Answers to Solicitation Questions-HT9425R0002 Surgical Instrument Maintenance.pdf

Answers to Solicitation Questions

1. What is the main purpose of laser marking instruments and entering them into Censis?

a. Steamline set assembly, increasing productivity/efficiency, identify complex/difficult instrumentation/sets, and to better align with TJC standards/best practice.

2. If the answer is to track to the instrument level, what is the current % of instrument inventory already being scanned successfully within Censis? Scanning compliance %

a. None; not to track at the instrument level

3. Why only 2,000 instruments per year?

a. The engraving of 2,000 instruments falls under the initial compliance service as outlined in 1.5, Scope. This request will help ensure that the instruments that require engraving immediately (hard to identify instruments) are completed as soon as possible. Afterwords, the SOW states that monthly service will include “Continuous laser engraving of surgical instruments, trays, and case carts” and “Inspection and re-marking of previously laser-marked instruments and equipment as needed”

4. How many total instruments (estimate) in inventory need marking?

a. This is outlined in the CTW.

5. How will the vendor be able to prove that every instrument laser marked and commissioned into Censis will actually work during the assembly process? What metric will be used?

a. Vendor will validate with on-site verification; via Censis access.

6. How small of a mark will the scanners read?

a. From my experience the markings are generally one consistent size but can be adjusted based on the surface area of the instrument. The scanner reads a relatively small code.

7. What is the model number of the scanner that is reading current laser marks?

a. We currently use Honeywell TCGbarcode scanners Model: CCB01-010BT, which are compatible with laser marks, but all scanners that are compatible with our Censis instrument tracking system will be compatible with laser markings.

8. Do the scanners read laser marks placed on high polished rounded surfaces like dental instruments?

a. Yes.

9. Does the scanner read and verify GS1 codes before placing new instruments into Censis

a. We cannot speak to this at this time; can your question on ‘GS1’ be further clarified?

10. Does the scanner have an approved software by DHA that allows color changes and a magnified viewing window to assist technician in finding small marks?

a. Yes it does, through the Censis application; However, it won’t be necessary as the laser markings are easily seen by the naked eye.

11. How many total instruments approximately have been laser marked to date?

a. Early May 2025, we completed a test cycle here using a small tray so approximately 10 items in a rarely used set.

12. How many of your government customers have been successful tracking at the instrument level using Censis, their own laser, and scanners?

a. Unknown. That information may exist elsewhere beyond our levels on higher Enterprise platforms.

13. In reviewing the Performance Work Statement (PWS), specifically Section 1.6 “Period of Performance” and the “Monthly Standard Service” requirements, we respectfully request clarification on the expected service frequency. Could you please confirm how many days per month the Government anticipates the contractor will be on-site at David Grant Medical Center (DGMC) to perform the Monthly Standard Service requirements (including sharpening, inspection, laser marking, laparoscopic repair, etc.)?

a. Outlined in the PWS, the current tempo is a week per month; 5 business days, no expectation to change.

14. How many trays are expected to be serviced/repaired on each service day?

a. The quantity of sets will vary and is typically dictated by the frequency a given set requires preventative maintenance. Also depends on the size and complexity of a given instrument tray.

15. In addition to providing laser marking services during scheduled repair and maintenance visits, will there be a requirement to perform laser marking on days when no other repair or maintenance services are scheduled (e.g., for newly acquired instruments or trays) are services needed for laser marking solely outside of tray maintenance and sharpening service days such as for new instruments only?

a. No, all services including laser markings would take place during the scheduled repair and maintenance visits.

16. The Scope of Work references the laser marking of up to 2,000 surgical instruments with 2D data matrix codes. Can you please confirm whether this is a one-time requirement under the Initial Compliance Service or an annual expectation?

a. Please refer to the answer to question 3.

17. Clarification Request – Loaner Instrument Requirements for Off-Site Repairs: In reference to Section 1.5 “Fiscal Responsibility” of the Performance Work Statement, we would like to clarify the Government’s expectations regarding loaner instruments: Specifically, when off-site repairs are required, is the intent that the contractor provide general stainless steel hand instruments of the same type and function as the items being repaired, particularly in cases where the repair is more complex and cannot be completed onsite?

a. That is correct. This would not be required for every off-site repair, as the sterile processing department does have back-ups for most instruments, but if an off-site repair is required for an instrument for which DGMC does not have adequate alternates for, the vendor should be prepared to supply a loaner.