S02 RFQ 36C25820Q0369.docx

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. 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

36C25820Q0369

Bill Cook 602-795-4289 09-08-2020 12:00

Department of Veterans Affairs NCO22-Gilbert Network Contracting 777 E. Missouri, Suite 300 Phoenix AZ 85014

X

561720 $19.5 Million

N/A

Phoenix VA Healthcare System

NCO22-Gilbert Network Contracting

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

See CONTINUATION Page This requirement is for Pharmacy Cleanroom Suite cleanliness and sterility services in full compliance with United States Pharmacopeia (USP) 797/800 standards and regulations. These services will be performed at the Phoenix VA Health Care System (PVAHCS), Southern Arizona VA Health Care System (SAVAHCS), and Northern Arizona VA Health Care System (NAVAHCS).

See CONTINUATION Page

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 36C258

NCO22-Gilbert Network Contracting 777 E. Missouri, Suite 300 Phoenix AZ 85014

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.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

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

36C25820Q0369

Page 1 of Page 1 of Statement of Work Phoenix VA Health Care System (PVAHCS) Inpatient Pharmacy Intravenous (IV) Room Cleaning Service

1.0 Background

The purpose of this Statement of Work (SOW) is to provide IV room cleaning services that will keep PVAHCS 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, 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.

2.0 Tasks: The contractor shall provide all labor, equipment, Personal Protective Equipment (PPE), disinfecting solutions, and sporicidal agents to perform all Inpatient Pharmacy IV cleanroom Level 1, daily, and Level 3, monthly, cleaning services in accordance with USP 797 and USP 800 standards.

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

· 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.

· 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.

2.2 Work Requirements: The contractor shall perform the following cleaning, disinfecting, and application of sporicidal agent activities on a daily or monthly basis as designated by protocol and in accordance with USP 797 and USP 800 standards:

Daily Level 1 cleaning and disinfecting activities 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:

· 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.

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

· 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).

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

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

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

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

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

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

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

· The contractor shall clean and disinfect sinks and fixtures.

· The contractor shall clean and disinfect pass throughs (inside and out, including glass, handles, etc.).

· The contractor shall clean and disinfect each laminar flow hood (2) and each Biological Safety Cabinet (BSC) (in HD room) (2) – 4 in total.

· The contractor shall wipe down tables and tops of designated equipment (e.g. outside of refrigerators).

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

· The contractor shall wipe down all designated vertical surfaces.

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

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

Monthly Level 3 terminal cleaning shall be in accordance with USP 797 and USP 800 standards and include, but not necessarily limited to, daily cleaning and disinfecting, along with the following additional tasks:

· 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.

· After cleaning and disinfecting in accordance with the Level 1 protocols 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.

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

· 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.

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

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

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

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

· The contractor shall wipe down and apply a sporicidal agent to all chairs, wheels included (2 in IV room, 1 in HD room).

3.0 Evaluation of contractor personnel performance: Phoenix VAHCS 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 PVAHCS:

· 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 Level 1 and 3 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 Level 1 and 3 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 Level 1 and 3 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 PVAHCS; and, the log shall remain in the anteroom for the month it is in use.

4.0 Security and Health Insurance Portability and Accountability Act (HIPAA) Compliance:

In reference to VHA Handbook 6500.6 Appendix A, block 6 and 7, the cleaning service requested in this contract does NOT involve connection of Information Technology (IT) devices to a VA network and no sensitive information is accessed. Therefore, certification and accreditation (C&A), Systems Applications and Products in Data Processing (SAP), and the following from Appendix C apply:

· During contract performance, contractor may require access to VA facility, equipment, information systems, or sensitive data to provide services, install, train, maintain, or repair equipment.

· VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training shall be completed prior to being granted access to facilities, equipment, or to the data therein. Training is available on the VA Training Management System (TMS) website at: http://www.tms.va.gov/SecureAuth35/.

· The contractor shall provide evidence of training to the Contracting Officer’s Representative (COR) if requested.

· The Contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards and VA directives and Handbooks regarding information protection, patient privacy and information system security as delineated in this contract.

5.0 Guidance and oversight: Contractor personnel will work with the PVAHCS Regulatory and Compliance Quality Pharmacy 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.

NOTE: This diagram of the cleanroom is not drawn to scale and is only a spacial representation.

Statement of Work Southern Arizona VA Health Care System (SAVAHCS) Compounding Facilities Terminal Service

1.0 Background

The purpose of this Statement of Work (SOW) is to provide terminal cleaning of the intravenous (IV) room, anteroom, Hazardous Drug (HD) room, segregated compounding area (SCA), counters and passthroughs outside the IV/HD/anterooms, and HD repacking area that will keep SAVAHCS compounding facilities’ 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, 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.

