Brand Name Justification_Redacted.pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items

Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C256-21-AP-2340

Contracting Activity:

Department of Veterans Affairs, VISN 16, Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC). Requisition Number: 580-21-4-167-0857

Nature and/or Description of the Action Being Processed:

This procurement is for brand name Spacelabs Healthcare L.L.C.’s patient monitoring system equipment in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically Federal Acquisition Regulation (FAR) 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The period of performance is September 9, 2021 through October 8, 2021. The Government intends to award a firm fixed price Purchase Order.

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

Spacelabs Healthcare L.L.C. is the Original Equipment Manufacturer (OEM) of the Xprezzon monitors and Qube Mini transport monitors. Spacelabs Healthcare L.L.C. is a large business located at 35301 SE Center Street in Snoqualmie, Washington 98065-9216. The estimated value of this action is

This system includes brand name Xprezzon monitors, Qube Mini transport monitors and supporting equipment. The patient monitoring system provides easy access to patient data and ensures appropriate clinical presentation for patient status updates.

The Xprezzon monitors optional dual-display allows a dedicated full screen view of physiologic information plus a secondary screen for an alternative presentation of the patient’s clinical data. The frameless display integrates highly visible light emitting diode alarm lights. These illuminate the front and rear, enhancing the clinicians ability to identify which monitor is alarming in the busy care environment. With a single touch, clinicians can access different trend views based on observation needs, type of procedure or clinical protocols. Trends can be displayed continuously for real-time updates of critical patient information. They can also be sized and arranged as preferred, providing clinicians with their own uniquely customized views

The Qube Mini transport monitors are optimized for transport. The Qube Mini ensures an uninterrupted level of vigilance when the patient is most vulnerable. Qube Mini’s large screen size makes patient data readable from the bedside or across the room. Qube Mini patient monitor is lightweight and rugged to withstand accidental drops, meeting the needs of busy transport and midacuity environments. The patent-pending integrated intravenous pole mount and 8-inch touchscreen display with alarm light delivers vital information at the bedside or on the go. With wireless networking and an integrated battery, Qube Mini supports transport up to five hours. All of the equipment is listed in the attached equipment list.

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 5 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

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):

The MEDVAMC Emergency Department has Spacelabs Healthcare L.L.C.’s patient monitoring system installed and requires new patient monitors for the newly constructed emergency department. The MEDVAMC Gastroenterology and Pulmonary areas were using GE patient monitors which have become obsolete. Any malfunctions on these monitors will no longer be able to be fixed.

The use of Spacelabs Healthcare L.L.C.’s patient monitoring system will decrease staff training hours and its familiarity will aid the critical transition of the newly constructed emergency department to ensure a fully trained and functional staff immediately following the test, audit and release for clinical operations. Spacelabs Healthcare L.L.C.’s patient monitoring system is a cost-efficient, easy-to-use software product for managing the patient vital signs and biometrics while under the care of staff. Currently this equipment is being used within the MEDVAMC. This product is reliable and effective. The capability of having lightweight, transportable and efficient system flow is essential for the highest quality patient monitoring and medical management. Equipment must have the same functionality throughout the different locations to allow for staff familiarity with processes and enhanced safety.

The use of Spacelabs Healthcare L.L.C.’s patient monitoring system is essential to the MEDVAMC due to compatibility with the existing equipment, duplication of costs to replace the entire system and undue delay to train the entire staff on a new system. The nurses, nurse assistants, medical instrument technicians and related staff have received training on the Spacelabs Healthcare L.L.C.’s patient monitoring system. The current Spacelabs Healthcare L.L.C.’s patient monitoring system is estimated over $1,500,000.00. The estimated cost to replace the entire system with a competitor is estimated between $1,000,000.00 and $3,000,000.00. The cost of training already spent for the current staff is estimated at $4,500.00. The estimated cost to receive training on a new system is estimated at $5,917.00. Procuring a new patient monitoring system would cost the Government an estimated amount between $1,005,917.00 and $3,005,917.00. This duplication of costs to replace the current system would be necessary to ensure system compatibility and patient safety.

