36C25523Q0251_AMENDMENT 0002.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 8

36C255

Department of Veterans Affairs

Network Contracting Office (NCO) 15

3450 S 4th Street Trafficway

Leavenworth KS 66048

36C255

Department of Veterans Affairs

Network Contracting Office (NCO) 15

3450 S 4th Street Trafficway

Leavenworth KS 66048

To all Offerors/Bidders

36C25523Q0251

03-14-2023

X

X X

X 1

The purpose of Amendment 0002 is as follows:

1) See Questions & Answers on the Continuation pages.

2) See revised SOW on the Continuation pages, new information has been typed in GREEN font.

3) The solicitation Receipt of Offers date is changed; From April 17, 2023, To April 24, 2023 by 11:00 A.M. CDT.

Teresa Cabanting

Contracting Officer

VHALEACabanT Highlight

CONTINUATION PAGE

QUESTIONS & ANSWERS

1. How often will these areas need to be serviced (daily, weekly, monthly)?

Answer: This is clearly stated in the SOW under the section, Requirements, “Monthly terminal cleaning of IV compounding areas involves SURFACE cleaning of the entirety of the space and application of a sporicidal disinfectant agent. Terminal cleaning must meet or exceed all requirements in USP 797

Standards (updated standards published November 1st, 2022).”

2. The cleaning materials (PPE, supplies, sporicidal agent, etc.). Since the hospitals undoubtedly have the supplies on hand, typically we send in our team to clean using the supplies that are already there and provided by the hospital. If I’m reading the SOW correctly, it appears that on these jobs, it would be the contractor’s job to provide those things.

Answer: The Government will supply all of the cleaning products.

Statement of Work

Background- The purpose of this requirement is to obtain monthly cleaning services for our IV Compounding Clean Rooms, in both Topeka and Leavenworth Veterans Affairs

Medical Centers (VAMC), per requirements set forth in USP 797 standards. Cleaning shall be done by highly trained personnel to prevent contamination of room surfaces and potential contamination of compounded intravenous products.

Scope of Work- The Contractor shall provide the services for the IV Compounding

Areas as described in the ‘Task’ paragraph below to at minimum meet and/or exceed

USP 797 required standards. They also will deliver and provide all necessary labor, management, skills, materials, etc. required to clean the IV compounding areas as described above.

Task- Both IV Compounding rooms and Segregated Compounding Areas (SCA) in

Topeka and Leavenworth must be thoroughly cleaned monthly to meet USP 797 standards. This includes cleaning, disinfecting, and applying a sporicidal agent in the IV

Classified Compounding Areas and within the perimeter of the Segregated

Compounding Area. The following areas/items in each IV room and SCA must be cleaned, disinfected, and have sporicidal agent applied: Ceiling, Walls, Floors, Primary

Engineering Control (PEC) (exterior only), Countertops, Doors, Carts, Chairs, Storage

Shelving, Refrigerators (exterior), Sharps Container(s) (exterior), Sink, Waste

Receptacles, Pass-Throughs, Phone/Electronic Equipment/Monitors/etc., and

Chemicals and Sanitizers used in the cleaning process. The Government will supply all cleaning agents and PPE.

Information Security- The Contractor must comply with VA information security and privacy requirements throughout the entire operation and be in compliance with VA Security Handbook 6500. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. The Contractor will adhere to all HIPAA rules and regulations.

• The Contractor(s) shall insure the confidentiality of all patient and employee information and shall be held liable in the event of breach of confidentiality according to federal regulations contained in HIPPA. Any person who knowingly or willingly discloses confidential information from any VA Medical Center may be subject to fines of up to $50,000 and may be subjected to civil litigation from the patient(s).

Contact with Contractors – It is requested that an appointment be made prior to arrival onsite to complete the monthly cleaning service. This can be coordinated with the facility’s Compounded Sterile Products Program Manager. On the date of the appointment, it is asked that all contracted employees have their company ID, preferably a photo ID if available, in plain view upon arrival to the facility.

Contracted employees will report directly to main pharmacy and allowed inside the pharmacy area by an authorized employee only. All contracted employees must ensure to sign in upon arrival and sign out once their service has been completed.

Name, date, check-in, and check-out time are required to be documented.

Additionally, no access will be allowed to patient care, locked or other “sensitive” areas unless accompanied by an authorized employee.

Requirements

Monthly terminal cleaning of IV compounding areas involves cleaning of the entirety of the space and application of a sporicidal disinfectant agent. Terminal cleaning must meet or exceed all requirements in USP 797 Standards (updated standards published

November 1st, 2022).

