P03 PM_Part813.5_Atch1_FAR13.5_JA 36C25520Q0614.rev3.pdf

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C255-20-AP-2163

1. Contracting Activity: Department of Veterans Affairs, VISN 15, for:

Department of Veterans Affairs, VISN 15, John J. Pershing VA Medical Center, 1500 North Westwood Blvd, Poplar Bluff, MO 63901

2237# 657-20-3-3750-0206

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

This is a justification and approval for a brand name only procurement which will be awarded as a new firm-fixed-priced contract for Guldmann Inc. ceiling mounted patient lifts.

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

The following Guldmann Inc. supplies are required to meet the Agency’s need

Guldmann GH3+ 770 lb Lifting Systems with scale and continuous charge system to include all necessary accessories, hardware and installation in all designated areas.

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

( ) 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).

Identification of the Requirement

The patient lifts must have the following functional capabilities:

(1) The patient lifts must support the goal of VHA Directive 1611 entitled Safe Handling and Mobility Program and Facility Design, and all VISN 15 facility SPHM policies which protect caregivers and patients from injuries due to patient handling and movement.

(2) Aligns with the General Duty clause of the Williams-Steiger Occupational Safety Act and support VISN-wide equipment standardardization initiatives.

(3) Ceiling lift manufacturer must allow and warrant the use of their lifts with the full range of Guldmann loop slings.

(4) The rail system must allow for continuous charging of the lift motor by recharging at any location on the rail.

(5) Lifts shall be mounted (using ceiling, wall, or floor support as determined by building structure and room covering layout needs) to provide lifting capability for the maximum area possible within each room which means wall to wall – not just over the bed.

(6) Ceiling Lifts must be capable of supporting patients up to 770 Ibs, from the floor to an elevated position.

(7) Contractor is responsible to install lifts without relocating or interfering with operations of existing sprinkler heads, lights, HVAC grills, curtain tracks, IV tracks, televisions, permanent furniture, or other permanent structure. Contractor must describe any such fixtures that must be moved upon submission of proposal. Installation may be delayed, canceled, or moved to a mutually acceptable location if building changes cannot be made in ways that allow lift installation.

(8) Contractor shall not breach any firewalls during installation of these lifts. If a fire barrier is accidentally penetrated, VA safety personnel will be notified and fire barrier repaired immediately.

(9) Each room where lifts are installed shall be returned to original condition, excluding the newly installed ceiling lift.

(10) Ceilings must not be slotted exposing space above ceiling to the room below.

(11) Ceiling lift motors shall be motorized, capable of a single motor lifting at least 770 pounds or dual motor configuration of at least 1,100 pounds.

(12) Integrated scales must be built into the lifts, using the same controller and the same power source as the lift. The scale must not make the hanger bar extend any lower than it would without the scale present. The scale must be readable without looking up above the patient; a display on the controller is acceptable.

(13) A specific opportunity for Service Agreements, Preventive Maintenance Agreements, and Extended Warranty Agreements should be presented.

(14) Warranty shall include all travel or shipping associated with any warranty repair.

Motors shall be GFCI protected and the entire system shall be UL certified.

(15) Ceiling lifts must include a hanger bar suitable and allowable for use with the full range of Guldmann slings.

(16) Ceiling lifts must recharge automatically, by recharging at any location on the rail. Lifts that recharge without employee action will be preferred.

(17) Ceiling lifts must include safeguards to prevent patients from being trapped or hurt, such as emergency stop buttons or emergency lowering devices in case of power failure. Use of emergency lowering devices must not require tools or ladders.

(18) Contractor shall provide certified in-service training for Safe Patient Handling Coordinator, Unit Peer Leaders, and direct patient care staff as requested by SPH Coordinator for all shifts at no additional cost to the Government, for any equipment new to this facility. This training must include competency verification.

What are the unique features or attributes of the brand name item?

(1) The GH3+ is a faster, sturdier and more powerful version of the standard GH3 lifting

(2) motor. It is designed for use in almost all professional care settings, and with a lifting

(3) capacity in a single motor of up to 400 kg/880 lbs on a single motor/strap or dual motor configuration up to 1,100 lbs which makes either configuration ideal for use in bariatric care.

(4) The GH3+ ceiling lift can be fitted with one or more modules from the Guldmann Care Lift Management (CLM) system, which streamlines everyday use of the ceiling hoist system

(5) and helps make it more efficient. These CLM modules can be used for monitoring and

(6) improving procedures for safe patient handling, and for optimizing resource planning.

(7) The GH3+ lifting motor is available in models with lifting capacities of 440, 550, 600, 660,

(8) 770, 825, 880, and 1,100 lbs (200, 250, 275, 300, 350, 375, 400, 500 kg), respectively.

