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Based on observation, interview, and record review, the facility failed to follow it's chosen professional organization of choice's (i.e. the Joint Commission, a medical services accreditation organization) recommendations for surgical counts for two of four sampled patients (Patients 11and 16), when:

1. A foreign object was left in Patient 16 and,
2. Surgical staff who participated in a surgical procedure did not account for vaginal packing that was to be intentionally retained in the vaginal vault of Patient 11.

These failures resulted in a second surgery to remove the retained foreign object for Patient 16 and, for in Patient 11, in retaining vaginal packing for longer than necessary, thereby putting her at risk for developing toxic shock syndrome (a condition, the likelihood of which is increased, by prolonged retention of a foreign object in the vagina) (refer to A-0951).

Based on observation, interview, and record review, the facility failed to follow it's chosen professional organization of choice's (i.e. the Joint Commission, a medical services accreditation organization) recommendations for surgical counts for two of four sampled patients (Patients 11and 16), when:

1. A foreign object was left in Patient 16 and,
2. Surgical staff who participated in a surgical procedure did not account for vaginal packing that was to be intentionally retained in the vaginal vault of Patient 11.

These failures resulted in a second surgery to remove the retained foreign object for Patient 16 and, for in Patient 11, in retaining vaginal packing for longer than necessary, thereby putting her at risk for developing toxic shock syndrome (a condition, the likelihood of which is increased, by prolonged retention of a foreign object in the vagina).

Findings:

1. Patient 16 was admitted to the general acute care hospital (GACH) with a chief complaint of neck pain.

The GACH sent an email to the Department which indicated that Patient 16 presented to the operating room for an anterior cervical spine (C5-7) (refers to the front (anterior) aspect of the cervical spine, which is the neck region of the vertebral column) decompression discectomy (a surgical procedure that aims to relieve pressure on spinal nerves, often caused by a herniated disc or spinal stenosis) with fusion (fusing the adjacent vertebrae together (fusion) to stabilize the spine and relieve nerve compression) and possible posterior (the back aspect) discectomy and fusion with O arm navigation (a surgical imaging and navigation system that provides real-time, 3D images of a patient's anatomy during surgery, particularly in spinal procedures).

During an interview with the director of surgical services (DSS) on 6/2/25 at 12:35 p.m., she stated that during surgery, they used fluoroscopy, an O-arm. It is portable and surrounds patient and spins like a CT scan.

During an interview with DOR (operating room director) on 6/3/25 at 10:08 a.m., she stated the distractor pins are used to hold a retractor device during anterior cervical procedures and should be removed at the end of the procedure. Generally, the pin would be sticking out, so the surgeon cannot close the operative site; however, it was possible to close Patient 16's operative site with one pin still there. At the time during Patient 16's procedure, the pins were not items that were counted, though sponges and needles were counted.

During an interview with registered nurse A (RN A) on 6/3/25 at 10:33 a.m., she stated distractor pins are used to anchor a double retraction device, to a vertebra, to retract the tissue to allow the surgeon to visualize the vertebra. When the retraction device is removed, each pin is removed individually. The patient was larger than typical, so possibly, one of the pins was hidden by her tissue, and not removed.

During an observation and interview with DSS on 6/6/25 at 10:33 a.m., she stated the part of the pin sticking out of Patient 16's vertebra was about 2 inches to 1 ½ inches, and showed a sample of the type pin that was used from a package.

During an interview with the director of risk management and compliance on 6/6/25 at 10:45 a.m., she stated, "At the time [of Patient 16's procedure], we used the Universal Protocol through Joint Commission, for surgical counts.

During a review of the Surgeon D's (SMD) CT Cervical Spine w/o IV contrast note, it indicated the CT was ordered on 6/26/25, for follow up. The results indicated findings: metallic rod projecting from the anterior C4 vertebral body. The rod courses between the internal jugular vein and the trachea.

