplies, chemicals, equipment, tools, garb, and supporting materials to successfully perform the necessary services to help PVAMC meet the compounding requirements of USP 797/800. All services shall be performed in accordance with the terms and conditions specified in this solicitation and in compliance with the Performance of Work Statement. The company must be regularly established in the business. The company must be able to provide primary services under the condition of scope of work. The company, in the judgement of the Contracting Officer, is financially responsible and shows evidence of their reliability, ability, experience, facilities and personnel directly employed or supervised by them to render prompt, detailed service in accordance with USP and industry standards. The contractor shall be licensed by the state or local health authority in those localities where licenses are required.

The vendor and its personnel performing the cleaning should be knowledgeable in the most current USP 797/800 requirements and be capable of improving the site’s cleanroom practice through disinfection techniques that meet the specified requirements. Each serviceperson 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, VA and local regulations governing the cleaning and be following USP guidance on usage of approved chemicals and equipment. The company must provide documentation to the Contracting Officer prior to performing any work under the contract. All chemicals (MSDS) or controlled substances used to perform service must be submitted and filed with the Contracting Officer’s Representative (COR). The company shall demonstrate competency in compliance with industry standards for USP 797. Company service personnel must be trained for disinfection of Secondary Engineering Controls (SECs) (i.e. buffer rooms, anterooms, storage rooms) and Primary Engineering Controls (PECs) (i.e. biological safety cabinets, CAI, CACI). {ISO 5/7/8}.

All company service personnel shall always have their company’s name indicated on their uniform or a name badge, 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 knowledgeable of the location and work site where the USP 797 sterile cleaning and related services are to be performed. On each visit the company serviceperson shall report to the COR or his designee prior to performing services.

SCOPE OF WORK: This contract will include the following locations, services, and equipment. Related services, such as IV consumable supplies, added by the covered service(s) will be included within this service contract. Quotes shall include identifiable pricing for each of the major aspects of the required services for the four (4) locations as follows:

I. Location & Equipment:

Providence VA Medical Center 830 Chalkstone Ave.

Providence, RI 02908

1. (Contingency) Inpatient Pharmacy, 2nd Floor, Building 1, Room 238B

A. Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238 (Anteroom and Prep Room)

· Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CAI

· Germfree Versaflow

Floor, ceiling and walls. Approximately 150 sq. ft. This area is to be used for preparation of IV antibiotics, IV admixtures and IV products that do not require the use of a BSC or CACI. This room utilizes a Compounding Aseptic Isolator (CAI).

B. Inpatient Pharmacy Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238A (Anteroom and Prep Room)- Contingency

· Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CACI

· Germfree Laminar Flow LFGI CACI

Floor, ceiling and walls. Approximately 150 sq. ft. This area is to be used for preparation of Hazardous agents, including Chemotherapeutic agents only in a Compounding Aseptic Containment Isolator (CACI).

2. New Inpatient Pharmacy Room, 2nd Floor, Building 1, Room 253

A. Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253B (Anteroom) and Room 253C (Prep Room)

· ISO 8, ISO 7 and ISO 5 for Ante room, Buffer Room and Laminar Flow Hood

· Baker EdgeGARD HF Horizontal Flow Clean Bench

Floor, ceilings and walls. Approximately 215 sq. ft. (Anteroom – 95 sq. ft. and IV Prep – 120 sq. ft.). This area is to be used for preparation of IV antibiotics, IV admixtures and IV products that do not require the use of a BSC or CACI. This room utilizes a Laminar Flow Hood.

B. Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253D (Anteroom), Room 253E (Prep Room), and Room 253F (Storage area).

· ISO 8, ISO 8, ISO 7 and ISO 5 for Storage Area, Ante room, Buffer Room and Biosafety Cabinet

· Baker SterilGARD E3 Class II, Type A2 Biological Safety Cabinet

Floor, ceilings and walls. Approximately 215 sq. ft. (Hazardous Anteroom – 100 sq. ft. and Hazardous IV Prep Area– 115 sq. ft.). This area is to be used for preparation of Hazardous agents, including Chemotherapeutic agents. This room utilizes a Biological Safety Cabinet (BSC).