(9) The GH3+ can feature a built-in motor for horizontal movement along the traverse rail, where the lifting module is operated either through a hand control or an infra-red (IR) remote control unit.

(10) GH3 Sealing kit - For environments where a very high hygiene standard is required

(11) In environments in which a high hygiene standard are required around the ceiling lift, e.g.

(12) in an operating theatre, a sealing kit is offered for the GH3, which protects against

(13) external dirt and particles. The GH3 Sealing kit consists of three silicone covers to seal the openings on the top of the ceiling lift where the trolley is attached, as well as two large O-rings for sealing the groove along with the side cover of the GH3 lift.

(14) GH3 Combi Locks - The manufacturer must also be able to provide and install ceiling lifts that have the ability to connect two rail systems together when tracks are required to align that allow the same lift system motor to travel from one location to another within a defined area without having to actuate a separate hand/remote control to connect the two systems (often referred to as a gate/switch capacity that links two rail systems in two different spaces together).

(15) GH3 Therapy Trainer Module- The manufacturer must also be able to provide a dynamic, dual mode (standard ceiling lift operating mode and dynamic active weight loading/unloading mode) and therapy training module system that is able to support up to a maximum 605 lb. lifting capacity. This therapy training module must be able to dynamically unload up to 100kg of patient body weight in an active manner/mode in which the caregiver is able to initiate, monitor, and control the trainer module on the integrated hand control. This module must be able to be turned on and off by the caregiver on the integrated hand control/digital scale displaying total patient weight level relieved and training time duration.

(16) GH3 Positioning Locks- Two locks per system that are activated/deactivated by separate infrared remote control which have the capacity to lock the ceiling lift motor and traverse rail independently or separately. These locks are optional but highly desireable when added to the Therapy Trainer Module system or in any setting in which the end user desires to lock individual components of the system for clinical use.

How does the existence or nonexistence of these features affect the project?

Guldmann lifts and slings have been used since 2008 at all VISN 15 facilities. Total Guldmann ceiling lift systems installed at VISN 15 totals approximately 1068 units and constitutes a vast majority of patient lifting equipment in use throughout the 9 medical facilities in VISN 15. Replacing the obsolete Guldmann GH2 system with Guldmann GH3 systems in lieu of other ceiling lift systems will build on already established staff training programs and contribute to increased efficiency and continuity of use for equipment already in place which will benefit the patients served. Potential injury to patients, staff and overall staff safety is improved by eliminating the potential of confusion by intermixing more than one type/manufacturer of ceiling lift systems. Logistical systems are already in place to maintain sling inventory, user function, and equipment serviceability. If another system was installed, it would need logistical systems management changes adding increased material costs and additional man-hours that could not be overcome by procurement of another system.

Training health care staff on a different lift system would be prohibitive. Working in a COVID-impacted environment, staff have found that additional training opportunities are extremely limited due to unnecessary PPE usage and social distancing limitations within training environments. Additionally, the need to bring in additional manufacturer trainers to certify staff on a different style of equipment will further deplete the facility’s COVID-related resources. Guldmann Inc. has already provided multiple clinical training support offerings to all VISN 15 facilities with no additional costs incurred. Staff has already been specifically trained on the various types of Guldmann slings and generations of lifts.

VA clinical staff training dollars saved-conservatively since 2008, all VISN 15 facilities have avoided sending clinical staff off-site to receive SPHM training related to ceiling lift operations and clinical use. This has resulted in over $104,000 total cost savings across VISN 15 ($50K average salary cost per employee-$26/hr hourly rate of pay, 8 hr training day, total of VISN 15 clinial staff that attend annual SPHM training events (500) =$104,000).

Clinical Training Support-Guldmann has supported multiple clinical training support offerings to all VISN 15 facilities with no additional costs incurred. Typically Guldmann charges $500/clinical training day plus round trip airfare ($1000/trip estimate). To date, Guldmann has provided over 120 trips since 2008. Total of $180,000 VHA dollars saved (10 trips/yr x$1,500/trip x 12 years since 2008 have been funded/supported by Guldmann). In 2017, 2018, and 2019 VISN 15 Guldmann provided an additional 60 days of SPHM education and consulting support at no extra cost for a standardized VISN 15 SPHM traveling training platform for an additional market value of $104,000.00. They also had scheduled and committed to doing the same at no cost in 2020 prior to the COVID-19 pandemic.

On-Site Technical Evaluations-Guldmann has provided consultation for multiple projects per year at no cost to VISN 15; including cooperative analysis of clinical application vs cost, and structural viability in layout options, with a market value of $1,500 per day. In the time period from 2008 through 2020, Guldmann provided an average of 11 trips per year to the VAs in VISN 15. Total of $198,000 VHA dollars saved ($16,500/year x 12 years=$198,000) since have been funded/supported by Guldmann).

