36A77619Q0166-001.pdf

OFOC SOP Revision 06 Page 1 of 5 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (<$150K)

Acquisition Plan Action ID: VA776-19-AP-1753

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity Central (PCAC), in support of

VA Nebraska-Western Iowa Health Care System (NWIHS) located at 4101 Woolworth Avenue; Omaha, NE, 68105

2. Nature and/or Description of the Action Being Processed:

FAR Part 13 Simplified Acquisition Procedures: This is a justification for a Brand Name in accordance with FAR 13.106-1 Soliciting Competition and specifically FAR 13.106-1(b) Soliciting from a Single Source, 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.

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

BD/CareFusion Alaris PC unit (Model 8015) BD/CareFusion Alaris 8100 Volume Pump Modules BD/CareFusion Alaris Guardrails Point-of-Care Software for Alaris PC Units BD/CareFusion Alaris Guardrails Point-of-Care Software for Alaris Pump Modules

VA NWIHS requires the delivery and upgrade of the Alaris software system for the ambulatory surgery departments at the new Ambulatory Care Center that operates throughout the VA NWIHS.

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR Part 13 Simplified Acquisition Procedures: The authority for applying the Simplified Procedures for Commercial Items of FAR Part 13 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(1)(ii).

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 VA NWIHS is pursuing an upgrade of the CareFusion Alaris infusion therapy system. Infusion therapy involves the intravenous administration of medication. It is prescribed when a patient’s condition is so severe that it cannot be treated effectively by oral medicaions. The CareFusion Alaris infusion therapy system includes the following items: drug management library software, infusion device maintenance software, Alaris PC unit, Alaris high volume IV unit, Alaris ETCO2 unit, Alaris Syringe unit, and PCA unit. This requirement is for the 25 Alaris model #8015 PC Units, 25 Alaris model #8100 Volume Pump Modules, 25 software licenses for Guardrails Point-of-Care Software for Alaris PC Units, and 25 software licenses for Guardrails Point-of-Care for Alaris Pump Modules.

According to the Agency for Healthcare Research and Quality at the Department of Health and Human Services, the leading cause of patient harm is medication errors and account for almost 20% of medical injuries.

Administration is the stage of the medication use process most vulnerable to error, and the intravenous (IV) route of drug administration often results in the most serious outcomes of medication errors. IV infusion errors that

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Revision 06 Date: 08/30/2017 involve high-risk medications delivered directly into the patient’s bloodstream have been identified as having the greatest potential for patient harm.1

The CareFusion Alaris infusion therapy system is the primary infusion therapy system in use at the VA NWIHS.

Uniformity of infusion therapy systems, and the components of those systems, are essential for patient safety, specifically the safety of veterans seeking treatment. The VA National Patient Safety Center (NPSC) recognizes that uniformity of infusion therapy systems significantly increases patient safety and specificially the compatability of Drug Error Reduction Software (DERS) between the different components of the infusion therapy system. The VA NPSC received over 750,000 saftety reports over 11 years including 12,000 root cause analyses (RCAs). There were 12,000 RCAs, of which 129 involve infusion pumps. Of the 129 RCAs that involve infusion pumps, 60 were on general purpose infusion pumps, 69 were on PCA pumps, and 129 RCAs account for over 13% of medical device related RCAs for just the two types of pumps. As a result, 60% of the actions taken by the RCA teams were to standardize on devices as well as protocols, clinical guidelines, and order sets. 625 of the PCA pump related RCAs were candidates where an integrated EtCO2 monitoring system would have averted the adverse events.2

Additionally, a joint Association for the Advancement of Medical Instrumentation (AAMI)/Food and Drug Administration (FDA) Infusion Devices Summit conducted October 5-6, 2010 at FDA headquarters generated 13 top priorities to prevent adverse events related to infusion devices. These top priorities include: incompatibility across devices and with systems (cleared products that support data transfer); standardization of terminology used in the infusion related systems (same wording, same spelling, etc. across the process and devices, containers, etc); lack of knowledge/familiarity with the device; lack of standardization that supports data aggregation; lack of formulary and standards – standardization of concentrations and transparency (e.g. sharing between facilities) of drug librarities; and dealing with the complexity of multiple infusions, including secondaries, disposables, etc.

As a result, the Infusion and Patient Controlled Analgesia (IV/PCA) Integrated Product Team (IPT) that met May 19-21, 2009 at the National Acquisition Center (NAC) in Hines, Illinois identified the following as minimum recommendations for any infusion system purchased: Single platform and single user device interface; Dose Error Reduction System (DERS); Electronic drug libray; QI data extraction capabilities; and wireless networking consolidation of infustion data into the patient electronic record [requiring FIPS-2 certification].

