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Tag No.: A0940
Based on record review and staff interviews, it has been determined that the hospital failed follow their policies to ensure surgical services were well organized, and provided in accordance with acceptable standards of practice.
Findings are as follows:
Patient ID # 1 was sent to the emergency department (ED) on 11/21/2024 by her primary care physician after 3 days of left side flank pain. An outpatient CAT scan revealed a 5 mm stone in the left ureter which the PCP wanted the patient to receive an evaluation and treatment. When in the ED, the Urology PA, Staff K, saw and examined the patient, completed a history and physical, and contacted the surgeon. After review of the case, the surgeon agreed the patient needed an urgent cystoscopy and left stent placement. The Urology, PA Staff K completed a surgical consent with the patient at this time. The patient remained in the ED until the Surgeon came to get the patient in the ED, and transported him/her to the OR suite.
Upon arrival in the OR, the surgeon did not see a surgical consent in the patient chart. The Surgeon then completed a consent with the patient which was signed for a right stent placement (in error). A bracelet was applied to the Patients limb by the surgeon per protocol, but was also placed on the incorrect side. The patient underwent a right stent placement (in error) on 11/21/2024.
On 11/22/2024, the Urology PA, Staff K, was reviewing the record and noted a right-side stent had been placed, not left as scheduled. She contacted the surgeon who confirmed the stent was placed on the patient's right side. The patient was notified of the error and returned to the OR on 11/22/2024 for removal of the right side stent, and placement of the left side stent as previously intended.
Please refer to the following:
1. The hospital failed to ensure qualified personnel necessary to furnish surgical services in accordance with acceptable standards, for completion of the pre-op assessments/checklist by the pre-op nurse (A 941)
2. The hospital failed to ensure policies and protocols were implemented, relative to the preoperative work up, including a nurse-to-nurse handoff report, and scanning documents into the electronic medical record for patients transferring from the ED to the OR. (A 951)
3. The hospital failed to ensure a properly executed informed consent form for the operation was completed. (A 955)
30526
Tag No.: A0941
Based on record review and staff interviews it has been determined that the hospital failed to ensure that qualified personnel are available to furnish surgical services in accordance with acceptable standards, related to the completion of the pre-operative assessment and pre-operative checklist for 1 of 1 patient who required an urgent surgical procedure, Patient ID #1.
Findings are as follows:
Review of the Operating Room (OR) Nurse job description, states in part under Responsibilities
1. Clinical competence in patient care,
...1.9 accurate identification of correct surgical site patient using the Universal Protocol (conducting a pre-procedure verification process, marking the procedure site, and performing a time-out).
...1,10 Performs and documents the pre-operative nursing assessment with attention to per-op lab findings, physical findings, psychological data, educational needs, and significant person/family support.
Review of Elsevier (Mosby's) states in part; A preoperative assessment is conducted to plan for the patient's need during and after the operative or invasive procedure ....
"A preoperative checklist be completed for each patient to ensure that all the preoperative procedures have been completed and that all the necessary information has been documented in the patient's chart for the delivery of safe patient care. The preoperative checklist should be reviewed with the uncurbed perioperative team member before the patient is transported to the OR, or procedure room. Patient hand-off communication should be clear, concise, and complete."
Review of the hospital's policy titled "Universal Protocol for Surgical/Invasive or Radiation therapy Procedures" dated 7/28/2021, states in part, under Section C: Pre-Operative/Procedure Check-In ...
#2 b. "confirming the presence of H & P, consents with date and time, pre-anesthesia assessment, nursing assessment, blood products, diagnostic and radiology test results, implants, devices and/or special equipment are present."
Review of the record for Patient ID #1, revealed that s/he presented to the emergency department (ED), referred by the Primary Care Provider on 11/21/2024, after an outpatient CAT scan found a 5 mm stone in the left ureter. Due to a concern for infection, the emergency department physician consulted urology services to evaluate the patient. The Urology PA, Staff ID K, completed a history and physical and documented the findings in the patient record.
The findings indicated a 5 MM stone obstructing the left ureteral and pyuria. After consulting the surgeon, the plan was for the patient to have an urgent cystoscopy, left retrograde, pyelogram and ureteral stent placement.
Patient ID #1 was taken to the OR for treatment and a stent was placed in the right ureter in error.
Review of the patient record failed to reveal the OR Nurse completed a pre-operative check list or pre-operative assessment which is required to be completed by nursing staff prior to surgery.
During surveyor interview with the OR Nurse, Staff H on 12/3/2024 at 10:00 AM, she stated that she was on-call, called at home, notified by the Physician, Staff D to present to the hospital for an urgent "cysto/stent placement." She stated that she was the first of the surgical team to arrive. Staff H stated that she did not assess the patient or complete the pre-operative check list.