Maintenance support-Initial maintenance lift training/certification to all VISN 15 facilities provided free of charge to all of VISN 15 facilities, $30K in cost savings achieved for this one-time training offering offered on three separate occasions. Guldmann has also offered ongoing training support at reasonable pricing as requested to facilitate VISN 15 facilities being able to maintain their own equipment. VISN 15 staff are able to provide recurring and ongoing maintenance needs of Guldmann equipment without having to introduce substantial new product base and not having to spend additional time acquiring training to maintain/repair new ceiling lift equipment. As a result of most facilities within VISN 15 having in-house staff capacity to perform a majority of needed repairs, most service calls are not needed. A service call ranges in average from $825-$1,100 plus parts for a call-varies because the time and travel costs vary. The total collective cost of having in-house staff able to maintain Guldmann lifting equipment is invaluable.

5-year annual/preventative maintenance (PM) VISN 15 Guldmann contract-fixed pricing results in added value and prevents increased associated costs with one more than contract having to be put in place to maintain more than one brand of ceiling lifts. This increases patient safety and also facilitates ongoing compliance with the National Center Patient Safety Patient Alert AL 14-07. Guldmann has historically provided at no-charge to each facility a loaner motor ensuring no interruption of patient care. A non-functioning motor could be removed by biomed and the loaner put up while they work on the motor with virtually no-down time for continued patient lifting needs. This potentially pre-empts the need to relocate a patient (new room prep, moving the patient) and reduces potential for injury as a result of continuous ceiling lift operational readiness

Competitive sling and equipment pricing (discount below previous FSS/GSA pricing despite not being on current FSS/GSA contract). Any new sling or lift innovation that is added to our VISN 15 SPHM portfolio is also inserviced and demonstrated by the vendor at no additional cost prior to purchase and implementation. These costs have never passed onto VISN 15 and can be calucated based upon values above but have not been quantified up until this point.

Requirement for the integrated scale: Obtaining patient weights on mobility impaired veterans are high risk situations for injury to veterans and staff. Using an Integrated scale on ceiling lifts will assist in reducing these injuries and obtaining accurate weights for proper treatment, specifically medication titrations based on weight. Integrated scales must be built into the lift hand control, using the same controller and the same power source as the lift for proper lifting function and accuracy.

Provide a detailed description of other companies similar or competing brands that lack the particular feature(s).

The exact specifications and features from other other manufactures are not completely known at this time. However it is known that other manufactures do not have the ability to offer the brand name specific equipment from Guldmann. Due to actual cases of equipment failure and damage to include falling from the ceiling, (SEE ATTACHMENTS),VISN 15 does not inend or desire to consider mixing another manufacture’s motor to the existing manufacturer’s rail. It is the recommendation of the Safe Patient Handling and Mobility Facility Coordinator that vendors who will allow mixing and matching other motors on other Manufacturer’s rails should not be given consideration.

(1) Compatibility

This facility has a fully stocked inventory of Guldmann compatible slings. Guldmann cannot guarantee the quality or compatibility of other manufacturer’s slings, or attest to whether they will accomplish the tasks that the lift system was intended to perform.Nor will Guldmann assume the warranty or liability for the failure of the 3rd party sling itself.

It is not recommended, but not prohibited to mix and match manufacturer slings provide they are of the same type and design (i.e-loop style sling on a loop style lift-all Guldmann lifts meet this criteria). Several manufacturers have issued letters on this (including Guldmann) and are available from each manufacturer upon request. This is an individual facility decision that must be approached carefully and should include a multi-disciplinary risk assessment for best value, and improved potential for outcomes and safety. This decision should also involve the SPHM facility coordinator, front line, patient safety, risk and quality management stake holders.

(2) Safety

a) Guldmann systems are tested through a 3rd party using published safety tests and guarantee the Guldmann components will safely function as a whole system. The published tests and resulting safety certification does not cover testing using mixed manufacturer components. Exceptional circumstances and modifications to the standard protocol of both installation and servicing of the Celling Lift System would be required which would be costly to the facility and with no guarantee that the system would pass testing. Due to the fact that there are no published 3rd party accredited safety tests involving the mixing of components between multiple OEMs and situations where this would occur would result in inconsistent safety test results.

Therefore it is impossible to identify any and all compatibility issues that would or could emerge.

b) In addition, when it comes to the –Safe working Load‐ (SWL): Guldmann maintains a standard by which 1.5X the SWL of the Guldmann Lift Motor on Guldmann rails is part of the testing and certification of the installation process. This permits Guldmann Inc. to remain compatible to ISO 10535 specifications. Since Guldmann Inc. cannot confirm that other manufacturers adhere to this policy it would deem impossible to validate and/or certify any 3rd Party involvement.

