Justification for Intent to Sole Source Notice 36C25921Q0399 Posting 4-26-21.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP

Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

2021-02-18T08:39:08 Acquisition Plan Action ID: 36C259-21-AP-0998

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration (VHA) Regional Procurement Office West, Network Contracting Office 19, 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111

Organization Activity: Oklahoma City Veterans Affairs Health Care System (OKCVAHCS), 921 NE 13th Street, Oklahoma City, OK 73104

2237: 635-21-2-201-0017

2. Nature and/or Description of the Action Being Processed: The action is being reviewed and approved as a Single Source Justification for a new contract to continue the use of a fully equipped Modular Cath Lab Building and uninterruptable power source (UPS) for the Oklahoma City Veterans Affairs Health Care System’s Cardiology Catheterization (Cath) Laboratory (Lab). The Lab was placed per Contract 36C25920P0348 with Modular Devices, Inc., which was awarded on 03/01/2020. A Base period from 03/01/2020 to 08/31/2020 and an Option Period from 09/01/2020 to 4/30/2021 were exercised and funded. A new Firm-Fixed-Price Contract to include a base plus four (4) option years to Modular Devices, Inc. is required to allow the continued use of the Modular Cath Lab and UPS to begin on 5/1/2021.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This requirement is for a logical follow-on new contract for the OKCVAHCS’s ongoing requirement for a Modular Cath Lab building with an uninterruptable power source. The Modular Cath Lab that is currently in place is necessary until construction of the new facility is completed. OKCVACHS’s current Cath labs 1 and 2 have been shut down and will be undergoing construction for equipment replacement and room renovation. The Cardiac Cath Lab volume requires the use of two cath labs. The modular cath lab building provides the second room required to address patient care needs. In addition, it provides an Uninterruptible Power Supply (UPS) and power conditioner. The power is critical due to the power fluctuations experienced at the OKCVAHCS. These power fluctuations are referred to as brownouts. Brownouts are intentional or unintentional drops in voltage in the electrical power supply. Brownouts time will range from a few minutes to several hours. The UPS is vital due to Oklahoma’s history of icy weather during December through February and severe weather from April to July. Interruptions in power to the equipment (e.g. no electricity or brownout) equipment functionality can be difference between a successful procedure and possible death or major procedural complication for the patient.

OFOC SOP Revision 08

Original Date: 03/22/11

Revision 08 Date: 04/18/2018

The Modular Cath Lab Building is equipped with a Cardiac Cath Lab X-Ray System, ceiling mounted radiation shield, x-ray protection field on the table, ceiling mounted examination light, at least a 10-inch detector on the x-ray system, three viewable monitors in the procedure room and the viewing room, is compatible with the Merge Hemodynamic Monitoring System and Merge Picture Archived Communication System (PACS). All this equipment will be used to complete the following procedures:

i. Cardiac Cath/ STEMI.

ii. Intra-aortic Balloon Pump.

iii. Intravascular Ultrasound/ FFR.

iv. Pericardiocentesis.

v. Peripheral Angiography/ Interventions.

vi. Pacemakers/ ICD.

vii. Temporary Pacing Wire.

viii. Carotid Angiography and Stenting.

ix. Coronary Angiography and Interventions.

x. Implantable Loop recorder.

The period of performance will be 5/1/2021 to 4/30/2026, if all option years are exercised and funded.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

FAR 13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Modular Devices Inc. is the only company providing a mobile solution for a modular cath lab building. All other companies who provide mobile medical solutions use trailers that are similar to Recreational Vehicles (RV). These trailers have sections that extend on either side and make the width of the footprint very large.

There is only one location that is equipped with all items required for the medical trailer and patient care (e.g. patient ramp from building, protected from weather, electrical hook ups, and water hooks ups). Unfortunately, the location is directly next to the backing

OFOC SOP Revision 10 Page 3 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020 area of the main OKC VAHCS dock. The radiology trailer sustained a significant impact from a semi, and it was deemed a patient and staff safety risk. The only mobile solution available to fit this location and footprint standards is manufactured and provided by Modular Devices Inc.

Currently there are 2 modular cath lab buildings provided by Modular Devices Inc. located at the OKC VAHCS. The buildings were extremely difficult to place. It required two cranes, strategically located, lifting in unison to place the buildings. The placement of the buildings causes the smoking area to be closed, the dock to be shut down, partial closure of the emergency room road, and a main employee exit/entrance to be blocked off for over 6 hours. This caused a major disruption to normal hospital operations and required the combined effort of the Police Service, Medicine Service, Logistics Service, Biomedical Service, Engineering Service, Chief of Staff’s Office, Assistant Director’s Office, and Ambulatory Car Service. Once the buildings were put into place it took two full weeks to set up for patient and staff use. The set up took hospital wide coordination. The Director’s Office, Chief of Staff’s Office, Medicine Service, Police Service, Engineering Service, Biomedical Service, IT Service, Infection Control Office, Patient Safety Service, Office of Quality and Safety, Environmental Management Service, Logistics Service, Environment of Care Office, and Nursing Service had critical parts to fulfil in ensuring the buildings were appropriately inspected and connected for patient care.

The current buildings were modified to fulfill policies and patient care:

• Installed PIV readers

• Installed magnetic locks

• Installed a camera

• Installed specialized equipment and software call Merge. It is a hemodynamic monitoring system used during invasive cath lab procedures. The equipment is standardized in Cardiology and is required to perform cath procedures. Special wiring was run from the fluoroscopy system to the merge system. This required the building’s floor to be opened up and the wires to be run.

• Special metal support was added to one of the counters to support the Pharmacy Medication Dispensing machine (Omni-Cell).

• The Omni-Cell was bolted to the countertop to with pharmacy and security regulations regarding narcotics.

The Government has invested approximately $400,000.00 into the installation of each building and modifications described above. A cost of as much as $100,000.00 would also be involved per lab if the labs were to be replaced. The VA would have to shut down the main VA loading dock and bring in a large crane to move the current Cath lab and then place the new one.

Estimated the new Cath lab would not be l-laced and operational for 6 months at least.

Replacing is not an option at this point and replacement would hinder patient care and safety.

It would not be logical nor cost effective to remove the existing buildings while an ongoing requirement for its continued operation is required by OKCVACHS.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: It is anticipated that an offer will be solicited from one source in accordance with FAR 13.106-1(b)

OFOC SOP Revision 10 Page 4 of 4 Original Date: 03/22/11 Revision 10 Date: 09/10/2020

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The price will be analyzed using the procedures of FAR 13.106-3 to ensure it is fair and reasonable prior to award. The anticipated cost has been compared to prices found fair and reasonable on a previous purchase. The anticipated cost to the Government will be fair and reasonable.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A query of the Vendor Information Pages (VIP) database produced 110 SDVOSB concerns when using the NAICS 621512. However, further Market Research indicates that this requirement is only available from Modular Devices, Inc., the small business vendor, that is currently providing the Modular Cath Lab buildings.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts supporting the use of other than full and open competition.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Modular Devices, Inc., 6678 Guion Rd, Indianapolis, IN 46268.

10. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: It is not possible for the facility to remove barriers for the market. Due to the facility’s requirements and limited capabilities only one responsible source exists in the current market. It is possible that changes in market conditions could support a future competition.

11. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

c. NCO Director (Required if going to HCA): I have reviewed the justification and certify it is ready for HCA review and approval.

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx