RFI MW-2206-93 CENTRAL VENOUS CATHETER TRAYS. TRIPLE LUMEN.docx

REQUEST FOR INFORMATION (RFI)

Central Venous Catheter Trays, Triple Lumen

1.0 Introduction

1.1 General. The purpose of this request is to obtain information from industry to support the government’s intent to establish a Qualified Supplier List (QSL) for the standardization of Central Venous Catheter Trays, Triple Lumen. This RFI is an invitation to submit to the Defense Health Agency (DHA) Medical Logistics (MEDLOG) Division Medical Materiel Enterprise Standardization Office (MMESO), technical information and all related supporting documentation for Central Venous Catheter Trays, Triple Lumen. This request is a market research effort undertaken by the government which will be used for information gathering purposes. The information received may be used for acquisition planning purposes and may help define future requirements for the subject items. This is not a request for quote or proposal.

1.2 RFI Submission Package. Vendors are requested to provide responses to this RFI via the RFI Package Worksheet. Complete answers and provide supporting documentation with response. Responses for each salient characteristic should be in the form of yes, no, or descriptive explanation. Additional comments may be provided for all responses.

2.0 Scope

This Central Venous Catheter Trays, Triple Lumen product line is to include Maximal Sterile Barrier Trays and Procedure Trays with an antimicrobial coated catheter and a non-coated catheter. The required tray components with their characteristics for the Maximal Sterile Barrier Trays and Procedure Trays are specified below. Product line products are not made with natural rubber latex.

3.0 Characteristics/Specifications

Feedback Requested: Vendors are requested to provide information about their Central Venous Catheter Tray, Triple Lumen products (See RFI Package Worksheet).

3.1 Maximal Sterile Barrier Tray with antimicrobial catheter.

Required tray components. Please supply trays with the component amounts as indicated:

a. One (1) Indwelling catheter: 7 FR X 20 cm, antimicrobial coated, pressure injectable (maximum pressure limit of 325 psi greater than or equal to), radiopaque, with cm depth markings.

b. One (1) Introducer needle

c. One (1) Catheter introducer needle

d. One (1) Guide wire

e. One (1) Tissue dilator

f. Two (2) Luer lock syringe, 5 mL - 6 mL

g. One (1) Filter straw or blunt fill needle

h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN

i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN

j. One (1) 5 mL ampule, 1% lidocaine

k. One (1) Sharps safety system including but not limited to a needle block or sharps stick pad

l. Two (2) Site skin prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70 % isopropyl alcohol (IPA) solution

m. Five (5) Gauze sponge, 2 IN x 2 IN (minimum 4 ply)

n. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply)

o. One (1) Safety scalpel, #11 blade

p. One (1) Suture, silk with curved needle

q. One (1) Needle holder/driver

r. One (1) Primary catheter stabilization device

s. Three (3) Prefilled Luer lock syringe, normal saline 0.9% NaCl, 10 mL

t. Three (3) Luer activated needleless connectors, neutral fluid displacement, clear, non-tinted housing

u. One (1) Ultrasound probe cover, universal size

v. Two (2) Rubber bands, not made with natural rubber latex

w. One (1) Packet, ultrasound gel

x. One (1) Central venous catheter securement dressing, transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk

y. One (1) Drape, full body

z. One (1) Bouffant cap, universal size

aa. One (1) Surgical gown, AAMI/ANSI:PB70 Level 4

ab. One (1) ASTM level 3, Mask with anti-glare and anti-fog resistant Eye shield

3.2 For each required component provide the following:

a. Tray part number and Country of Origin (COO)

b. Component manufacturer (MFR)

c. Component MFR part number

d. Component COO

e. Detailed component description (i.e., type, style, size, ply, material, woven, non-woven, etc.) PLEASE DO NOT USE ABBREVIATIONS AND/OR ACRONYMS.

f. Please indicate which components have supply chain backlogs, if applicable. Please provide the duration of any expected product availability delays.

3.3 Please identify the specific antimicrobial coating your catheter is coated with for component 3.1.a.

3.4 Describe how each tray would be packaged. Please provide a photo if you have examples of similar packaged trays.

3.5 Is this tray commercially available?

3.6 Provide any additional information, in addition to the specific information requested, which you consider relevant to this initiative.