II. Description of Services:

The required cleaning is to be performed to provide IV room cleaning services that will keep PVAMC Inpatient Pharmacy IV Cleanroom Suite cleanliness and sterility in full compliance with United States Pharmacopeia (USP) 797/800 standards and regulations. The scope of work includes cleaning, disinfecting, and applying a sporicidal agent to designated surfaces to remove organic and inorganic materials. This is completed usually with a cleaning agent; disinfecting, which involves destruction of microorganisms, usually with a chemical agent; applying a sporicidal agent to destroy bacterial and fungal spores; and applying sterile 70% Isopropyl Alcohol (IPA) to remove any residue. Hours of operation are Monday through Friday, (excluding holidays) between the hours of 7:00 am – 4:30 pm.

Contractor must log in when reporting to pharmacy to perform cleanroom service and log out after service is conducted. All personnel servicing the pharmacy cleanroom areas must complete appropriate clearance through VA security process. Vendor workers must be on the access roster prior to entering pharmacy compounding space. Contractor shall provide all necessary personnel, supervision, labor, equipment, materials, supplies, chemicals (including D/I water) and disposal necessary to provide cleanroom cleaning and related services for the four (4) specific locations identified above.

The contractor shall provide all labor, equipment, Personal Protective Equipment (PPE), disinfecting solutions, and sporicidal agents to perform all required Inpatient Pharmacy IV cleanroom services. The contractor shall perform the following cleaning, disinfecting, and application of sporicidal agent activities on a weekly or monthly basis as designated by protocol and in accordance with USP 797 and USP 800 standards:

Weekly cleaning and disinfecting of the Hazardous Storage, IV Ante, IV Buffer and IV Prep Rooms (and the equipment contained within) shall be accomplished using the appropriate supplies, cleaners and disinfectants and be in accordance with USP 797 and USP 800 standards and include, but not necessarily limited to, the following:

a. The contractor shall remove visible particles, debris, or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers.

b. Using a low-lint wiper, the contractor shall apply a cleaning agent, followed by a disinfecting agent, or apply an Environmental Protection Agency (EPA)-registered (or equivalent) one-step disinfectant cleaner to equipment and all interior surfaces.

c. Clean and sanitize ceilings, walls and floors with USP 797 acceptable agent (i.e. Vesphene) using clean room mopping system.

d. Clean and sanitize designated surfaces including benches, carts and hoods with IPA and cleanroom wipes. (According to USP 797 Guidelines)

e. Clean all doors, glass and exterior of equipment with IPA and D/I Water. (According to USP 797 Guidelines)

f. Wipe down inside of pass thru, shelves, bins and refrigerator with IPA and cleanroom wipes. (According to USP 797 Guidelines)

g. The contractor shall ensure the contact time specified by the manufacturer is achieved.

h. Using a low-lint wiper, the contractor shall apply sterile 70% IPA to equipment and all interior surfaces.

i. Surfaces shall be completely dry before PVAMC staff begins compounding. The contractor shall follow proper protocol when entering and exiting the cleanroom environment.

j. The contractor shall follow proper protocol for donning PPE when entering the cleanrooms (including using second pair of booties and hazardous drug (HD) gown for cleaning in HD IV room).

k. The contractor shall follow proper protocol for use of cleaning equipment in the cleanrooms.

l. The contractor shall follow proper protocol for use of all supplies and solutions used for cleaning in the cleanrooms.

m. The contractor shall empty waste receptacles, clean containers (inside and out) and replace liners.

n. The contractor shall vacuum floors with a cleanroom-certified vacuum cleaner having High-Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filtration.

o. The contractor shall mop floors with a cleanroom-certified bucket, mop, and mop head and shall ensure baseboards are also cleaned and disinfected.

p. The contractor shall remove and/or change tacky mats per protocol.

q. The contractor shall clean and disinfect doors, door handles, door frames, light switches, and high touch areas, including glass surfaces on doors.

r. The contractor shall clean and disinfect sinks and fixtures.

s. The contractor shall clean and disinfect each PEC – 4 in total.

t. The contractor shall wipe down tables and tops of designated equipment

u. The contractor shall wipe down all designated horizontal surfaces, including tables and work surfaces.

v. The contractor shall wipe down all designated vertical surfaces.

w. The contractor shall document attendance by log sign-off as per customer protocol.

x. The contractor shall document procedure completion by log sign-off as per customer protocol.

