HospitalInspections.org

The facility failed to meet the regulatory requirements for the Condition of Participation: CFR §482.51 Surgical Services as evidenced by the following:

Based on interview and record review the facility failed to implement policies governing surgical care when:

1a. One of one surgeon (Primary Surgeon [PS]) did not perform one of one sampled patient's (Patient 1) surgery consistent with the documented informed consent (IC - process for health care provider to educate patient about the risks, benefits, and alternatives of a procedure) on 2/7/25 at 8:48 a.m. This failure resulted in Patient 1 having a wrong site surgery, an unnecessary second surgery, prolonged anesthesia (medication given before surgical operations to lessen awareness and/or pain), prolonged intubation (a tube to deliver oxygen), admission to the Intensive Care Unit (ICU), prolonged hospital stay, and social trauma to the family. (Refer to A-0951)

1b. One of one surgeon (Primary Surgeon [PS]) did not perform one of one sampled patient's (Patient 1) surgery consistent with the documented informed consent on 2/7/25 at 7:15 p.m. This failure had the potential to result in Patient 1 and family consenting for a procedure they did not fully understand. (Refer to A-0951)

1c. Staff did not obtain informed consents for blood transfusions for one of one sampled patient's (Patient 1) cervical laminectomy procedures. This failure resulted in the hospital staff unaware of Patient 1's wishes regarding blood transfusions and the potential for the hospital to not have correct blood type available if needed. (Refer to A-0951)

1d. One of one surgeon (Primary Surgeon [PS]) failed to use all available methods to determine the correct level of cervical vertebrae (C- C1 through C7, neck bones of the spine) in the operating room (OR) for Patient 1's surgery." This failure resulted in a wrong site surgery, exposure of Patient 1 and surgical staff to excessive radiation from extensive fluoroscopy (real-time x-ray, medical imaging) equipment use, and prolonged time Patient 1 was under anesthesia. (Refer to A-0951)

1e. One of one sampled patient's (Patient 1) preoperative X-rays were not visible to all surgical staff in the operating room. This failure had the potential for the surgical team to not be fully aware of patient's condition. (Refer to A-0951)

1f. One of one surgeon (Primary Surgeon [PS]) failed to consider the advice of surgical staff who suggested repositioning the patient during fluoroscopy. This failure resulted in the inability to obtain good quality images during the surgery, prolonged exposure to radiation during fluoroscopy, and potentially contributed to the wrong site surgery. (Refer to A-0951)

1g. One of one surgeon (Primary Surgeon [PS]) asked the advice of an Implant Device Representative (IDR) for placement of surgical implants. This failure had the potential to result in advice from an unqualified IDR being implemented by PS. (Refer to A-0951)

1h. One of one surgeon (Primary Surgeon [PS]) did not order X-ray images after procedure on 2/7/25 7:15 p.m. This failure resulted in the inability to confirm the correct procedure was done. (Refer to A-0951)

1i. One of one sampled patient's (Patient 1) medical record did not clearly and accurately document Patient 1's wrong site surgery. This failure had the potential to effect Patient 1's continuity of care due to healthcare providers being unaware of the wrong site surgery, putting Patient 1 at risk due to misinformation being relied on, and an inaccurate medical record. (Refer to A-0951)

1j. One of one surgeon (Primary Surgeon [PS]) failed to fully disclose to one of one sampled patient's (Patient 1) family the reason Patient 1 required a second surgery. This failure had the potential to result in confusion for Patient 1's family. (Refer to A-0951)

2. OR staff did not consistently monitor and maintain temperature and humidity in seven of seven operating rooms (OR) (OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7). This failure had the potential to result in an unsafe environment for surgical procedures.(Refer to A-0951)

3. Temperature and humidity log variances were not presented to the quality improvement committee. This failure resulted in the delay of the hospital's ability to take corrective action. (Refer to A-0951)

4. Physician signatures were not documented on blood transfusion consents for 18 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 27, Patient 28, and Patient 29). This failure had the potential to result in these patients unable to make informed medical decisions regarding blood transfusions during surgical procedures and resulted in inaccurate patients' records. (Refer to A-0955)

6. Informed consents did not have legible (easy to read) witness signature for 17 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 30). This failure resulted in the inability to determine who witnessed the informed consent. (Refer to A-0955)

7. One of one surgeon (Primary Surgeon [PS]) did not immediately complete an operative report following a "lumbar laminectomy [surgical procedure to remove portion of spine/back bone] of L4, L5 [two lowest spinal bones together support the upper body and allow trunk motion] and S1 [bottom of spine provides weight support, movement, and absorbs stress]" for one of 30 sampled patients (Patient 14). This failure resulted in an incomplete medical record for Patient 14 and the potential to affect Patient 14's continuity of care due to an unrecorded surgery. (Refer to A - 0959)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safe quality health care, in compliance with Conditions of Participation for Surgical Services.


