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The hospital's surgical team failed to follow standards of practice and policy and procedures according to the American Peri-Operative Registered Nurses (AORN) when the wrong side of Patient 1's head was marked for Right Craniotomy to drain a subdural hematoma (surgical procedure by drilling a hole on and into the head to the dura matter in order to evacuate the pool of blood) and failed to verify the signed consent was in accordance to the prepared site during the "surgical timeout" (the final verification of patient identity, surgical site, and planned procedure before the surgical procedure is initiated). Refer to A131.


The cumulative effect of these systematic problem resulted in a wrong site surgery and the hospital's inability to protect and promote patient's rights, and provide quality patient care.

Based on interview and record review, the facility failed to ensure policy and procedures and standards of practice according to the AORN (Association of Peri-Operative Registered Nurses) Guidelines were followed for one sampled patient (Patient 1), when:


1. Patient 1's consented operative site (right side of the head) was not marked prior to the procedure right craniotomy for drainage of subdural hematoma .This failure resulted to a wrong surgery site.


2. The surgical team during the "surgical timeout" (the final verification of patient identity, surgical site, and planned procedure before the surgical procedure is initiated) failed to verify the surgery site (right side of the head) was marked prior to surgery in accordance to the informed consent (IC) signed by Patient 1. This failure resulted to the surgical team performing a wrong site procedure contrary to what the patient had consented which is a violation of patient's rights.


Findings:


1. According to the AORN guidelines, "Standards of Peri-Operative Nursing Practice-Team Communication", dated (2012-2019), the guideline indicated in part ... "The patient's identity, procedure, and procedural site including laterality must be verified and the site marked ...identifying the correct site on the patient's body where the procedure or surgery is to be performed helps to decrease the risk for wrong site surgery ...the site marking process must be consistent throughout the health care organization and not open to interpretation ...consistent site marking processes applied throughout the health care organization decrease confusion and risk for wrong site surgery ...identify procedures that will require site marking ...at a minimum, perform site marking when there is more than one possible location for the surgery to occur ...the procedure site must be marked before the procedure begins ...marking the site before the procedure helps to promote patient involvement and minimize the risk for wrong site surgery ...involve the patient or the patient's representative in the marking of the site if possible ...the procedure site must be marked by a licensed independent practitioner who is accountable and will be present when the procedure is performed ...the mark should be made at or near the procedure site and be visible after surgical skin antisepsis and draping."


During a review of the hospital document titled,"Op/Inv Proc Note- Brief "dated 5/11/21 indicated Patient 1's pre-operative diagnosis was Acute Right SDH (subdural hematoma- accumulation of blood in the dura probably due to blunt force) ..procedure performed - L (left) sided burr hole (wrong side) , R (right) side burr hole for SDH evac (evacuated)."


During an interview on 5/18/21, at 2:46 p.m.,with the physician's assistant (PA 1), PA 1 stated, "During the time out the consent was read but I did not visualize if the site was marked."


During an interview on 5/21/21, at 3:30 p.m., with the surgeon (S 1) who performed the surgical procedure on Patient 1, S 1 indicated the normal practice is to mark the surgery site in the Intensive Care Unit (ICU) or Operating Room (OR), S I stated, "Usually I ask the nurse for the pen but they were busy, I did not mark the site. There were several failures, lack of mark in the ICU or OR and lack of confirmation of the marking."


During an interview on 6/2/21, at 10:26 a.m., with the chief of surgery (COS), the COS indicated the operative site marking is supposed to be done before the patient enters the OR and on surgical time out everyone (all staff) in the room; stops, pays attention, everyone participates, and verifies and visualizes the operative site is marked, and the site is correct.


During an interview on 6/2/21, at 10:39 a.m., with the director of surgical services (DOSS), the DOSS indicated the surgical prep (preparation) of the patient is normally done prior to surgery and the nurse makes sure the consents are signed, the operative site is shaved, or hair is clipped, and the site is marked. The site marking is done by the surgeon during the prep. The DOSS further indicated in this case Patient 1's head was not shaved, and the right site was not marked prior to surgery.


During another interview with the DOSS on 6/2/21, at 10:45 a.m., the DOSS indicated on 5/11/21 Patient 1 was brought to the OR and while on the OR table, the patient's hair was clipped, site was prepped and Patient 1 was draped (covered) by S 1 and the PA. The DOSS further indicated in the case of Patient 1, at this point the site could have been marked.


