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Based on interview and record review, the facility medical staff failed to follow the facility's physician bylaws by not ensuring a patient's Operative Report (a report written in a patient's medical record to document the details of a surgery) was completed for 1 of 21 sampled patients (Patient 1).

The deficient practice resulted to Surgeon 2 not documenting in Patient 1's Operative Report, on 5/3/2022, information regarding a surgical instrument (cutter) had broken during Patient 1's surgery procedure. On 5/9/22, Patient 1's second surgery Operative Report indicated a "Foreign body," (object not intended to be in the surgical site) was one of the specimens removed from Patient 1.

Findings:

During a review of Patient 1's Operative Report, date of service 5/3/2022, indicated that Patient 1 underwent surgery which included reconstruction of near total tongue and floor of mouth and fixation (joining) of jaw bones in order to realign The operative report verified that the primary surgeon was Surgeon 1 while Surgeon 2 was the assistant surgeon. The operative report disclosed that after solving the problems encountered in the patient's mouth and tongue; the operative report indicated Surgeon 1 completed fixation of the jaw (the jaw was broken in order to give access to the tumor that was previously removed in the tongue). The document then described how metal plates (2) were used to join the broken jaw. The operative report had no written information regarding a piece of the cutter (medical instrument used to cut the metal plate) used to properly fitting to hold Patient 1's jaw) breaking during Patient 1's surgical procedure prior to closing the surgical site.

During a review of Patient 1's Operative Report, date of service 5/9/2022, indicated Patient 1 underwent surgery to repair a broken jaw bone and exploration of a neck blood vessel. The Operative report indicated that during the part of the surgery involving the neck, "Turbid appearing fluid was expressed from the neck," during reopening a incision created during the previous surgery. The Operative Report noted that the fluid was sent to be cultured (tested in a medical laboratory to determine if any harmful microorganisms exist). The final part of this indicated that a, "Foreign body," was found during the procedure. The operative report did not indicate when or where this object was discovered.

During an interview, on 8/12/2022 at 1:58 PM, Surgeon 2 stated that he was the assistant surgeon for Patient 1, on 5/3/2022. Surgeon 2 stated that he assisted with the reconstruction part of the surgery. Surgeon 2 clarified that there were issues encountered during this surgery, among them was a broken instrument (cutter) at the end of reconstruction of the jaw and problems during the microsurgery involving the flap (sample of tissue is lifted from a donor site having an intact blood supply and moved to another site to rebuild an intricate structure, e.g. jaw). Surgeon 2 then recounted that Surgeon 1 was not pleased with 1 metal plate placement on the patient's jaw after he had secured them to the patient's jaw with screws. Surgeon 2 stated Surgeon 1 removed the assembled plate from the jaw and attempted to trim it (metal plate) with a cutter. Surgeon 2 stated he (Surgeon 2) removed it (part of the broken piece of the cutter) from the mouth; He assumed he had captured all the broken pieces of the instrument. Surgeon 2 stated that the scrub nurse during the surgery and other staff (not specified) new the broken piece had been placed on a back table. When asked if he was responsible for documenting his actions during any given surgery, Surgeon 2 stated that it (documenting that the broken piece had been place on a back table) was not his responsibility to record his involvement in the surgery as an assistant surgeon.

During an interview, on 8/16/2022 at 5:06 PM, the Risk and Regulatory Manager stated it (documenting) was expected that a physician would document any unexpected happenings during a procedure in a progress note.

During a review of the facility's physician by-laws, last approved by Board of Directors 5/19/2022 (form of self-governing regulations for licensed medical providers at a facility), the document indicated that practitioners must complete all medical records within 14 days after patient discharge from the facility or outpatient encounter. Also practitioners must comply with medical record requirement including, but not limited to, signing of orders or designating patient diagnoses.

During a review of the facility's P&P for Surgical Services, revised date 6/5/2020, indicated perioperative (time period of a patient's surgical procedure) documentation will include, but not limited to, "Documenting of sponge, sharp, and instrument counts, and outcomes." The P&P also indicated documenting included, "Surgical debriefing and any significant or unusual occurrences pertinent to perioperative patient outcomes."

Based on interview and record review, the facility failed to ensure Registered Nurse (RN) 1 provided an accurate record of a patient's surgical procedure events for one of twenty one sampled patients (Patient 1) in the operating room. A piece of the metal plate cutter (a medical instrument) had broken during Patient 1's surgical site during the surgical procedure, on May 3, 2022.

This deficient practice resulted in Patient 1 having an unintended retained foreign object during Patient 1's first surgery, on May 3, 2022. The foreign object was recovered on May 9, 2022 during Patient 1's second surgery.

Findings:

On August 11, 2022 at 10:17 a.m., during interview with RN 1 regarding Patient 1's surgery, on May 3, 2022, RN 1 stated the following:

1. She was the circulating RN for Patient 1 on May 3, 2022, who helped prepared the operating room (OR) with the needed equipment and medications for the patient.

2. As circulating RN, in the OR, she poured medications into the sterile surgical field for the physicians and was a runner who gets items needed for the surgeons.