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Based on interview and record review the facility failed to implement policies governing surgical care when:

1a. Primary Surgeon (PS) did not perform one of one sampled patient's (Patient 1) surgery consistent with the documented informed consent (IC - process for health care provider to educate patient about the risks, benefits, and alternatives of a procedure) on 2/7/25 at 8:48 a.m. This failure resulted in Patient 1 having a wrong site surgery, an unnecessary second surgery, prolonged anesthesia (medication given before surgical operations to lessen awareness and/or pain), prolonged intubation (a tube to deliver oxygen), admission to the Intensive Care Unit (ICU), prolonged hospital stay, and social trauma to the family.

1b. PS did not perform one of one sampled patient's (Patient 1) surgery consistent with the documented informed consent on 2/7/25 at 7:15 p.m. This failure had the potential to result in Patient 1 and family consenting for a procedure they did not fully understand.

1c. Staff did not obtain informed consents for blood transfusions for one of one sampled patient's (Patient 1) cervical laminectomy procedures. This failure resulted in the hospital staff unaware of Patient 1's wishes regarding blood transfusions and the potential for the hospital to not have correct blood type available if needed.

1d. One of one surgeon (Primary Surgeon [PS]) failed to use all available methods to determine the correct level of cervical vertebrae (C- C1 through C7, neck bones of the spine) in the operating room (OR) for Patient 1's surgery." This failure resulted in a wrong site surgery, exposure of Patient 1 and surgical staff to excessive radiation from extensive fluoroscopy (real-time x-ray, medical imaging) equipment use, and prolonged time Patient 1 was under anesthesia.

1e. One of one sampled patient's (Patient 1) preoperative X-rays were not visible to all surgical staff in the operating room. This failure had the potential for the surgical team to not be fully aware of patient's condition.

1f. One of one surgeon (Primary Surgeon [PS]) failed to take the advice of surgical staff who suggested repositioning the patient during fluoroscopy. This failure resulted in the inability to obtain good quality images during the surgery, exposed exposure to radiation during fluoroscopy and potentially contributed to the wrong site surgery.

1g. One of one surgeon (Primary Surgeon [PS]) asked the advice of an Implant Device Representative (IDR) for placement of surgical implants. This failure had the potential to result in advice from an unqualified IDR being implemented by PS.

1h. One of one surgeon (Primary Surgeon [PS]) did not order X-ray images after procedure on 2/7/25 7:15 p.m. This failure resulted in the inability to confirm the correct procedure was done.

1i. One of one sampled patient's (Patient 1) medical record did not clearly and accurately document Patient 1's wrong site surgery. This failure had the potential to effect Patient 1's continuity of care due to healthcare providers being unaware of the wrong site surgery, putting Patient 1 at risk due to misinformation being relied on, and an inaccurate medical record.

1j. PS failed to fully disclose to one of one sampled patient's (Patient 1) family the reason Patient 1 required a second surgery. This failure had the potential to result in confusion for Patient 1's family.

2. Operating Room (OR) staff did not monitor and maintain temperature and humidity for seven of seven operating rooms (OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7). This failure had the potential to negatively impact patient safety due to hypothermia (condition that occurs when core body temperature drops below 95 degrees Fahrenheit), increased risk of surgical site infections, increased risk of compromised sterile packaging.

3. OR staff did not report out range temperatures and humidity levels for seven of seven operating rooms (OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7) to the hospital quality committee. This failure resulted in the delay of the hospital's ability to take corrective action.

Findings:

1a. During a review of Patient 1's "Encounter Type: Office Visit," (OV) dated 1/23/25, the OV indicated, "[Patient 1] is a 74-year-old female . . . who complains of neck pain for over one year . . . Assessments: The patent had a magnetic resonance scan [MRI- uses strong magnets to create detailed images of the body's internal structures] of the cervical [C- neck] spine performed on 10/14/24. The study is remarkable for severe stenosis [narrowing] at the C5-C6 [neck bones 5 and 6] level. . . Patient wishes to proceed with C5-C6 Posterior [back] Cervical Laminectomy and Lateral Mass Fusion [Surgically removing parts of cervical vertebrae (bones of the spine) at C5 and C6 to relieve pressure on the spinal cord (bundle of nerves running through spinal vertebrae), then fusing (connecting parts of) the vertebrae together to stabilize the spine using bone grafts and metal screws and rods]."

During a review of Patient 1's "CONSENTIMIENTO PARA CIRUGIA O PROCEDIMIENTO ESPECIAL [Consent to Surgery or Special Procedure]," (CSSP) dated 2/7/25 at 7:43 a.m., the CSSP indicated, "Posterior Cervical Laminectomy and Lateral Mass Fusion of Cervical Five- Cervical Six."

During a review of Patient 1's "Perioperative Record," (PR) dated 2/7/25 at 9:40 a.m., the PR indicated, "Procedure Description . . . DISCECTOMY [remove all or part of the cushioning structures between spinal bones] SPINE CERVICAL POSTERIOR APPROACH WITH FUSION WITH IMAGING [X-ray- medical images] GUIDANCE C5-C6 POSTERIOR LAMINECTOMY AND LATERAL MASS FUSION." The PR indicated surgery started at 8:48 a.m. and ended at 1:50 p.m. (5 hours).

During a review of Patient 1's "Operative Report," (OPR) dated 2/7/25 at 9:46 p.m., the OPR indicated, "The patient earlier today underwent a cervical laminectomy fusion. Postoperatively, the images revealed malposition of the instrumentation [metal implants to correct or hold bone in place] and revision [repeat surgery of same site to modify prior surgery] surgery was undertaken."

During an interview on 4/3/25 at 11:41 a.m. with Chief Medical Officer (CMO), CMO stated PS told him the metal implants were "misplaced," meaning the surgery was not done on the right site, and Patient 1 would need to have the correct procedure done. CMO stated the impact to Patient 1 for having a wrong site surgery included having to undergo a second surgery, admission to the ICU, prolonged stay in the hospital, prolonged anesthesia and intubation, and social trauma to the family.

During an interview on 4/3/25 at 12:06 p.m. with Vice Chief of Staff (VCOS), VCOS stated Patient 1 had a wrong site surgery.

During a concurrent interview and record review on 4/3/25 at 12:18 p.m. with Medical Director Radiology Department (MDRD), Patient 1's "XR [X-ray] C [cervical] Spine 1 view," dated 2/7/25 at 3:30 p.m. was reviewed. The X-ray indicated, "INDICATIONS: S/P [status post- after] C5-C6 Posterior Cervical Laminectomy . . . BONES/DISCS: . . . Mild disc space narrowing at C5-6 and C6-7. Posterior instrumentation with bilateral pedicle screws [screws placed on both sides of the vertebrae and connected by rods to stabilize the spine] at C7 [seventh cervical vertebrae] - T1 [first thoracic (upper back) vertebrae] . . . CONCLUSION: 1. Posterior instrumentation C7- T1." MDRD stated there was no instrumentation on C5-C6 vertebrae.

During an interview on 4/3/25 at 4:35 p.m. with Post Anesthesia Care Unit Registered Nurse (PACU RN), PACU RN stated she cared for Patient 1 after her surgery. PACU RN stated PS had ordered an X-ray for Patient 1. PACU RN stated PS told her Patient 1 was going back into surgery, but did not tell her why. PACU RN stated she found out why when the House Supervisor came to the unit and asked who was taking care of the patient with the wrong site surgery. PACU RN stated the results of the X-ray taken in PACU and the informed consent for the surgery did not match.

1b. During a review of Patient 1's CSSP, dated 2/7/25 at 6:50 p.m., the CSSP indicated, "CERVICAL 5, 6 LAMINECTOMY FUSION REVISION, POSTERIOR." Patient 1's husband signed the CSSP.

During a review of Patient 1's "XR C Spine 2-3 views" dated 2/12/25 at 4:01 p.m., the X-ray indicated, "INDICATIONS: post-op . . . FINDINGS: BONES/DISC: There is a posterior spinal hardware consisting of pedicle screws [screws placed on both sides of the vertebrae and connected by rods to stabilize the spine] and posterior rods which extends from C5 to C7 on the right side and C5-T1 [first thoracic (upper back) vertebrae] on the left."

During a review of Patient 1's Operating Report (ORP) dated 2/7/25 at 9:46 p.m., the ORP indicated, "The patient [Patient 1] earlier today underwent a cervical laminectomy fusion. Postoperatively, the image revealed a malposition of the instrumentation and revision surgery was undertaken . . . Instrumentation of C5 and C6 was performed . . . new rods were placed to bridge C5, C6, C7, and T1 levels . . . Kerrison rongeurs [specialized surgical instruments used for precise bone removal, particularly in spinal and cranial procedures] were used to remove the remainer of the lamina [plates of bone that form the posterior walls of each vertebra, enclosing the spinal cord] of C5 and C6, decompressing the spinal cord."

During an interview on 4/3/25 at 11 a.m. with Director of Surgical Services (DSS), DSS stated the informed consent for the second surgery (dated 2/7/25 6:50 p.m.) did not fully describe the surgery. DSS stated the bridge should have been included in the consent.

During a concurrent interview and record review on 4/3/25 at 12 p.m. with CMO, Patient 1's CSSP, dated 2/7/25 at 6:50 p.m. was reviewed. The CSSP indicated, "CERVICAL 5, 6 LAMINECTOMY FUSION REVISION, POSTERIOR." CMO stated he assumed PS meant he was revising the previous surgery, but he would have left off "revision."