During an interview with the ED Manager, Staff I, she was asked if she had assessed the patient or completed the pre-op check list as required prior to the procedure, she stated that during regular hours, they have a pre-operative nurse who completes the assessments and checklist. Additionally, she stated that for on-call cases such as this case, the checklist and nursing assessment is to be completed by the staff where the patient is located (in patient units or the emergency department). Staff I acknowledged she did not assess the patient or complete the pre-operative checklist.
During an interview with Professional Nurse Specialist, Staff L, on 12/3/2024 at approximately 12:30 PM, she provided the surveyor with a copy of Elsevier (Mosby's) preoperative assessment which identified a preoperative assessment and pre-operative check list. She stated the hospital does not have a specific policy but refers this manual for the standard of practice. She stated that all patients require an assessment and pre-operative checklist to be completed prior to surgery.
During an interview with the OR Nurse Manager, Staff E, on 12/3/2024 at approximately 10:30 AM, she stated that parts of the preop checklist were completed by the ED staff, however she was unable to produce evidence that the OR Nurse had assessed the patient or completed the pre-operative checklist as required. Additionally, she was unable to produce evidence that the nurse had reviewed the patient's record according to hospital policy to confirm the presence of a nursing assessment, or diagnostic and radiology test results.
30526
Tag No.: A0951
Based on record review and staff interviews it has been determined that the hospital failed to follow their policies and protocols relative to Nurse to Nurse handoff and scanning medical documents into the electronic patient medical record for 1 of 1 patient, Patient ID #1 who was transferring from the Emergency Department (ED) to the Operating Room (OR).
Findings are as follows:
Review of the medical record for Patient ID #1, revealed a "Westerly Emergency Department Handoff Report", which states in part;
..." patient presented to the emergency department seeking treatment for Flank Pain."
The record indicated the Patient had an outpatient CAT scan which found a 5 mm stone in the L (left) ureter. The hand off note which is approximately a 4-page document, included: arrival notes, vital signs, lab results, medications administered, and imaging reports. This Handoff report was signed by the ED nurse, Staff N, on 11/21/2024 at 6:08 PM.
Review of an additional note attached to the Handoff Report, noted at 6:55 PM, states: Antibiotic given, patient transported to the OR by the Physician, (Staff D). This note is signed and dated by the Nurse, Staff N on 11/21/2024 at 6:56 PM.
The record lacked evidence that a verbal handoff between the ED Nurse and the OR Nurse had occurred per hospital protocol.
During surveyor interview with Nursing Professional Specialist, Staff L, on 12/3/2024 at approximately 1:00 PM, she stated according to the manual "Elsevier" referral source used for current Standards of Practice the Nurse to Nurse handoff is considered a "professional standard" when a patient is being transferred from one area to another area in the hospital.
During a surveyor interview with the ED Nurse Manager, Staff I, on 12/3/2024 at approximately 1:30 PM, she stated that the ED nurse had completed the SBAR (situation, background, assessment, background) form which is documented in the patient's chart. She stated that the ED always completes a Nurse-to-Nurse handoff. She informed the surveyor that the ED staff usually, will call the OR to see if they are ready for the patient to be transported to the OR, and will give a verbal report at that time. She also informed the surveyor that in addition to the ED staff scanning the surgical consent form into the patients record, that a paper copy of the OR consent form, is physically sent to the OR with the patient when they are transported. The surveyor asked the ED Manager, how long the ED had been completing and documenting the ED handoff report in the electronic patient record, and she said, "about 2 years."
Review of the medical record for Patient ID #1, and per conversation with the ED Nurse Manager, Staff I, there is no evidence that a verbal handoff was ever completed. Staff I informed the surveyor that, due to the Physician (Staff D) coming to the ED and transporting the patient to the OR (which is not normal procedure), the ED staff did not contact the OR to see if they were ready for the patient. This resulted in no verbal communication between the ED and OR staff nurses.
During surveyor interview with OR nurse, Staff H, on 12/3/2024 at 10:00 AM, she acknowledged that there was no Nurse-to-Nurse verbal report from the ED because the patient was transported by the surgeon who went to the ED to get the patient. She also acknowledged that she did not review the patient's chart, because she was preparing the surgical room. Additionally, she informed the surveyor that when the patient was transported to the OR, they usually have the paper copies of reports or consent, however Patient ID #1 did not come to the OR with any paper reports.
During surveyor interview with the OR Nurse Manager, Staff E, on 12/3/2024, when asked if she was aware of the ED handoff report (SBAR) located in the patient's medical record which identified the left side stone. She stated she was unaware of report. When informed by the surveyor that the ED Manager stated that the ED has been completing the handoff report in the electronic medical record for approximately 2 years, she stated she was unaware of the electronic handoff report. She was unable to produce evidence that the OR staff was aware of, or reviewed the electronic ED handoff report, which clearly identified the ureteral stone was on the left side, or that a verbal Nurse to Nurse communication had occurred as required.