Monthly terminal cleaning (Once a month in place of weekly cleaning) shall be in accordance with USP 797 and USP 800 standards and include, but not necessarily limited to, weekly cleaning and disinfecting along with the following additional tasks:

a. Cleaning of ceilings, walls and floors will be done with USP 797 acceptable agent (i.e. Spoklenz). This will be done once per month during a regular weekly cleaning.

b. The contractor shall remove visible particles, debris, or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers.

c. After cleaning and disinfecting in accordance with the weekly protocol mentioned above, and in accordance with USP 797 and USP 800, the contractor shall apply the sporicidal agent using a low-lint wiper to all surfaces of primary engineering controls and the area underneath the work tray (if applicable). If the sporicidal agent is an EPA-registered (or equivalent) one-step disinfectant sporicidal cleaner, separate cleaning and disinfecting steps are not required.

d. The contractor shall ensure the contact time specified by the manufacturer is achieved.

e. Using a low-lint wiper, the contractor shall apply sterile 70% IPA to all interior surfaces of primary engineering control, including underneath the work tray (if applicable).

f. Surfaces shall be allowed to dry completely before PVAMC staff begins compounding.

g. The contractor shall wash and apply a sporicidal agent to ceilings and walls.

h. The contractor shall wipe down and apply a sporicidal agent to all medication/supply bins and shelves (in ante-area, HD room, and IV room), including wheels.

i. The contractor shall wipe down and apply a sporicidal agent to all medication bins in refrigerator.

j. The contractor shall wipe down and apply a sporicidal agent to castors on shelving units and tables.

k. The contractor shall wipe down and apply a sporicidal agent to outside surfaces of all hoods.

l. The contractor shall wipe down and apply a sporicidal agent to air returns and air grids.

m. The contractor shall wipe down and apply a sporicidal agent to all chairs, wheels included

n. All cleaning is to be performed by trained personnel using contractor’s equipment and supplies. Contractor will mix all chemicals fresh on site and utilize monthly cleaning logbook kept on site.

o. Contractor may use a bucket-less mopping system that eliminates the contamination that occurs with a 2 or 3 bucket mopping system. However, a single bucket with cleanroom spec single use mop heads is also acceptable.

p. All specifications are required by VA Pharmacy policy and USP 797 clean room regulations.

Note: if it is determined that additional cleaning and follow-up environmental testing is needed due to results of environmental monitoring, additional services may be requested. Contingency areas may require less frequent cleanings in the future. PVAMC reserves the right to change the frequency of cleanings and quantity of areas that are serviced/types of services needed due to infrequent use or mechanical problems.

III. Selection of Supplies: The contractor shall select chemicals and supplies and use them in accordance with USP 797 and USP 800 standards:

a. The contractor shall select cleaning, disinfecting, and sporicidal agents to be used with careful consideration of compatibilities, effectiveness, and user safety. Considerations when selecting and using disinfectants include their antimicrobial activity, inactivation by organic matter, residue, shelf life, preparation requirements of the agent, and suitability for surfaces being disinfected. After the disinfectant or sporicidal agent is applied to the surface, the agent must be allowed to dwell for the minimum contact time specified by the manufacturer.

b. All cleaning supplies (e.g., wipers, sponges, and mop heads) with the exception of tool handles and holders shall be low-lint. Wipers, pads, and mop heads should be disposable. Disposable cleaning supplies shall be discarded after each cleaning activity. Reusable cleaning tools shall be made of cleanable materials (e.g., no wooden handles) and shall be cleaned and disinfected before and after each use. Reusable cleaning tools shall be dedicated for use in the classified areas or Segregated Compounding Area (SCA) and shall not be removed from these areas except for disposal. They shall be discarded as determined, based on the condition of the tools. Cleaning supplies used in the classified areas and SCAs shall be disposed in a manner that minimizes the potential for dispersing contaminants into the air (e.g., with minimal agitation, away from work surfaces). Items and equipment brought into the ISO Classified areas will be appropriately disinfected before they are brought across the line of demarcation in the anteroom.