• Shall meet all USP 797 Cleaning Standards.

• Negative Sample Testing of Area after each Monthly Cleaning.

The following detailed steps are required (note that daily cleaning should be completed before monthly cleaning is started):

• Hand Hygiene and Donning of PPE o Present to ante room in clean appropriate attire and manner with outerwear removed.

o Wear no cosmetics, artificial nails, or jewelry.

o Don head cover.

o on facial mask.

o Don facial hair cover, if necessary.

o Don safety goggles when performing cleaning or when working with irritants or HD that could allow for eye exposure.

o Don shoe covers (One shoe cover at a time while standing at line of demarcation. Place foot with shoe cover on clean side of anteroom. HD preparation requires 2nd set of shoe covers.)

o Wash hands up to the elbows with soap and warm water for at least 30 seconds after removing debris from under fingernails using a nail cleaner under running water.

o Dry hands and forearms with lint-free towel.

o Don non-shedding gown (must be at least knee length, fit snug around neck, sleeves must fit snug around wrist, and be closed, zipped or snapped closed in front). For HD room Cleaning, Cleaning staff will also don chemo gown) o Perform hand hygiene with waterless alcohol-based hand scrub and allow to dry before donning non-sterile or sterile gloves. For HD room cleaning a second pair of chemo gloves must be donned o Enter Buffer Room

• Positive Pressure Buffer Room monthly cleaning steps o Ceilings

▪ Wipe with non-shedding microfiber mop cover saturated with EPA registered sporicidal agent Decon Spore 200 Plus or equivalent product,

▪ Starting at far side of room and working towards exit using overlapping strokes (including lights and fixtures).

▪ Allow 2 minute dwell time and remove any residue from surface using sterile water saturated microfiber mop cover o Walls and Windows

▪ Wipe with non-shedding microfiber mop cover or wiper saturated with Decon Spore 200 Plus or equivalent product.

▪ Starting at cleanest side of room wipe left to right from top to bottom and working toward exit.

▪ Cleaning must be done behind all equipment and shelving.

▪ Allow 2 minute dwell time and remove any residue from surface using sterile water saturated microfiber mop cover or non-shedding wiper.

o Equipment (Hoods, shelving, carts, bins, furniture, wheels, trash cans)

▪ Wipe all outside surfaces of hoods with non-shedding wiper saturated with Decon Spore 200 Plus or equivalent product.

▪ Wipe all surfaces of shelving, carts, bins and trash cans, and furniture including wheels with no-shedding wiper saturated with

Decon Spore 200 Plus or equivalent product.

▪ Allow 2 minute dwell time and remove any residue from surfaces using sterile water saturated non-shedding wiper.

o Floors

▪ Clean floors with non-shedding microfiber mop cover saturated with

Decon Spore 200 Plus or equivalent product.

▪ Starting at far end of room using working toward exit

▪ Allow 2-minute dwell time and remove any residue from surfaces using sterile water saturated non-shedding microfiber mop cover o Exit Positive Pressure Buffer Room

• HD (Negative Pressure) Buffer Room o Don second pair of shoe covers, HD gown and chemo gloves before entering o Ceilings

▪ Wipe with non-shedding microfiber mop cover saturated with EPA registered sporicidal agent Decon Spore 200 Plus or equivalent product,

▪ Starting at far side of room and working towards exit using overlapping strokes (including lights and fixtures).

▪ Allow 2-minute dwell time and remove any residue from surface using sterile water saturated microfiber mop cover o Walls and Windows

▪ Wipe with non-shedding microfiber mop cover or wiper saturated with Decon Spore 200 Plus or equivalent product.

▪ Starting at cleanest side of room wipe left to right from top to bottom and working toward exit.

▪ Cleaning must be done behind all equipment and shelving.

▪ Allow 2-minute dwell time and remove any residue from surface using sterile water saturated microfiber mop cover or non-shedding wiper.

o Equipment (Hoods, shelving, carts, bins, furniture, wheels, trash cans)

▪ Wipe all outside surfaces of hoods with non-shedding wiper saturated with Decon Spore 200 Plus or equivalent product.

▪ Wipe all surfaces of shelving, carts, bins and trash cans, and furniture including wheels with no-shedding wiper saturated with

Decon Spore 200 Plus or equivalent product.

