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Based on document review and interviews, it was determined that the Critical Access Hospital (CAH) failed to follow hospital policy to ensure that a contaminated surgical tray was not used during surgery for one patient out of three (Pt #1), who had an open reduction internal fixation, after staff identified debris on a drill bit. Therefore, the Condition of Participation 485.639, Surgical Services, was NOT met, as evidenced by:

Findings Include:

1. Policy titled, "Sterile Technique- AORN eGuidelines was reviewed. Review of the policy revealed, "When contaminated instruments are found in the instruments that consider the entire set to be contaminated (recommendation). If one instrument in an instrument set is not properly disassembled or has organic or other debris present, sterility or high-level disinfection (HLD) of the item may not have been achieved, and the sterility of the entire set is in question; therefore, the entire set is considered contaminated ..."

2. The policy titled "Sterilization of Instruments and Supplies Policy" (approved by the hospital, 10/24/2023) was reviewed on 12/31/2024. The policy noted "Purpose: A. To provide an effective method of rendering articles free of all microorganisms, i.e. sterilizing ... I ... B. Articles to be steam sterilized must be decontaminated, cleaned an inspected before wrapping ... Procedure: A. The Instrument Processing Technician, Scrub Technician or RN Circulator makes sure that items are thoroughly cleaned, inspected for integrity and dried prior to sterilization."

3. An incident report was filed for Pt#1 on 10/21/24 and indicated,"'During opening of supplies for surgical case, a tray was opened and contents placed on sterile field. Inside was found to be a 'used' drill bit, that had patient bone on it. The tray had been delivered from an outside hospital. Dr and OR charge nurse notified. Per both, 'OK to proceed with surgery because tray had been sterilized.' Scrub tech removed said item and sterile gloves were changed. Proceeded with surgical case with remaining instruments in tray. Parties Involved: Surgical Technician: (E#9), Circulator 1: (E#8), Circulator 2: (E#12), Scrub 1: (E#7), Scrub 2: (E#11). RNFA ( Registered Nurse First Assist): (E#10) Other: Outside Distributing Representative (E#13) " The Report was given to Risk Management and then the Chief Nurse Operator (E#5), who then contacted (E#13) and had a staff meeting. There have been a total of four orthopedic surgeries completed since this incident per the Chief Administrative Officer (CAO) E #6.

4. Per Surgery Staff Meeting Minutes on 10/24/24, staff was reeducated on procedure for contaminated instruments. The reeducation reiterated document titled, "Sterile Technique- AORN eGuidelines" verbatim.

5. An interview was conducted E#7 on 12/30/24 at 2:10 PM. When discussing Pt#1's incident , E#7 stated, "They (the surgical processing technician) just get them from downstairs where our sterile processing is and then the sterilization technician processor (E #11) sterilizes them. The sterilization technician processor (E #11) puts biological in every load and, as long as it passes, the sterilization technician processor (E #11) brings it up. Of course, when we open them, we check the packages and make sure everything's good." When questioned regarding whether the hospital receives sterilized trays from outside companies E#7 shared the following information. "We share our trays with two outside hosiptals (referring to Hospital A and Hospital B) and there's one distributing company that we share them with. There are multiple drill bits in every tray, but the only thing that we keep are the plates because the plates all come in a caddy. If anything goes directly into the bone, it's automatically discarded. If we use a screw and it's not the right size, it'll be discarded at the end of the case. It (the surgical pack) had been through two washers, a sterilizer, and then our sterilizer with the biological. I immediately got the circulator's attention and gave it to her and told her what was going on. I got it to the surgeon (E #9) and the Rep (E#13) told them I thought it was contaminated. When I picked it up I saw it, I told them that there were other ones on the tray but I only touched that one. The drill bits are all kept in their own little caddies (each one has their own slot within the tray) so the drill bit did not touch any other item. I told them that I wanted to toss this one, but it was their decision to make. I took my gloves and gown off as I was the only one who touched it. They decided to proceed with a new drill head. Also, as a precaution, we irrigated with betadine and stuff just so it was washed out again in case there was something that we missed, but the same tray was used." When asked if the facility would do anything differently today, E#7 stated, "We would do the same thing. I've not been told to do anything differently."