During a review of Patient 16's electronic record, an informed consent form, dated 6/26/25 and signed at 3:42 p.m., indicated it was for removal of surgical vertebral pin.

During a review of SMD's notes, an operative note, dated 6/26/25 at 4:19 p.m., indicated the procedure was for removal of a surgical vertebral pin. The operative note indicated anterior cervical exploration was conducted for removal of a Kaspar vertebral body distraction pin. The indication for the surgery was listed as 1 day status post complex reconstruction for severe ossification of the posterior longitudinal ligament with morbid obesity with a retained C4-5 vertebral body distraction pin. The procedure in detail indicated Patient 1 was brought to the operating room and placed under general anesthesia. The anterior neck was prepped and draped. The patient's previous anterior cervical incision was opened and a soft tissue dissection was taken down to the spine. An easily exposed C4 vertebral body Caspar distraction pin was removed.

During a review of the facility's policy and procedure (P&P) titled, "Surgical Count and Retained Foreign Object Prevention and management (General Patient Care Policy)," effective date 2023, it indicated, "C. An instrument/surgical soft good count is indicated when ... 2. There is a possibility that an instrument/surgical soft good could be retained ... G. Inspect the integrity of all objects prior to use and immediately upon removal from the patient ... H. Every effort is made to remove all surgical/procedural items and/or device fragments."

During a review of the Association of periOperative Registered Nurses (AORN) guidelines, titled Retained Surgical Items from their website www.aornguidelines.org, it indicated ...Standard Procedure ...During the initial count and when adding items to the sterile field, count packaged items according to the number in which the item is packaged ... Instruments and Device Fragments ... account for individual pieces of assembled instruments and record these on the count sheet. Inspect instruments for all removable parts, breakage, or fragmentation immediately on the instrument's removal from the surgical site.

During a review of the Joint Commission's publication titled, "The Joint Commission Sentinel Event Alert, Issue 51, dated October 17, 2013, it indicated, "A counting procedure should ... Include soft goods (including therapeutic packing), needles/sharps, instruments, and small miscellaneous item, and document unretrieved device fragments ... Be applicable in all settings where invasive procedures are performed ... Wound opening and closing procedures should include ... Methodical wound exploration, including visual and, whenever possible, manual examination. This can and should be done for laparoscopic procedures as well."

2. Review of the document titled "OB Vaginal Delivery Note", dated 1/17/25, indicated Patient 1 delivered a viable male infant. Review of the document also indicated Patient 1 sustained a vaginal laceration, which was repaired with sutures (stitches meant to close surgical wounds or incisions). Review of the document also indicated there was nothing documented about the presence of packing in the vaginal vault.

During an interview with the Family birthing Center Assistant Director (FBC-AD) on 6/3/25 at 1:02 PM, the FBC-AD stated, "intentional vaginal packing would come with a note, either in the AVS or a provider note." The FBC-AD also stated that vaginal packing is not something the providers want patients to remove on their own, and that providers would have instructions to not remove the packing until they are seen by their provider.

Review of facility policy titled "Surgical Count and Retained Foreign Object Prevention and Management (General Patient Care Policy) ," unknown revision date, indicated, "An instrument/surgical soft good count is indicated when ... The surgical wound encompasses a body cavity, such as abdomen, pelvis or chest ... There is a possibility of progressing to an open procedure or of extending an incision to allow for an instrument to be left behind ... Any retained foreign objects are recorded in the patient record, including but not limited to location of item and rationale for leaving the item in patient."

Review of "Appendix F-Family Birthing Center Vaginal Deliver Table Counts" in the above policy "Surgical Count and Retained Foreign Object Prevention and Management (General Patient Care Policy)," also indicated, "Vaginal delivery counts include but are not limited to all surgical soft goods and sharps that might be used during a vaginal delivery ... An initial count of surgical soft goods and sharps is performed during table set up ... The count is written on the designated area of the Family Birth Center (FBC) communication board in each patient room, and is documented in the FBC Delivery Record."