2.0 Tasks: The contractor shall provide all labor to perform all compounding facilities cleanroom Level 1, daily, and Level 3, monthly, cleaning services, as appropriate, in accordance with USP 797 and USP 800 standards. Contractor personnel shall follow SAVAHCS protocols for use of personal protective equipment in the hazardous and sterile compounding areas and understand the risks associated with the cleaners and equipment designed for storage and preparation of hazardous drugs.

2.1 Selection of Supplies: The SAVAHCS inpatient pharmacy supplies all necessary Personal Protective Equipment (PPE), cleaners, and cleaning supplies for the contractor. The contractor shall provide spray fogging equipment for the following location(s):

BA081 – Inpatient Pharmacy; BA 086 – IV room; BA 093 Research office (SCA location)

2.2 Work Requirements: All cleaning activities shall be accomplished as designated by protocol and in accordance with USP 797 and USP 800 standards. The contractor shall perform the terminal cleaning, disinfecting, and application of sporicidal agent activities at least monthly. Terminal cleaning activities shall be conducted on a more frequent basis under the following conditions:

1. A regulation change when more frequent terminal cleaning is required.

2. Equipment is relocated.

3. A mechanical failure of an IV hood or room occurs and lasts more than 24 hours duration.

4. A Viable/Environmental failure occurs.

5. Initial certification of facilities

6. Prior to rectification of facilities

The Government has the option to request Daily Level 1 cleaning and disinfecting activities be conducted by the contractor. In the event the contractor performs Daily Level 1 cleaning and disinfecting, these activities 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:

· 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.

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

· 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).

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

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

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

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

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

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

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

· The contractor shall clean and disinfect sinks and fixtures.

· The contractor shall clean and disinfect pass throughs (inside and out, including glass, handles, etc.).

· The contractor shall clean and disinfect each laminar flow hood (2) and each Biological Safety Cabinet (BSC) (in HD room) (2) – 4 in total.

· The contractor shall wipe down tables and tops of designated equipment (e.g. outside of refrigerators).

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

· The contractor shall wipe down all designated vertical surfaces.

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

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

Monthly Level 3 terminal cleaning shall be in accordance with USP 797 and USP 800 standards and include, but not necessarily limited to, daily cleaning and disinfecting, along with the following additional tasks:

· 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.

· After cleaning and disinfecting in accordance with the Level 1 protocols 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.

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

· 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.

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

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

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

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

· The contractor shall wipe down and apply a sporicidal agent to all chairs, wheels included (2 in IV room, 1 in HD room).

Terminal cleaning shall be performed from cleanest to dirtiest and from top to bottom (ceiling to floor) in the following rooms/areas to include all equipment in these areas. The order of cleaning shall be performed as follows:

· HD Room

· IV Room

· Anteroom

· SCA

· Tables and passthroughs outside IV/HD/ante room

· HD repacking area

· Inpatient pharmacy-only if contamination IV/HD/anteroom is found to have originated in the inpatient pharmacy.

3.0 Evaluation of contractor personnel performance: SAVAHCS 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 SAVAHCS:

· 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 Level 1 and 3 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 Level 1 and 3 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 Level 1 and 3 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 similar to that found in Appendix B of this SOW. The log shall remain in the anteroom for the month it is in use.

4.0 Security and Health Insurance Portability and Accountability Act (HIPAA) Compliance:

In reference to VHA Handbook 6500.6 Appendix A, block 6 and 7, the cleaning service requested in this contract does NOT involve connection of Information Technology (IT) devices to a VA network and no sensitive information is accessed. Therefore, certification and accreditation (C&A), Systems Applications and Products in Data Processing (SAP), and the following from Appendix C apply:

· During contract performance, contractor may require access to VA facility, equipment, information systems, or sensitive data to provide services, install, train, maintain, or repair equipment.

· VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training shall be completed prior to being granted access to facilities, equipment, or to the data therein. Training is available on the VA Training Management System (TMS) website at: http://www.tms.va.gov/SecureAuth35/.

· The contractor shall provide evidence of training to the Contracting Officer’s Representative (COR) if requested.

· The Contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards and VA directives and Handbooks regarding information protection, patient privacy and information system security as delineated in this contract.

5.0 Guidance and oversight: Contractor personnel shall work with the SAVAHCS Inpatient Pharmacy Sterile Compounding Program Manager to ensure cleanroom cleaning complies with USP 797 and 800 standards and regulations, appropriate written Standard Operating Procedures (SOPs), and this SOW. Inspection, testing, certification, and acceptance criteria shall be in accordance with the most recent versions of the USP 797 and 800, as applicable. Evaluations may be conducted more frequently as deemed necessary.

All contractor personnel performing terminal cleaning shall meet with the Inpatient Pharmacy Sterile Compounding Program Manager prior to cleaning to:

1. Review expectations of the terminal cleaning

2. Perform a walkthrough of the areas that need to be cleaned

3. Provide a checkoff sheet of all areas that need to be cleaned (Appendix B)

4. Perform a competency assessment on donning/doffing PPE, how to use cleaners, how to clean and how to utilize Powered Air Purifying Respirator (PAPR) (Appendix A).