The amount of time to train the staff on a new patient monitoring system is estimated at 48 hours total for each staff member. The MEDVAMC would also need additional time to conduct market

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 5 Original Date: 08/30/17 Revision 03 Date: 02/11/2021 research on other patieint monitoring systems. Procuing the Spacelabs Healthcare L.L.C.’s patient monitoring system would prevent undue delays since additional training would not be required for the staff.

Accordingly, Spacelabs Healthcare L.L.C. is the only firm capable of providing the supplies described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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

The Contracting Officer issued Request for Information number 36C25621Q1159 on June 9, 2021 and it closed on June 14, 2021. The Request for Information was issued to obtain information on Contractors able to provide the Government’s requirement. One response was received from a Service Disabled Veteran Owned Small Business (SDVOSB), . The is an authorized distributor of Spacelabs Healthcare L.L.C. The Contracting Officer searched the Small Business Association Dynamic Small Business Search website at https://web.sba.gov under the North American Industry Classification System (NAICS) code 339112 with the keywords patient monitor. The search returned five small businesses but they were all distributors of medical equipment. The Contracting Officer searched the Vendor Information Pages at https://www.vetbiz.va.gov/vip/ under NAICS code 339112 with the keywords patient monitor.

The search returned five contractors. The five Contractors listed were distributors and not manufacturers.

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

The Government intends to award a firm-fixed price contract for the required services. The Government will conduct a price analysis in accordance with FAR 13.106-3(a)(2)(vi), comparison to an independent Government estimate. The Government will also conduct a price analysis in accordance with FAR 13.106-3(a)(1), base price reasonableness on competitive quotations or offers.

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

The Contracting Officer searched the Vendor Information Pages (VIP) under NAICS code 339112 and it returned 420 results. The Contracting Officer searched VIP under NAICS code 339112 and the keywords patient monitor. The search returned five results. All of the Contractors listed were distributors and not manufacturers. The Contracting Officer searched the General Services Administration (GSA) Advantage website under the search term xprezzon monitor. The search returned one result. AVMedical, a SDVOSB, was listed as a seller of this item under contract number 36F79718D0350. The Contracting Officer also searched the GSA Advantage website under the search term qube mini transport monitor. The search did not yield any results. The Contracting Officer searched the Small Business Association Dynamic Small Business Search website at https:// web.sba.gov under keywords xprezzon monitor and qube mini transport monitor. The search did not return any results. The Contracting Officer searched the Small Business Association Dynamic Small Business Search website under the NAICS code 339112 with the keywords patient monitor.

The search returned five small businesses but they were all distributors of medical equipment.

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 5 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

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

The Government is not able to tailor the requirement due to compatibility issues with competitor’s equipment and patient safety.

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

The Government Technical Expert provided informal market research quotes from and Spacelabs Healthcare, L.L.C. (Large ). The Government Technical Expert determined all of these contractors were capable of providing the requested items.

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 Government will continue to survey the market on future requirements to determine if other contractors are able to offer compatible equipment with little or no additional training.

EQUIPMENT LIST

Item Number

Description Quantity

91393 Xperezzon monitor 24 91393-A Xperezzon base 24 91393-1 English Language 24 91393-08 Eight Waveforms 24 91393-N Vital Signs Calculations 24 91393-Q Data Shuttle 24 91393-V Full View 24 91393-W Full Bed Review 24 91496 Ultraview SL Command Module 24 91496-1 English Language 24 91496-C Invasive/Cardiac Output Parameter Set 24 91496-H Advanced Multiview Arrhythmia (MVII) 24 91496-N Nellcor SpO2 24 91496-D 12-lead diagnostic ECG with measurements and interpretation

91496-R Adult/Neonatal Respiration 24 91496-S ST Segment Analysis 24 91496-V Varitrend 4 24 96102 Xhibit Central Station 2 96102-B Xhibit central station, base Computer 2 96102-28 Xhibit central station, 28 bed bundle 2 910-6102-01 Single patient license for Xhibit central station 56

94267-19 19in Premium XPREZZON display with integrated high resolution front & rear LED alarm lights & ambient light dimming sensor

010-1971-01 Printer, Laserjet, HP, M506N, 110V** 2 010-1863-00 USB Cable A-Male to B-Male 2.0, 6ft** 2 999-0222-51 Basic CEC Support. Includes 3 consecutive days of customized clinical onsite training (workflow process development, alarm management, eLearning administration). Up to 7 hours of class time per day, between the hours of 8 A.M. and 8 P.M.