During an interview on 6/2/21, at 11:10 a.m., with licensed nurse (LN 1), LN 1 indicated it is the hospital's policy to do the pre-op (pre- procedure) checklist before the patient goes to surgery. LN1 further indicated the unit is short staffed and the hospital fired all the ancillary staff which affects patient care. LN 1 stated, "We were swamped and had no secretaries to answer phones, Patient 1 became combative, and I did not fill out the pre-op checklist."


During a review of the facility's "Pre-procedure Checklist" indicated in part ...
"What the patient states the procedure is:
Procedure and sites confirmed and marked per policy:
Patient identified by two identifiers:
MD (medical doctor) orders reviewed:
Procedure documentation verified and available:
Consents complete, valid, and available ..."


During a concurrent interview and record review on 6/2/21 at 11:19 a.m., with the patient safety officer (PSO), the PSO confirmed Patient 1's pre-procedure checklist on 5/11/21 was not filled out. The PSO stated, "The pre-procedure checklist should have been filled out prior to surgery per hospital policy and it was not."


During an interview on 6/2/21, at 11:15 a.m., with LN 1, LN 1 stated, "The surgeon normally marks the site, but we had no surgical marking pens on the unit. I had never seen those pens before ,we only had sharpies." LN 1 further stated,"The surgeon (S 1) took responsibility and indicated he did not mark the site and performed surgery on the wrong site."


The facility policy and procedure titled, "Safe Procedural and Surgical Verification - Universal Protocol", revised 9/26/19, indicated in part ... "PURPOSE: This policy is intended to ensure the consistent use of a standardized approach to identify the correct patient, the correct procedure, and the correct side or site ...POLICY: processes for reliable performance of safe surgical of invasive procedures will include pre-procedure verification, marking the operative or procedural site ... these processes are to be consistent and standardized throughout the organization ...the procedural or operative site is to be correctly identified and marked by the surgeon/proceduralist performing the procedure. The mark is intended to eliminate any ambiguity and ensure correct laterality and level, even after the patient is prepped and draped. PROCEDURE: Verification: The verification process is to ensure that the correct patient, procedure, and side/site have been verified at every hand-off of the patient from one person/location to another and that relevant documents have been assemble prior to the start of the procedure ... Relevant documents to be reviewed include: Registered Nurse pre-procedure assessment ...Surgeon/proceduralist or one other member of the team will verify: team's understanding of the intended patient, procedure, and side/site ...Pre-Procedure Site Marking: Marking of the surgical/procedure site will be performed by the surgeon/proceduralist after verification and reconciliation of all available documents, prior to administration of regional or local anesthesia and/or sedation, and with participation of awake and aware patient and/or patient representative. The mark should be made using a marker that is sufficiently permanent to remain visible after completion of the skin prep and drape ...the surgeon's/proceduralist's/NP/PA initials are required to denote the site...correct side, site, and position are confirmed by visualizing site marking within the sterile field."


2. According to the AORN guidelines, "Standards of Peri-Operative Nursing Practice-Team Communication", dated (2012-2019), the guideline indicated in part ... "The perioperative team must perform a time out before an operative or invasive procedure begins ...the collective evidence supports the time out as a tool to prevent wrong site surgeries ...the purpose of the time out is to conduct a final check that the correct patient, correct site, and correct procedure are identified ...a time out provides an opportunity for all perioperative team members to speak up and address any concerns or problems that would affect the safety of the patient ...the time out should be a standardized process as defined by the facility ...a standardized process is most effective when it is conducted consistently throughout the facility ...a designated perioperative team member should call for the time out to begin ...the time out should involve all members of the perioperative team ...the participating team members must include the individual performing the procedure, the anesthesia professional, the RN circulator, the scrub person, and any other team members who will be participating in the procedure from the beginning ...during the time-out process, the team must confirm, at a minimum, the correct patient, site, and procedure to be performed ...stop all unnecessary activities and conversations in the OR when the time out is called ...if perioperative team members have not introduced themselves, each person should state his or her name and role on the team ...discuss any patient safety concerns or concerns about the procedure during the time out ...document the time out as completed in accordance with facility policy (amount and type of documentation) ...use a standardized surgical safety checklist during the time-out process ...high-quality evidence supports the use of a standardized safe surgery checklist during the time-out process to improve communication, reduce the potential for error, reduce patient complications, improve adherence to critical processes and safety measures, and decrease surgical mortality. A surgical safety checklist is designed to enhance communication and teamwork and helps create an environment in which perioperative team members' input is solicited and welcomed and information sharing is encouraged."