3. She checked the patient's history and physical and the preop report, before Patient 1's surgery.

4. Another nurse relieved her for breaks and lunches, during Patient 1's surgery, which lasted more than 12 hours.

5. During the second part of the patient's surgery, Surgeon 1 asked for a plate cutter instrument for Surgical Technologist 2 (ST 2).

6. Surgeon 2 informed RN 1 and ST 2 that the plate cutter instrument broke and told them that the broken piece has been recovered.

7. Surgeon 2 set the broken plate cutter instrument with the recovered broken piece aside.

8. I don't know if the correct plate cutter instrument was given to Surgeon 1.

9. The instrument tray was not a vendor tray.

10. The surgeon's preference card was used by the sterile processing department to put together the tray of instruments for the surgeon.

On August 16, 2022 at 5:03 p.m., during interview with RN 1 and concurrent record review of
Patient 1's Intraoperative report (documentation of events during a patient's surgical procedure), dated May 3, 2022, RN 1 stated the following:

1. She was the circulating RN for Patient 1, when the instrument plate cutter (medical instrument) broke, on May 3, 2022.

2. The plate cutter instrument was given to Surgeon 1 by ST 2.

3. She stated she didn't know how the instrument broke.

4. Surgeon 2 showed RN 1 the broken plate cutter instrument.

5. Before a surgical patient was closed, the surgical team, including the scrub tech, circulating RN, surgeons, and anesthesiologist must make sure all the broken pieces of an instrument are recovered.

6. The broken instrument was removed from the surgical field and was red tagged (facility's way to track an instrument that needed to to be sharpened, if dull, or fixed if broken). Then the surgeon was notified.

7. The surgeon, who was sterile, can explore the patient's cavity for broken pieces of instrument.

8. RN 1 stated she was not sterile, in the OR, and stated she did not know how the plate cutter instrument looked like when it was intact and not broken.

9. RN 1 stated Surgeon 2 set the broken instrument aside.

10. RN 1 saw the broken plate cutter instrument but did not verify that all the pieces that broke off the instrument were recovered.

11. RN 1 did not file an incident report regarding the broken plate cutter instrument during Patient 1's surgery on May 3, 2022.

12. RN 1 did not notify the supervisor of the broken plate cutter instrument incident with Patient 1's surgery on May 3, 2022.

13. RN 1 did not document the incident of the broken plate cutter instrument in Patient 1's Introspective report, dated May 3, 2022.

A review of facility's surgical services policy for counting instruments, dated July 2022, indicated the following:

1. All counts will simultaneously be completed audibly and visually by the Scrub Tech (Surgical Technologist) and RN circulator.

2. Instrument counts will be completed on all procedures when the possibility of the entrance into a major body cavity exists.

3. An initial instrument count will occur when the possibility of the entrance into a major body cavity exits.

4. The Scrub Tech and the RN circulator will count the instruments prior to the beginning of the procedure to verify the set is complete and the count matches the instrument list missing items will be noted on the list.

5. Instruments broken or disassembled during the procedure will be accounted for in their entirety.

6. Incorrect counts will be documented by the RN circulator on the perioperative record and on the online Tracking Information for Patient Safety (TIPS) report.

A review of facility's policy for Event Identification and Tracking System (TIPS), dated July 2022, indicated the following:

1. The event identification and tracking system is designed to identify events or occurrence that are not consistent with the routine or expected operations of the facility, including actual accidents or situations that may result in an accident or a near miss or great catch, that places a patient at risk.

2. The TIPS is available online to report all occurrences or events that involve risk or unexpected outcomes at the facility, that involve damage to property of any other unusual event.

3. Document in the medical record: factual statement of the event, location, date and time, patient's condition, immediate action, and clinical procedures implemented, medical assessment by physician, notification of attending physician and nursing supervisory personnel, patient's family.

4. Medical equipment will be sequestered with all attachments with original packaging and record manufacturer, model number, serial number, and control number on the TIPS report form.



38310

Based on interview and record review, the facility failed to ensure a patient's Operative Report (a report written in a patient's medical record to document the details of a surgery) was completed for 1 of 21 sampled patients (Patient 1), according to facility policy and procedure (P&P) for Surgical Services.

The deficient practice resulted to practitioners (Surgeon 2 and scrub nurse [Registered Nurse 1, RN 1]) not documenting in Patient 1's Operative Report, on 5/3/2022, information regarding a surgical instrument (cutter) had broken during Patient 1's surgery procedure. On 5/9/22, Patient 1's second surgery Operative Report indicated a "Foreign body," (object not intended to be in the surgical site) was one of the specimens removed from Patient 1.


Findings:

During a review of Patient 1's Operative Report, date of service 5/3/2022, indicated that Patient 1 underwent surgery which included reconstruction of near total tongue and floor of mouth and fixation (joining) of jaw bones in order to realign The operative report verified that the primary surgeon was Surgeon 1 while Surgeon 2 was the assistant surgeon. The operative report disclosed that after solving the problems encountered in the patient's mouth and tongue; the operative report indicated Surgeon 1 completed fixation of the jaw (the jaw was broken in order to give access to the tumor that was previously removed in the tongue). The document then described how metal plates (2) were used to join the broken jaw. The operative report had no written information regarding a piece of the cutter (medical instrument used to cut the metal plate) used to properly fitting to hold Patient 1's jaw) breaking during Patient 1's surgical procedure prior to closing the surgical site.