The Inpatient Pharmacy Sterile Compounding Program Manager or designee will be present to evaluate cleaning, perform a physical check of area(s), evaluate the safety of contractor personnel, answer questions, and to review documentation logs for completeness, to include ensuring contractor personnel sign the terminal cleaning log. Any concerns or questions regarding quality of cleanliness, documentation, or other issues will be brought to the attention of the contractor. Any issue with recertification of ISO classified areas that reveal microbial or fungal contamination shall also be brought to the attention of the contractor.

Appendix A: Evaluation of Ancillary Personnel Gowning/Garbing PPE and Cleaning

Name: ________________________ Position: ________________________ Date: ________________________

Qualified Evaluator will check each space for which the person being assessed and has acceptably completed the described activity. Provide comments for possible deficiencies.

(C: Competent; U: Unacceptable)

surface in even strokes towards the operator ________ Allows for proper dwell time for sporicidal agent before rinsing off with sterile water for irrigation for ceiling, walls and floor ________ Allows for proper dwell time for sporicidal agent before rinsing off with Sterile 70% IPA for all equipment

date performed.

If any of the above are marked ‘U - Unacceptable’, explain why and a plan of action for correction.

*The person assessed is immediately informed of all unacceptable activities

Appendix B: Terminal Cleaning Signoff Sheet

ANTE ROOM

OUTSIDE IV ROOM/ANTE ROOM

CONTINGENCY CAI HOOD

OUTSIDE HD ROOM

Statement of Work Northern Arizona VA Health Care System (NAVAHCS) Inpatient Pharmacy Intravenous (IV) Segregated Compounding Area Cleaning Service

1.0 Background

The purpose of this Statement of Work (SOW) is to provide IV room cleaning services that will keep NAVACHS Inpatient non-hazardous Pharmacy Segregated Compounding Area (SCA) cleanliness and sterility in full compliance with United States Pharmacopeia (USP) 797 standards and regulations. The scope of work includes cleaning, disinfecting, and applying a sporicidal agent to designated surfaces to remove organic and inorganic materials, 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.

2.0 Tasks: The contractor shall provide all labor, equipment, Personal Protective Equipment (PPE), disinfecting solutions, and sporicidal agents to perform all Inpatient Pharmacy IV Segregated Compounding Area monthly, cleaning services in accordance with USP 797.

2.1 Selection of Supplies: The contractor shall select chemicals and supplies and use them in accordance with USP 797:

· 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.

· 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 Segregated Compounding Areas will be appropriately disinfected.

2.2 Work Requirements: The contractor shall perform the following cleaning, disinfecting, and application of sporicidal agent activities on a monthly basis as designated by protocol and in accordance with USP 797:

Monthly terminal cleaning shall be in accordance with USP 797 standards and include, but are not necessarily limited to the following additional tasks:

· 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.

· After cleaning and disinfecting in accordance with the Level 1 protocols mentioned above, and in accordance with USP 797, 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.

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

· The contractor shall wipe down and apply a sporicidal agent to all medication/supply bins and shelves in the Segregated Compounding Area, including wheels.

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

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

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

· The contractor shall wipe down and apply a sporicidal agent to all chairs, wheels included (1 chair).

3.0 Evaluation of contractor personnel performance: Northern Arizona VAHCS 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 standards. Contractor personnel shall perform the following functions, which are subject to evaluation by NAVACHS:

· 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 Segregated Compounding Area.

· 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 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 Level 3 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 Level 3 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 Level 3 protocols.

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

· Contractor personnel shall properly doff PPE and washes hands prior to leaving the Segregated Compounding Area.

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

· 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 NAVACHS; and, the log shall remain in the Segregated Compounding Area for the month it is in use.

4.0 Security and Health Insurance Portability and Accountability Act (HIPAA) Compliance:

In reference to VHA Handbook 6500.6 Appendix A, block 6 and 7, the cleaning service requested in this contract does NOT involve connection of Information Technology (IT) devices to a VA network and no sensitive information is accessed. Therefore, certification and accreditation (C&A), Systems Applications and Products in Data Processing (SAP), and the following from Appendix C apply:

· During contract performance, contractor may require access to VA facility, equipment, information systems, or sensitive data to provide services, install, train, maintain, or repair equipment.

· VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training shall be completed prior to being granted access to facilities, equipment, or to the data therein. Training is available on the VA Training Management System (TMS) website at: http://www.tms.va.gov/SecureAuth35/.

· The contractor shall provide evidence of training to the Contracting Officer’s Representative (COR) if requested.

· The Contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards and VA directives and Handbooks regarding information protection, patient privacy and information system security as delineated in this contract.

5.0 Guidance and oversight: Contractor personnel will work with the NAVACHS Pharmacy Compliance and Quality Program Manager to ensure Segregated Compounding Area cleaning complies with USP 797 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 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.

NOTE: This diagram of the cleanroom is not…