36C24822P0063_1.docx

SUBJECT*

FY22: Hemodialysis Equipment PM Service

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 8 (NCO 8) VA Caribbean HCS (Admin Bldg) #10 Calle Casia Suite #4M440 San Juan PR 00921-3201

POINT OF CONTACT*

Contract Specialist Elder Vazquez elder.vazquezmelendez@va.gov

(787) 641-7582

AWARD INFORMATION

MODIFICATION NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:___ 36C248-21-AP-6224____________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 8, VA Caribbean Healthcare Systems (VACHS), San Juan, PR 00921. Justification for Other than Full and Open Competition.

2. Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition. Contract period 11/01/2021 to 10/31/2026 for twenty (20) Phoenix and two (2) Prismaflex units. These systems are located at OPA 2 Renal Clinic. This action is a new follow-on firm-fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Service contract to provide preventive and corrective maintenance to twenty (20) Phoenix and two (2) Prismaflex units.The Estimated Amount for the Base and all option years is $455,400.00.

4. Statutory Authority Permitting Restricted Competition:

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

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Prime Medical Supply INC. is the only manufacturer local representative in Puerto Rico. Due to the proprietary nature of the equipment, a factory certified field service technician from Prime Medical Supply INC. is required to access, troubleshoot, repair, and calibrate the unit to proper specifications. Service company has the required certification, training, and access service codes to restore and certified the system to proper operation.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The service is for exclusive vendor with exclusivity letter. However, an intent to “Sole Source” was posted in beta SAM on 09/16/2021 to 09/20/2021.We received (0) zero correspondence to the posting.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Independent Government Estimate (IGE) was prepared by the customer based on market research and historical data of previous contract VA248-17-C-0015 awarded on 10/28/2016 on a sole source basis. The CO will determine price reasonableness by comparing the proposed price with similar purchases.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Used VA’s VIP database to identify verified capable SDVOSBs. Search came up with 18 SDVOSbs and 7 VOSBs vendors. However, one of the requirements of the SOW is be at (VACHS) withing 1-hours of any service emergency due the importance nature of this equipment to the patients. One VOSB is in P.R Endoscopy Medical Systems Corp. but they do not work or are certified for Hemodialysis Equipment. And the rest of the group were not contacted since there is only one business that have exclusivities rights on Baxter equipment to be serve in P.R.

MR was conducted in SBA search utilizing NAICS 811219 provided a result of 0 SBA. Searching just by location I found one company BiomedtechPr located in Puerto Rico. I called and spoke with Joel Vega he confirms that they are not certified to provide preventive and corrective services to Hemodialysis equipment.

Discussions were held with COR regarding possible sources. COR provided one vendor Prime Medical Supply INC. the manufacturer local representative in Puerto Rico. As I mentioned above due to the proprietary nature of the equipment, a factory certified field service technician from Prime Medical Supply INC. is required to access, troubleshoot, repair, and calibrate the units to proper specifications. Hemodialysis equipment are for direct patient care. Failure to obtain in timely manner will result in a threat to health, welfare and or safety. It will decrease VACHS ability to provide critical care in the Surgical Department, furthermore, increasing operational cost to the government.

Contracting office contacted mentioned vendor and spoke with the owner Marcelino Prieto. He explained that he is been working for over 20 years with VA Hemodialysis equipment and is the only manufacturer local representative in Puerto Rico to perform the services but did not have exclusivity letter. He gave me the phone number of Carlos Rentas Manager at the machine manufacturer Baxter.

Contracting office contacted Mr. Rentas to get more information. Mr. Rentas confirmed that indeed Prime Medical Supply INC. is the only certified vendor to provide preventive and corrective services to Hemodialysis equipment. He mentioned that Baxter only provide maintenance services to one hospital in Puerto Rico due to not enough personal that Medical Supply INC. cover the rest in Puerto Rico. Mr. Rentas assure that he will request the exclusivity letter and send it to me.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: These items are for direct patient care. Failure to obtain in timely manner will result in a threat to health, welfare and or safety. It will decrease VACHS ability to provide critical care in the Surgical Department, furthermore increasing operational cost to the government. Original Manufacturer Parts (OEM) must be used to repair this unit. In order to maintain the manufacturer specifications in accordance with FDA Class I, II, and III devices intended for human use. Additional information can be found on the FDA site under Premarket Notification (510k) at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition

Medical Supply INC Marcelino Prieto mprieto.dejesus@gmail.com Office: 787-744-5040 Cell: 787-630-4575

11. 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:

The San Juan Contracting Office will continue performing market research to identify any future competition available.

12. 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.

Title: Biomedical Equipment Support Specialist Facility: VA Caribbean Healthcare Systems (VACHS)

13. 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.

Title: Contract Officer

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

NCO-8 / RPO East Supervisory Contract Specialist

PM Part 813.5 SAP for Certain Commercial Items Page 6 of 6 Original Date: 08/30/17 Revision 03 Date: 02/11/2021