Sole Source Justification Over SAT Germfree Signed HCA_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Acq. # 36C241-23-AP-1536

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:____ 36C241-23-AP-1536_________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Boston Medical Center Pharmacy

523-23-2-7071-0017

2. Nature and/or Description of the Action Being Processed: The purpose of this action is to provide the Jamaica Plain campus within the VA Boston Healthcare System with a USP <797> and USP <800> compliant mobile cleanroom. This ensures the continuation of patient care for both hazardous and non-hazardous compounded sterile products (CSPs). This procurement is a Firm Fix Price contract with one (1) base year and four (4) option years for the rental of the mobile unit (pharmacy cleanroom) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501.

The estimated total value of this contract is to include options.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The fully integrated Pharmacy Trailer Includes,

(1) Negative Pressure Room <USP 800> containing:

(2) BSC Class II Type A2 Chemo hoods (externally ducted)

(1) upright refrigerator

(1) HEPA purging passthrough (pass box for passage of materials from the main entry into the negative pressure suite) ample stainless-steel casework and storage.

(2) Positive Pressure Room <USP 797> containing

(2) Vertical Laminar Flow Workstations

(1) upright refrigerator,

(1) HEPA purging pass box for passage of materials from the main entry into the positive pressure suite stainless-steel casework and storage.

Each compounding suite has its own anteroom (ISO 7 and ISO 8 respectively) containing storage for PPE, changing bench and sink with eyewash.

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

Effective Date: 02/01/2022 Page 2 of 5

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Currently, Boston VAMC is renting a Specialized Trailer from Germfree Inc, using contract 36C24120P1013. The Trailer is using the facility infrastructure to include entrance, exit, Utilities, and on-site accessibility. The current Trailer from Germfree includes the following, Mobile cleanroom on site at Boston (Jamaica Plain), Is 53’ unit with barriers and water, electric hookup

Currently, the clean room on site is USP <797> and USP <800> compliant. This lease ensures the continuation of patient care for both hazardous and non-hazardous compounding sterile products (CSPs) the GERMFREE trailer provides this working environment for both hazardous and non-hazardous medications.

The staff is currently Trained in the daily operation of the Germfree trailer. The staff operates the mobile unit to maintain a sterile environment as directed by USP <797> USP <800> and VHA 1108.12. More specifically- According to VHA directive 1108.12 the pharmacy department must adhere to USP <797>, USP <800> and USP <795> standards for sterile compounding (and oral medications via USP 795).

The Current Germfree trailer has been on site for several years and has undergone upgrades to address increased innovation. Pharmacy is renting the trailer due to infrastructure problems in Jamaica Plain and is currently working with engineering to take corrective action with is not expected to happen till FY27. The compounding suite provides oncology support (and occasionally on Saturdays/Sundays). In some cases, there are 15-20 chemotherapy regimens compounded for Jamaica Plain. The GERMFREE mobile cleanroom has become a mainstay in compounding especially for hazardous materials. A scenario where the trailer is removed, (or replaced with another vendor mobile clean room) would create a delay in patient care. Specifically, a new trailer (or any movement of the current located trailer) would require a triple clean, environmental monitoring report to be completed and possible training of employee(s).

This would shut down operations (within the trailer) and delay critical patient care.

Patients directly affected would be hematology/oncology patients. A delay in chemotherapy would have a direct negative impact to veterans within the VA Boston Healthcare System.

The GERMFREE trailer directly supplies medications for Jamaica Plain, with the ability to supply medications to West Roxbury and Brockton if needed. An on-site GERMFREE trailer is necessary to avoid delays in patient care and minimize disruptions in workflow of the pharmacy staff which could potentially be harmful to patients as well.

The Jamacia Plain, Boston has a need to continuously rent mobile cleanroom units for various patient care services (i.e., oncology, urgent care, inpatient acute care, inpatient intensive care). The

Effective Date: 02/01/2022 Page 3 of 5 minimum day charge applies each day the mobile unit is effectively operating in the designated space on the Jamaica Plain campus.

a. Only One Responsible Source – This Unit is a highly specialized equipment/services. To rationale substantial duplication of cost the Hospital has done the research and identified multiple areas of concern as it relates to cost and downtime.