During a review of Patient 1's Operative Report, date of service 5/9/2022, indicated Patient 1 underwent surgery to repair a broken jaw bone and exploration of a neck blood vessel. The Operative report indicated that during the part of the surgery involving the neck, "Turbid appearing fluid was expressed from the neck," during reopening a incision created during the previous surgery. The Operative Report noted that the fluid was sent to be cultured (tested in a medical laboratory to determine if any harmful microorganisms exist). The final part of this indicated that a, "Foreign body," was found during the procedure. The operative report did not indicate when or where this object was discovered.

During an interview, on 8/12/2022 at 1:58 PM, Surgeon 2 stated that he was the assistant surgeon for Patient 1, on 5/3/2022. Surgeon 2 stated that he assisted with the reconstruction part of the surgery. Surgeon 2 clarified that there were issues encountered during this surgery, among them was a broken instrument (cutter) at the end of reconstruction of the jaw and problems during the microsurgery involving the flap (sample of tissue is lifted from a donor site having an intact blood supply and moved to another site to rebuild an intricate structure, e.g. jaw). Surgeon 2 then recounted that Surgeon 1 was not pleased with 1 metal plate placement on the patient's jaw after he had secured them to the patient's jaw with screws. Surgeon 2 stated Surgeon 1 removed the assembled plate from the jaw and attempted to trim it (metal plate) with a cutter. Surgeon 2 stated he (Surgeon 2) removed it (part of the broken piece of the cutter) from the mouth; He assumed he had captured all the broken pieces of the instrument. Surgeon 2 stated that the scrub nurse during the surgery and other staff (not specified) new the broken piece had been placed on a back table. When asked if he was responsible for documenting his actions during any given surgery, Surgeon 2 stated that it (documenting that the broken piece had been place on a back table) was not his responsibility to record his involvement in the surgery as an assistant surgeon.

During an interview with RN 1 and concurrent record review of Patient 1's Intraoperative report (documentation of events during a patient's surgical procedure), dated 5/3/2022, RN 1 stated the following:

1. She was the circulating RN for Patient 1, when the instrument plate cutter (medical instrument) broke, on 5/3/2022.

2. The plate cutter instrument was given to Surgeon 1 by Surgical Technologis 2 (ST 2).

3. She stated she didn't know how the instrument broke.

4. Surgeon 2 showed RN 1 the broken plate cutter instrument.

5. Before a surgical patient was closed, the surgical team, including the scrub tech, circulating RN, surgeons, and anesthesiologist must make sure all the broken pieces of an instrument are recovered.

6. The broken instrument was removed from the surgical field and was red tagged (facility's way to track an instrument that needed to to be sharpened, if dull, or fixed if broken). Then the surgeon was notified.

7. The surgeon, who wass sterile, can explore the patient's cavity for broken pieces of instrument.

8. RN 1 stated she was not sterile, in the OR, and stated she did not know how the plate cutter instrument looked like when it is intact and not broken.

9. RN 1 stated Surgeon 2 set the broken instrument aside.

10. RN 1 saw the broken plate cutter instrument but did not verify that all the pieces that broke off the instrument were recovered.

11. RN 1 did not file an incident report regarding the broken plate cutter instrument during Patient 1's surgery on 5/3/2022.

12. RN 1 did not notify the supervisor of the broken plate cutter instrument incident with Patient 1's surgery on 5/3/2022.

13. RN 1 did not document the incident of the broken plate cutter instrument in Patient 1's Introspective report, dated 5/3/2022.

During an interview on 8/16/2022 at 5:06 PM, the Risk and Regulatory Manager stated it is expected that a physician would document any unexpected happenings during a procedure in a progress note (general documentation identifying the status of a patient not included in the Operative Note). Further review of Patient 1's medical record did not reveal documentation of the surgical instrument breaking during surgery on 8/12/2022.

During a review of the facility's P&P for Surgical Services, revised date 6/5/2020, indicated perioperative (time period of a patient's surgical procedure) documentation will include, but not limited to, "Documenting of sponge, sharp, and instrument counts, and outcomes." The P&P also indicated documenting included, "Surgical debriefing and any significant or unusual occurrences pertinent to perioperative patient outcomes."

A review of the facility's "Count: Sharps, Sponges, and Instruments in Surgical Services," reviewed 2/19/2020, indicated sponge, needle/sharp, and small item, counts will be completed on all procedures: Radiopaque soft goods (sponges that are visible by X-ray), sharps (device or object used to puncture or tear the skin) and device fragments were included in the count. This document also indicated instrument counts will be completed when there was the possibility of the device having a chance of landing in a large body cavity (defined as not including the mouth) exists, e.g., instruments broken or disassembled during the procedure will be accounted for in their entirety. Counts were conducted before and after to ensure all instruments, devices are accounted for during the procedure.