During an interview on 4/3/25 at 3:56 p.m. with CRNA 2, CRNA 2 stated the CSSP indicated Patient 1 was having a cervical laminectomy revision. CRNA 2 stated there were discussions between nursing staff and PS about doing the consent the right way.

During a concurrent interview and record review on 4/3/25 at 12:18 p.m. with MDRD, Patient 1's "XR C Spine 1 view," dated 2/7/25 at 3:30 p.m. was reviewed. The X-ray indicated, "INDICATIONS: S/P [status post- after] C5-C6 Posterior Cervical Laminectomy . . . BONES/DISCS: . . . Posterior instrumentation with bilateral pedicle screws at C7 [seventh cervical vertebrae] - T1 . . . CONCLUSION: 1. Posterior instrumentation C7- T1." MDRD stated there was no instrumentation on C5-C6 vertebrae.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent," dated 5/25/2022 the P&P indicated, "2.4. Informed Consent. . .The patient's physician is responsible for providing the information the patient needs in order to make an informed decision. . . 7.1. Physician Responsibility. The physician is responsible for providing the patient or an incompetent patient's surrogate decision-maker with the information that is necessary to allow an "informed decision" to be made. The topics that must be addressed, at a minimum are: 7.1.1 The nature of the operation or procedure."

1c. During a review of Patient 1's Medical Record (MR) on 4/1/25 at 12:34 p.m., the Medical Record did not contain any informed consents for blood transfusions for either cervical laminectomy procedures dated 2/7/25 at 8:48 a.m. and 7:15 p.m.

During a review of literature from the Journal of Spine Surgery titled, "Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies," dated March 2020, the literature indicated, "Abstract . . . The most common immediate complications included acute blood loss anemia . . . Overall complication rate . . . The most common complications reported across the literature included acute [sudden, rapid] blood loss anemia requiring postoperative transfusion . . . Increased number of fusion levels was also associated with increased risk of postoperative complication . . . increasing the number of fused levels lead to increased blood loss and operative times, which in turn adversely impacts patients' postoperative risk . . . "

During an interview on 4/3/25 at 11:15 a.m. with PS, PS stated he had a case in the past involving a patient with an unanticipated anatomical anomaly who started spurting blood during spinal surgery. PS stated the case was written up in a medical journal.

During an interview on 4/3/25 at 4:50 p.m. with DSS, DSS stated her expectation was informed consents for blood transfusions would be obtained on everybody having surgery.

1d. During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated his concerns included the fact that PS implanted metal within Patient 1's spine without knowing where it was going. CMO stated PS should have been aware of and used other options available to him in surgery, including taking plain X-rays or using an O-arm (surgical imaging system that provides real-time, two- and three-dimensional images of a patient's anatomy, especially the spine, during surgery.) CMO stated his biggest concern was if PS was not using every available option, then what would happen with the next patient.

During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated PS did not look at different modalities (methods) to verify the position. VCOS stated he had concerns about PS's decision-making processes.

During an interview on 4/3/25 at 4:55 p.m. with IDR, IDR stated the images from the C-arm fluoroscopy were not good during the procedure. IDR stated a massive amount of fluoroscopy images were taken, which was not good for Patient 1 or the staff due to radiation exposure. IDR stated the hospital had different types of imaging systems available for PS to use. IDR stated it was PS's decision to use other equipment or not. IDR stated determining the correct cervical level typically takes five to ten minutes and in this case took almost two hours. IDR stated if you are taking two hours to determine what level you are, then you need to bring in the pre-op films (X-rays), mobile Computed Tomography (CT- medical imaging scan using X-rays to create detailed cross-sectional images, of the body) scanner, or the O-arm, which would have given a 360-degree picture and provided navigation to the correct site.

1e. During an interview on 4/3/25 at 10:35 a.m. with Operating Room Charge Nurse (ORCN), ORCN stated PS usually has X-ray images on his laptop computer but does not put them up in the X-ray box in the operating room.

During an interview on 4/3/25 at 11:58 a.m. with CMO, CMO stated there were no preoperative images up in the operating room, which had been discussed with the medical staff as an expectation during surgery. CMO stated everyone in the room needs to be able to see the images.

During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated images should be up in the operating room during surgery. VCOS stated this was the standard.

During a review of the WHO [World Health Organization] Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, dated 2009, the WHO guidelines indicated "Factors such as the absence of radiographic images and wrong site labelling on the images play a causative role in faulty orthopaedic and spinal procedures..."

During a review of the Agency for Healthcare Research and Quality (Division of the United Stated Department of Health and Human Services) Patient Safety Network (PSNet) article titled "Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery" dated 5/21/2013, the article indicated "In July 2004, The Joint Commission enacted a Universal Protocol that was developed through expert consensus on principles and steps for preventing wrong-site, wrong-procedure, and wrong-person surgery. The Universal Protocol applies to all accredited hospitals, ambulatory care, and office-based surgery facilities."

