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Based on interview and record review, the facility's Governing Body failed to ensure that the Medical Staff reported a wrong site surgical procedure was performed for one of 30 sampled patients (Patient 3).

This deficient practice resulted in surgery center's inability to ensure the provision of quality health care in a safe environment for patients.

Findings:

On 9/25/20 at 9:10 am during an interview with the Chief Medical Officer (MD12), MD 12 stated the facility was informed of the wrong site surgery for Patient 3 on June 18, 2020, when Patient 1 called the facility and stated she had a wrong site surgical procedure performed.

Concurrently, during a review of Patient 3's medical records, Physician's Notes, dated June 18, 2020, indicated Medical Doctor (MD) 1's documentation of an addendum regarding a communication with Patient 3's discovery of the wrong site procedure.

Concurrently, during review of Risk Management records, there was no documentation of the facility reporting the wrong site surgery that occurred on June 18, 2020.

Concurrently, during a review of the Medical Staff and Governing Body minutes from June to September 2020, there was no documentation indicating a discussion of the wrong site surgery that occurred on June 18, 2020. Also, there was no documentation of a meeting and/or in-services for the Medical Staff regarding the incident of the wrong site surgery that occurred on June 18, 2020.

Concurrently, during interview with MD12 and Administrator (Admin 2), both stated the facility conducted two investigations with a Root Cause Analysis (RCA - a method of problem solving used for identifying the root causes of faults or problems) completed on September 10, 2020 and a second RCA recently completed, with no date provided.

A review of a facility document titled, " Unanticipated Adverse Outcomes (UAO) Policy - Disclosure of," dated 10/2017, indicated "UAO's shall be reported to the Risk Management and Quality Management Departments."

A review of a facility document, titled "Event Management Policy," dated 3/2017, indicated the following:
1. The Event reporting system shall be used to report any occurrences that is not consistent with routine operations.
2. Documentation should be reported to the supervisor, Quality management and Risk management, Medical Executive Committee.
3. All significant events will be reported to the Incident Review Committee, Clinical Excellence Committee and Governing Body.

Based on interview and record review the facility failed to ensure the medical doctor (MD 1) performed a surgical procedure to the correct site for one of thirty sampled patients (Patient 3). Patient 3 had dacrocystorhinostomy (DCR, a type of surgery done to create a new tear drain between the eyes and the nose) performed on the right eye instead of the left eye.

This deficient practice resulted in Patient 1 returning the next day for a second surgery on the correct eye.

Findings:

During an interview, on 9/24/20 at 12:20 pm, medical doctor (MD) 1 stated Patient 3 was scheduled for both a septoplasty (a surgical procedure to straighten the bone and cartilage dividing the space between your nostrils), and a left dacrocystorhinostomy (DCR, a type of surgery done to create a new tear drain between the eyes and the nose) on 6/18/2020. MD 1 stated he performed the DCR after the septoplasty was performed. MD 1 stated Patient 3 consented for left dacrocystorhinostomy (DCR) during an outpatient exam on 6/10/2020. MD 1 stated he marked the surgical site, above the left eye in the preoperative area on 6/18/20. MD I stated he attended the first Safety Sign in and the first time out with the Plastics team prior to the start of Patient 3's DCR surgery.

MD 1 stated he returned to the operating room (OR) when the septoplasty was completed. MD 1 stated did not recall a second safety sign in or a second time out before starting the DCR surgical procedure. MD 1 stated the surgical site was marked above the left eye. MD 1 stated he proceeded with the surgical procedure and introduced the endoscope through the right nare instead of the left nare and proceeded to operate in the right eye instead of the left.

MD1 stated he was informed that Patient 3 called the afterhours on 6/18/20 inquiring as to why there was a tube in the right nose when the surgery was in the left nose. MD 1 stated he discussed with Patient 3 the surgery was performed on the wrong side. MD 1 stated after discussing with Patient 3 and family, Patient 3 was offered and had the left DCR surgical procedure on 6/19/20.

A review of Patient 3's medical chart indicated Consent for Left Endonasal DCR was signed on 6/10/20.

A review of RN 1's, notes dated 6/18/2020, indicated Patient 3 surgical site was documented as marked by MD 1 at 11:53 am. RN 1 documented MD 1 was present at the first safety sign prior to the start of the septoplasty at 2:02 pm and the first time out at 2:11 pm. RN 1 documented MD1 present at the second time out prior to the start of the left DCR surgery at 2:55 pm.

A review of Patient 3's operative note, dated 6/18/20, indicated the surgical procedures were: endonasaldacryocystorrhinostomy, endonasal anterior turninectomy, and intranasal anterior ethoidectomy, no laterality was documented. A review of the description of procedure section of the operative note did not document laterality of the surgical procedure.

A review of an addendum documented in the medical record dated 6/18/20 documented communication with Patient 3 disclosing a tube was placed on the right side of the nose instead of the left and offering surgery for the right side for the next day.

A review of the Facility policy and procedure titled "Universal Protocol Policy-site marking Process and Time out Process "dated 2/2019" procedural check lists will guide staff and providers through the verification process and team briefings to assure that all steps are completed" and under Procedure and site/side verification " The Consent form will be used as the primary source of information when verifying the surgical .procedure and procedure site/side the surgical procedure and site/side on the consent form should be verified against the information on all other relevant documents, including the surgery schedule, H &P orders, and surgeon clinic notes" and that during Time Out " All staff present are to stop what they are doing and participate in the Time-out.

