SSJ Arjo final signed P_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:

1. Contracting Activity:

a. Department of Veterans Affairs, VISN 04, VAPHS, University Drive Campus, Pittsburgh, PA 15240

2. Nature and/or Description of the Action Being Processed: This VA Pittsburgh project requires installation of eight (8) overhead ceiling lifts per bases of design for the renovation of 2E at the Pittsburgh VAMC at university drive/ The Pittsburgh VAMC currently keeps a small stock of Arjo ceiling lift motor replacements in the facility inventory for ease of maintenance and to ensure continued operation of these lifts without the need to schedule Arjo to come to the location itself.

These spare parts ensure that we always have continuity of operation with the Arjo lifts, another brand could disrupt this continuity for maintenance requiring down time on the lift and increased risk to patients or staff by forcing them to manually lift any patient that is in that room at the time.

Ensuring that the lifts are functional, and parts are on hand is critical to patient and staff safety.

The facility also currently utilizes an Arjo, Inc. ceiling lift system maintenance contract. Utilization of new Arjo, Inc. ceiling lift systems and motors will keep the facilities ability to maintain product maintenance, inspections, and repair so lifts are safe for patient care at a minimum cost to the government with minimal turnaround time for repairs. Changing of manufacture product will require a new maintenance contract for care and upkeep of lifts, which adds significant cost to this project. This item will be approximately

Description of Supplies/Services Required to Meet the Agency’s Needs: These specific Arjo products (Maxi Sky 2 Ceiling Lifts) are required to provide continuity in the Safe Patient Handling and Mobility (SPHM) program organization wide. These products are currently utilized throughout the VA Pittsburgh Health Care System and offer multiple benefits for continued use. Uniformity improves staff familiarity with use, making training efforts more streamlined and effective, resulting in increased use of equipment by employees, decreased patient injuries or harm, and decreased employee injuries or harm.

Also, uniformity allows maintenance and repair by Bio-Med more effective and efficient, as Bio-Med employees are already trained on these products and bring years of experience to their troubleshooting efforts. Uniformity also improves access and storage of accessory parts such as batteries, hanger bars, charging stations, and other hardware, which improves repair efforts by Bio-Med to return equipment to safe working conditions when maintenance is required. In considering the above, the information below outlines specific salient characteristics that when considered all inclusively, supersede competing products.

The equipment Lift Unit:

a. The lift unit is constructed of a steel frame system driven by a gear reduced high torque motor.

b. Lift unit and all non-disposable accessories meet the proper infection control regulations for products our institutions use regularly.

c. Lift unit has the following features.

i. Lift Capacity: 600 lbs. which supports the current weight average of our Veterans.

ii. Emergency lowering device, with redundant, manual lowering device.

iii. Emergency stopping device with safety features that our staff are familiar operating. (See staff training for more details)

iv. Circuit Overload Protection to prevent damage in case of overload.

v. Safety device that stops the motor to lift when batteries are low.

vi. Lifting speed: 1. Minimum 2.0 in/s when there is no load on the lift, minimum 1.3in/s in full capacity for 600 lbs. lift.

vii. Cab: VO plastic-fire retardant, UL94 compliant

viii. Vertical Axis Motor at minimum 110 watts

ix. Emergency Brake (in case of mechanical failure)

x. Strap length greater than 94” which is important as we need this device to assist with patients who have fallen to the floor.

xi. Electronic Soft-start and soft stop motor control to prevent jerking of patients.

xii. Easily removable motor assembly for part replacement in rails

xiii. Quick disconnect spreader bar system which is important in the clinical setting so staff can quickly and safety change bars to accommodate patient mobility.

d. Batteries

i. The Life cycle for batteries shall be in compliance with IEC 801-2.

ii. Provide rechargeable batteries with up to 110 transfers with a load of 200 lbs. and a minimum of 35 transfers with maximum rated loads.

e. Charger

i. Charger input: 100-240 VAC, 50/60 Hz. Type: Continuous Charge via Lined Rail system so the lift is always ready for the impromptu needs of patient care.

f. Infection Prevention

i. non-porous surfaces utilized throughout lift unit exterior.

ii. Plastic covered spreader bar

iii. Silicon emergency stop cord for easy cleaning/disinfection.

iv. non-porous lift strap

Spreader Bars:

Power Dynamic Positioning System, integrated with the spreader bar is a powered dynamic positioning system (PDPS) that enables the patient to be repositioned in the sling, minimizing the need for manual handling, thus reducing staff injuries and decreasing workers compensation claims.

There are multiple styles available. Spreader bars come in different types and sizes, including standard loop (2pt or 4pt), DPS (Dynamic Positioning System) spreader bars, and specialty spreader bars, for supine lifts, or the Morgue Spreader bar, designed for use in mortuary or funeral home settings.

Versatility - Optional interchangeable spreader bars using the Quick Connect Feature gives caregivers a flexible system that also enables them to select from a comprehensive range of bars and slings already used throughout the facility.

Clinical Salient Characteristics

• Key infection control features when tested against porous material used in conventionally constructed ceiling lift straps.

• 100% silicon emergency stop cord for easy wipeable disinfection.

• Non-porous wipeable strap

• ABC plastic-covered two-point spreader bar

• Independently tested using the four most common, hard-to-disinfect bacterial strains represented in health centers/hospitals: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia.

• Designed for flexibility and ease of use to deliver a tailored solution for each facilities requirement.

• Powered Dynamic Positioning System (PDPS) ensures the positioning and turning of your patient or resident can be effortless and precise.

• Large, LCD display provides instant and clear feedback with usage data available at the push of a button.

• Featuring an easy-to-use handset control and color display cassette showing essential data and battery life, Maxi Sky 2 is designed to optimize the working routine of a single caregiver.