999-0222-52 Additional Week of Clinical Education Project Management.

Includes 3 consecutive days of onsite support. Up to 7 hours of class time per day, between the hours of 8 A.M. and 8 P.M.

Required for units with >50 users to train and/or >11 beds.

999-9999-42 Depot Support Plan. Unit price is per year.

Monitoring Products only.

016-0888-01 M-Series Arm, Backpack, 12 in 24

016-0899-00 KIT, BRACKET, BKPK, 91393 24

016-0863-00 Power Supply Holster, Wall Mounted 48 016-0512-00 Crossmember for mounting power supply holsters side by side

012-0887-02 20 inch Display Alarm Cable** 24 012-0893-01 16 inch DVI Cable** 24 012-0894-01 12 inch Touch Screen Cable** 24

016-0884-00 KIT, DISPLAY HANDLE, 94267 24

016-0866-00 Hook, dual (undermount), arctic white 24 700-0008-56 ECG combiner cable, 5+5-Lead Spacelabs monitors, AAMI** 24 700-0010-01 ECG combiner lead wire set, 5L, multi-pinch, AAMI, 130cm/51 in**

700-0010-02 ECG combiner lead wire set, 5L, multi-pinch, AAMI, 130cm/51 in**

690-0003-01 Nellcor OxiMax DS-100A finger sensor, adult 24 714-0018-00 BP hose, single tube, adult 24 715-1141-10 BP cuff, TruLink nylon, 1T, adult, 26-36cm, HP 24 700-0292-01 INVBP integrated adapter cable, Edwards Lifesciences, dual pressure

700-0027-00 TruLink cardiac output adapter cable** 24 306655-003 Cardiac output cable, Baxter/Edwards/Abbott 24 704-0173-00 CO2 airway adapter, mainstream, 92517, adult/pediatric, 25/bx

010-1980-00 CO2 mainstream sensor, 92517 24 103-0234-00 CO2 Nomoline adapter, sidestream, FLL, multi- use, 25/bx 24 704-0183-00 CO2 oral/nasal cannula w/O2 delivery, MLL, adult, 2.1m/7 ft, 25/cs**

700-0792-00 Nellcor OxiMax sensor adapter cable** 24 084-2301-06 Operation Manual, CD, Xhibit/Telemetry 1 084-1479-06 Service Manual, CD, Xhibit/Telemetry 1 92517 Capnography Module 24 92517-1 English Language 24 92517-A Capnography Module, base unit 24 91390 qube Compact Monitor 4 91390-A qube Compact Monitor, base unit 4 91390-1 English Language 4 91390-06 Six Waveforms 4 91390-D Perioperative 4 91390-N Vital Signs Calculations 4 91390-Q Data Shuttle 4 91390-R Patient Data Logger (PDL) 4 91390-V Full View 4

91390-W Full Bed Review 4 91390-P Wireless (802.11 a/b/g) 4 91496 Ultraview SL Command Module 4 91496-1 English Language 4 91496-B Invasive Parameter Set 4 91496-H Advanced Multiview Arrhythmia (MVII) 4 91496-N Nellcor SpO2 4 91496-R Adult/Neonatal Respiration 4 91496-S ST Segment Analysis 4 91496-V Varitrend 4 4 92516 Capnography Pod 4 92516-1 English Language 4 92516-A Capnography Pod, base unit 4 999-9999-42 Depot Support Plan. Unit price is per year. Monitoring

Products only.

700-0008-57 ECG combiner cable, 5-Lead Spacelabs monitors, AAMI** 4 700-0010-01 ECG combiner lead wire set, 5L, multi-pinch, AAMI, 130cm/51 in**

690-0003-01 Nellcor OxiMax DS-100A finger sensor, adult 4 103-0234-00 CO2 Nomoline adapter, sidestream, FLL, multi- use, 25/bx 4 704-0183-00 CO2 oral/nasal cannula w/O2 delivery, MLL, adult, 2.1m/7 ft, 25/cs**

010-1649-00 Masimo RD SET SpO2 Cable, 12 ft. 4 999-0510-00 Trade-in credit for 1-3 year old 90496/91496 towards the purchase of new 91496. REQUIRES the completion and return of the Trade-in Equipment Form on page 9 with your purchase order.

