36C26322P0978_1.docx

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

GENERAL INFORMATION

BASE NOTICE TYPE

NETWORK 23 CONTRACTING OFFICE

Contract Officer 4801 Veterans Drive St. Cloud MN 56303

POINT OF CONTACT*

WENDY HOESCHEN

AWARD INFORMATION

LINE ITEM NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

EMAIL DESCRIPTION

Award Notice Award Notice

DESCRIPTION

*= Required Field Award Notice Award Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C263-22-AP-3683

1. Contracting Activity: Department of Veterans Affairs, Network 23 Contracting Officer, 4801 Veterans Drive, Saint Cloud, MN 56303

2. Nature and/or Description of the Action Being Processed: Brand Name procurement of 125 each Hill-Rom LIKO Lift Motor Packages and installation for the Nebraska Western Iowa VA Health Care System located Omaha, NE. 2237# 636-22-3-1963-02294, Estimated Cost: $411,592.50

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The vendor shall provide 125 each Hill-Rom Likorall 250 Lift Motors, motor carriages and hand-controls for wall charging. This is a brand name requirement to replace existing Likorall motors with new motors to be use on the existing Likorall overhead tracks at the Omaha VA. The vendor shall provide LIKO Onsite Installation Training and Certification for three (3) VA attendees to remove existing lift motors and assembly/install new lift motors on rail systems. Training includes procedures for final load testing and for certifying the lift system for staff/patient use. Training to be completed at the Omaha installation site within one (1) working day; (8) hours maximum. Travel, lodging, and meal expenses for the instructor shall be included. Training should be provided within 30 days of notification site is ready. Each trainee shall receive a certificate of training citing they have been trained to Hill-Rom factory standards for this type of equipment.

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

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

This procurement will replace 60 existing Hill-Rom LIKO Lift Motors that are at end of life. The Nebraska Western Iowa VA Health Care System currently has 200 Hill-Rom LIKO Overhead Lift Systems at their Omaha facility, of which many are at end of life.

The following in italics is a statement from Shelly Crisler at CEOSH:

The Healthcare Technology Management Patient Safety workgroup leadership and the Safe Patient Handling and Mobility office recommend that patient lift motors must be installed on rail from the same manufacturer, unless all of these conditions are met:

1. Both manufacturers have submitted in writing that the track and lift motors are compatible and supportable on the intended track, including the power and charging mechanisms;

1. The motor manufacturer agrees to do the PM according to the VA checklist and their own procedures; and

1. The motor manufacturer accepts all liability and warranty related to the entire structure once they have installed their lifts on the rails.

At this time there is only budget approval to replace 60 out of the 117 motors requiring replacement. At the Omaha location, excluding the ACC building (which uses 2 types of Amico models) and including only ceiling mounted rails, all of the patient lift systems belong to the same model: Liko 250 ES.

The Liko Overhead Patient Lift system is composed of the permanently installed ceiling rails, a charging station, a carriage that connects the motor to the rails, the patient lift motor itself, the spreader bar that hangs below the motor, the patient sling that connects to the spreader bar, and the hand control which hangs down from the motor and also connects the motor to the wall-mounted charging station. Of this system we only need to replace the motor, with the carriage and hand controls being standard to replace at the same time. The carriage can be expected to have suffered significant wear and tear and should be expected to be replaced in order to pass the new installation inspection checklist. The same applies to the hand piece, especially given that the motor’s battery charges when the hand piece is placed inside the cradle of the charging station. The hand piece is recommended to replace because of the wear and tear it will experience, and because of the fact that the it is vital part of charging the Liko 250 ES internal battery.

The replacements we require must be compatible the ceiling rails, spreader bar, and charging station. The ceiling rails are permanently installed into the walls and/or ceiling and their installation required a structural analysis and seismological analysis. It would be prohibitively expensive to replace the ceiling rails. The spreader bar can be detached from the motor and so choosing a brand of motor that is non-compatible with the spreader bar models at the Omaha VA would then require a further purchase of replacement spreader bars. As for the charging station, the hand control is composed of molded plastic with charging contacts on the bottom and is meant to fit securely in the charging station. Given the custom nature of this charging station it is very unlikely that a different brand of motor would be compatible with the Liko charging station. A purchase of non-Liko brand motors would require also purchasing replacement charging stations and also purchasing the installation services required to install them.

In order to accommodate bariatric patients some of the rooms use a pair of Liko 250 ES motors working in tandem. Using 2 motors has the added benefit that the distance between the two spreader bars allows for a larger and more comfortable sling to be used. In this setup the speed of the motors also matters – such that both ends of the sling can be raised at identical speeds. The design of the hand piece also matters, as the staff have to hold one handpiece in each hand in order to use a bariatric setup.

