Attachment 2 - SOW - Gowns Surgical-Isolation - REVISED - 07.01.2020.pdf

Department of Veterans Affairs Veterans Health Administration, Procurement and Logistics (10NA2)

Medical Supply Program Office, Medical Surgical Prime Vendor Program

Statement of Work (SOW) for Coronavirus (COVID-19) Personal Protective Equipment (PPE) Gowns

STATEMENT OF WORK

A. GENERAL GUIDANCE

1. Title of Project: Veterans Health Administration (VHA), Procurement and Logistics (10NA2), Medical Supply Program Management Office (MSPO) Coronavirus (COVID-

19) Personal Protective Equipment (PPE) Acquisition.

2. Scope of Work: The purpose of this requirement is to obtain appropriate PPE to combat the spread of the Coronavirus and provide the necessary protection for VHA staff and the Veterans they serve. This action is to streamline an urgent requirement to procure Gowns (Surgical/Isolation) to prepare for COVID-19 treatment within VA healthcare facilities. The procurement of these gowns will allow VHA to properly support VA facilities nationwide with the critical PPE to properly care for veterans.

3. Background: The U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA) manages the United States’ largest integrated healthcare system, providing care at 1,243 healthcare facilities, including 172 medical centers and 1,062 outpatient sites of care of varying complexity (VHA outpatient clinics), serving approximately 9 million enrolled Veterans each year.

Coronaviruses make up a large family of viruses that can infect birds and mammals, including humans. Historically, these viruses have been responsible for several outbreaks around the world, including the severe acute respiratory syndrome (SARS) pandemic of 2002-2003 and the Middle East respiratory syndrome (MERS) outbreak in South Korea in 2015. Recently, a novel coronavirus (2019-nCoV) triggered an outbreak in China in December 2019, sparking international concern. There at least 570 confirmed cases of novel coronavirus in more than 25 countries and territories outside mainland China, including the United States.

The current coronavirus is highly contagious and is most often, spread from person-to-person contact within close range (about 6 feet) of an infected individual. Person-to-person spread is thought to occur primarily via respiratory droplets produced when an infected person coughs or sneezes, similar to how influenza and other respiratory pathogens spread. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. It’s currently unclear if a person can get 2019-nCoV by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes.

In humans, coronaviruses typically cause a respiratory infection with mild to severe flu-like symptoms, with an incubation period of 14 and up to 24 days after exposure. This incubation period increases the potential for impact to the US population as infected persons who do not display symptoms are active and can pass the virus on to multiple individuals. A subset of individuals, including those with cardiopulmonary disease or a weakened immune system, are at high risk of the viral infection progressing to a more severe lower-respiratory infection such as pneumonia or bronchitis.

To date, the 2019-nCoV has an estimated mortality rate of 2% of infected individuals however, the ease of transmission combined with the lengthy incubation period before an infected individual begins to display symptoms could skyrocket this estimated mortality rate.

The Centers for Disease Control and Prevention (CDC) risk assessment for 2019-nCoV recommends use of the PPE described above to minimize exposure and infection for patients and healthcare professionals alike.

Although VHA maintains appropriate levels of PPE items via the Medical/Surgical Prime Vendor-Next Generation (MSPV-NG) Program, the spread of COVID-19 could have high impact on existing PPE supplies. The procurement of additional Gowns (Surgical/Isolation) will allow VHA to properly stage and supply VA medical facilities nationwide with critical PPE to properly care for veterans for a minimum 12-month period.

4. Performance Period: The contract will begin effective the contract award date and all supplies shall be delivered based on the timeframes specified herein.

5. Type of Contract: Firm-Fixed-Price

B. CONTRACT AWARD MEETING

The contractor shall only commence work upon notification of an approved contract award from the contracting officer.

C. GENERAL REQUIREMENTS

The purpose of this requirement is to obtain the highest quality Gowns (Surgical/Isolation) at the best possible price to be used uniformly, as medically appropriate, in an inpatient and/or outpatient VA healthcare setting.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

The contractor shall provide the quantity of Gowns (Surgical/Isolation) to meet all salient characteristics that are provided in the Minimum Technical Requirements (MTR) below as required in the delivery schedule.

Surgical Gown – Level 4 The contractor shall provide 2,000,000 Level 4 Surgical Gowns.

The Level 4 surgical gown shall meet the following Minimum Technical Requirements (MTRs).

Surgical Gown Level 4 Brand name or equal to: Aero Chrome

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 4 Liquid Barrier Protection (Highest fluid and microbial barrier)

Literature Review

MTR 2

Sizes: Regular/Large, Medium, XL, XXL, XXXL

Literature Review

MTR 3 Raglan Sleeves Literature Review

MTR 4 Elastic Wrist Literature Review

MTR 5

Material (Spunbond/Meltblown/ Spunbond)/Polyester film/SMS.

Literature Review

MTR 6

Fully cover the front torso and arms and should tie in the back

Literature Review

MTR 7 Disposable/Single use Literature Review

MTR 8

MUST BE STERILE for surgery/procedure area use

Literature Review

MTR 9

Closure - Hook-and-Loop, Tape Tab Neck, or Neck Ties

Literature Review

MTR 10 Must meet FDA standards Literature Review

MTR 11

GELBO LINT TEST Determines the relative number of lint particles released from a fabric: Lowest result possible

Literature Review

MTR 12

Class 1: Non-flammable. Laser and ignition resistance (ISO 11810): High resistance level

Literature Review

MTR 13

Martindale Abrasion Test (ASTM D4966):

Higher result the better

Literature Review

MTR 14

Pass ASTM F1671 in the critical zones (two in the front chest and two on the sleeves) in order to be labeled an AAMI level 4 surgical gown. No penetration at 2 psi (13.8 kPa)

Literature Review

MTR 15

Intended Use: Long, fluid-intensive procedures in which the surgeon’s hands and arms are in a body cavity; Orthopedic procedures during which tourniquets are not used; Open cardiovascular or thoracic procedures; Trauma procedures; Cesarean sections

Literature Review

Surgical Gown – Level 3 The contractor shall provide 3,000,000 Level 3 Surgical Gowns.