During an interview on 6/2/21, at 10:30 a.m., with the COS, the COS indicated the informed consent (IC) is a two-part process. The first part happens when the surgeon discusses the risks and benefits of the procedure with the patient, then documents in the patient's chart. The second part is the written consent, which is read during the surgical time out.The surgeon reads the consent while the circulating nurse is looking at the chart and everyone in the room verifies the consent matches the correct operative site. If the the procedure and operative site does not match the written consent, the surgery should be halted and the correct site needs to be verified and remarked. The COS further indicated the IC is part of Patient's Rights and if the surgical site does not matched the IC and the surgical procedure is not halted, it is a violation of Patient's Rights. The COS stated, "If the procedure is not halted, the patient rights would not be honored and it is wrong."


During a review of Patient 1's clinical record, the IC, dated 5/11/21 at 1:48 p.m., indicated in part ... "Right Craniotomy for drainage of subdural hematoma" as the operation to be performed.


During a review of the facility's "Surgical & Procedural Safety Checklist" undated, indicated in part ... "Time Out: before skin incision or start of procedure (surgeon/proceduralist initiates)
All team members introduced by name and role
State the correct patient, procedure, and side (images are displayed and verified as correct by surgeon-required to determine laterality/location)
Procedure site is verified with the consent
Side/site is verified with markings and reports and physical verification
Position is correct
Additional time out needed
What are safety concerns for this patient ...
Does everyone agree."


During an interview on 6/2/21, at 10:50 a.m., with the DOSS, the DOSS indicated during the surgical time out, it is the responsibility of everyone (staff) in the room to verify the written consent, the correct procedure, and the operative site. The surgical time out card (checklist) needed to be read aloud, in order, from top to bottom, so steps are not missed. If the procedure about to be performed does not match what is written on the consent then the surgeon needs to be notified. The DOSS stated, "Patient rights is not honored if the wrong procedure was performed, if the procedure is not emergent, patient rights should be honored and the procedure should match the consent." The DOSS indicated the rights of Patient 1 was not honored when the surgical procedure was done on the wrong site initially.


During an interview on 6/2/21, at 11:13 a.m., with LN 1, LN 1 indicated the purpose of getting the IC is to inform the patient about the risks and benefits of the procedure and obtaining the consent is part of patient rights. LN1 further indicated if the written consent procedure did not match the surgery performed, it would be a violation of patient rights.


During a review of the facility's policy and procedure titled, "Safe Procedural and Surgical Verification - Universal Protocol", revised 9/26/19, indicated in part ... "PURPOSE: This policy is intended to ensure the consistent use of a standardized approach to identify the correct patient, the correct procedure, and the correct side or site ...POLICY: processes for reliable performance of safe surgical of invasive procedures will include pre-procedure verification, marking the operative or procedural site, and a Time-Out immediately prior to starting the procedure ... these processes are to be consistent and standardized throughout the organization ...A Time-Out, which is led by the surgeon/proceduralist, will be performed immediately prior to starting the procedure by completing a final verification of correct patient, procedure, and side/site. Any members of the team may express questions or concerns, and all questions and concerns will be resolved prior to incision or start of the procedure ...Relevant documents to be reviewed include: Patient's signed informed consent ...Briefing, Time-Out, and Debriefing: Once the patient is in the operating room or procedure area, team members will stop activity and respond through active verbal acknowledgement and confirmation to each question of the Briefing, Time-Out, and Debriefing. Time-Out (immediately prior to incision and or start of procedure): Correct procedure is confirmed and verified against signed procedure consent. DEFINITIONS: Time-Out is a period of time after induction and before puncture or incision during which all activity and conversation in the procedure area ceases. All members of the surgical/procedural team participate in the positive verification of the patient, the intended procedure, and the visualization of the marked site of the procedure."