IV. Cleanroom Consumable Supplies:

Contractor will supply disposable cleanroom garments for ~10 assigned users in sizes necessary for each user. Resupply of the disposable garments will be determined at the discretion of the VA Pharmacy Service. Quoted pricing will be provided on a cost per unit basis. Monthly invoicing will be based on actual quantities ordered by Pharmacy. Consumable cleanroom supplies are to be stocked by contractor and replenished only when requested by the VA Providence Pharmacy. Supplies to be included, but not limited to are:

Consumable Supplies

Quantity

Cost Monthly Cost

YR TOTAL

Contractor Personnel Security Requirements:

Contractor employees who have access to the Providence VA Pharmacy 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 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 and 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 e-mailed to them once the Contracting Officer initiates the investigation.

When the request is submitted, the Contractor Request database will generate an “initial” e-mail with the website link and instructions to all e-mail addresses listed on the request worksheet. This e-mail 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 a complete security package is received from the contract employee and can be forwarded to OPM.

e. Timeframes: The following is a breakdown by level of each investigation handled by SIC. Timeframes may vary due to OPM. Low risk (NACI) the case is open for 30 days except in rare occasions when a finding in the person’s background requires an extension. This investigation is done by mail and is the reason for stringent adherence to paperwork requirements. The average turnaround time is 45 days.

V. Evaluation of contractor personnel performance: PVAMC personnel shall perform routine evaluation of contractor personnel to assess that proper cleaning, disinfecting, and application of sporicidal agents’ activities are properly executed in accordance with this Statement of Work and USP 797 and USP 800 standards. Contractor personnel shall perform the following functions, which are subject to evaluation by PVAMC:

· Contractor personnel shall present themselves clean, groomed, and in a clean appropriate attire.

· The Contractor shall not have any personnel cleaning if they have any respiratory illness, gastrointestinal illness, conjunctivitis, sunburn or any skin condition where there is possibility of weeping/oozing, or any other illness that may be considered contagious

· Contractor personnel, prior to entering the anteroom, shall be dressed in appropriate attire and perform all necessary steps to prepare for cleaning activities.

· Contractor personnel shall be aware of the line of demarcation separating clean and dirty sides in the anteroom, as well as the line of donning/doffing in the HD room.

· Contractor personnel shall don hair covering, beard covering (if applicable), and mask, prior to donning shoe covers.

· Contractor personnel shall properly don shoe covers, one at a time, placing the shoe cover on the clean side of line of demarcation as appropriate.

· Contractor personnel shall properly don PPE in the correct order prior to entering a non-HD room.

· Contractor personnel shall properly don PPE in the correct order prior to entering the HD room, prior to crossing the donning/doffing line (HD gown shall be worn over non-HD gown/bunny suit).

· Contractor personnel shall perform proper hand-washing procedures prior to the start of cleaning services.

· Contractor personnel shall prepare all cleaning, disinfecting, and sporicidal solutions, if applicable, and in accordance with manufacturer’s guidelines.

· Contractor personnel shall clean, disinfect, and apply sporicidal agents to ceilings, walls, and doors using the appropriate chemicals according to protocols.

· Contractor personnel shall clean, disinfect, and apply sporicidal agents to all designated equipment going from “top to bottom” format using the appropriate chemicals according to USP protocols.

· Contractor personnel shall mop floors starting at the wall opposite the room entry door, mopping the floor surface in even strokes towards the operator. Contractor personnel shall ensure baseboards are cleaned, to include disinfecting and the application of a sporicidal agent, according to USP protocols.

· Contractor personnel shall allow for the sporicidal agent to dwell for the minimum contact time, in accordance with manufacturer recommendations.

· Contractor personnel shall use proper deactivating/decontaminating agents for all HD areas and surfaces.

· Contractor personnel shall properly doff top shoe covers, chemo gown and gloves prior to crossing the doffing line in the HD room. These items shall be discarded in the appropriate “trace chemotherapy” (yellow) bags that are in the HD room, prior to leaving HD room.

· Contractor personnel shall properly doff PPE and washes hands prior to leaving the anteroom.