30526
Tag No.: A0955
Based on record review and staff interviews it has been determined that the hospital failed to ensure a properly executed informed consent form was in the patient's chart prior to surgery, for 1 of 1 patient, Patient ID # 1.
Findings are as follows:
Patient ID # 1 was sent to the emergency department (ED) on 11/21/2024 by the Primary Care Provider after review of an outpatient CAT scan which showed a 5 mm stone in the patients left ureter.
The patient was seen by the ED, by Physician Assistant, Staff M who requested a urology consult. Urology, PA, Staff K, assessed the patient while in the ED, and completed a history and physical. The on-call Surgeon was notified and after review of the case, agreed the patient needed an urgent cystoscopy and left stent placement.
Review of the urology PA, Staff K's consultation note documented on 11/21/2024 and signed at 6:30 PM, reveals the outpatient CAT scan done earlier in the day which is documented as a 5 mm left ureteral stone. The consultation note identified a radiologist report which states "obstructing distal left ureteral stone".
Review of the surgical consent form completed by the PA, Staff K, and signed by the patient on 11/21/2024 at 6:04 PM, states the name of the Surgeon, procedure identified as cystoscopy, left retrograde pyelogram and stent insertion.
During a surveyor interview with the urology PA, Staff K, on 12/3/2024 at 1:05 PM via phone, she informed the surveyor that she was on call for Urology and was in the ED seeing other patients when she received the call to consult on Patient ID #1. Staff K stated after evaluating the patient, reviewing the lab and CT scan results, she called the Surgeon who agreed with her assessment and plan, and documented her consultation. She said the Surgeon said he would call in the on-call team and was finishing writing her note and completing the surgical consent. Additionally, the PA told the surveyor that after completing the consent, the emergency room secretary scanned the consent into the patient's chart, and that the paper copy of the signed consent should have gone with the patient to the operating room.
On 12/2/2024 at 1:20 PM the surveyor interviewed the Surgeon, Staff D, who reports when notified, he called the on-call Nurse, Staff H, and told her the surgical team needed to come in as there was a patient in the ED who needed an urgent cystoscopy and left stent placement. He said upon arrival, the nurse was setting up the room, and the patient was still in the ED. At this time, he offered to go to the ED to get the patient (which is not the usual protocol). He proceeded to the ED spoke with the patient. He then rolled the patient to the OR and notified the nurse that the patient was there.
Staff D said the Nurse, Staff H, and Anesthesiologist, Staff J were in the OR when he returned to the OR suite with the patient. He said the blank surgical consent and a wrist band were on the counter, so he filled out the surgical consent, "cystoscopy and right stent", (which was incorrectly identifying the right side) and had the patient sign and he signed at 7:00 PM.
The surveyor asked the Surgeon, about the surgical consent that the PA had completed earlier in the ED, and he stated that since it was not identified in the record and there was a blank form on the counter along with the wrist band to mark the correct side, he completed the consent with the patient and initialed the band, wrote R indicating right side and placed it on the patients right wrist. He acknowledged to the surveyor that he made the error in documenting the wrong side for the stent placement when he wrote right instead of left. He said that when he was in the ED he knew it was left side, had confirmed with the patient which side, and does not know how/why he wrote right stent when he filled out the consent. He said the patient did not indicate or question the right side when he filled out the consent with h/him or placed the wrist band on the right side.
During surveyor interview with the OR nurse, Staff H, on 12/3/2024 at 10:00 AM, she stated that after receiving the call from the Surgeon, that she called him back to ensure that she had the correct procedure so she could complete the booking sheet and prep the room. She said that he said "cystoscopy and right stent" which is what she wrote on the booking sheet. She said she couldn't talk to the patient as the anesthesiologist, Staff J was at the desk speaking with the patient and filling out forms. She said the consents, and wrist bands are on a shelf at the desk. She said the patient did not come with any paper forms from the ED. The Surgeon just brought the patient. When asked by the surveyor if she was aware that the PA had completed a consent and it was scanned into the chart by the ED staff, she said she was not aware and had not looked for it. She stated that she reviewed the consent that the Surgeon filled out which indicated right side stent.
During an interview with the ED Nurse Manager, Staff I, on 12/3/2024 at 1:30 PM, who informed the surveyor that the staff scan the consents into the patient's chart and then a hard (paper) copy is placed in a bin and when the patient is transported to the OR that the signed paper consent goes with the patient along with any other information needed by the OR. She said that the Surgeon, may not have known about the ED process when transporting the patient to the OR.
During surveyor interview with the OR Manager and the Risk Manager on 12/3/2024 at approximately 11:00 AM, they were unable to provide evidence that the consent form was properly executed.
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