During a review of The Joint Commission's Poster titled "Speak Up", undated, the poster indicated, "Use a standardized list to verify the availability of items for the procedure. At a minimum, these include: . . . labeled diagnostic and radiology test results that are properly displayed. Examples: radiology [x-ray] images and scans..."

1f. During an interview on 4/3/25 at 10:35 a.m. with ORCN, ORCN stated she assisted with positioning Patient 1 for Patient 1's first surgery on 2/7/25 at 8:48 a.m. ORCN stated Patient 1 was positioned posterior (back facing up) and Patient 1's head was secured with a Mayfield (stabilizer with three pins attached to the head). ORCN stated Patient 1's head was not positioned to expose the neck. ORCN stated she suggested to PS to reposition the Mayfield. PS refused the suggestion and stated this was Patient 1's anatomy.

During an interview on 4/3/25 at 11:15 a.m. with PS, PS stated nurses did not have the technical background to make recommendations.

During an interview on 4/3/25 at 4:55 p.m., IDR stated Patient 1 had normal anatomy but the main issues with getting good images were Patient 1's size and positioning. IDR stated if the patient was not positioned correctly, then the images would look liked there was anatomy on top of anatomy, especially in the cervical spine. IDR stated the images did not have Patient 1's anatomy laid out properly.

During a review of the WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, dated 2009, the WHO guidelines indicated, "Failures in communication between team members and problems with leadership were the major contributory factors in the report of the Joint Commission for Accreditation of Health Organizations...Organizational culture, interpersonal dynamics and steep hierarchical structures [chain of command] in the operating room contribute to error by creating an environment in which persons who could prevent an error are reluctant to speak up."

1g. During an interview on 4/1/25 at 1:13 p.m. MPOS, MPOS stated PS and IDR looked at the C-arm Fluoroscopy images and decided they (PS and IDR) were at the right level of the cervical spine, so PS proceeded with the surgery.

During an interview on 4/3/25 at 10:13 a.m. with Radiology Technician (RT) 1, RT 1 stated PS was having a hard time determining the correct cervical spine level for the surgery. RT 1 stated PS and IDR were counting Patient 1's cervical spine to determine what level they were working on. RT 1 stated she was shooting images, and PS was talking to IDR.

During an interview on 4/3/25 at 11:15 a.m. with PS, PS stated the IDR was an expert on the implants used in the surgery and the IDR spent all day, every day looking at images. PS stated he would go to the level the IDR thought would be good.

During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated his concerns included the fact that PS implanted metal within Patient 1's spine without knowing where it was going, that PS took the advice of a device representative (IDR) during the surgery for placement of the metal implants, and that PS should have been aware of and used other options available to him in surgery, including taking plain X-rays or using an O-arm.

During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated Patient 1 had a wrong site surgery. VCOS stated PS should have known what position he was in or should have been in. VCOS stated he had concerns about PS's decision-making processes and where he was getting his advice.

During an interview on 4/3/25 at 3:27 p.m. with CRNA 1, CRNA 1 stated Patient 1's surgery was unusual because there were always conversations regarding the level of the cervical spine. CRNA stated multiple X-rays were taken. CRNA stated the surgeon was not sure of the exact location (cervical level).

During an interview on 4/3/25 at 4:55 p.m. with IDR, IDR stated his role in spinal surgeries was to provide equipment, hardware, and implants. IDR stated he was able to advise on how to tape, position, and have proper C-arm fluoroscopy shots. IDR stated he was in surgery to be responsible for the equipment and was not there to tell the surgeon where he was at on the cervical spine. IDR stated he is not allowed to touch a patient ever. IDR stated normally he helps with positioning a patient prior to surgery but he was not in the room when Patient 1 was positioned. IDR stated PS was asking him to confirm and agree on levels. IDR stated, when asked if they were at the correct level, he said, "It maybe, but I cannot confirm we are at that level." IDR stated PS proceeded with the
surgery.

During a review of The Joint Commission's "The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery," (UP) dated 5/21/23, the UP indicated, "Use a standardized list to verify the availability of items for the procedure. At a minimum, these include: . . . labeled diagnostic and radiology test results that are properly displayed."

1h. During an interview on 4/1/25 at 1:13 p.m. with MPOS, MPOS stated PS did not do another X-ray after the second procedure.

During an interview on 4/3/25 at 11:03 a.m. with DSS, DSS stated she was concerned because an X-ray was not done after the second surgery.

During an interview on 4/3/25 at 11:58 a.m. with CMO, CMO stated, "I would assumed if you have done a wrong site procedure, you would get x-rays to confirm you are in the right place."