· Contractor personnel shall not remove inner shoe covers until crossing the line of demarcation while departing the anteroom.

· Contractor personnel shall document all cleaning activities as to who performed what activities, date performed, agent(s) used, and in accordance with local procedures. The documentation shall be done on a log that is approved by the contractor and PVAMC; and, the log shall remain in the anteroom for the month it is in use.

VI. Guidance and Oversight:

Contractor personnel will work with the PVAMC Regulatory and Compliance Quality Program Manager to ensure cleanroom cleaning complies with USP 797 and 800 standards and regulations, appropriate written Standard Operating Procedures (SOPs), and this SOW. Routine monthly evaluations of contractor cleaning services will also be conducted by the Regulatory and Compliance Quality program manager or designee. Evaluations may be conducted more frequently as deemed necessary.

Documentation logs shall be reviewed for completeness, along with a physical check of area(s) to be cleaned. Any question on cleanliness, quality of cleanliness, issues with documentation, or other concerns will be brought to the attention of the contractor. Any issue with recertification of ISO classified areas that reveal microbial or fungal contamination will also be brought to the attention of the vendor.

VII. SPECIAL CONSIDERATIONS:

1. Contractor Furnished Materials:

A. All materials and tools to complete the work identified.

B. Contractor to ensure all staff that perform on-site testing arrive in clean apparel. Contractors will follow facility and service hand hygiene and gowning procedures for testing areas.

C. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments. Equipment must be visibly clean and in good repair. Government may request new equipment be obtained by the contractor for use within the cleanroom environment.

2. Government Furnished Materials and Services:

A. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

B. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

C. May also provide desk phone service as needed.

3. Additional Considerations A. The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles. Local facility POC(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Eastern Standard Time (CST), Monday through Friday, excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM EST (CST) to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

4. Liable Insurance Requirements A. Contractor must provide proof of liability insurance

Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253D (Anteroom), Room 253E (Prep Room), and Room 253F (Storage area).

A. ISO 8, ISO 8, ISO 7 and ISO 5 for Storage Area, Ante room, Buffer Room and Biosafety Cabinet

· Baker SterilGARD E3 Class II, Type A2 Biological Safety Cabinet

Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253B (Anteroom) and Room 253C (Prep Room) A. ISO 8, ISO 7 and ISO 5 for Ante room, Buffer Room and Laminar Flow Hood

· Baker EdgeGARD HF Horizontal Flow Clean Bench

Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238A (Anteroom and Prep Room)- Contingency A. Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CACI

· Germfree Laminar Flow LFGI CACI

Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238 (Anteroom and Prep Room)-Contingency A. Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CAI

· Germfree Versaflow

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Pharmacy Clean Room Cleaning for multiple locations on Providence VAMC campus Contract Period: Base POP Begin: 08-25-2020 POP End: 08-24-2021

Pharmacy Clean Room Cleaning for multiple locations on Providence VAMC campus Contract Period: Option 1 POP Begin: 08-25-2021 POP End: 08-24-2022

Pharmacy Clean Room Cleaning for multiple locations on Providence VAMC campus Contract Period: Option 2 POP Begin: 08-25-2022 POP End: 08-24-2023

Pharmacy Clean Room Cleaning for multiple locations on Providence VAMC campus Contract Period: Option 3 POP Begin: 08-25-2023 POP End: 08-24-2024

Pharmacy Clean Room Cleaning for multiple locations on Providence VAMC campus Contract Period: Option 4 POP Begin: 08-25-2024 POP End: 08-24-2025

GRAND TOTAL

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SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS 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.1 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)

C.2 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 5; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 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.3 SUPPLEMENTAL INSURANCE REQUIREMENTS

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

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

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

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

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

(End of Clause) C.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.

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

[X] 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) (End of Addendum to 52.212-4)

C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020)

(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 2019) (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:

[X] (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] [X] (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 Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

[X] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-3.

[X] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020).

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219–9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (JUN 2020) of 52.219–9.

[] (18) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

[X] (22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (MAR 2020) (15 U.S.C 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219-28.

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).

[] (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)) [X] (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).

[X] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (31)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (33) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (35)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[X] (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)).