According to a 2015 British Journal of Healthcare Management article3, user error is one of the most common issues with infusion devices and can have catastrophic consequences. To reduce the risk to patients from user errors, DERS is recommended to be used. The Alaris drug management software provides the DERS for the Alaris infusion therapy system. By separating the high volume pumps from the Alaris infusion therapy system, the DERS used would be differing between the two systems and provides an increase chance for error.

With unique and seperate infusion systems, the nursing and clinical staff would need to program two infusion devices and the DERS systems would not interact. This could increase the chance of negative drug interactions

1 Maddox, Ray, et al. “Intravenous Infusion Safety Initiative: Collaboration, Evidence-Based Best Practices, and “Smart” Technology Help Avert High Risk Drug Events and Improve Patient Outcomes,” Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 4: Technology and Medication Safety), Agency for Healthcare Research and Quality, August 2008, available at https://www.ncbi.nlm.nih.gov/books/NBK43752/.

2 VA National Patient Safety Center via VA generated patient safety and root cause analysis reports gathered from the VA NPSC SPOT system.

3 Blandford, Ann, et al., “Infusion Device Standardisation and Dose Error Reduction Software,” British Journal of Healthcare Management, Volume 21, Issue 2, February 9, 2015.

https://www.ncbi.nlm.nih.gov/books/NBK43752/

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Revision 06 Date: 08/30/2017 due to the DERS not capturing all the drugs or doses being administered to a patient through one software. An additional critical patient safety feature includes the shut down of the PCA pump if the ETCO2 device is in the alarm mode.

Standardization of infusion pumps was a recommendation brought forward through the 2010 British Journal of Nursing article titled, “A Team Approach to Identify and Manage Risk in Infusion Therapy” by Paul T. Lee (Lee, 2010)4. For the evaluation of two large acute care hospitals, there were over 30 different infusion devices being used, and many different consumable sets for each of these devices. Patients were being swapped to different therapy devices, with different infusion sets, which inevitably increases the chance for user errors. The hospital systems had significant risk reduction by establishing a standardized infusion therapy system and reduced unnecessary duplication through multiple devices.

One infusion therapy system would also improve patient safety by limiting the training required for nurses, physicians, other medical practitioners, and users of the system. One system at a medical facility greatly increases the understanding users of the system will have as opposed to having to maintain proficiency on multiple systems that logically increases the risks to patients.

All infusion pump systems utilized by the VA must have National Institiute of Standards and Technology (NIST) FIPS-2 validated cryptographic modules. The current Alaris sytem is NIST FIPS-2 validated. The used Alaris pumps would not function without an Alaris PC unit to control setup for clinical use and there is no other product on the market that can control the Alaris ETCO2, PCA, or Syringe pumps as CareFusion holds the patents on the proprietary integrated infusion pump container and fluid infusion system.

Fielding multiple infusion therapy systems at the VA NWIHS increases the risk to veteran patients at the point of care and is a leading cause of patient harm. Maintaining uniformity in the infusion therapy system at the VA NWIHS is essential to the VA’s requirement for upgrades to its infusion therapy system.

If the VA NWIHS were to procure a brand new system, it would be required to purchase additional large volume infusion pump units not covered under this requirement. As the facility is currently using the Alaris infusion therapy system, these units currently in place could be reused. Additionally, the VA NWIHS would be required to purchase an entirely new DERS drug library. As the facility currently owns Alaris CareFusion modules that will be used with the equipment being purchased, the VA NWIHS recognizes a substantial savings in not having to purchase modules compatible with an entirely new system.

Based on an analysis of the cost of a brand new infusion therapy system versus purchasing only the Alaris CareFusion equipment, software, and services not currently owned by the facility, the estimated savings are substantial. The savings and estimated cost of a new system do not take into account the added cost of purchasing and maintaining spare equipment for two (2) or more infusion therapy systems that would be required in order to keep an adequate number of working systems available for patient use and also do not include delivery, installation, operations and maintenance, and training. In accordance with the authority prescribed in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(ii)(A), award to another source would result in substantial duplication of costs to the Government that is not expected to be recovered through competition.

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

See section 8 below for detailed efforts to ensure offers will be solicited from as many potential sources as

4 Paul Lee, “A Team Approach to Identify and Manage Risk in Infusion Therapy,” British Journal of Nursing, Volume 19 Issue Sup1 (2010): online https://doi.org/10.12968/bjon.2010.19.Sup1.47080 https://doi.org/10.12968/bjon.2010.19.Sup1.47080

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Revision 06 Date: 08/30/2017 deemed practicable.