3.7 Maximal Sterile Barrier Tray with non-coated catheter.

Required tray components. Please supply trays with the component amounts as indicated:

a. One (1) Indwelling catheter: 7 FR X 20 cm, non-coated, pressure injectable (maximum pressure limit of 325 psi or greater), radiopaque, with cm depth markings.

b. One (1) Introducer needle

c. One (1) Catheter introducer needle

d. One (1) Guide wire

e. One (1) Tissue dilator

f. Two (2) Luer lock syringe, 5 mL - 6 mL

g. One (1) Filter straw or blunt fill needle

h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN

i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN

j. One (1) 5 mL ampule, 1% lidocaine

k. One (1) Sharps safety system including but not limited to a needle block or sharps stick pad

l. Two (2) Site skin prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70 % isopropyl alcohol (IPA) solution

m. Five (5) Gauze sponge, 2 IN x 2 IN (minimum 4 ply)

n. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply)

o. One (1) Safety scalpel, #11 blade

p. One (1) Suture, silk with curved needle

q. One (1) Needle holder/driver

r. One (1) Primary catheter stabilization device

s. Three (3) Prefilled Luer lock syringe, normal saline 0.9% NaCl, 10 mL

t. Three (3) Luer activated needleless connectors, neutral fluid displacement, clear, non-tinted housing

u. One (1) Ultrasound probe cover, universal size

v. Two (2) Rubber bands, not made with natural rubber latex

w. One (1) Packet, ultrasound gel

x. One (1) Central venous catheter securement dressing, transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk

y. One (1) Drape, full body

z. One (1) Bouffant cap, universal size

aa. One (1) Surgical gown, AAMI/ANSI:PB70 Level 4

ab. One (1) ASTM level 3, Mask with anti-glare and anti-fog resistant Eye shield

3.8 For each required component provide the following:

a. Tray part number and Country of Origin (COO)

b. Component manufacturer (MFR)

c. Component MFR part number

d. Component COO

e. Detailed component description (i.e., type, style, size, ply, material, woven, non-woven, etc.) PLEASE DO NOT USE ABBREVIATIONS AND/OR ACRONYMS.

f. Please indicate which components have supply chain backlogs, if applicable. Please provide the duration of any expected product availability delays.

3.9 Describe how each tray would be packaged. Please provide a photo if you have examples of similar packaged trays.

3.10 Is this tray commercially available?

3.11 Provide any additional information, in addition to the specific information requested, which you consider relevant to this initiative.

3.12 Procedure Tray with antimicrobial catheter.

Required tray components. Please supply trays with the component amounts as indicated:

a. One (1) Indwelling Catheter: 7 FR X 20 cm, antimicrobial coated, pressure injectable (maximum pressure limit of 325 psi or greater), radiopaque, with cm depth markings.

b. One (1) Introducer needle

c. One (1) Catheter introducer needle

d. One (1) Guide wire

e. One (1) Tissue Dilator

f. Two (2) Luer lock syringe, 5 mL - 6mL

g. One (1) Filter straw or blunt fill needle

h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN

i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN

j. One (1) 5 mL ampule, 1% lidocaine

k. One (1) Sharps safety system including but not limited to a needle block or sharps stick pad

l. Two (2) Site Skin Prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70 % isopropyl alcohol (IPA) solution

m. Five (5) Gauze sponge, 2 IN x 2 IN (minimum 4 ply)

n. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply)

o. One (1) Safety scalpel, #11 blade

p. One (1) Suture, silk with curved needle

q. One (1) Needle holder/driver

r. One (1) Primary catheter stabilization device

s. Three (3) Prefilled Luer lock syringe, normal saline 0.9% NaCl, 10 mL

t. Three (3) Luer Activated Needleless Connectors, neutral fluid displacement, clear, non-tinted housing

u. One (1) Ultrasound probe cover, universal size

v. Two (2) rubber bands, not made with natural rubber latex

w. One (1) Packet, ultrasound gel

x. One (1) Central venous catheter securement dressing, transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk

y. One (1) Drape, full body

3.13 For each required component provide the following:

a. Tray part number and Country of Origin (COO)

b. Component manufacturer (MFR)

c. Component MFR part number

d. Component COO

e. Detailed component description (i.e., type, style, size, ply, material, woven, non-woven, etc.) PLEASE DO NOT USE ABBREVIATIONS AND/OR ACRONYMS.

f. Please indicate which components have supply chain backlogs, if applicable. Please provide the duration of any expected product availability delays.