Using two different arrangements of buttons simultaneously on the handpieces would introduce needless difficulty for the staff. For example, current hand pieces have “Up” on the left and “Down” on the right. In the same way that switching the location of the gas and brake pedal in a car would increase the chance of user error, constantly switching between different button configurations in different rooms will increase the possibility of user error in staff. The best case of these user errors is reducing the confidence a patient has in their healthcare provider and the worst case is patient injuries. Consider this example for when the Omaha location has to direct where the last 2 to 3 motors in this procurement should be placed: in the event of two bariatric lifts requiring one new motor each the Omaha location would not be free to fix both systems but instead have to choose one to replace entirely and the other to leave with end-of-life motors. The Omaha location has dozens of bariatric lifts installed

To choose a non-Liko brand motor would start a chain of queries necessary to accommodate it. The highest concerns involve the safety risks, such exceeding weight limits or introducing fire or electrical shock hazards. There are a variety of other charging systems for patient lift motors on the market, such as continuous in-rail charging. The rails for our current system are made of steel that is presumably conductive and an electrical short in the charging system could lead to a fire or electrical shock. A significant difference in systems may require an engineering safety analysis – which will require the NWI HCS to hire an engineering firm.

The other safety risk concerns the weight capacity of the lift system. First is the weight of the motor itself and whether it is equal or less than the weight of the existing motors. While the overhead rails are all composed of Hill-rom’s Liko rails, given the diversity of the shapes and sizes of patient rooms and the needs of different departments, the patient lift systems have a variety of different rail dimensions. This diversity of set-ups complicates our ability to know the margin of safety for additional load on the rails. For example, the traverse rail setup will have two models of rails because one pair of rails needs to be capable of bearing the load of the traversing rail. In this example, even if the single traversing rail may be able to easily bear the load of the extra weight of a non-Liko motor the system may still not be safe until it is confirmed that the supporting pair of rails can bear the combined load of the traversing rail along with the motor. The traversing rails are differing lengths according to the needs of specific room they are placed in and thereby their differing weights create differing loads on the supporting rails. This means that some rooms will have a smaller margin of safety than other rooms. The Omaha location would not be able to freely install motors in any room as necessary but would instead need to consider the weight capacity of each room independently.

The statement below from Karie Darnley in Safe Patient Handling & Mobility at Hillrom points out the voiding of warranties of the rail system and a safety feature unique to Hillrom’s motors (emphasis added).

We are reaching out today related to the inquiry on the use of competitive motors on your existing Hillrom overhead lift rail system.

We would like to clarify that the rail system installed at your facility was designed to support patient weights of up to 550lbs. We cannot certify or in any way guarantee that this system would support weights beyond this capacity. The Hillrom lifts in use today, do not allow for the lifting of a patient beyond the capacity of the motor. This means that your current motor does not allow you to lift beyond the capabilities of your rail system. If another motor that is not designed and installed by Hillrom is used, we cannot guarantee this safeguard will be in place.

We would also like to clarify that should a competitive motor be placed on your existing rail structure, the warranty of your rails will no longer be valid.

The second issue is the weight capacity of lifting a patient for a non-Liko motor compared to the Liko 250 ES. If the weight capacity differs then the staff will not merely need to be retrained in the replacement model of motor but also be constantly aware of which rooms have unique weight capacities. This introduces room for human error on the part of the staff. Instead of replacing motors in the rooms with the heaviest use, the NWI Hospital will instead have to consider options for reducing the risk of human error. Some solutions, such as by replacing all the motors in one department, can then introduce new complications, such as forcing departments to feel they need to compete with each other in proving they should be the one to get the new motors.

The above issues are assuming that we will be able to keep using Liko model slings. If we cannot, then the of weight of the slings will also be a concern.

The statement below from Pete Zawodniak in Safe Patient Handling & Mobility at Hillrom points out the voiding of the Liko Lift System, along with pointing out the logistics issues resulting from mixing manufacturers in a patient lift system (emphasis added).

This letter is to provide information regarding the use of other manufacturer lifts on Liko rails.

The facility currently has Liko lifts facility wide and introducing multiple lift manufacturers increases the learning curve of the staff. Staff would need to learn how to use both lifts in order to safely move/reposition patients. The staff are all currently trained on the Liko lift products and bringing in a new lift manufacturer would unnecessarily place additional training requirement on the hospital staff.

Additionally, as the OEM we are unable to recommend using other manufacturer slings on our lifts or our slings on other manufacturers’ lifts as we would not be confident on the security and safety of the patient. Any interchangeability could result in patient vulnerability or incident. Including other manufacturer slings would therefore require the facility to purchase slings from multiple vendors and keep on hand stock of each size and type from multiple manufacturers. The parts on hand would also need to be kept for not only Liko products, but also the new manufacturer’s lifts to ensure timely response to any downtime issues. This would also increase the purchasing burden to do multiple purchases for each order for typically stocked parts.

The use of non-Liko brand motors on Likorall brand ceiling lift rails will also void any warranty of the Liko Lift System. Below is an excerpt from our Liko Warranty.