The Isolation gown shall meet the following MTRs:

Surgical Gown – Level 3

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 3 Liquid Barrier Protection (Moderate fluid and microbial barrier)

Literature Review

MTR 2

Sizes: Regular/Large, Medium, XL, XXL, XXXL

Literature Review

MTR 3 Raglan Sleeves, Elastic Wrist Literature Review

MTR 4 Weight: Heavy fabric Literature Review

MTR 5

Material (Spunbond/Meltblown/ Spunbond)/Polyester film/SMS

Literature Review

MTR 6

Fully cover the front torso and arms and should tie in the back

Literature Review

MTR 7 Disposable/Single use Literature Review

MTR 8

MUST BE STERILE for surgery/procedure area use

Literature Review

MTR 9

Closure - Hook-and-Loop, Tape Tab Neck, or Neck Ties

Literature Review

MTR 10 Must meet FDA standards Literature Review

MTR 11 Hood (with/without) Literature Review

MTR 12 Non-flammable Literature Review

MTR 13

Performance Requirements at 4% AQL:

AATCC 42 Impact Penetration ≤ 1.0 g, AATCC 127 Hydrostatic Pressure ≥ 50 cm

Literature Review

MTR 14

Intended Use: The widest range of surgical procedures, where moderate fluid protection is indicated; Mastectomies; Arthroscopic orthopedic procedures; Endoscopic urological procedures, Transurethral Prostate Resections (TURP), Open gastrointestinal and genitourinary procedures.

Isolation Gown – Level 2 The contractor shall provide 3,000,000 Level 2 Isolation Gowns.

The Isolation gown shall meet the following MTRs:

Isolation Gown - Level 2

TECHNICAL SPECIFICATIONS METHOD OF EVALUATION

MTR 1

AAMI Level 2 Liquid Barrier Protection (Minimal to low fluid and microbial barrier)

Literature Review

MTR 2

Sizes: Regular/Large, Medium, XL, XXL, XXXL

Literature Review

MTR 3 Raglan Sleeves, Elastic Wrist Literature Review

MTR 4 Weight: Medium fabric Literature Review

MTR 5

Material (Spunbond/Meltblown/ Spunbond)/Polyester film/SMS

Literature Review

MTR 6

Fully cover the front torso and arms and should tie in the back

Literature Review

MTR 7 Disposable/Single use Literature Review

MTR 8

NON-STERILE: used for medical use isolation gown

Literature Review

MTR 9

Closure - Hook-and-Loop, Tape Tab Neck, or Neck Ties

Literature Review

MTR 10 Must meet FDA standards Literature Review

MTR 11 Hood (with/without) Literature Review

MTR 12 Non-flammable Literature Review

MTR 13

Performance Requirements at 4% AQL:

AATCC 42 Impact Penetration ≤ 1.0 g, AATCC 127 Hydrostatic Pressure ≥ 20 cm

Literature Review

MTR 14

Intended Use: Minimal to low fluid and microbial barrier for use only for low-fluid, minimally invasive surgical procedures;

Simple orthopedic procedures during which tourniquets are used; Open hernia repair;

Minimally Invasive Surgery (MIS);

Interventional radiology or catheter laboratory procedures.

E. SCHEDULE FOR DELIVERABLES

The contractor shall provide the requested PPE as soon as possible after contract award, but no later than the below schedule for deliverables at the designated distribution centers as determined by the contract.

Deliverable Item Delivery Date

1 25% of PPE awarded to be delivered NLT 14 days of award 2 50% of PPE awarded to be delivered NLT 30 days of award 3 100% of PPE awarded to be delivered NLT 60 days of award

If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed.

F. CHANGES TO THE STATEMENT OF WORK

The Deliverables and Schedule for Deliverables identified in Sections D and E are based upon the urgency of this requirement. If the planned changes by the contractor would render Sections D and E materially inaccurate, the contractor shall notify the Contracting Officer (CO) as soon as practical before signing the contract. Any changes to this SOW shall be authorized and approved only through written correspondence from the CO and changes will be definitized via contract modification. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

G. REPORTING REQUIREMENTS

The contractor shall report to the COR and/or contracting officer in writing within one (1) business day upon awareness of any concerns about products or delay in delivery as outlined in this SOW to include an estimated timeframe for resolution, identification of the problem preventing the timely delivery, and the plan to mitigate this problem from occurring again.

H. GOVERNMENT RESPONSIBILITIES

The Government is responsible for communicating with the contractor promptly if assistance is needed in any matter related to this contract and for allowing reasonable time for contractor response and follow through.

I. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

J. Delivery and Location

The contractor shall deliver the supplies ordered under this contract to location specified in the quantities outlined herein.

Shipments will include packing slips / bill of ladings that provides appropriate delivery information as indicated below:

COVID-19 PPE and PPE Item (Example: COVID-19 Hand Sanitizer) Contracted Vendor Company Name Brief Description of PPE Item: (Example: 8oz. Bottle) Quantity of Units to be delivered (Example: 20 Cases, Boxes, etc) Total per Unit and Total PPE Item (Example: 12 per Case, Total 240 bottles)

The primary point of delivery will be the Health & Human Services Supply Service Center HHS/PSC/SCMS unless otherwise specified during contract negotiations.

HHS/PSC/SCMS

4 Center Drive North East, MD 21901 Attn: VHA- COVID 19