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

The anticipated cost to the Government has been determined fair and reasonable by previously conducted market research by VA NWIHS technical experts in addition to comparing pricing with the pricing of the existing GSA contract held by CareFusion for the exact Alaris software and server systems. Further, an informal quote was received by the facility from the OEM. Pricing received from any authorized dealers will be compared to the OEM price. A determination the price is fair and reasonable will be performed before award.

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

Preliminary Market Research was conducted by the requiring activity’s technical experts. The Government’s technical experts conducted market research by reviewing other similar equipment and software. The other similar equipment reviewed included Baxter and Hospira Infusion systems. Based on reviews of these products, the Government’s technical experts determined that none of these products can meet the Government’s interoperability and compatibility requirements previously discussed. Review of these products is based on actual VA an DoD experience using the competing volumetric infusion pump systems for treatment procedures. Based on all of these market research efforts, the Government’s technical experts have determined that only BD Alaris Infusion Pump system brand name equipment can meet all of VA’s needs.

On May 15, 2019 the Contracting Officer (CO) posted a notice of intent to sole source to FedBizOpps asking any vendor that believes they are capable to submit a response. Responses were due at 1:00 PM (Eastern) on Friday May 31, 2019. No responses were received.

Additionally, a search in VetBiz of NASICS 339113 and FSC code 6515 for both Service Disabled Veteran Owned Small Businesses (SDVOSBs) and Veteran Owned Small Businesses (VOSBs) yielded 105 results, total. An email was sent to all 105 SDVOSB and VOSB vendors asking for a response if they believe they are willing and capable of providing the items detailed in the Statement of Work (SOW) and are an authorized dealer/distributor of the Original Equipment Manufacturer (OEM) for all items. No responses were received.

The Medical Surgical Prime Vendor (MSPV) Next Generation (NG) Formulary was downloaded from https://www.va.gov/opal/sac/mspvNG.asp. The prime vendor for Omaha, NE is Kreisers, LLC. A search of Kreisers, LLC’s formulary for the keywords “infusion pump” found one (1) result for a cardiovascular saline infusion pump. The BD/Carefusion Alaris brand infusion pump system is a medication infusion system, is not the same as a cardiovascular saline infusion pump, and the infusion pumps are not interchangeable. The MSPV is not an appropriate source at this time.

A search for “infusion pump” was conducted on July 5, 2019 on the National Strategic Source Listing. No results were found.

This requirement includes installation and training and purchases using ECAT cannot fulfill the installation or training need. ECAT is not an appropriate source for this requirement at this time.

The CO contacted BD/CareFusion, the OEM of the Alaris brand infusion pump, to request a list of authorized dealers that are able and authorized to provide the equipment and services detailed in the SOW. The OEM provided a letter that identified three (3) SDVOSB vendors are authorized dealers for the Alaris infusion pump line of products: Veterans Healthcare Supply Solutions, Inc. (VHSS), Four Points Technology, and MicroTechnologies, LLC (DBA: MicroTech, LLC).

https://www.va.gov/opal/sac/mspvNG.asp

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A search pm the GSA eLibrary for “infusion pump” led to Schedule 65 II A (Medical Equipment and Supplies), Category A-64 (IV Pumps). There are eight (8) SDVOSB and 10 VOSB vendors on the subject schedule. The list was compared to the listing of authorized dealers provided by the OEM BD/Carefusion. Only one (1) of the vendors, Veterans Healthcare Supply Solutions, is an authorized dealer for the OEM on GSA Schedule 65 II A, Category A-64. As using GSA would restrict competition, posting an RFQ to GSA eBuy is not an appropriate source at this time.

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

BD/CareFusion is the sole manufacturer of the Alrais Infusion System and is the sole patent holder of the proprietary integrated infusion pump container and the fluid infusion system. There is no other existing product on the market that can control the Alaris EtCO2, PCA, or Syringe pump units.

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

• Veterans Healthcare Supply Solutions, Inc.

• Four Points Technology

• MicroTechnologies, LLC (DBA: MicroTech, LLC)

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:

To remove or overcome any barriers to competition before future acquisitsions for the same supplies and services are conducted, at the system’s end of life, the VA will ensure extensive market research is performed in a timely manner to evaluate vendor capabilities with the intent of opening competition to all brands of IV infusion pump therapy systems that can potentially meet the Government’s requirements. The estimated lifecycle of infusion therapy systems is approximately eight (8) years.

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.

Date

Biomedical Engineer VA Nebraska-Western Iowa Health Care System

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.

Date

Contracting Officer Program Contracting Activity Central (PCAC) http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx