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Based on interview, record review, and review of the "Bylaws of the Medical and Dental Staff," it was determined the facility failed to have an effective Governing Body responsible for the conduct of the facility. The Governing Body failed to develop and implement written surgical policies directing surgeons to identify laterality on Informed Consent for Surgery or Invasive Medical Procedure forms. Because of this failure, Patient #1 underwent a wrong site surgical procedure at the left sacroiliac (SI) joint to drain an infectious abscess at the patient's right sacroiliac (SI) joint.

Record review revealed, on 10/15/2020, Surgeon #7 attempted to perform an incision and drainage to wash out the infected sacroiliac joint on Patient #1's right side. Review of Surgeon #7's 10/15/2020 Operative-Procedure Report revealed the surgeon performed a wrong site surgical procedure by performing a left sacroiliac joint, arthrotomy inferior portion of joint, aspiration of joint procedure. Review of Patient #1's medical record revealed, on 10/15/2020, Surgeon #7 wrote the surgery order for "incision and drainage washing out of infected sacroiliac joint." The documented laterality of the surgery order was the right sacral joint. Review of Patient #1's History and Physical, dated 10/12/2020, revealed the patient presented to the Emergency Department, on 10/12/2020, with worsening lumbar and right lower extremity pain. Review of Patient #1's Informed Consent for Surgery or Invasive Medical Procedure document, dated 10/15/2020, revealed the patient consented to have Surgeon #7 perform an "incision, drainage, debride abscess spine procedure." Further review of the consent document revealed that Surgeon #7, on the document, did not write the laterality of the surgical procedure.

Interview with the Chief Medical Officer, on 11/02/2020 at 2:30 PM, revealed it was the facility's policy for surgeons to document laterality on informed consent forms and to mark the patient's skin at the surgical site in the Pre-Operative area.

Interview with Surgeon #7, on 11/04/2020 at 11:00 AM, revealed he failed to document laterality on the Informed Consent form he completed and had Patient #1 sign. Surgeon #7 also stated he failed to mark Patient #1's skin in the Pre-Operative area. Once in the OR, Surgeon #7 stated he became disoriented due to an X-ray machine being set up on the opposite side of the patient. Surgeon #7 stated he mistakenly made the wrong site incision and was unable to locate an abscess to drain; he closed the patient and ended the surgical procedure.

Interview with Staff Nurse #21, on 11/05/2020 at 11:45 AM, revealed, on 10/15/2020, she was assigned to care for Patient #1 following the surgical procedure. Staff Nurse #21 stated she immediately became suspicious when she received report from the Post Anesthesia Care Unit nurse that Patient #1 had a surgical bandage on the left sacral region. Upon performing her initial assessment of Patient #1, Staff Nurse #21 contacted Surgeon #7 and related her concerns that a wrong site surgical procedure had occurred.

(Refer to A0049, A0115, A0144, A0940, A0942, and A0955).

Based on interview, record review, and review of the facility's "Bylaws of the Medical and Dental Staff," it was determined the Governing Body failed to effectively manage the hospital and ensure facility policies were followed by Surgical Services.

Patient #1, on 10/15/2020, underwent a wrong surgical site procedure. The patient was to have an abscess drained at his/her right sacral region. Surgeon #7 mistakenly made an incision at the patient's left sacral region, believing that was the location of the abscess.

The findings include:

Review of the facility's "Bylaws of the Medical and Dental Staff," dated 03/28/17, revealed the Bylaws were adopted to establish the organization of the Medical and Dental Staff of the facility. The Governing Council made the determination as to whether a prospective member was eligible to apply for membership to the facility's Medical Staff. The Governing Council had the authority over the Medical Governing Council. The Bylaws stated whenever a physician's conduct appeared to require immediate action to protect the life, wellbeing, or safety of a patient or other person, the Chief Executive Officer (CEO) could summarily restrict or suspend the privileges of membership of such physician.

Further review of the facility's "Bylaws of the Medical and Dental Staff" revealed the duties of the Peer Review Committee were to ensure the organization, through the activities of its medical staff, assessed the ongoing practice evaluation of individuals granted clinical privileges and used the results of such assessments to improve care and, when necessary, direct Focused Professional Practice Evaluation. The Peer Review Committee was designated by the Medical Governing Council to conduct the review of individual practitioner performance for the medical staff member. Members of the peer review body may render assessments of the performance based on information provided by individual reviewers with appropriate subject matter expertise.

Interview with the facility's Chief Medical Officer (CMO), on 11/02/2020 at 2:30 PM, revealed the wrong surgical site case involving Patient #1 was presently under Peer Review. The CMO acknowledged some patient safety policies were not followed by Surgeon #7 in regards to the patient's medical care. The CMO stated Surgeon #7 failed to document laterality on the Informed Consent form he completed for the patient's signature. The CMO also stated Surgeon #7 failed to mark Patient #1's skin at the surgical site in the Pre-Operative area prior to the procedure.

Review of Patient #1's medical record revealed the patient arrived at the facility's Emergency Department, on 10/12/2020, with complaints of worsening lumber and right lower extremity pain. The patient was admitted to the facility with diagnoses of Metastatic Breast Cancer, Right Sacroiliac (SI) Joint Septic Arthritis/Abscess, and Severe Low Back Pain with Radiation to Right Lower Extremity.

Continued review of Patient #1's medical record revealed, on 10/13/2020, a Magnetic Resonance Imaging (MRI) procedure was performed that revealed Patient #1 had an abnormal appearance of the right SI joint; there was fluid collection anterior to the right SI joint measuring thirty-three (33) millimeters (mm), and edema in the right gluteal musculature and right iliac muscle were found. A follow-up MRI, on 10/15/2020, again revealed Patient #1 had extensive abnormal fluid involving the right SI joint, with a loculated fluid collection anterior to the SI joint, now measuring twenty-eight (28) by ten (10) mm. Following the 10/13/2020 MRI, Surgeon #7 documented he met with Patient #1 and discussed the procedure of surgically removing infectious material that had collected behind the patient's sacroiliac joint at the inferior portion of the sacroiliac joint. However, further review of Surgeon #7's 10/15/2020 Operative-Procedure Report revealed he documented the patient's preoperative diagnosis as possible left sacroiliac joint infection.

Review of the Order Sheet, dated 10/15/2020, revealed Surgeon #7 wrote a surgery order for an incision and drainage washing out of infected sacroiliac joint, identifying laterality as on the Patient #1's right side.

Review of the Informed Consent for Surgery or Invasive Medical Procedure, completed by Surgeon #7, revealed the procedure Patient #1 was consenting to was an "incision, drainage, debride, abscess spine." Further review of the surgical consent form revealed laterality was omitted by Surgeon #7.

Review of the facility's Main OR Intraoperative Report, dated 10/15/2020, revealed Patient #1 was brought to OR Suite #4 at 1:29 PM. At 1:55 PM, Circulating Nurse #4, a Registered Nurse, documented a Time Out was conducted. The Circulating Nurse documented the correct patient was identified, correct procedure side was identified, surgical procedure site was marked, and the consent form was present. Per report, proceeding with the procedure following the Time Out, Surgeon #7 made an incision at the patient's left SI joint region in an attempt to drain the abscess; but, he was unable to locate an abscess on the patient's left side, and Surgeon #7 ordered the incision he made on the patient's left side to be closed with sutures. Per report, Patient #1 was transported out of OR Suite #4, at 1:30 PM, for recovery. The total surgical procedure time was sixty-one (61) minutes.

Interview with Staff Nurse #21, on 11/05/2020 at 11:45 AM, revealed, on 10/15/2020, she was assigned to care for Patient #1 following the surgical procedure. Staff Nurse #21 stated she immediately became suspicious when she received report from the Post Anesthesia Care Unit nurse that Patient #1 had a surgical bandage at his/her left sacral region. She stated, upon performing her initial assessment of Patient #1, Staff Nurse #21 contacted Surgeon #7 and related her concerns that a wrong site surgical procedure had occurred.

Interview with Surgeon #7, on 11/04/2020 at 11:00 AM, revealed the process leading up to the wrong surgical site procedure. Surgeon #7 stated, on 10/15/2020, he was on-call for Orthopedic Services and was informed Patient #1 had an abscess at his/her right sacral area. He stated Patient #1 was in extreme pain when he examined him/her the morning of 10/15/2020. He stated, following the medical examination of the patient, Surgeon #7 wrote the surgery order for later that afternoon, specifying right side laterality on the order. Surgeon #7 stated he completed the Informed Consent signed by Patient #1 and witnessed by Circulating Nurse #4 in the Pre-Operative area. Surgeon #7 stated he should have documented laterality of the patient's right side on the Informed Consent form; but, he was unable to explain why he omitted laterality of the surgical procedure. Surgeon #7 stated he failed to mark the patient's surgical site in the Pre-Operative area because he believed Patient #1 was in too much pain to position for the marking of the skin. The surgeon stated he knew the surgical procedure was supposed to be done on the right side of the patient's sacral region. Per interview, Surgeon #7 stated there was a large piece of equipment in OR Suite #4, the X-ray machine, located on the opposite side of the room to which he was accustomed. Surgeon #7 stated he used the X-ray machine to locate the abscess during the procedure, claiming the positioning of the X-ray machine caused him to become disoriented and mistakenly believe he should be operating on the patient's left sacral area, not the right sacral area where the abscess was located. Surgeon #7 denied that a Time Out was not performed in the OR suite prior to the surgical procedure. Surgeon #7 stated, two (2) hours following the procedure, he was contacted by Patient #1's Medical/Surgical Nurse and informed she believed a wrong site surgical procedure had been performed on the patient.

Interview with the Chief Executive Officer (CEO), on 11/06/2020 at 2:30 PM, revealed the facility annually reviewed quality of care and credentialing issues of Physicians. He stated potential safety events were reported through the facility's Quality Group. The CEO stated serious safety issues, such as wrong site surgical procedures, that could potentially cause harm to patients were reviewed. The CEO stated the Governing Body worked through the Medical Staff to have identified safety issues addressed with individual Physicians.

Based on interview, record review, and review of the facility's policy, "Patient's Rights," it was determined the facility failed to provide care in a safe setting and protect and promote each patient's rights for Patient #1, who underwent a wrong site surgical procedure to drain an infectious abscess at the patient's right sacroiliac (SI) joint.

Record review revealed, on 10/15/2020, Surgeon #7 attempted an incision and drainage to wash out an infected right SI joint. However, after becoming disoriented in the operating room, Surgeon #7 mistakenly made the incision at the patient's left SI joint area.

Interview with Surgeon #7, on 11/04/2020 at 11:00 AM, revealed he failed to identify laterality on the Informed Consent form, failed to mark the patient surgical site in the Pre-Operative area, and performed a wrong site surgical procedure on Patient #1.

Interview with Circulating Nurse #4, a Registered Nurse (RN), on 11/06/2020 at 9:20 AM, revealed she failed to perform the duties of a circulating nurse. She stated she failed to reconcile Patient #1's medical record to ensure the accuracy of the procedure, failed to visualize skin markings in the Pre-Operative area indicating the procedure location, and failed to recognize laterality was not documented on the patient's consent form.

Interview with the Chief Medical Officer (CMO), on 11/02/2020 at 2:30 PM, revealed Surgeon #7 failed to document laterality on the Informed Consent form he completed for the patient's signature. The CMO also stated Surgeon #7 failed to mark Patient #1's skin at the surgical site in the Pre-Operative area prior to the procedure which contributed to the error.

(Refer to A-0043, A0049, A0144, A0940, A0942, and A0955)

Based on interview, record review, and review of the facility's policy, it was determined the facility failed to ensure patients received surgical services in a safe environment as evidenced by a Surgeon performing a wrong site surgical procedure on Patient #1, one (1) of ten (10) sampled surgical patients.

The findings Include:

Review of Patient #1's General Consent on Admission form, dated 10/12/2020, revealed the patient signed he/she had received a copy of the facility's Rights and Responsibilities of Patients document. Review of the facility's Outpatient Services Information Guide revealed Patient Rights and Responsibilities was written within the guide.

Review of the facility's policy, "Patient Rights and Patient Responsibilities," dated 12/2016, revealed patients had the right to receive safe and appropriate medical care to the best of the organization's ability. Per policy, patients had the right to be informed of their rights before care was provided or discontinued, whenever possible. In addition, the policy stated patients had the right to receive information including risks, benefits, and reasonable alternatives in a language or method of communication the patient could understand pertaining to the patient's health status, current diagnosis, treatment plan and prognoses, in order for the patient to give informed consent or to refuse consent.

Review of Patient #1's medical record revealed the patient arrived at the facility's Emergency Department, on 10/12/2020, with complaints of worsening lumbar and right lower extremity pain. The patient was admitted to the facility with medical diagnoses of Metastatic Breast Cancer, Right Sacroiliac (SI) Joint Septic Arthritis/Abscess, and Severe Low Back Pain with Radiation to the Right Lower Extremity.

Continued review of the medical record revealed, on 10/13/2020, a Magnetic Resonance Imaging (MRI) procedure was performed on Patient #1 and showed an abnormal appearance of the right SI joint due to fluid collection anterior to the right SI joint, measuring thirty-three (33) millimeters (mm); in addition, edema in the right gluteal musculature and right iliac muscle was found. Further review revealed a follow-up MRI was done, on 10/15/2020, which again revealed Patient #1 had an extensive abnormal fluid involving the right SI joint. There was a loculated fluid collection anterior to the SI joint, which now measured twenty-eight (28) by ten (10) mm.

Continued review of the medical record revealed following the 10/13/2020 MRI, Surgeon #7 documented he met with Patient #1 and discussed the procedure of surgically removing infectious material that had collected behind the patient's sacroiliac joint at the inferior portion of the sacroiliac joint. However, further review of Surgeon #7's 10/15/2020 Operative-Procedure Report revealed he documented the patient's preoperative diagnosis as possible left sacroiliac joint infection.

Review of the Order Sheet, dated 10/15/2020, revealed Surgeon #7 wrote a surgery order for an incision and drainage washing out of infected sacroiliac joint, identifying laterality as on Patient #1's right side.

Review of the Informed Consent for Surgery or Invasive Medical Procedure, completed by Surgeon #7, revealed the procedure Patient #1 consented to was "incision, drainage, debride, abscess spine." Further review of the surgical consent form revealed laterality was omitted by Surgeon #7.

Review of the Main OR Intraoperative Report, dated 10/15/2020, revealed Patient #1 was brought to OR Suite #4 at 1:29 PM. At 1:55 PM, Circulating Nurse #4 documented a Time Out was conducted. Per report, the Circulating Nurse documented the correct patient was identified, correct procedure side was identified, surgical procedure site was marked, and the consent form was present. Then, following the Time Out, Surgeon #7 made an incision at the patient's left SI joint region in an attempt to drain the abscess. Per report, Surgeon #7 was unable to locate an abscess on the patient's left side, and he ordered the incision he made on the patient's left side to be closed with sutures. Per report, Patient #1 was transported out of OR Suite #4, at 1:30 PM, for recovery. The total surgical procedure time was sixty-one (61) minutes.

Interview with Staff Nurse #21, on 11/05/2020 at 11:45 AM, revealed she was assigned to care for Patient #1 following the surgical procedure. Staff Nurse #21 stated she immediately became suspicious when she received report from the Post Anesthesia Care Unit nurse that Patient #1 had a surgical bandage at his/her left sacral region. Staff Nurse #21 stated, upon performing her initial assessment of Patient #1, she contacted Surgeon #7 and related her concerns that a wrong site surgical procedure had occurred.

Interview with Surgeon #7, on 11/04/2020 at 11:00 AM, revealed, on 10/15/2020, he was on-call for Orthopedic Services and was informed Patient #1 had an abscess at his/her right sacral area. He stated the patient was in extreme pain when examined the morning of 10/15/2020, and following the medical examination of the patient, Surgeon #7 wrote the surgery order, specifying right side laterality on the order. Surgeon #7 stated he completed the Informed Consent signed by Patient #1 and witnessed by Circulating Nurse #4 in the Pre-Operative area. Surgeon #7 stated he should have documented laterality of the patient's right side on the Informed Consent form, but was unable to explain why he omitted laterality of the surgical procedure. Surgeon #7 stated he failed to mark the patient's surgical site in the Pre-Operative area because he believed Patient #1 was in too much pain to position for the marking of the skin. The surgeon stated he knew the surgical procedure was supposed to be done on the right side of the patient's sacral region. Per interview, Surgeon #7 stated there was a large piece of equipment in OR Suite #4, the X-ray machine, located on the opposite side of the room to which he was accustomed. Surgeon #7 stated he used the X-ray machine to locate the abscess during the procedure, claiming the positioning of the X-ray machine caused him to become disoriented and mistakenly believe he should be operating on the patient's left sacral area, not the right sacral area where the abscess was located. Surgeon #7 denied that a "Time Out" was not performed in the OR suite prior to the surgical procedure. Surgeon #7 stated, two (2) hours following the procedure, he was contacted by Patient #1's Medical/Surgical Nurse and informed she believed a wrong site surgical procedure had been performed on the patient.

Interview with the facility's Chief Medical Officer (CMO), on 11/02/2020 at 2:30 PM, revealed the wrong surgical site case involving Patient #1 was presently under Peer Review. The CMO acknowledged some patient safety policies were not followed by Surgeon #7 in regards to the patient's medical care. The CMO stated Surgeon #7 failed to document laterality on the Informed Consent form he completed for the patient's signature. The CMO also stated Surgeon #7 failed to mark Patient #1's skin at the surgical site in the Pre-Operative area prior to the procedure which contributed to the error.

Based on interview, record review, review of the Medical Staff Bylaws and Rules and Regulations, and review of the facility's policies, it was determined the facility failed to ensure correct site surgical procedures were performed by medical providers. This failure affected one (1) of ten (10) sampled surgical patients, Patient #1, who, after the Circulating Nurse failed to correctly perform her duties and the patient signed an incomplete Informed Consent form, underwent a wrong site surgical procedure at the left sacroiliac (SI) joint to drain an infectious abscess located at the patient's right sacroiliac (SI) joint.

Review of Patient #1's medical record revealed the patient was admitted to the facility with diagnoses of Metastatic Breast Cancer, Right Sacroiliac (SI) Joint Septic Arthritis/Abscess and Severe Low Back Pain with Radiation to Right Lower Extremity. Magnetic Resonance Imaging (MRI) procedures revealed Patient #1 had extensive abnormal fluid collection involving the right SI joint. Surgeon #7 documented he met with Patient #1 and discussed the surgical procedure of removing infectious material behind the patient's SI joint. The surgeon documented the pre-operative diagnosis as possible left SI joint infection. Review of the Order Sheet revealed Surgeon #7 wrote a surgery order for an incision and drainage to wash out infected sacroiliac joint, identifying laterality as on Patient #1's right side. Review of the Informed Consent for Surgery or Invasive Medical Procedure, completed by Surgeon #7, revealed the procedure Patient #1 was consenting to was an "incision, drainage, debride, abscess spine". Further review of the surgical consent form revealed laterality was omitted by Surgeon #7. Review of the OR Intraoperative Report revealed Circulating Nurse #4 documented a Time Out was conducted, and she documented the correct patient was identified, correct procedure side was identified, surgical procedure site was marked, and the consent form was present. After the Time Out, Surgeon #7 made an incision at the patient's left SI joint region in an attempt to drain the abscess, but he was unable to locate an abscess on the patient's left side and ordered the incision closed. Patient #1 was then transported to the Post Anesthesia Care Unit (PACU).

Per interview, the identification of the wrong site surgical procedure being performed on Patient #1 was made by the Medical/Surgical nurse who cared for Patient #1 after he/she returned to the floor from PACU, approximately two (2) hours after the procedure ended.

Per interview, Circulating Nurse #4 stated she did not reconcile the patient's medical record for accuracy prior to Patient #1's surgical procedure.

Per interview, Surgeon #7, stated he should have documented laterality of the patient's right side on the Informed Consent form, and he failed to mark the patient's surgical site in the Pre-Operative area because he believed Patient #1 was in too much pain to position for the marking of the skin. The surgeon stated he knew the surgical procedure was supposed to be done on the right side of the patient's sacral region.

(Refer to A-0043, A-0049, A-0115, A-0144, A-0942, and A-0955)

Based on interview, record review, and review of the facility's policies it was determined the facility failed to ensure the duties and responsibilities of a Circulating Nurse were implemented. This failure affected one (1) of ten (10) sampled surgical patients, Patient #1, who, after the Circulating Nurse failed to correctly perform her duties, underwent a wrong site surgical procedure at the left sacroiliac (SI) joint to drain an infectious abscess located at the patient's right sacroiliac (SI) joint.

The findings include:

Review of the facility's policy, "Duties and Responsibilities of a Circulating Nurse," policy number 5662178, effective date 08/1990, revealed responsibilities of the Circulating Nurse included reviewing the patient's medical record in the Preoperative area. The policy revealed reviewing the medical record consisted of ensuring the preoperative orders, history and physical, and consents all matched in identifying the correct surgical procedure to be performed. The policy stated additional duties of the Circulating Nurse included ensuring the correct incision site was identified and actively participating in all phases of completing the Surgical Safety Checklist process.

Review of the facility's policy, "Correct Site and Time Out: Universal Protocol," policy number 6121752, effective date 06/2004, revealed during a Time Out event, every member of the patient care team would stop what they were doing, look at the team member providing the information, and not resume activity until the Time Out was completed and verified by all members of the care team. Further review revealed under Section II, Site Marking, marking of the operative or procedural site would occur in the pre-operative period and would be done by the provider performing the procedure or surgery. The site would be marked with a permanent marker prior to the patient being transferred to the procedure/operating room unless the anatomical site was exempted. Per policy, the procedure/surgical site would be marked with the provider's initials prior to the patient entering the procedure /operating room. The policy stated the safety measure of a Time Out occurred when the patient entered the procedure/operating room, and the point of care provider would confirm identity of the patient, procedure, and the site. The policy stated a verbal Time Out must be done in the location where the procedure was to be performed, immediately before the start of the case, and the entire team would initiate the verbal Time Out. Per policy, confirmation of the following would be made through active communication: correct patient, correct side/site, correct procedure, correct patient position, correct radiographs, and correct implants and special equipment. Per policy, site marking must be visible at the Time Out, and the procedure/surgery could not begin until all items were verified; in addition, Time Out would be documented in the medical record.

Review of the Order Sheet, dated 10/15/2020, revealed Surgeon #7 wrote a surgery order for an incision and drainage washing out of infected sacroiliac joint, identifying laterality as on Patient #1's right side.

Review of the Informed Consent for Surgery or Invasive Medical Procedure, completed by Surgeon #7, on 10/15/2020, revealed the procedure Patient #1 was consenting to was an "incision, drainage, debride, abscess spine". Further review of the surgical consent form revealed laterality was omitted by Surgeon #7.

Review of Patient #1's OR Intraoperative Report, dated 10/15/2020, revealed Circulating Nurse #4 was assigned to the surgical team. At 1:55 PM, the Circulating Nurse documented a Time Out was called in the OR prior to the surgeon making an incision. Circulating Nurse #4 documented, during the Time Out, the correct patient was identified, the correct side was identified, the surgical site was marked, and the consent form was present.

Interview with Circulating Nurse #4, on 11/06/2020 at 9:20 AM, revealed, prior to Patient #1's surgical procedure on 10/15/2020, she did not reconcile the patient's medical record for accuracy. Circulating Nurse #4 stated she did not perform a preoperative reconciliation of the medical record because Surgeon #7 had completed the Informed Consent form himself. She stated she thought since the surgeon completed the consent, he should have known what surgery he was going to do. In addition, she stated she thought she had seen the surgeons marking on the patient's skin. However, she stated it was difficult for her to be certain of this because when she viewed the patient's skin in the Preoperative area, the patient was being cleaned up by other nursing staff, after having an incontinence episode. She stated she thought she had seen a black mark on Patient #1's right lower hip at the sacral area. Circulating Nurse #4 stated she read directly from Patient #1's consent form, during Time Out, which was done prior to the procedure. She stated she did not specify laterality, during Time Out, because it was not listed on the consent form, and no one in the OR raised any concerns.

Interview with the OR Executive Director (ED), on 11/04/2020 at 9:50 AM, revealed the facility's policy was care, treatment, and services were written in full on documents. The ED stated the Circulating Nurse was responsible to complete the reconciliation of the patient's medical record before surgery which involved ensuring the Informed Consent form, the surgical order, and the History and Physical matched, which failed to happen in this case.

