26-008803 - Sole Source Memo Hill-Rom.docx

Date: June 7, 2026

From: David Ram, Supervisor of Biomedical Engineering—NIH Clinical Center

Subject: SOLE SOURCE JUSTIFICATION AND APPROVAL

To: NIH, CLINICAL CENTER, CONTRACTING OFFICER

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

David Ram, supervisor of Biomedical Engineering National Institute of Health Clinical Center 9000 Rockville Pike Bethesda, MD 20892 AO’s Name, contact information: Kevin Doty 301-496-5314

Contracting Activity:

NIH Clinical Center Office of Purchasing and Contracts 6707 Democracy Blvd Bethesda, MD 20892

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

The NIH/CC PICU needs overhead lifts. Baxter/Hill-Rom LIKO Ceiling Mounted Patient Lift, Traverse Rail System (800 lbs. Capacity) Includes Installation Services* PICU Rooms 3-3660, 3-3664, and 3-3684.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED, INCLUDING THE DELIVERY SCHEDULE AND/OR THE PERIOD OF PERFORMANCE and DOLLAR VALUE OF THE ACQUISITON.

This contract is to add 3 overhead patient lifts in the newly established PICU. LIKO Ceiling Mounted Patient Lift, Traverse Rail System (800 lbs. Capacity)

Total cost: $47,609.00

4. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION.

X FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED

· Usage in the Clinical Center: The NIH CC Standardization Committee previously approved the current NIH CC owned Hill-Rom lift models in 2001, 2005, 2013, and again in 2018. The NIH CC approved standard are the Liko Golvo 7007ES, 242S, 250ES, and Sabina II. Keeping standardization of the portable, sit to stand, and overhead lift system and program is indicated to meet the growing clinical need to be able to safely and efficiently turn, lift, and move clinically challenged patients not capable of independent motor movement. Currently, the CC uses 49 Hill-Rom Liko overhead lifts. There are no other brand lifts, slings or sling-bars used in the CC.

· Sole Source: The lift accessories and sling bars will need to follow FDA guidelines, “Match the sling to the specific lift”. The expansion of lifts is addition of equipment only and needs to interface with current lifts, sling bars, and accessories. These medical devices provide many benefits, including reduced risk of injury to patients and caregivers when properly used. However, improper use of patient lifts can pose significant public health risks. Patient falls from these devices have resulted in severe patient injuries, including head traumas, fractures, and deaths. The FDA (attached letter) has compiled a list of best practices that, when followed, can help mitigate the risks associated with patient lifts.

Users of patient lifts should:

· Receive training and understand how to operate the lift.

· Match the sling to the specific lift and the weight of the patient. A sling must be approved for use by the patient lift manufacturer. Baxter Hill-Rom has not approved any other slings or sling bar

· Sole Source company letter attached

· Sole Source Impact: If any other lift system or lift system service support is introduced to the Clinical Center, the CC would need to:

· Review NIH CC safe practice handling (SPH) and culture

· Review the incompatibility with the current equipment and supplies

· *Have multiple service contracts which will delay clinical care

· Consistency of applications within the Clinical Center, could pose a patient safety issue.

· An NIH CC safe practice and culture

· Develop new policy and procedures for implementation

· Review the long-term risk of a possible new source of infection

* Hill-Rom is the original equipment manufacturer (OEM) for Hill-Rom branded hospital beds, stretchers, and products of Hill-Rom owned subsidiaries. Hill-Rom does not provide training to third party providers unless contractually obligated to do so, such as Bio-Med Departments of Federal Agencies. Hill-Rom’s continuous improvement quality program requires on-going updates, training and support to ensure that products serviced by personnel are up to date on the latest engineering change orders, software releases, product updates or authorized service repair procedures. Hill-Rom, as the manufacturer and supplier, will always have the correct parts and control over the training of its employees on the most updated versions of the products.

The Clinical Center’s patient population requires a safe patient handling culture to include a service vendor with qualified and credentialed clinical resources that are local and accessible at a 24/7 call center.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE

This is a sole source item. The requirements in question 5 makes this brand the safest for patient care

7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

The actual cost of this device is consistent and lower when compared to non-dedicated systems. Cost comparison was measured against past procurements, ECRI market analysis, and industry standards.

8. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED

Researched sources include ECRI equipment comparison and guidance charts; ECRI Select Plus Market Intelligence Reports. Consultation and information gathering from the CC's Standardization Committee members, equipment managers, attendance at AAMI and HIMSS Technology Conference and Expositions.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION.

No other supporting documents other than the unique qualifications listed in question 5.

10. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION.

No other source expressed interest in acquisition.

11. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE REQUIRED SUPPLIES OR SERVICES.

There are currently no barriers

12. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

David Ram, Supervisory Biomedical Engineer, COR

[YOUR NAME, SIGNATURE, AND TITLE]

Administrative Officer or COR

13. CONTRACTING OFFICER’S CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”.”

[NAME AND SIGNATURE]

Contracting Officer image1.emf image2.png