Safety/ Training

Staff familiarity of a standardized lift is important as they are often pulled from one unit to another to manage patient care needs. Having different features throughout the facility places them and the patient at risk as there are varying differences between other manufacturer models. For example, for the Arjo Maxi Sky 2 model, when you pull the red emergency cord in an emergency, it stops the machine for safety reasons. On some other manufacturer models, when the emergency cord is pulled it automatically lowers the patient. Not having consistent emergency lowering features will place the patient at risk for injury as well as the staff. An unfamiliar model delays action in emergency situations.

Consistency in staff training and understanding of equipment use is imperative for patient safety and regulatory compliance from our accreditors as staff move throughout the facility.

Logistics We currently stock all the resources that are needed for the current ceiling lift models, and they can be used interchangeably with Arjo products. If another brand was purchased, logistics would now have to purchase an additional stock of new and different slings increasing costs in the long run. Additionally, sling manufacturers do not endorse the use of other companies slings on their equipment as they have not been tested. Having an overwhelming selection of slings from different manufacturers increase the likelihood that incidents can happen where staff are provided with the wrong slings, leading to sentinel events and injury. Arjo equipment is the only lift system capable of fulfilling the current equipment need at VAPHS to support our current protocols in clinical practice. VAPHS utilizes Arjo, Inc. slings on the current ceiling lift and floor lift models, if they were to change manufacturers or product this would require the replacement of over 500 reusable slings and additional new slings which would add a significant overall cost. A different manufacturer would require the training of over 350+ staff to accommodate this change in practice. Therefore, any new patient lifts that need to be added also need to be Arjo brand lifts to maintain standardization of the lifts across the facility.

Biomed Biomed staff currently have the specialized training needed to provide mechanical oversight to all the Arjo lifts. They currently also store parts for those lifts and can use parts interchangeably when maintenance is needed decreasing response time for repairs, thus staff have equipment readily available to provide safe care. Integrating another manufacturer would mean an increase in man hours for mechanical training, more wait times for repairs since equipment could not be used interchangeable and an increase in costs to maintain the new lifts. Consistency allows efficient monitoring of life cycles, and they vary for different manufacturers.

3. Statutory Authority Permitting Restricted Competition:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements in accordance with FAR 6.302-1(b)(1)(i)

( ) 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

4. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The acquisition is authorized pursuant to 10 U.S.C. 2304 (c)(1) and is implemented by FAR 6.302-1(b)(1)(i). Arjo lifts provide uniformity across the University drive campus of the Pittsburgh VA Medical center. Each manufacturer lift operates differently. Since the patients, and more importantly staff, have already been trained and understand the Arjo lift, it reduces any learning curve when dealing with patient care or a potential emergency situation with these lifts. Another manufacturer presents the potential for harm to patients and staff who are not trained on that specific lift, if not Arjo.

Additionally, with Arjo, the VA does not have an added cost of implementation that would be required for any other manufacturers’ lifts. Additionally, the unique characteristics of each manufacture’s lifts present the potential that patients and staff are adversely affected by utilizing a different manufacturer, since each manufacture’s lifts have different controls and operational capacities. This increases the burden on the nursing staff to ensure that patients are in a room where the lift is compatible with the patient that is in that assigned rooms. This could potentially be problematic in an emergency situation with the added burden of matching of appropriate patients to appropriate equipment. With a uniform lift across the medical center, this burden is eliminated, and the nursing staff knows that the capability and operation of each machine is identical. Sole sourcing the lift to Arjo presents a significant cost savings and safety advantage to renovating 2 East at the Pittsburgh VA medical center and the campus, as staff on every floor is trained the same and can seamlessly switch between floors without additional training or equipment concerns. The Pittsburgh VA medical center would endure undo burdens to have another patient lift manufacturers products within their facility this would cause a considerable cost implementation for training and spare parts and limit the staff’s ability to provide adequate care to the Veterans. The risk of having multiple lift that are not identical include staff unaware of the capabilities of the equipment putting patients at the risk of injury or death, the risk to injury of the staff, and the risk to the equipment itself. Arjo lifts have been successfully integrated into this facility to switch to any other manufacturers would be determinantal to the facility operations and the care that is provided to our nations veterans.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Although market research was done through Vet Biz, SBA, Sam.gov, Arjo is the only vendor who can provide this service. According to Arjo Inc.’s contract that explains that there are no authorized service technicians outside of their company. Arjo is the original manufacture of the National approved patient lifts, and these lifts are proprietary in design. All the patient lifts at the Pittsburgh VA Medical Center and CBOC’s are Arjo manufactured. Arjo would be a direct vendor to provide inspections, repair services, and preventative maintenance. There are other manufacturers of lift but as outline above utilizing other manufactures puts both patients and staff at increased risk.

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This item is being sole sourced under a larger construction project that will be competed as a 100% Service-Disabled Veteran Owned Small Business (SDVOSB) set aside. The proposed value of these eight (8) lifts is in line with other manufactures based off purchase price and installation. Additionally, this is a commercial item which in that distinction ensure reasonability with the pricing.

I have not made a commercial item determination this item is available for sale to the public this determines commercial.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The functionality and needs required by VA Pittsburgh points to Arjo being the only provider.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: Health and safety concerns as outline.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: No other sources have expressed interest in writing at this time. After the solicitation is issued if other sources express interest those concerns will be noted, and this could potentially be revoked based on those concerns.

10. 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: If concerns are noted and the other source can determine that they offer the same quality, training, and can ensure the same level of patient and staff safety. This justification will be revoked and opened to all that can provide the same level of benefits.

11. 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.

11. 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.