7000-0001-999 Trade in discount, monitoring items. REQUIRES the completion and return of the Trade-in Equipment Form on page 9 with your purchase order.

999-1510-13 Project Management: Manage all aspects of the equipment, technology, clinical workflow, and go- live activities from the initial project kickoff to project closure utilizing the 5 stages of the Project Management Process.

999-1898-23 Enhanced Software Support with cybersecurity support, price per year per Telemetry channel.

012-0395-00 Serial cable for PDL * 9 pin to 9 pin connector, male to male 4 131-1588-00 Adapter null modem 9m to9f 4 011-0241-01 Xhibit display, 22" high resolution touchscreen 6 084-0700-03 Patient Monitoring Service Manual, CD-ROM 2 084-1101-05 Ultraview SL Network Operations Manual, CD- ROM, English 2 161-0246-00 Power Cord, North America, 3 ft, 120V, 10A 52

999-9999-97 Installation 1

Item Number Description/Part Number* Quantity 016-0823-00 Roll Stand for 91389/91331/91330 6 016-0827-00 Roll Stand Mounting Kit for 91389/91331/91330 External

Power Supply

SL-0087-16 Mounting adapter, Qube Mini, 91389 6 92516 Capnography Pod 6 92516-1 English Language 6 92516-A Capnography Pod, base unit 6 999-0222-51 Basic CEC Support. Includes 3 consecutive days of customized clinical onsite training (workflow process development, alarm management, eLearning administration). Up to 7 hours of class time per day, between the hours of 8 A.M. and 8 P.M.

999-9999-42 Depot Support Plan. Unit price is per year. Monitoring Products only.

700-0008-57 ECG combiner cable, 5-Lead Spacelabs monitors, AAMI** 6 700-0010-01 ECG combiner lead wire set, 5L, multi-pinch, AAMI, 130cm/51 in**

690-0003-01 Nellcor OxiMax DS-100A finger sensor, adult 6 714-0018-00 BP hose, single tube, adult 6 715-1141-10 BP cuff, TruLink nylon, 1T, adult, 26-36cm, HP 6 704-0173-00 CO2 airway adapter, mainstream, 92517, adult/pediatric, 25/bx

010-1980-00 CO2 mainstream sensor, 92517 6 103-0234-00 CO2 Nomoline adapter, sidestream, FLL, multi- use, 25/bx 6 704-0183-00 CO2 oral/nasal cannula w/O2 delivery, MLL, adult, 2.1m/7 ft, 25/cs**

700-0792-00 Nellcor OxiMax sensor adapter cable 6 999-1389-02 Qube Mini Shuttle bundle: High Res 8in disp (6 trace, 18 parameter) & C Module. Advanced data shuttle, ruggedized transport-ready, integrated pole mount. Exergen Temp & CapnoPod ready w/integrated Wi-Fi. Limited time offer, contact sales rep for details.

91389 Qube Mini Transport Monitor 6 91389-1 English Language 6 91389-A Qube Mini, base unit 6 91389-06 Six Waveforms 6 91389-Q Data Shuttle 6

91389-R Patient Data Logger (PDL) 6 91389-V Full View 6 91389-W Full Bed Review 6 91389-P Wireless (802.11 a/b/g) 6 91496 Ultraview SL Command Module 6 91496-1 English Language 6 91496- CDHNRSV 3, 5 or 12 lead ECG w/interpretation & reasoning statement, advanced event based arrhythmia, Multi-lead ST, four invasive pressures, cardiac output, Nellcor SpO2 technology, Non- Invasive Blood Pressure & temp from Neonatal to Adult.

084-0700-03 Patient Monitoring Service Manual, CD-ROM 1 084-1101-05 Ultraview SL Network Operations Manual, CD- ROM, English 1 161-0246-00 Power Cord, North America, 3 ft, 120V, 10A 6 999-9999-97 Installation 1