Revised J and A Signed July 16_Redacted.pdf

VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 5 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C263-20-AP-3169

1. Contracting Activity: Department of Veterans Affairs, NCO23, 4801 Veterans Drive, St. Cloud MN

56303-2099. Organizational Activity: US Department of Veterans Affairs, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis MN 55417.

2237 Number: 618-20-3-6040-0033

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: To establish a firm fixed price purchase order for the BRAND NAME ONLY procurement of HandiCare (formerly MedCARE) C625 Ceiling Lift Motors and 4-Point Hanger Systems. Items will be used in connection with the construction project number/Contract: 36E77620C0058, but is not duplicative of any items that are purchased in that contract. These items will also be used in connection with the existing rail systems used in the Minneapolis VA Health Care System. This order is for equipment only, no installation.

1. C625 Manual Traverse (Medcare) Stock# 323120

2. 4 Point Hanger System 1”

Stock#: 400602

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Rail Lift System being installed in the Minneapolis VA Health Care System (MVAHCS) is by HandiCare (formerly MedCare), the same rail system we have throughout the MVAHCS. There are currently 332 C625 HandiCare (formerly MedCare) lift motor systems owned by MVAHCS, with 329 operational throughout the MVAHCS facility (either in a patient care area or ready for issue as needed); 3 are non-functional requiring repair or replacement. Lift motors routinely require replacement due to inoperability and/or routine maintenance. These lift motors (including the lift motors being purchased in this order) are not assigned to specific rooms but rather rotate throughout the facility as needed. To change manufactures at this time will cause compatibility issues for VA Staff that are maintaining and using the existing lift equipment. Any other manufacturer’s lift motor system cannot provide a 100% interchangeability with the existing infrastructure at the MVAHCS due to trademark and proprietary design, thus limiting our ability to immediately change a lift motor in a patient care area when needed.

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Some vendors claim their lift motors are compatible with competitors’ ceiling lift track systems by using a conversion kit on the ceiling lift motor (e.g. Savaria lifts). The MVAHCS would need to purchase an equal number of conversion kits along with the lift motors and hanger systems in order to make the competitors lifts work with the existing railing system. This could increase costs associated with the need for the conversion kits for the competitor motor system to fit existing rail systems. It also calls into question the physical integrity of a ceiling lift system that requires a conversion kit in order to be used on an existing rail system. Using equipment on a rail system that is not designed by the same manufacturer increases the risk of malfunction, installation issues, and incompatible hanger systems being used; placing staff and patients at risk. Although lift motors may be compatible with other rail systems via a conversion kit, the hanger systems to these lift motors are not; they are proprietary to lift motor. By not purchasing a Handicare (formally MedCare) motor system, MVAHCS would be required to purchase additional hanger systems specific to the new lift motor systems.

While the basic function of ceiling lifts is similar throughout the industry, each manufacturer has Hanger Systems (carry bars, connectors & clips), batteries, and hand controls specific to their product. To change manufacturerss at this time will cause compatibility issues with replacement parts for VA Staff that are maintaining the existing lift equipment. The use of a compatible (with conversion kit), but different, motors would also increase costs due to training staff on differentiating between the systems installed; and, how to properly use, clean, supply chain manage, maintain, inspect, load test, and repair the different systems.

Bringing in a competitors’ lift motor would require MVAHCS to purchase additional batteries and repair parts in order to maintain VA owned equipment. Lift batteries are only rated for a certain number of lifts (60 to 120 lifts) before they must be replaced. New compatible lifts, not HandiCare (formally MedCare), would require the MVAHCS to stock an additional battery type in order to maintain the competitor lifts. Currently MVAHCS purchases 16-20 replacement batteries annually at a cost of roughly $4000.00.

Additional training for maintenance staff will be required if a second lift motor system is acquired in order to obtain, and sustain, proficiency in repairing two different systems.

Maintenance training takes 6-12 months for employees to become proficient with a new lift motor. MVHACS currently has 4 maintenance staff that work on lift motors.

Currently, annual lift testing is contracted for our existing lift motors. Adding a different manufacturer’s lift motor would require an additional testing contract, or modification to our existing contract, which adds additional cost as well as another level of complexity for Engineering and the Safe Patient Handling Coordinator to manage.

Patient Room/Bed down time for lift motor replacement can be minimized by having only one redundant system.

The ceiling lift construction project requires increasing the lift motor inventory by approximately 22% from our current inventory. This is significant enough of an increase that incompatible pieces of equipment (hanger systems and hand controls) could be mixed between lift motor systems within patient care areas. Many manufacturers require the use of their specific supplied patient slings and will not accept responsibility for the VA’s use of another manufacturer’s products. The FDA encourages to only use a sling specifically designed for the lift system; using the wrong sling may cause serious injury.