During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated PS failed to get X-ray images after the second surgery.

1i. During a concurrent interview and record review on 4/1/25 at 12:59 p.m. with Quality Manager (QM), Patient 1's OPR, dated 2/7/25 at 9:46 p.m., was reviewed. The OPR indicated, "The patient earlier today underwent a cervical laminectomy. Postoperatively, the images revealed malposition of the instrumentation and revision surgery was undertaken." QM stated the OPR indicated malposition of the instrumentation placed during Patient 1's first surgery.

During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated PS told him the metal implants were "misplaced [implanted in the wrong position]" and Patient 1 would need to have the correct procedure done.

During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated the wording regarding malposition of the instrumentation was not clear.

During a review of the WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives, dated 2009, the WHO guidelines indicated, "Objective 1 The team will operate on the correct patient at the correct site. While wrong-site or wrong-patient surgery is rare, even a single incident can result in considerable harm to the patient."

1j. During an interview on 4/3/25 at 10:49 a.m. with DSS, DSS stated she was told PS did not disclose the wrong site surgery error to Patient 1's family.

During an interview on 4/3/25 at 11:41 a.m. with CMO, CMO stated PS told him the metal implants were "misplaced" and Patient 1 would need to have the correct procedure done. CMO stated he had met with Patient 1's family and he was not sure they fully understood what "misplaced" meant, but they knew Patient 1 needed another surgery to get better.

During an interview on 4/3/25 at 12:06 p.m. with VCOS, VCOS stated Patient 1 had a wrong site surgery. VCOS stated PS's description to the family regarding what happened was ambiguous.

During a review of the facility's "MEDICAL STAFF BYLAWS," (MSB) dated September 2020, the MSB indicated, "PREAMBLE . . . Whereas, it is recognized that the Medical Staff is responsible for the quality of medical, dental and podiatric care in the Hospital and accepts this responsibility to be accountable to and subject to the ultimate authority of the [Hospital] Board of Directors. . ."



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2a. During a concurrent interview and record review on 4/3/25 at 12:20 p.m. with Director of Surgical Services (DSS), the facility's operating room (OR) logs, for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated March 2025 were reviewed. The OR logs indicated the normal temperature range for the OR was "68-75" degrees Fahrenheit. The OR Temperature Logs indicated Directions: 1) Read, initial, and record the temperature daily ...3) Notify manager / director of any variance 4) complete columns 1,2,3 and 4. The OR Temperature Logs indicated Variance Analysis and Action. Column 1 indicated Limit Exceeded: Column 2 indicated Noted by:________on__/__ Column 3 indicated Analysis and Actions(s) taken and Column 4 indicated Result (Outcome).

The OR temperature logs indicated the following:

OR 1 temperature log for March 2025 indicated:
3/15/25 - temperature was 67 degrees.
3/16/25 - temperature was 67 degrees.
3/21/25 - temperature was 59 degrees.
3/22/25 - temperature was 59 degrees.
3/23/25 - temperature was 59 degrees.

OR 2 temperature log for March 2025 indicated:
3/15/25 - temperature was 67 degrees.
3/22/25 - temperature was 67 degrees.
3/23/25 - temperature was 67 degrees.

OR 3 temperature log for March 2025 indicated:
3/16/25 - temperature was 67 degrees.
3/23/25 - temperature was 67 degrees.
3/31/25 - temperature was 67 degrees.

OR 4 temperature log for March 2025 indicated:
3/15/25 - temperature was 67 degrees.
3/16/25 - temperature was 67 degrees.

OR 5 temperature log for March 2025 indicated:
3/22/25 - temperature was 67 degrees.

OR 6 temperature log for March 2025 indicated:
3/16/25 - temperature was 67 degrees.
3/23/25 - temperature was 67 degrees.

OR 7 temperature log for March 2025 indicated:
3/15/25 - temperature was 67 degrees.
3/22/25 - temperature was 67 degrees.
3/23/25 - temperature was 67 degrees.

None of the Temperature Logs indicated staff had completed Columns 1,2,3 and 4 when variances occurred.
DSS stated there was no documentation staff notified engineering, or any action was taken to correct the OR temperature. DSS stated when the OR temperatures were out of range engineering should have been notified.

During a concurrent interview and record review on 4/3/25 at 12:36 p.m. with DSS, facility's OR temperature logs dated December 2024 were reviewed. The OR temperature logs indicated the following:

OR 3 temperature log for December 2024 indicated:
12/27/24 - temperature was 60 degrees.
12/28/24 - temperature was 61 degrees.
12/29/24 - temperature was 61 degrees.

OR 5 temperature log for December 2024 indicated:
12/21/24 - temperature was 67 degrees.
DSS stated the ORs' temperatures were out of range and engineering should have been notified. DSS stated there was no documentation engineering was notified of the out of range OR temperatures, or any action was taken.