A new trailer would require redesigning the current infrastructure and the total down time could take anywhere from 3 – 6 months. Engineering would have to evaluate the current infrastructure and compare it to the required hookups for a new trailer.

The current trailer would need to be decommissioned and moved resulting in substantial downtime which would cause patients to experience significant delays in thier care for 30 – 60 days.

A new trailer would need to be tested for compliance and this testing is done every 6 - 12 months.

The Staff would need to be trained on the new trailer and this training would take approximately 6 – 12 months

b. As explained above, award to anyone other than Germfree will result in a 50% duplication of cost that would not be recouped through competition and delay critical patient care by an estimated 30 - 60 days for Infrastructure and 6 – 12 months for training staff.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A sources sought synopsis was not done for this action, during the market research other vendors were known to provide trailers, but no other vendors identified would be able to provide an identical trailer with the same capabilities and integration of the existing infrastructure without significant modifications to the trailer or the VA hospital. There are no other vendors that would be able to fix or mitigate the substantial duplication of cost nor eliminate the unacceptable lapse in critical patient care that would happen if the Boston VA were to have another company other than Germfree provide the Trailer rental.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Based on the cost of the Germfree trailer rentals from current pricing (Contract # 36C24120P1013) at the JP campus when compared to the at the West Roxbury Campus (contract# 36C24121P0661) and at the West Haven, CT Campus (Contract # 36C24120P0756) the current cost of per year is considered fair and reasonable.

7. Description of the Market Research Conducted and the Results, or a Statement

Market Research was done to ensure that the best value was achieved. Best value is this case was determined to include the overall scope of the requirement to include the following, Germfree Pricing when compared to industry pricing (Industry was 200% - 300% higher) Perhaps this was due to the level of sophistication in the equipment.

Continuing with Germfree will allow no downtime in providing patient care Additional infrastructure would add to the cost of a new trailer and would result in another than reasonable cost.

Additional staff training would not only impact the level of care, but it would also require additional time for implementation.

Acq. # 36C241-23-AP-1536

Effective Date: 02/01/2022 Page 4 of 5

Site preparation could also be impacted as current location of the trailer could possibly require additional services from other departments on the Jamacia Plain Campus.

The customer has filled out Market research from which shows, VIP verified Service- Disabled, Veteran-Owned (SDVOSB), Stripes Mobile INC, Incumbent, Germfree Inc, HUBZone Small Business and Odulair and Mobile Healthcare Facilities LLC.

A comprehensive market research report was provided and VETBIZ, DSBS and GSA was searched.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition:

In accordance with FAR 19.1306 (a)HUBZone sole-source awards. As the current vendors price will not exceed 7 million and the current price is being made at a fair and reasonable price. Also, the performance of the current contractor is considered satisfactory.

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

Odulair and Mobile Healthcare Facilities LLC Stripes Mobile INC GermFree

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: The current barrier to competition is the inability to experience any downtime to the current system.

Should a new trailer be acquired there would be substantial downtime. This will be removed once the JP Campus builds a new compounding room on site in the hospital.

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.

Marci Salow Date Chief of Pharmacy Services

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.

Harold Nice Date Contracting Officer

Marcelle Salow 193853

Digitally signed by Marcelle Salow 193853 Date: 2023.02.07

HAROLD

NICE

Digitally signed by

HAROLD NICE

Date: 2023.02.08 16:23:05 -05'00'

Effective Date: 02/01/2022 Page 5 of 5

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.

JOSHUA DAVIS Date Commercial Team 2 Branch Chief RPO East / NCO 1

c. 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 approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

JOSEPH P. MALETTA Date Executive Director,RPO East

JOSHUA

DAVIS

Digitally signed by

JOSHUA DAVIS

Date: 2023.02.08 16:38:24 -05'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2023.02.09 16:43:58 -05'00'