Based on interview, record review, review of the Medical Staff Rules and Regulations, and review of the facility's policy, it was determined the facility failed to ensure patients were provided informed consent for scheduled surgical procedures. This failure affected one (1) of ten (10) sampled surgical patients, Patient #1, who, after signing an incomplete surgical consent form, underwent a wrong site surgical procedure at the left sacroiliac (SI) joint to drain an infectious abscess located at the patient's right sacroiliac (SI) joint.

The findings include:

Review of the "Medical Staff Rules & Regulations, Section 7, Informed Consent" revealed written, signed, informed consent would be obtained and placed on the patient's chart prior to the operative procedure or other special procedure. The regulations stated the attending practitioner or another physician acting for him/her, would inform the patient of the nature of the illness, the treatment, test or examination to be performed, the calculated risk, anticipated results, and alternatives to the treatment. In addition, the regulations stated the procedure should be spelled out in its entirety without abbreviations.

Review of the facility's policy, "Consent and Informed Decision Making", policy number 7822015, effective date 06/2014, revealed informed consent was obtained to ensure patients and their physicians or other health care providers engaged in a collaborative relationship to support and foster informed consent for all medical procedures and treatments. Per policy, when obtaining informed consent from a patient, all discussions, consultations, and decisions were executed by the licensed independent provider and were clearly documented in the patient's medical record. Per policy, the completed consent form was a permanent part of the medical record and should have the procedure clearly written, with no abbreviations used.

Review of Patient #1's medical record revealed, on 10/15/2020, Surgeon #7 attempted to perform an incision and drainage to wash out the patient's infected right side sacroiliac (SI) joint. Review of Surgeon #7's 10/15/2020 Operative-Procedure Report revealed the surgeon performed a wrong site surgical procedure by performing a left sacroiliac joint, arthrotomy inferior portion of joint, aspiration of joint procedure. Additional review of Patient #1's medical record revealed, on 10/15/2020, Surgeon #7 wrote the surgery order for an incision and drainage washing out of infected sacroiliac joint. The documented laterality of the surgery order was the right sacral joint. Review of Patient #1's History and Physical, dated 10/12/2020, revealed the patient presented to the Emergency Department, on 10/12/2020, with worsening lumbar and right lower extremity pain. Review of Patient #1's Informed Consent for Surgery or Invasive Medical Procedure, dated 10/15/2020, revealed the patient consented to have Surgeon #7 perform an "incision, drainage, debride abscess spine procedure." Further review of the consent document revealed Surgeon #7, on the document, did not write the laterality of the surgical procedure.

Interview with Surgeon #7, on 11/04/2020 at 11:00 AM, revealed he failed to document laterality on the Informed Consent form he completed and Patient #1 signed. The surgeon acknowledged he completed the Informed Consent form, and stated he could not provide an explanation of why he did not specify laterality on the Informed Consent form.

Interview with the OR Executive Director (ED), on 11/04/2020 at 9:50 AM, revealed the issue was informed consent because the Informed Consent form did not have the surgical site (laterality) documented on it. The ED stated the facility's policy was care, treatment, and services were written in full on documents. After the wrong surgical site event of 10/15/2020, the ED stated physicians were re-educated that laterality was required to be written on surgical consent forms. In addition, the ED stated Physicians had been re-educated on pre-procedure policies and processes. The ED stated re-education had been provided to Surgeon #7, by the Chief Medical Officer (CMO), on 10/16/2020, on the need to ensure the Informed Consent form, the surgical order, and the History and Physical were to be completed before a surgical procedure, so the Circulating Nurse could complete the reconciliation of the patient's medical record.

Interview with the CMO, on 11/02/2020 at 2:30 PM, revealed it was the facility's policy to have the surgeon document laterality on Informed Consent forms and to mark the patient's skin at the surgical site in the Pre-Operative area. The CMO stated it was his clear expectation that all facility surgeons follow facility policies regarding completion of Informed Consent forms. The CMO stated the consent should have matched the surgery order for laterality, and he had educated Surgeon #7, the day after the 10/15/2020 procedure, on pre-procedure processes and requirements.