26-005175 - Sole Source Justification (Covidien Situate).docx
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- Situate Detection System X
- Solicitation number
- 26-005175
About this file
This is a Justification for Limited Competition/Sole Source Procurement document for a medical device acquisition by the National Institutes of Health Clinical Center, Department of Perioperative Medicine. The procurement seeks to purchase the Covidien Situate device, a surgical sponge counting system designed to prevent retained surgical sponges in patients post-operatively. The requirement falls under the $10,000 to $250,000 procurement threshold and is being pursued as a sole source acquisition under FAR 13.106-1(b), citing only one source available due to brand name product specification and operational requirements unique to the organization's clinical workflow.
The Department of Perioperative Medicine conducted market research evaluating three competing sponge counting technologies from Stryker, Steris, and Covidien, ultimately determining that the Covidien Situate best aligned with departmental needs and counting procedures based on feedback from nursing staff, technicians, and surgeons. The clinical justification emphasizes that missing sponges are detected by x-ray only 67 percent of the time, which extends operating room time and anesthesia exposure. The contracting activity is the NIH Office of Acquisition, Clinical Center, with the procurement request dated April 9, 2026. No specific contract vehicle, delivery timeline, or pricing terms are identified in this justification document.
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JUSTIFICATION FOR LIMITED COMPELTITION
LIMITED SOURCES / BRAND NAME / SOLE SOURCE
($10,000 TO $250,000)
1. Requiring Activity: National Institutes of Health (NIH), Clinical Center (CC), Department of Perioperative Medicine.
2. Contracting Agency: NIH, Office of Acquisition, CC
3. Purchase Request: POTS
Description of Requirement: DPM is requesting the purchase of Covidien Situate device used for counting sponges in the Operating Room. This device is needed to support ensuring sponges are not retained in patients after surgery. AORN recommends hospitals use adjunct technology to supplement manual counting processes for surgical soft goods for the prevention of retained surgical sponges. This unit is used to support manual counting and helps prevent human error.
4. Authority permitting other than full and open competition (Check as applicable):
· GSA Federal Supply Schedules or Blanket Purchase Agreement:
__ _ FAR 8.405-6(a) (Circle as applicable):
A. An urgent and compelling need exists, and following the procedures would result in unacceptable delays;
B. Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or
C. In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issue under sole-source or limited-source procedures.
__ FAR 8.405-6(b):
Item(s) is peculiar to one manufacture (brand name, product, or feature of a product, is peculiar to one manufacturer, whether available on one or more schedules).
· Open Market:
__X_ FAR 13.106-1(b):
Only one source available (e.g., urgency, exclusive licensing agreement, brand name product, etc.).
5. Justification for action:
This request is due to the change in practice in the operating room. To prevent sponges from being retained in a patient the operating room looked at several different devices to determine the one that would best support their practice. During a count if a sponge is missing an x-ray will only find the sponge 67 percent of the time and this also adds to the OR time and prolonged anesthesia exposure.
6. Market Research/Other Facts:
DPM looked at three different companies sponge counting devices. They looked at Stryker, Steris and Covidien. Based on Nurse, Technician, and Surgeon feedback the sponge counting device that was determined to best meet their needs, and workflow was the Covidien Situate.
7. Suggested Sources(s):
As stated above there are other manufacturers that have similar sponge counters however the Operating Room determined that the Covidien Situate was the unit that best met the needs of the department and aligns with the counting policy.
8. Steps to improve competition: N/A I hereby certify this justification is accurate/complete to the best of my knowledge and belief.
CUSTOMER SIGNATURE
(Technical Expert/)
DATE: ____4-09-2026_________
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