MVAHCS currently has an inventory of over 800 slings specifically designated for the HandiCare Lift System. Adding additional slings to MVAHCS would create unnecessary hardship for the VA Laundry

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Service to launder and sort; and, Logistics Service to stock additional slings for an additional manufacturer lift motor system. Logistical systems are already in place to maintain sling inventory, cleaning/disinfecting and checking serviceability. The potential to purchase new slings for a new lift motor system would add labor costs (currently one employee and several volunteers manage existing sling inventory) to keep them separated as well as increased risk for the delivery of an incompatible sling to a lift motor system. More importantly, the possibility of the VA clinical staff then using a different manufacturers’ sling on another manufactures’ lift motor would create unnecessary risks to patient safety. Slings can slip out of hanger systems dropping a patient and creating a situation where the patient and health care working are at risk for injury. In the last year MVAHCS has had 12 patient safety events involving ceiling lifts and associated slings; involving battery issues, lifts being stuck in an elevated position/unable to lower, not working at all, and a sling that was attached to the hanger system incorrectly resulted in a Veteran dropping from the lift. Having two different lift motors, hanger systems, and potential slings could increase the risk of more patient safety events.

4. Description of market research conducted and results or statement why it was not conducted:

Historically, opportunities have been offered to other vendors that can provide patient lift systems, to present their equipment at the MVAHCS. Each vendor’s system was reviewed by Engineering, Logistics, Nursing, and Safe Patient Handling for compatibility. Although these vendors could provide a similar product, they would not be able to install a system that is 100% interchangeable with the MVAHCS’s existing HandiCare (formerly MedCare) ceiling lift system. A new lift motor system would potentially cause issues with VA clinical staff and patient safety staff with lift system exchanges. Routine preventative maintenance is predictable and scheduled for every lift motor within MVAHCS. Malfunctions and unresponsive motors contribute to the MVAHCS requirement to maintain a back-up stock of lift motors. To date, our existing lift motors installed in patient care areas have required exchanges approximately four times per month. This does not include our annual load testing which also removes the lift motor from service while being tested by the contractor. Having back-up, operational lift motors that can be used with ease throughout the MVAHCS is vital to sustaining continuous operations.

An extensive investigation was completed by the MVAHCS Engineering Projects Section and Safe Patient Handling Coordinator regarding the use of different manufacturer’s sling with the currently installed HandiCare (formerly MedCare) ceiling lift rail system when MVAHCS purchased hundreds of HandiCare (formerly MedCare) slings. During that investigation, HandiCare (formerly MedCare) indicated some compatibility on their equipment with other manufacturer slings. However, it was also noted during the investigation that other manufacturers require the use of their specific manufacturer supplied patient slings with their lift motors and would not accept responsibility for the VA use of their slings on another manufacturer’s lift motor. Additionally, the possibility of the VA Logistics staff delivering, and nursing staff using, a different manufacturers’ sling on another manufactures’ lift motor would create unnecessary risks to patient safety (see prior note above regarding the patient safety events). MVAHCS currently stocks hundreds of slings that have been tested for use with their existing ceiling lift system. A new motor lift system would have to be

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Revision 02 Eff Date: 03/31/2020 compatible with our existing slings, if not, this would require MVAHCS to purchase additional slings.

While it is possible for other motor lift systems to be compatible with existing slings, the MVAHCS’s investigation suggests that using such non HandiCare motor systems would leaves the VA with little contractual protection should there be issues relating to the connection of the non-HandiCare motor systems and the HandiCare slings.

The Minneapolis VA has experienced that no matter how carefully supplies are labeled for specific manufacturer’s equipment, mixing similar equipment requiring specific supplies within a Ward/Clinic/Unit ends up being more difficult than anticipated. Having two different ceiling lift motor systems within the same medical facility dramatically increases the risk of staff using the wrong attachments (hanger system) with a ceiling lift, or mistakes in using the hand controls. The possibility of VA’s nursing staff using a different manufacturers’ sling on another manufactures’ lift motor creates questionable levels of patient safety. Patient safety is affected directly by staff having to be trained on and operate two different ceiling lift systems. Hand controls will be different (they are specific to manufacturers) as well the hanger system being different (also specific to manufacturers). For MVAHCS staff to use the equipment properly will require a separate training and competency program for each system putting unnecessary & redundant training requirements on an already taxed healthcare staff. Safe patient handling is paramount to providing healthcare to our Veterans. Staff currently participate in a 1-hour competency training session annually on safe patient handling using ceiling lifts. MVAHCS has nearly 2000 existing staff that participate in this annual training. In addition, all new nursing care staff are trained on the ceiling lifts upon new hire training. Having to train staff on two different ceiling lift motor systems would double this requirement. Potential injury to patients, staff and overall safety is improved by eliminating the potential of confusion by intermixing more than one type/manufacturer of ceiling lift systems.

A VIP search of NAICS 339112 yielded 354 matches. Another VIP search using NAICS 339112 and the keyword ‘MedCare’ yielded no matches. The manufacturer ‘HandiCare’ was contacted regarding potential authorized small business distributors and he stated that they have two SDVOSB authorized small business distributors: , however, the NAICS code for this procurement is 339112- Surgical & Medical Instrument Manufacturing. As there is no SBA class waiver for NAICS 339112, and the manufacturer of the product (HandiCare) is a large business, the procurement cannot be set aside for SDVOSBs because the nonmanufacturer rule cannot be met.

See VAAR 819.7003 (DEVIATION) (July 2019). However, it will be set aside for Small Businesses because the nonmanufacturer rule does not apply to procurements set aside for small business concerns that fall at or below the simplified acquisition threshold. 13 CFR 121.406(c).

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5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

July 16, 2020 Date