Based on interview and record review, the facility failed to ensure a surgical procedure was performed on the correct site for one of thirty sampled patients (Patient 3). Patient 3 had dacrocystorhinostomy (DCR, a type of surgery done to create a new tear drain between the eyes and the nose) performed on the right eye instead of the left eye. The facility's Medical Staff failed to prevent an adverse event with wrong site surgical procedure for one of 30 sampled patients (Patient 3).

This deficient practice resulted in a wrong site surgery, and Patient 1 returning the next day for a second surgery on the correct eye.

Findings:

During an interview, on 9/24/20 at 12:20 pm, medical doctor (MD1) stated Patient 3 was scheduled for both a septoplasty (a surgical procedure to straighten the bone and cartilage dividing the space between your nostrils), and a left dacrocystorhinostomy (DCR, a type of surgery done to create a new tear drain between the eyes and the nose) on 6/18/2020. MD 1 stated he performed the DCR after the septoplasty was performed. MD 1 stated Patient 3 consented for left dacrocystorhinostomy (DCR) during an outpatient exam on 6/10/2020. MD 1 stated he marked the surgical site, above the left eye in the preoperative area on 6/18/20. MD I stated he attended the first Safety sign in and the first time out. With the Plastics team prior to the start of Patient 3's DCR surgery.

Concurrently, MD 1 stated he returned to the operating room, before the Septoplasty surgery was completed by the Plastic Surgery team. MD 1 stated the surgical site was marked above the left eye.MD 1 stated did not recall a second safety sign in or a second time out before starting the DCR surgical procedure. MD 1 stated the surgical site was marked above the left eye. MD 1 stated he proceeded with the surgical procedure. MD 1 stated Patient 3 was discharged on 6/18/2020 at 3:38 p.m.

MD1 stated he was informed that Patient 3 called the afterhours on 6/18/20 inquiring as to why there was a tube in the right nose when the surgery was in the left nose. MD 1 stated he discussed with Patient 3 the surgery was performed on the wrong side. MD 1 stated after discussing with Patient 3 and family, Patient 3 was offered and had the left DCR surgical procedure on 6/19/20.

A review of Patient 3's medical chart indicated Consent for Left Endonasal DCR was signed on 6/10/20.

Concurrently, during review of Patient 3's surgical records, dated 6/18/2020, MD 1 stated, Patient 3 was evaluated by MD 1 in the preoperative area of the Ambulatory Surgical Center (ASC) of the GACH. MD 1 stated he marked the surgical site of Patient 3, above the left eye in the preop area on 6/18/2020. MD 1, further stated he attended the first safety sign-in and the first surgical time-out (the last part of the universal protocol which is performed in the operating room, immediately before the planned procedure is initiated) with the Plastic Surgical team, prior to the start of Patient 3's first surgery.

A review of RN 1's, notes dated 6/18/2020, indicated Patient 3 surgical site was documented as marked by MD 1 at 11:53 am. RN 1 documented MD 1 was present at the first safety sign prior to the start of the septoplasty at 2:02 pm and the first time out at 2:11 pm. RN 1 documented MD1 present at the second time out prior to the start of the left DCR surgery at 2:55 pm.

A review of Patient 3's operative note, dated 6/18/20, indicated the surgical procedures were: endonasaldacryocystorrhinostomy, endonasal anterior turninectomy, and intranasal anterior ethoidectomy, no laterality was documented. A review of the description of procedure section of the operative note did not document laterality of the surgical procedure.

A review of an addendum documented in the medical record dated 6/18/20 documented communication with Patient 3 disclosing a tube was placed on the right side of the nose instead of the left and offering surgery for the right side for the next day.

On September 25, 2020, during interview with MD 12, MD 12 was asked, what was the Departmental system for oversight and reporting of adverse events? MD 12 stated the Performance plan is that each department was responsible to report any unsafe occurrences.

On September 25, 2020, during interview with Regulatory Director (Admin) 2, Admin 2 stated the Root Cause Analysis (RCA - a method of problem solving used for identifying the root causes of faults or problems) for the wrong site surgical incident was being completed, therefore, the meeting minutes and in-services have not been completed.

A review of a facility document titled, "Performance Improvement and Patient Safety plan FY 2020, indicated, "All departments within the organization are responsible to report healthcare safety occurrences" with documentation via "electronic event report system ...to report unexpected events and near misses."

A review of the facility's policy and procedure, titled, "Universal Protocol Policy - Site Marking Process and Time out Process," dated 2/2019," indicated the following:
1. Procedural check lists will guide staff and providers through the verification process
2. Team briefings performed to assure that all steps are completed."
3. Under the Procedure - site/side verification.
4. The Consent form will be used as the primary source of information when verifying the surgical procedure
5. The procedure site/side, on the consent form, should have been verified against the information on all other relevant documents, including the surgery schedule, History and Physical, phsician orders, and surgeon's clinic notes" during Time Out."
6. All staff present are to stop what they are doing and participate in the Time-out.

During review of facility documents, there was no documentation available that indicated the Surgery department reported the Wrong side/site surgery to Risk management, when the event occurred on 6/18/2020.

During review of facility documents, the Facility had no documentation or meeting minutes discussing any in-services or trainings on wrong side surgery after the wrong site surgery incident on 6/18/2020.

A review of the Facility policy and procedure titled "Universal Protocol Policy-site marking Process and Time out Process "dated 2/2019" procedural check lists will guide staff and providers through the verification process and team briefings to assure that all steps are completed" and under Procedure and site/side verification " The Consent form will be used as the primary source of information when verifying the surgical .procedure and procedure site/side the surgical procedure and site/side on the consent form should be verified against the information on all other relevant documents, including the surgery schedule, H &P orders, and surgeon clinic notes" and that during Time Out " All staff present are to stop what they are doing and participate in the Time-out.



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