ATTACHMENT A Statement of Work.pdf

Draft Statement of Work Sterile Cleaning, Sterile Disinfecting, and Sterile Sporicidal Agents

1. INTRODUCTION

a. The Veterans Health Administration is seeking proposals from suppliers and manufacturers for the procurement of sterile cleaning and disinfecting products used by Pharmacy Service in the maintenance of Primary Engineering Controls (PECs) used for making compounded sterile preparations such as infusion bags. Products will be used in approximately 170 locations in the United States and Puerto Rico. The products must comply with the requirements outlined in the current versions of United States Pharmacopeia (USP) Chapter 797 Pharmaceutical Compounding—Sterile Preparations and Chapter 800 Hazardous Drugs—Handling in Healthcare Settings.

b. These products are outlined in paragraph 5 and include:

(1) Dry Wipes

(2) Isopropyl Alcohol (sIPA)

(3) One-Step Disinfectant Cleaner

(4) One-Step Disinfectant Cleaner with sporicidal and chemotherapy deactivating properties

c. Products must meet salient characteristics specified in paragraph (6).

2. DESCRIPTION / SCOPE / OBJECTIVE. The Vendor must provide products meeting compliance requirements of USP Chapter 797 and Chapter 800 as outlined below.

3. APPLICABLE DOCUMENTS. The following laws, regulations, policies, and procedures in effect on date of contract issuance and all subsequent changes or updates apply:

USP 797 United States Pharmacopeia (USP) Chapter 797

USP 800 United States Pharmacopeia (USP) Chapter 800

EPA U.S. Environmental Protection Agency

FAR Federal Acquisition Regulation

VAAR Veterans Administration Acquisition Regulation

4. GLOSSARY. Acronyms used in this document are listed below for easy reference:

a. PEC Primary Engineering Controls

b. USP United States Pharmacopeia

c. EPA U.S. Environmental Protection Agency

d. sIPA Sterile Isopropyl Alcohol

e. QAC Quaternary Ammonium Compound

f. COR Contracting Officer’s Representative

g. FAR Federal Acquisition Regulation

5. PERFORMANCE REQUIREMENTS. The sterile products must comply with requirements outlined in USP Chapter 797 and USP Chapter 800 for sterile compounding in each of the following categories:

a. Dry Wipes

b. Isopropyl Alcohol (sIPA)

(1) Pre-saturated Wipes

(2) Trigger Spray Solution Bottles

(3) Push-pull Cap Solution Bottles

c. Quaternary Ammonium Compound (QAC)

(1) Pre-saturated Wipes

(2) Trigger Spray Solution Bottles

(3) Push-pull Cap Solution Bottles

d. Hydrogen Peroxide

(1) Pre-saturated Wipes

(2) Trigger Spray Solution Bottles

(3) Push-pull Cap Solution Bottles

e. Sporicidal and chemotherapy deactivating properties (Hydrogen Peroxide with Acids and Bleach)

(1) Pre-saturated Wipes

(2) Trigger Spray Solution Bottles

(3) Push-pull Cap Solution Bottles

f. Bleach

g. Bleach wipes for deactivating hazardous drugs

6. SALIENT CHARACTERISTICS

a. All proposed products should be accompanied by relevant documentation demonstrating compliance with USP Chapter 797 and Chapter 800 requirements and EPA registration for the disinfecting agents.

b. EPA-Registered One-Step Disinfectant Cleaning agents are preferred.

c. Preferred disinfectant products will be low toxicity formulations: Quaternary Ammonium Compounds (QAC), Accelerated Hydrogen Peroxide products (H2O2).

d. Agents containing phenol will not be considered.

e. Products with dwell time of 3 minutes or less are preferred.

f. Products with dwell time clearly printed on the product label will be preferred.

g. Storage temperature will be appropriate for cleanrooms (65 to 70 deg F).

h. Dry Wipes

(1) Wipes must be dry, sterile, and low lint.

(2) Wipes must be a minimum of 4 inches X 4 inches in size.

(3) Wipes must be packaged in a resealable pouch to prevent contamination.

(4) Each pouch shall contain a minimum of 20 wipes per pouch.

(5) Each pouch must be labeled with a lot number and an expiration date and include supporting certification or documentation validating that products are sterile.

(6) Sterile containers should be double-bagged or individually packaged.

i. Isopropyl Alcohol (sIPA) Wipes:

(1) Wipe must be pre-saturated with 70% sterile isopropyl alcohol.

(2) Wipes must be sterile and low lint.

(3) Wipes must be a minimum of 4 inches X 4 inches in size.

(4) Wipes must be packaged in a resealable pouch to prevent evaporation and contamination.

(5) Each pouch shall contain a minimum of 20 wipes per pouch.

(6) Each pouch must be labeled with a lot number and an expiration date and include supporting certification or documentation validating that products are sterile.

(7) Sterile container shall be double bagged.

j. Sterile Isopropyl Alcohol (sIPA) trigger-spray Solution Bottle:

(1) Product should include a trigger-spray solution bottle containing sterile 70% sterile isopropyl alcohol.