2b. During a review of the hospital's Humidity Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated September 2024, the Humidity Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated 9/13/24, 9/20/24 and 9/25/24 did not indicate the humidity in each OR and were not initialed by OR staff.

During a review of the hospital's Temperature Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated September 2024, the Temperature Log for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7, dated 9/13/24, 9/20/24 and 9/25/24 did not indicate the humidity in each OR and were not initialed by OR staff.

During a concurrent interview and record review on 4/3/25 at 12:52 p.m. with DSS, hospital's "Surgery Schedule" (SS), dated 9/13/24, 9/20/24, and 9/25/24 were reviewed. The SS indicated the hospital performed surgical procedures on 9/13/24, 9/20/25, and 9/25/24. DSS stated surgical procedures were performed on 9/13/24, 9/20/25, and 9/25/24. DDS stated the staff should have recorded OR temperatures and humidities.

During a review of the facility's policy and procedure (P&P) titled, "Temperature and Humidity in Procedural Areas," dated 8/19/24, the P&P indicated, "1. At least once per day, the humidity and temperature levels will be checked and recorded for each department. 2. Any variance will be reported to engineering and affected department(s). . .4. Document corrective actions taken on any variance."

3. During an interview on 4/3/25 at 5:15 p.m. with DSS, DSS stated neither the temperature nor the humidity variances and the lack of action for OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, and OR 7's were discussed in quality committee meetings.

During a review of the facility's P&P titled, "Temperature and Humidity in Procedural Areas," dated 8/19/24, the P&P indicated, "7. Quarterly, the log including variances and actions taken will be presented to the facility quality committee."

Based on interview and record review, the hospital failed to:

1. Ensure documented physician signatures on blood transfusion consents for 18 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 27, Patient 28, and Patient 29). This failure had the potential to result in these patients unable to make informed medical decisions regarding blood transfusions during surgical procedures and resulted in inaccurate patients' records.

2. Ensure witnesses printed their names legibly (easy to read writing) on informed consents for blood transfusions for 17 of 26 sampled patients (Patient 10, Patient 11, Patient 12, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, and Patient 30). This failure resulted in the inability to determine who witnessed the informed consents and inaccurate patients' record.

Findings:


47734


1. During a concurrent interview and record review on 4/1/25 at 3:34 p.m. with Director of Surgical Services (DSS), Patient 10's "CONSENT TO TRANSFUSION OF BLOOD AND/OR BLOOD PRODUCTS" (CTB), dated 3/25/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 3:47 p.m. with DSS, Patient 11's "CTB", dated 3/9/25 was reviewed. The "CTB" indicated physician signed the consent but there were no date and time documented. DSS stated a date, and time should be documented.

During a concurrent interview and record review on 4/1/25 at 3:48 p.m. with DSS, Patient 11's "CTB", dated 3/11/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented, she stated she did not know why there were two consents for transfusion of blood.

During a concurrent interview and record review on 4/1/25 at 3:57 p.m. with DSS, Patient 12's "CTB", dated 3/7/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 4:19 p.m. with DSS, Patient 14's "CTB", dated 2/3/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 4:25 p.m. with DSS, Patient 15's "CTB", dated 3/27/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 4:31 p.m. with DSS, Patient 16's two "CTB", dated 3/27/25 were reviewed. Both "CTB" indicated "Physician Signature" were blank with no date and time documented. DSS stated a physician's signature should be documented, and she did not know why there were two consents for blood transfusion.

During a concurrent interview and record review on 4/1/25 at 4:35 p.m. with DSS, Patient 17's "CTB", dated 3/25/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 4:40 p.m. with DSS, Patient 18's "CTB", dated 3/29/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 4:42 p.m. with DSS, Patient 19's "CTB", dated 2/10/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented. DSS stated there needs to be date and time for both patient signature and witness and there was only one.

During a concurrent interview and record review on 4/1/25 at 4:48 p.m. with DSS, Patient 20's "CTB", dated 3/4/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/1/25 at 4:51 p.m. with DSS, Patient 21's "CTB", dated 3/7/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 4:13 p.m. with DSS, Patient 22's "CTB", dated 3/12/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 4:33 p.m. with DSS, Patient 23's "CTB", dated 3/16/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 4:43 p.m. with DSS, Patient 24's "CTB", dated 3/8/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 4:46 p.m. with DSS, Patient 25's "CTB", dated 3/14/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 5:02 p.m. with DSS, Patient 27's "CTB", dated 3/7/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 5:05 p.m. with DSS, Patient 28's "CTB", dated 3/10/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

During a concurrent interview and record review on 4/3/25 at 5:08 p.m. with DSS, Patient 29's "CTB", dated 2/4/25 was reviewed. The "CTB" indicated "Physician Signature" was blank with no date and time documented. DSS stated a physician's signature should be documented.