3.14 Please identify the specific antimicrobial coating your catheter is coated with for component 3.12.a.

3.15 Describe how each tray would be packaged. Please provide a photo if you have examples of similar packaged trays.

3.16 Is this tray commercially available?

3.17 Provide any additional information, in addition to the specific information requested, which you consider relevant to this initiative.

3.18 Procedure Tray with non-coated catheter.

Required tray components. Please supply trays with the component amounts as indicated:

a. One (1) Indwelling Catheter: 7 FR X 20 cm, non-coated, pressure injectable (maximum pressure limit of 325 psi or greater), radiopaque, with cm depth markings.

b. One (1) Introducer needle

c. One (1) Catheter introducer needle

d. One (1) Guide wire

e. One (1) Tissue Dilator

f. Two (2) Luer lock syringe, 5 mL - 6mL

g. One (1) Filter straw or blunt fill needle

h. One (1) Hypodermic safety needle, 25 Ga X 0.625 IN - 1 IN

i. One (1) Hypodermic safety needle, 22 Ga X 1.5 IN

j. One (1) 5 mL ampule, 1% lidocaine

k. One (1) Sharps safety system including but not limited to a needle block or sharps stick pad

l. Two (2) Site Skin Prep, 3 mL applicator with 2% chlorhexidine gluconate (CHG) and 70 % isopropyl alcohol (IPA) solution

m. Five (5) Gauze sponge, 2 IN x 2 IN (minimum 4 ply)

n. Five (5) Gauze sponge, 4 IN x 4 IN (minimum 4 ply)

o. One (1) Safety scalpel, #11 blade

p. One (1) Suture, silk with curved needle

q. One (1) Needle holder/driver

r. One (1) Primary catheter stabilization device

s. Three (3) Prefilled Luer lock syringe, normal saline 0.9% NaCl, 10 mL

t. Three (3) Luer Activated Needleless Connectors, neutral fluid displacement, clear, non-tinted housing

u. One (1) Ultrasound probe cover, universal size

v. Two (2) rubber bands, not made with natural rubber latex

w. One (1) Packet, ultrasound gel

x. One (1) Central venous catheter securement dressing, transparent face, impregnated/integrated with CHG OR One (1) Central venous catheter securement dressing, transparent face, with One (1) protective CHG disk

y. One (1) Drape, full body

3.19 For each required component provide the following:

a. Tray part number and Country of Origin (COO)

b. Component manufacturer (MFR)

c. Component MFR part number

d. Component COO

e. Detailed component description (i.e., type, style, size, ply, material, woven, non-woven, etc.) PLEASE DO NOT USE ABBREVIATIONS AND/OR ACRONYMS.

f. Please indicate which components have supply chain backlogs, if applicable. Please provide the duration of any expected product availability delays.

3.20 Describe how each tray would be packaged. Please provide a photo if you have examples of similar packaged trays.

3.21 Is this tray commercially available?

3.22 Provide any additional information, in addition to the specific information requested, which you consider relevant to this initiative.

*Any information provided in response to this RFI will be considered and treated as unrestricted information, which can be used by the Government in any future planning or acquisitions. All information, comments, and suggestions may be incorporated into future acquisition documents, without identifying the source or obtaining prior approval from the source.*

4.0 Liability

The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI.

5.0 RFI Responses

The vendors’ responses shall include all detailed information requested in the RFI Vendor Response Worksheet and shall also include: (1) Company name and address; (2) Company POC (Name, phone number, fax number, and E-mail address); and (3) Commercial and Government Entity (CAGE) Code.

6.0 Response Information:

Responses to this RFI must be submitted via email to MMESO Clinical Analyst, MMESO Team Lead, and DLA KO listed below.

Vendor questions regarding this RFI are due no later than 5:00 pm EDT on 31 January 2023. Vendor responses to this RFI must be received by MMESO office no later than 5:00 pm EDT on 2 February 2023.

Technical Questions Only:

Mr. Riley Whittlesey Lead MMESO West Clinical Analyst Contractor riley.w.whittlesey.ctr@health.mil

Ms. Gabrielle Burns Lead MMESO West Team Lead Contractor gabrielle.m.burns2.ctr@health.mil

Contracting Questions and Extension Requests:

Tara Perrien DLA Troop Support Medical Contracting Officer tara.perrien@dla.mil

HD – 4/17/20 Page 6 of 6