From our Liko warranty:

“ANY INSTALLATION, MAINTENANCE, REPAIR, SERVICE, RELOCATION, OR ALTERATION TO OR OF, OR OTHER TAMPERING WITH, THE PRODUCTS PERFORMED BY ANY PERSON OR ENTITY OTHER THAN HILL‐ROM AND OTHER THAN FACILITY‐AUTHORIZED, PROPERLY TRAINED PERSONNEL WITHOUT HILL‐ROM’S PRIOR WRITTEN APPROVAL, OR ANY USE OF REPLACEMENT PARTS NOT SUPPLIED BY HILL‐ROM, SHALL IMMEDIATELY VOID AND CANCEL ALL WARRANTIES WITH RESPECT TO THE AFFECTED PRODUCTS. THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER EXPRESS WARRANTIES AND IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS OF PURPOSE. HILL‐ROM’S OBLIGATION UNDER THESE WARRANTIES SHALL NOT INCLUDE ANY LIABILITY FOR LOSS OF PROFITS, DIRECT, INDIRECT OR CONSEQUENTIAL DAMAGES OR DELAYS.”

One important aspect of this requirement is the need for installation service. While the installer will be required to fill out the Installation Checklist for Ceiling Mounted Patient Lifts provided in the Statement of Work, it is also valued is an installer who has experience with patient lift systems like ours. For example, someone who may potentially spot signs of defects or damage to the system as a whole that is otherwise missed by the staff and by installers of a different rail system. An installer of a different patient lift system may incorrectly make the assumption that the Liko patient lift system operates the same way as the one that they’re familiar with. An installer experienced with Liko ceiling mounted systems is desired.

There are other questions that will need to be answered. If the need for repairs is discovered who will take responsibility? What if the repairs are the result of errors in the original install? What if repairs are needed to the lift system in the future? What if the lift rails need repairs in the future? What if several years from now the Omaha VA replaces non-Liko motors with Liko brand motors, and then later requires routing maintenance performed by Hillrom?

To switch to a different system for these 25 lift systems would increase the risk of injury to the veterans and staff, as staff have been trained on the operation, disinfection, maintenance of this system, compatible education, slings, maintenance and clinical support. Continuing to purchase LIKO brand lift systems improves patient and staff safety through standardized education/training, slings, maintenance and clinical expertise.

Patient care providers have been trained in the use of this lift, and the goal is to maintain standardized patient lifts to mitigate known risks associated with having multiple lift systems. Standardizing alleviates the need for staff to attend recurring training on various brands of lifts. This will also negate the need to buy an excessive number of additional slings as VA Nebraska Western Iowa has already purchased numerous slings and straps for existing LIKO lifts. LIKO slings are also interchangeable with LIKO floor lifts, which are also in use at the Nebraska Western Iowa VA Health Care System.

With this standardization, VA Nebraska Western Iowa can interchange equipment if there is a failure of parts. This also reduces the need for numerous spare parts, as only one type of product is being used. The initial purchase of patient lift systems was conducted through a competitive solicitation. It would be unreasonable to have these five lift systems (12.5% of the total lift systems at the facility) be different from the existing lifts, and for this reason the Hill‐Rom LIKO Overhead Lift System is required.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A search was conducted on Vetbiz.gov, using NAICS code 339113, and 438 potential sources were identified. A Sources Sought was issued on the Contracting Opportunities portion of beta.SAM.gov. Several lifts were identified that can be retrofitted to the existing rail system; however, after a review by the government, and given the situation as detailed in Section 3, a Brand Name Only procurement is in the best interest of the government. This is an acquisition under NAICS 339113, where there is not a class waiver to the Non‐Manufacturer Rule (NMR), and therefore, any Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSBs) that would submit a quote under a 100% set aside for SDVOSB or VOSB would be in violation of the NMR, as Hill‐Rom, the manufacturer, is a large business.

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

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A search was conducted on Vetbiz.gov, using NAICS code 339113, and 438 potential sources were identified. A Sources Sought was issued on the Contracting Opportunities portion of beta.SAM.gov. Several lifts were identified that can be retrofitted to the existing rail system; however, after a review by the government, and given the situation as detailed in Section 3, a Brand Name Only procurement is in the best interest of the government. This is an acquisition under NAICS 339113, where there is not a class waiver to the Non‐Manufacturer Rule (NMR), and therefore, any Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSBs) that would submit a quote under a 100% set aside for SDVOSB or VOSB would be in violation of the NMR, as Hill‐Rom, the manufacturer, is a large business.

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

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

Hill-Rom Baxter Electa-Med Alliant Janz Corporation

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:

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.

(This signature is the requestor’s supervisor, fund control point official, chief of service, someone with responsibility and accountability)

Title Facility

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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.

Title Facility

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

NCO/PCO XX Duty Title Facility

c. VHA SAO 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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

VHA Head of Contracting Activity (HCA)

d. VHA Senior Procurement Executive Approval (over $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs OFOC SOP Revision 08 Page 9 of 9 Original Date: 03/22/11 Revision 08 Date: 04/18/2018