2. During a concurrent interview and record review on 4/1/25 at 3:34 p.m. with DSS, Patient 10's "CTB" and "CONSENT TO SURGERY OR SPECIAL PROCEDURE" (CTS), dated 3/25/25 were reviewed. The "CTB" and "CTS" indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 3:49 p.m. with DSS, Patient 11's "CTB" and "CTS", dated 3/9/25 were reviewed. The "CTB" and "CTS" indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 3:57 p.m. with DSS, Patient 12's "CTB" and "CTS", dated 3/7/25 were reviewed. The "CTB" and "CTS" indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:19 p.m. with DSS, Patient 14's "CTB", dated 2/3/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:25 p.m. with DSS, Patient 15's "CTB" and "CTS", dated 3/27/25 were reviewed. The "CTB" and "CTS" indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:31 p.m. with, Patient 16's two "CTB", dated 3/27/25 were reviewed. The two "CTB" indicated witness names were not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:35 p.m. with DSS, Patient 17's "CTB", dated 3/25/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:40 p.m. with DSS, Patient 18's "CTB", dated 3/29/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:48 p.m. with DSS, Patient 20's "CTB", dated 3/4/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:49 p.m. with DSS, Patient 20's "CTS", dated 3/10/25 was reviewed. The "CTS" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:51 p.m. with DSS, Patient 21's "CTB", dated 3/7/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/1/25 at 4:52 p.m. with DSS, Patient 21's "CTS", dated 3/10/25 was reviewed. The "CTS" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 4:13 p.m. with DSS, Patient 22's "CTB", dated 3/12/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 4:33 p.m. with DSS, Patient 23's "CTB" and "CTS", dated 3/16/25 were reviewed. The "CTB" and "CTS" indicated witness name were not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 4:43 p.m. with DSS, Patient 24's "CTB", dated 3/8/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 4:46 p.m. with DSS, Patient 25's "CTB", dated 3/14/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 4:49 p.m. with DSS, Patient 26's "CTB", dated 3/7/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 5:02 p.m. with DSS, Patient 27's "CTB", dated 3/7/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a concurrent interview and record review on 4/3/25 at 5:11 p.m. with DSS, Patient 30's "CTB", dated 3/20/25 was reviewed. The "CTB" indicated witness name was not legible. DSS stated she did not know who signed the consent, she cannot read it.

During a review of the facility's policy and procedure (P&P) titled, "Informed Consent," dated 5/25/2022 the P&P indicated, "2.4. Informed Consent. . .The patient's physician is responsible for providing the information the patient needs in order to make an informed decision. . . 7.1. Physician Responsibility. The physician is responsible for providing the patient or an incompetent patient's surrogate decision-maker with the information that is necessary to allow an "informed decision" to be made. The topics that must be addressed, at a minimum are: 7.1.1 The nature of the operation or procedure . . . 8.2. Documentation. The witness should legibly print his or her name, sign the document and note the date and time the witness signed the document."

Based on interview and record review, the facility failed to follow the "General Medical Staff Rules and Regulations (RR)," when one of one sampled Primary Surgeon (PS) did not immediately complete an operative report following a "lumbar laminectomy [surgical procedure to remove portion of spine/back bone] of L4, L5 [two lowest spinal bones together support the upper body and allow trunk motion] and S1 [bottom of spine provides weight support, movement, and absorbs stress]" for one of 30 sampled patients (Patient 14). This failure resulted in an incomplete medical record for Patient 14 and the potential to affect Patient 14's continuity of care due to an unrecorded surgery.

Findings:

During a review of Patient 14's "History and Physical (H&P)," dated 1/24/25, the "H&P" indicated, "[Patient 14] with low back pain radiating to bilateral [both sides] lower extremity [legs] exacerbated [made worse] by standing and walking, relieved by sitting down. . .Patient wishes to proceed with lumbar laminectomy of L4, L5 and S1.

During a review of Patient 14's "Perioperative Record (POR - record of the time before, during, and after surgery)," dated 2/7/25, the "POR" indicated PS performed the surgery Patient 14's surgery start time was 3:51 p.m. and surgery end time was 5:14 p.m.

During a concurrent interview and record review on 4/1/25 at 4:20 p.m. with Director of Surgical Services (DSS), Patient 14's electronic medical record (EMR) was reviewed. DDS stated an operative report was not found in Patient 14's EMR for the lumbar laminectomy surgical procedure performed on 2/7/25 T 3:51 p.m. by PS. DDS stated PS was required to complete the operative report within 48 after hours following the end time of procedure, DSS stated she did not know why the operative report was not written. DS stated there were no other notes by PS.

During a review of the facility document titled, "RR," dated April 2024, the "RR" indicated, "G. Operative or procedure reports shall be written or dictated immediately after an operative or other high risk procedure."