Brand Name Jusitification - Ohio - CO.docx

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

DEPARTMENT OF VETERANS AFFAIRS

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

Acquisition Plan Action ID: 36C250-21-AP-4159

1. Contracting Activity: Department of Veterans Affairs, NCO 10, Cleveland, Cincinnati, and Dayton VA Medical Centers, 101-21-3-5209-0378

2. Nature and/or Description of the Action Being Processed: This is a brand name only procurement for additional Codonics barcode scanners for Louis Stokes VA Medical Center (Cleveland) and a new medication safe label systems for Cincinnati VA Medical Center and Dayton VA Medical Center in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically 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 action will be awarded as a new firm-fixed price contract.

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

This system will allow for compliance in medication labeling and documentation within the Cerner SA Anesthesia charting module. This interfacing allows for reduction of human errors and automates the workflow for Anesthesia providers during care.

Cleveland currently has installed the Codonics Safe Label System (SLS) and will need necessary barcode scanners to allow bedside medication documentation within the Cerner SA Anesthesia Module.

All remaining sites will need a full system installation, to include label printing systems, barcode scanners, backend servers, and professional services for the installation and training on the system.

Product lead time is 4 to 6 weeks. Installs typically take 12 weeks plus/minus. The variability is related to site approvals and IT readiness. Typically a new VA site takes a little longer (16 weeks) and an existing site shorter (8 weeks).

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 BRAND NAME ONLY ( ) 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):

BRAND NAME ONLY:

The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Office of Electronic Health Record Modernization (OEHRM) Perioperative Services Council has reviewed the integration between the Codonics Safe Label System (SLS) and the Cerner SA Anesthesia module and recommend pursuing a standardized medication verification system for patient safety. Below are some of the factors that make an automated medication verification system essential:

1. The recently convened High Risk Medication Management Workgroup mandated that a 2-person verification process be performed in the OR for high risk medication as the OR bypasses the usual pharmacy checks. Medication preparation at the point of care (POC) is integral to anesthesia practice. During the administration of an anesthetic there may not be an available 2nd verifier if the medication is needed urgently. The workgroup determined that an automated system which has audio and visual capability (speaks the name and concentration of the drug, as well as printing a label with the information for the drug on it) would be acceptable as a second verifier.

2. Currently SA anesthesia does not facilitate rapid documentation of medication administration potentially compromising patient safety, documentation, and dosing accuracy. Specifically, when a medication is selected, the screen that appears to the provider does not identify the amount/ml. A system that provides label production, barcode scanning capability for POC and prepared medications, that provides visual display of the drug name and concentration and immediate to documentation into the ARK (SA anesthesia) is necessary to rectify this critical gap. This integration was also supported by Cerner as the necessary proposed software modifications to their product were stated to have been determined not to be feasible.

3. Such a system will facilitate heading towards the goal of zero patients harmed due to medical error, including medication error, by utilizing a standardized system across the organization.

Codonics is proprietary and is the only known software/equipment that can interface with Cerner SA Anesthesia System. The interface allows medication documentation to be automated within the Anesthesia Module. The Codonics Safe Label System (SLS) and Barcode Scanner (SLS WAVE) are already operational in VISN 20 with necessary Cerner integration. For standardization, the Council has recommended the Codonics solution be implemented in VISN 10 to allow for a more automated medication documentation practice during Anesthesia care. Cleveland currently has installed the Codonics Safe Label System (SLS) and will need necessary barcode scanners to allow bedside medication documentation within the Cerner SA Anesthesia Module. All remaining sites will need a full system installation, to include label printing systems, barcode scanners, backend servers, and professional services for the installation and training on the system.

Without this system, the hazards and risks associated with manual medication documentation in the Cerner Anesthesia module can lead to patient safety concerns and financial repercussions to VA. The Codonics SLS allows for that process to be automated, and significantly reduces the chance of error during anesthesia care.

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

Brand Name Only procurement. Contacted the manufacturer to see if they have any authorized distributors. They provided one distributor, Becton, Dickinson and Company, a large business. Items can be procured open market through two different sources, the small business manufacturer and a large business distributor. Recommend open market, unrestricted, brand name procurement using FAR 13.

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

The brand name acquisition will be awarded to the lowest price of all quotes received. The CO will request catalog pricing from the manufacturer to make sure that the lowest quote pricing is fair and reasonable in comparison to the catalog pricing.

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

VIP was queried under NAICS 339112 and 415 concerns were found. A keyword search of “codonics” along with the NAICS resulted in zero concerns. Searched NAC and GSA and found one result under codonics which was “Omnicell”. Contacted Codonics and they confirmed that Omnicell is no longer an authorized distributor. Contacted the manufacturer to see if they have other distributors. They provided one distributor, Becton, Dickinson and Company, a large business. VA Rule of Two cannot be attained. Acquisition cannot be set aside for SDVOSB or any small business category. Items can be procured open market through two different sources, the small business manufacturer and a large business distributor. Confirmed both vendors have an active SAM account. Confirmed manufacturer, Codonics, Inc. is listed in the SBA Database as a SB. Past Performance is good for both vendors (green in the CRA). Recommend open market, unrestricted, brand name procurement using FAR 13.

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

None

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

Codonics, Inc.

17991 ENGLEWOOD DR STE D

CLEVELAND, OH 44130

Ed Kubiez 216-408-0490 Ekubiez@codonics.com

Beckton, Dickinson and Company 1 Becton Dr.

Franklin Lakes, NJ 07417 Michael Collins michael.collins@bd.com

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:

Should a requisition of this nature recur, the market will be surveyed.

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 9 Original Date: 08/30/17 Revision 03 Date: 02/11/2021