B Brand Name Justification Welch Allyn.pdf

SIMPLIFIED ACQUISITION BRAND NAME JUSTIFICATION

FOR ACQUISITIONS UNDER $250K

April 2, 2020

1. Activity. The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a contract on a basis of Brand Name competition for the following acquisition as implemented by FAR Subpart 13.106.

2. Nature and/or description of the action being approved. Justification to solicit full and open completion for Brand Name Welch Allyn on FBO.

3. Description of Supplies or Services required to meet the agency’s needs (including the estimated value). This procurement request is for low acuity portable patient monitors. Physiologic monitors designed primarily for automated periodic and/or quasi-continuous real-time measuring and display of two or more of the vital signs (e.g., noninvasive blood pressure, temperature, heart rate) and oxygen saturation in the blood (SpO2); many devices may also perform continuous monitoring during transportation or at the bedside. These monitors typically consist of portable or mobile electronic units that facilitate movement from one location to other; the monitor may be connected to the line and/or powered by internal batteries. The main unit includes controls and a display; it also includes appropriate attached probes and sensors that make possible sequential and/or simultaneous measurements of the parameters. Noninvasive blood pressure (NIBP) is usually measured using cuffs and either auscultatory or oscillometric techniques; the measurement of temperature is typically accomplished using an intraoral sensor, and SpO2 is determined using pulse oximetry sensors. Vital signs physiologic monitors are intended mainly for periodic automated measuring of the parameters of one or more patients. Some monitors have additional capabilities (e.g., recording, alarm, printing). Some vital signs monitors are designed specifically for use in magnetic resonance imaging (MRI) environments (i.e., MRI-compatible anesthesia units) and are made from nonmagnetic materials so that they can be safely used in an MRI suite. Dedicated physiologic monitors that can provide electrocardiographic waveforms and/or invasive measurements such as invasive blood pressure measurements are not usually considered vital signs monitors. The Welch Allyn Connex Spot Monitor has been identified as meeting all IHS requirements for low-acuity patient monitoring in the Phoenix Area IHS.

Technical Specifications:

EMR Connectivity: Yes Connectivity to RPMS Warranty: 2 years Parameters: Blood Pressure, SPO2, Temperature Early Warning Score: Up to 3 Protocols Custom Documentation Fields: Up to 20 Wireless Connectivity: WiFi/Bluetooth Wired Connectivity: USB, Ethernet EMR Client Support: Thin, Thick Cleaning Agent Compatibility Coverage: High Memory (# Readings): 400

4. Identification of the statutory authority permitting other than full and open competition. 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirement

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited. The unique qualification of Welch Allyn Connex Vital Signs monitor is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for: noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) and body temperature in normal and axillary modes.

The monitors are used to monitor patients in general medical/hospital environments and provide low acuity patient monitoring. This is a brand name procurement only, as the low acuity vital signs monitors currently utilized and supported in Phoenix Area IHS are the Welch Allyn Connex Spot Monitors. All requested equipment is the same brand and quality found at Phoenix Indian Medical Center, Hopi Health Care Center, Parker Indian Health Center, and Whiteriver Indian Hospital in order to keep all vital signs monitor universal for staff training, patient care, and maintenance and parts availability. Existing inventory includes Welch Allyn Connex Integrated Wall Systems, Connex Spot Monitors, Connex Vital Signs Monitor 6000 Series, 6700 Series, and 6800 Series. In accordance with IHS Circular 24-05 medical equipment procurement and replacement guidelines, when procuring medical equipment, Area Offices should standardize on single manufacturers where practical and consolidate purchases where feasible. Using multiple different vendors for a type of medical equipment is not optimal.

The Connex monitors is FIPS 140-2 compliant (meets IHS security requirements) and an existing interface to the Indian Health Service electronic health record (RPMS) exists. The Connex monitors ensure that data is correctly time stamped, and they do not lose functionality during network downtime when connected to RPMS. Additionally, the Welch Allyn monitors are currently used in our hospitals and clinics and the Supply team currently carries the Welch Allyn consumables and accessories in their supply inventory including blood pressure cuffs, disposable/reusable sensors, thermometer probe covers, etc. The Biomedical Engineering team also currently carries a supply of Welch Allyn parts for repair and maintenance including Welch Allyn batteries, circuit boards, and service kits. The Biomedical Engineering departments currently utilize the Welch Allyn service tool software to perform maintenance and provide software updates and upgrades on the Welch Allyn patient monitors. The Welch Allyn online service dashboard allows facilities to remotely configure their fleet of Welch Allyn devices. The parts, software, and current Welch Allyn Connex patient monitoring network are not compatible with non-Welch Allyn monitors. Core vital signs monitors available on the market will be reviewed on an annual basis and before every procurement request. Medical equipment technology advances at a rapid pace and requires regular review of vendor capabilities and technological features. All FDA approved manufacturers that meet the technological requirements for patient monitoring equipment will be considered in the future.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies. We will publish Source Sought Notice on GSA Ebuy and SAM.GOV to find any Small Businesses or Other Than Small Businesses that have the capability to meet our requirement. After we receive our responses we will know determine our market research procurement method.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. We will determine price fair and reasonableness by competing this requirement on

SAM.GOV.

8. Description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted. We will publish Source Sought Notice on GSA Ebuy and SAM.GOV to find any Small Businesses or Other Than Small Businesses that have the capability to meet our requirement. After we receive our responses we will know determine our market research procurement method.

https://www.acquisition.gov/content/part-5-publicizing-contract-actions#i1120661 https://www.acquisition.gov/content/part-5-publicizing-contract-actions#i1120688 https://www.acquisition.gov/content/part-10-market-research#i1114815

9. Any other facts supporting the use of other than full and open competition. We are soliciting full and open competition for Brand Name Welch Allyn.

10. List of sources. To be determined from source sought notice.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. We are going to solicit this requirement on FBO to remove any barriers.

12. Program Office Certification. This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for limited sources, are accurate and complete.

13. Contracting Officer Certification. This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name Signature Date Contracting Officer

Contracting Officer

Official Name & Title Signature Date Point of Contact Supervisory Biomedical

Engineer