▪ Allow 2-minute dwell time and remove any residue from surfaces using sterile water saturated non-shedding wiper.

o Floors

▪ Clean floors with non-shedding microfiber mop cover saturated with

Decon Spore 200 Plus or equivalent product.

▪ Starting at far end of room using working toward exit

▪ Allow 2-minute dwell time and remove any residue from surfaces using sterile water saturated non-shedding microfiber mop cover o Immediately prior to exiting HD buffer room, remove and discard outer shoe covers, chemo gown, and chemo gloves and place in yellow trace waste container.

o Exit HD buffer room

• Ante Room o Ceilings

▪ Wipe with non-shedding microfiber mop cover saturated with EPA registered sporicidal agent Decon Spore 200 Plus or equivalent product,

▪ Starting at far side of room and working towards exit using overlapping strokes (including lights and fixtures).

▪ Allow 2-minute dwell time and remove any residue from surface using sterile water saturated microfiber mop cover o Walls and Windows

▪ Wipe with non-shedding microfiber mop cover or wiper saturated with Decon Spore 200 Plus or equivalent product.

▪ Starting at cleanest side of room wipe left to right from top to bottom and working toward exit.

▪ Cleaning must be done behind all equipment and shelving.

▪ Allow 2-minute dwell time and remove any residue from surface using sterile water saturated microfiber mop cover or non-shedding wiper.

o Equipment (Hoods, shelving, carts, bins, furniture, wheels, trash cans, sink)

▪ Wipe all outside surfaces of hoods with non-shedding wiper saturated with Decon Spore 200 Plus or equivalent product.

▪ Wipe all surfaces of shelving, carts, bins and trash cans, and furniture including wheels with no-shedding wiper saturated with

Decon Spore 200 Plus

▪ Allow 2-minute dwell time and remove any residue from surfaces using sterile water saturated non-shedding wiper.

o Floors

▪ Clean floors with non-shedding microfiber mop cover saturated with

Decon Spore 200 Plus or equivalent product.

▪ Starting at far end of room using working toward exit

▪ Allow 2-minute dwell time and remove any residue from surfaces using sterile water saturated non-shedding microfiber mop cover o Exit Ante Room

▪ Remove and discard PPE

▪ Wash hands with soap and water

• Segregated Compounding Area (SCA) o Perform Hand Hygiene and Don PPE as outlined for Cleanroom Suite with the following differences

▪ Wash hands for 30 seconds at sink outside SCA

▪ Enter SCA and don PPE starting with shoe cover, then head cover, then face mask and facial hair cover if required, then gown, then perform hand hygiene using waterless alcohol-based hand scrub and don non-sterile gloves o Ceiling only needs to be cleaned if visibly soiled o Clean walls working using non-shedding microfiber mop cover saturated with Decon Spore 200 Plus or equivalent product starting from cleanest side and working toward exit o Clean outside of equipment including hood, shelves and bins with non-shedding wiper saturated with Decon Spore 200 Plus or equivalent product.

o Allow 2-minute dwell time and remove any residue using sterile water saturated non-shedding wiper or microfiber mop cover o Remove and discard PPE and exit SCA

• Document Cleaning o Document all above cleaning as required by USP 797 regulatory requirements.

Work Hours

Services provided by this contract shall be furnished by the Contractor. The Contractor shall not be required to furnish such services on a national holiday or during non-working hours as described below.

The following terms have the following meanings:

(1) Normal Operating hours of Pharmacy: Monday through Friday, 7:30a.m. to 4:00 p.m.

(2) National Holidays: The eleven holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President's Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday

Service Locations

Colmery-O’Neal VA Medical Center

Inpatient Pharmacy Department

2200 SW Gage Blvd

Topeka, KS 66622

Dwight D. Eisenhower VA Medical Center

Inpatient Pharmacy Department

4101 South 4th Street

Leavenworth, Kansas 66048

Personnel Policy

The contractor is responsible for all costs, including personnel costs, associated with this contract.

Qualifications: Contractor staff must be well trained/have expertise in USP 797 cleaning requirements/standards to ensure continued compliance with these standards.

Contractor Staff, Roles and Responsibilities

Contractor staff must be in compliance with all United States Pharmacopeia (USP), state, local and The Joint Commission (TJC) guidelines.

Contractor Performance Assessments

• Assessments. The Government will do assessments of the Contractor’s performance. The Contractor shall have an opportunity to respond to assessments.

• Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection of cleaning providers for future projects. Past performance data may also be utilized in future procurement efforts.