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

IAW Veterans First Program, 38 U.S.C 8127, Rule of Two, market research was conducted using FPDS, GSA Advantage, VIP and SBA. A Sources Sought Notice (36C25520Q0614) was posted on 7/23/2020 through 7/28/2020. The primary purpose of the Sources Sought Notice was to identify potential SDVOSB/VOSB concerns that were capable and authorized to sell and install Guildmann GH3 materials and equipment.

The CO received a response from eight (8) SDVOSBs, they are as follows:

Ramp CO-SDVOSB Interior Fusion-SDVOSB Vets Access, LLC-SDVOSB 1st American Medical Distributors-SDVOSB Alliant Healthcare Products -SDVOSB TrillaMed, LLC – SDVOSB Infinity Operations, LLC - SDVOSB PXInc- SDVOSB

The facility also provided the vendor Guldmann, Inc (SB). Guldmann is the manufacturer of the lift and track systems in place and being replaced. Several new Guldmann lifts were also recently installed in other areas of the facility.

Email correspondence from Guldmann, Inc revealed two authorized distributor/installers:

Interior Fusion (SDVOSB) CR Lewis Mobility (SB)

Guldmann provided a OEM letter stating that Guldmann is the only OEM and direct vendor of GH3 patient lift systems and Guldmann branded safe patient handling solutions including design, certified installation and project management, training and education, as well as inspection and service to acute care facilities in the USA.

Guldmann stated that their systems and services may be obtained directly from Guldmann Inc., or indirectly through an approved partner SDVOSB reseller (where there is a set aside requirement), without affecting liability or product warranty.

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

The CO anticipates the price will be considered fair and reasonable based on competition between the resellers and the manufacturer plus comparison of published price lists.

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

Due to the proprietary nature, Guldmann Inc. or an approved partner reseller is the only authorized company able to provide or maintain the requested equipment. However, GSA, VetBiz, SBA, and the VA NAC Medsurg websites were used to determine if there were any other vendors capable of providing these products.

A search of the VetBiz.gov Registry website using NAICS code 339113 and keywords “ceiling mounted patient lift” resulted in 54 vendors. A search of the SBA dynamic small business site using NAICS 339113 and keywords “patient lift” yielded 19 vendors.

A search of FPDS yielded numerous awards.

A Sources Sought Notice (36C25520Q0614) was posted on 7/23/2020 through 7/28/2020.

The CO received a response from (8) SDVOSBs , and the OEM, Guildmann Inc. who is small business concern (SB).

However, based on additional market research, the Government determined that there were only two brand name resellers of the required equipment plus the manufacturer:

Interior Fusion (SDVOSB) CR Lewis Mobility (SB) Guldmann (SB)

Based on an analysis of the market research and the information provided by the OEM, Guldmann, the Contracting Officers does not have a reasonable expectation that two or more small business concerns owned and controlled by service-disabled veterans or veterans will submit offers. Therefore, pursuant to 38 U.S.C 8127, the acquisition will not be set aside for veteran-owned small business concerns.

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

Nonmanufacturer Rule (NMR) Considerations: In accordance with 13 C.F.R. § 121.406, the NMR applies to all SD/VOSB set-asides regardless of the dollar value of the acquisition.

Based on the market research conducted, the brand name manufacturer Guldmann, Inc.is currently classified as a small business and there is no indication that the sources identified cannot comply with the additional requirements contained in the C.F.R.

Accordingly, this acquisition will be set-aside exclusively for small businesses.

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

The following sources expressed an interest in the acquisition:

Interior Fusion (SDVOSB) Vets Access (SDVOSB) RampCo USA (SDVOSB) 1st American Medical Distributors (SDVOSB) TrillaMed, LLC (SDVOSB) Alliant Healthcare (SDVOSB) PX, Inc (SDVOSB) Infinity Operations, LLC (SDVOSB) Guldmann, Inc (SB) Arjo, Inc (large business)

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:

The Government will continue to moniter and survey the marketplace for patient lifts that can meet or exceed medical facility requirements.

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.

Lisa Bond Date Chief of Logistics John J. Pershing VAMC

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.

John Pratt Contracting Officer

NCO 15

Lisa J. Bond 173676

Digitally signed by Lisa J. Bond 173676 Date: 2020.09.11 14:40:21 -05'00'

John W Pratt 1625439

Digitally signed by John W Pratt 1625439 Date: 2020.09.11 15:05:39 -05'00'

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.

Peggy Becker Division Chief

NCO15