(2) The bottle may contain between 16-32 ounces.

(3) Each bottle must be labeled with a lot number and an expiration date and include supporting certification or documentation validating that products are sterile.

(4) Each sterile container should be double bagged.

k. Sterile Isopropyl Alcohol (sIPA) push/pull cap Solution Bottle:

(1) Product should include a push-pull cap bottle containing sterile 70% sterile isopropyl alcohol.

(2) The bottle may contain between 16-32 ounces.

(3) Each bottle must be labeled with a lot number and an expiration date and include supporting certification or documentation validating that products are sterile.

(4) Each sterile container should be double bagged.

l. Quaternary Ammonium Compound (QAC) with or without alcohol (Sterile Disinfectant Cleaner Agent)

(1) Wipes:

(a) Product shall contain a Quaternary Ammonium Compound that is sterile, broad-spectrum, fast-acting, and non-corrosive disinfectants effective against bacteria, viruses, and fungi.

(b) Product must be a disinfectant cleaner agent (usually containing a surfactant) that is compatible with materials commonly found in PECs (e.g., stainless steel, polycarbonate, high impact PVC).

(c) Product must remove substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.

(d) Wipes must be low lint.

(e) Wipes must be a minimum of 4 inches X 4 inches in size.

(f) Each sterile container should be double-bagged or individually packaged.

(g) Product should be EPA-registered as a One-Step Disinfectant Cleaner.

(2) Solution Bottles:

(a) Product shall contain a Quaternary Ammonium Compound that is sterile, broad-spectrum, fast-acting, and non-corrosive disinfectant effective against bacteria, viruses, and fungi.

(b) Product must be a disinfectant cleaner agent (usually containing a surfactant) that is compatible with materials commonly found in PECs (e.g., stainless steel, polycarbonate, high impact PVC).

(c) Product must remove substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.

(d) Trigger-spray bottles or push/pull cap bottles are acceptable.

(e) Each sterile container should double-bagged or individually packaged.

(f) Product should be EPA-registered as a One-Step Disinfectant Cleaner.

(g) Ready To Use formulations are preferred. Concentrated formulations requiring dilution may be considered.

m. Hydrogen Peroxide (Sterile Disinfectant Cleaner Agent)

(1) Wipes:

(a) Product shall contain Hydrogen Peroxide that is sterile, broad-spectrum, fast-acting, and non-corrosive disinfectant effective against bacteria, viruses, and fungi.

(b) Disinfectant cleaner agent (usually containing a surfactant) is preferred but disinfectant alone is acceptable.

(c) Product shall be compatible with materials commonly found in PECs (e.g., stainless steel, polycarbonate, high impact PVC).

(d) Product must remove substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.

(e) Wipes must be low lint.

(f) Wipes must be a minimum of 4 inches X 4 inches in size.

(g) Each sterile container should double-bagged or individually packaged.

(h) Product should be EPA-registered as a One-Step Disinfectant Cleaner.

(2) Solution Bottle:

(a) Product shall be a sterile, broad-spectrum, fast-acting, and non-corrosive disinfectant effective against bacteria, viruses, and fungi.

(b) Product must be a Disinfectant Cleaner agent (usually containing a surfactant) that is compatible with materials commonly found in PECs (e.g., stainless steel, polycarbonate, high impact PVC).

(c) Product must remove substances (e.g., dirt, debris, microbes, and residual drugs or chemicals) from surfaces.

(d) Trigger-spray bottles or push/pull cap bottles are acceptable.

(e) Each sterile container should double-bagged or individually packaged.

(f) Product should be EPA-registered as a One-Step Disinfectant Cleaner.

(g) Ready To Use formulations are preferred. Concentrated formulations requiring dilution may be considered.

n. Sterile Sporicidal Agents

(1) Requirements are the same as for Hydrogen Peroxide Solutions and additionally be a fast-acting sporicidal agent, effective against a wide range of microorganisms, including spores.

(2) If the sporicidal disinfectant is a one-step disinfectant sporicidal cleaner, it must be EPA-registered (or equivalent for entities outside the US).

o. Peroxide/acid Sterile Deactivating Agent for Hazardous Drug and Chemotherapy

(1) Requirements are the same as for Sterile Sporicidal Agents and additionally shall have demonstrated Hazardous Drug and Chemotherapy deactivating properties.

(2) Agents used for deactivation shall be sterile dry wipes wetted with appropriate solution and not delivered by a spray bottle to avoid spreading HD residue.

p. Sodium Hypochlorite 5.25% solutions for deactivating hazardous drugs (note Bleach solutions must be followed by sIPA wipe to remove residue)

(1) Same solution specs as Hydrogen Peroxide Solution Bottle except push/pull cap bottles are preferred but trigger spray tops are acceptable.

q. Hazardous Drug Deactivating two-part wipes

(1) Wipes must be sterile.

(2) Wipes must cover a minimum of 8 square feet.

(3) Wipes must be effective on a wide variety of hazardous drugs.