6. An interview was conducted with E #8 on 12/30/24 at 2:30 PM: When discussing Pt#1's incident, E#8 stated, "So we were getting the room set up for the case with the representative. I said I needed to go check with the surgeon (E #9) about something. I didn't know what the situation was yet. I walked in there. The scrub tech (E #7) said that there was a bone fragment that she (E#7) saw on a drill bit piece, and I didn't see it. It was already thrown in the trash at the time. I called the Registered Nurse First Assist (RNFA - E #10) because I wanted to get another set of eyes. Doctor (E #9) and RNFA (E #10) were all aware of the situation. (E #9) said it was okay to proceed. Scrub Tech (E#7) changed gloves and gown out, and we proceeded. The incident was reported. I know that our sterile processor tech (E #11), who processes our tray, was made aware of it after the fact."

7. An interview was conducted with E #10 on 12/30/24 at 2:40 PM. When discussing Pt#1's incident, E #10 states, "I was not in the room. I did hear about it. It was reported by the nurse who was in the case, I believe. The circulator informed me that there was a tray that had come into the sterilization process that the scrub noticed a drill bit that had a piece of bone fragment on it. It was contaminated, was processed, all the stuff was done the way we would normally do it. The scrub tech (E #7) removed the drill bit and changed her (E#7) gloves and gown. They asked me about it and if something else needed to be done, and I felt that that was appropriate to do, but I did go to the doctor (E #9), to let him know what had happened and asked if there was anything more he felt needed to be done When asked if the facility would do anything differently today, E #10 stated, "Pretty much the same thing I did before, as long as everything was not contaminated in the tray."

8. An interview was conducted with E #11 on 12/30/24 at 2:50 PM. When discussing Pt #1's incident, E #11 stated, "I didn't even hear about it until after the fact. When I get the instruments from other places, I take them (the instruments) and they go in our disinfectant. The packet came from an outside facility and I did not see anything. The Rep from outside facility (E #13) was here when it happened and was upset as the drill bit should have been thrown out at outside facility (Hosptal A) after use. The Rep ( E#13) was aware of the situation and the company was notified. The packet is sterilized at the outside facility (Hospital A), but it is also sterilized once it arrives here as I do not trust what happens enroute." When asked if the facility would do anything differently today, E #11 stated, "I would go to my manager because I'm not always sure of the exact right thing to do. I would ask what the next step would be. This would be the department head or the RNFA."

9. A phone interview was conducted with E#12 on 12/30/24 at 3:00 PM. When discussing Pt #1's incident, E #12 indicated she remembered the event. E #12 stated, "Yeah, there was a tray that had retained material in it that was found before the case started. I did personally witness this and, I did report it. That's the first time I've ever witnessed it. It was reported to the charge nurse (E#10) and to the surgeon (E#9) who then agreed how to proceed with the job. It was disposed of. I don't feel like all parties were talked to before proceeding with the surgery. We didn't talk to sterile processing to make sure that every step was taken to ensure that that whole tray was processed correctly, and they weren't actually even notified about it until days later when it was brought to everybody's attention. That's when I filed the complaint."

10. An interview was conducted with E#13 on 12/31/24 at 10:50 AM. When discussing Pt #1's incident, E #13 stated, "My trays get transferred in between hospitals. Drill bits should have been thrown out after use. I was notified. They then showed to the surgeon (E #9). Trays are by themselves in a corner, contained, not touching anything else. Tray had already been processed twice. Doctor (E #9) said to toss drill bit and get a new one and then proceed with surgery. I spoke with (name of Hospital A), which is one of our newer facilities that just started doing ortho surgeries. I educated the staff on the fact that everything needs to be thrown away. The staffing at (name of Hospital A) were educated verbally, but I plan to give them an in service regarding this as well, within the next week or two. "