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Based on review of facility policy, medical record review, facility documentation, and interviews the facility's Quality Assurance Performance Improvement (QAPI) failed to ensure an ongoing, hospital-wide quality assessment and performance improvement program related to surgical services and surgical implant verification for 1 orthopedic surgical patient (Patient #1) of 8 orthopedic surgical patients reviewed.

The findings include:

Patient #1 underwent a surgical procedure on 10/31/2022 for a Left Computer Navigated Total Knee Arthroplasty (Total Knee Replacement). A right femoral (thigh bone) component (artificial implant) was placed in the patient's left knee after a vendor (individuals who sell, distribute, or train for use of a product or service) retrieved the incorrect implant from the supply cart and took into the Operating Room (OR) Suite. The vendor and the surgeon verbally reviewed the implant. The OR nursing staff failed to ensure the implant verification process was followed. The vendor opened the incorrect sided implant onto the sterile table. The implant was then placed and cemented in the patient. The surgeon realized a right femoral component had been placed after the patella (kneecap) component had been placed and the patient's leg was extended. This resulted in removal of the implant with bone loss of the patient's femur, replacement of the implant, and the patient being under anesthesia longer than anticipated. Following the incorrect implant placement, the facility's Quality Assessment Performance Improvement (QAPI) committee failed to identify the adverse event as a serious patient safety event, conduct a root cause analysis, implement preventative actions, and systematically monitor processes to ensure no future patient safety events. The QAPI committee's failure to identify the adverse event as a serious patient safety event, failure to conduct an RCA, implement preventative actions and mechanisms and to systematically monitor processes to ensure no future patient safety events placed all orthopedic surgical patients at risk for placement of incorrect implants.

Refer to A-0286

Based on review of facility policy, medical record review, facility documentation, and interviews the facility failed to identify an adverse event (event in which care resulted in an undesirable clinical outcome) as a serious safety event, failed to conduct a root cause analysis (RCA-a process to find out what happened, why it happened, and determine what changes need to be made), failed to implement preventative actions and mechanisms and systematically monitor processes to ensure no future patient events occurred after an incorrect implant was placed in 1 orthopedic surgical patient (Patient #1) of 8 orthopedic surgical patients reviewed.

The findings include:

Review of the corporate policy "3004 Event Reporting Policy Version: 1" dated 10/14/2020 showed "...The Risk Manager with full access to the ERS [Event Reporting System] classifies and codes an event when the event meets the following definition of a sentinel event...Any procedure on the wrong patient, wrong side of the body, or wrong organ regardless of the magnitude of the procedure (Surgery, Treatment, Test, Procedure)...Additional Reportable Events...Any untoward or adverse occurrence defined as...Any process variation for which a recurrence carries a significant chance of serious adverse outcome...Severity Levels of Harm...It is the policy...to complete an Event Report on all levels of harm which is defined based on acuity of the injury...A. Unknown/Pending Further Information/To Be Determined B. Near miss/Potential to cause harm/Did not reach patient (Level 1)...An event or process variation that did not affect an outcome but could have caused an adverse effect...C. No apparent injury/No harm/Did reach patient (Level 2) D. Mild injury or reaction/Temporary harm/With monitoring (level 3) E. Moderate injury or reaction/Temporary harm/With treatment/Intervention (Level 4) F. Severe injury or reaction/Temporary harm/With Treatment/Intervention/Hospitalization or >length of stay (Level 5) G. Severe injury or reaction/Temporary harm/Life-saving intervention/Near death/Recovered (Level 6) H. Severe injury or reaction/Permanent harm or disability (Level 7) I. Severe injury or reaction/Death (Level 8)..."

Review of the corporate policy "Safe Procedure Review Policy Version: 4" dated 3/8/2022 showed "...The purpose of this policy is to prevent procedures on the wrong patient, wrong site or side, wrong level and wrong procedures by using multi-layered checks and verifications during scheduling and pre-procedure [before procedure] testing, procedure preparation, intra- [during surgery] and post- [after procedure] procedural patient care and to promote consistent procedural verification and readiness, site-marking, time-out, and care team communication in a safe and reliable culture...All disciplines involved in operative, invasive, and bedside procedures will perform the following required action steps of Safe Procedure Review during the scheduling, pre-procedure testing, pre-procedure verification and site-marking, pre-procedure preparation, pre-procedure brief and time-out, and post-procedure debriefing...Procedure Briefing [actively communicate patient specific information related to safety and the plan for the procedure] (before induction or sedation)...Procedure team discusses plan and concerns before the patient enters the room which may include (some items below may be inapplicable for the procedure/surgery being performed)...Verifies the required implants, supplies, and instruments are available...Procedure Time-out and Intra-procedure...Additional Timeout Required...Implant verification-prior to opening any implant verify size, expiration date, type and side, if applicable with the Surgeon or Proceduralist..." Review of additional guidance included in the policy showed "...The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating/procedure nurse, operating room/procedure room technician and other active participants who will be participating in the procedure from the beginning...Vendors [individuals who sell, distribute, or train for use of a product or service] and equipment representatives ARE NOT included in time-out...Visual Inspection and verbal verification of the implant information is used to ensure the procedure and/or surgical team is implanting the correct device..."

Review of the facility's policy "Safe Procedure Review" dated 10/26/2022 showed the facility's policy did not address a process for implant verification (process to verify correct type of implant, correct size, correct side right or left, and expiration date).

Review of the facility's policy "Management of Sentinel Events [a patient safety event that results in death, permanent harm, or severe temporary harm]/Adverse Outcome/Near Miss Version: 2" dated 10/26/2022 showed "...Adverse Sentinel Event: The Sentinel Event Policy applies to events that meet the following criteria...The event is one of the following (even if the outcome was not death or permanent loss of function unrelated to the natural course of the patient's illness or underlying condition)...Surgical and nonsurgical invasive procedure of the wrong patient, wrong side of the body, wrong site or wrong organ regardless of the magnitude of the procedure...An event, which potentially meets the Sentinel Event definition, should be reported to the Risk Manager...The Risk Manager shall immediately notify the CEO [Chief Executive Officer] and the CEO will immediately notify the Division President and Division Vice President. The Risk Manager must also notify the [named health system] PSO [Patient Safety Officer], Manager of Liability Claims, Risk Management, Director of Survey Management, Regional Quality and Clinical Transformation Director to consult with and determine adverse Sentinel Events...The Risk Manager in consultation with the aforementioned [previously mentioned], and, acting on the authority of the Patient Safety committee, will determine if the event meets the definition of a Sentinel Event...If the definition is or appears to be met, the Risk manager will notify the Chief Executive Officer, Quality and Regulatory Compliance Director, patient's attending physician, appropriate department managers, and others as deemed appropriate that a root cause analysis needs to be initiated..."

Review of the facility's policy "Vendor Relations Policy" dated 12/6/2022 showed "...Vendor sales representatives are sometimes required to participate in surgical and patient care procedures through direct involvement, such as programming a Cardiac pacemaker, or indirect involvement, such as making recommendations to the surgeon about which appliance to use. When this should occur, the facility shall follow these guidelines for vendors under these circumstances...During each visit to the Department of Surgery each vendor will adhere to the following rules...Vendors are not allowed direct patient contact in the Operating Room...The Health Care Industry Rep. [representative] is not ever to be considered part of the surgical team and will not be requested to perform tasks that are not part of his/her role as an industry representative...Vendors do not open sterile packages nor enter the sterile field...Vendors will not be allowed to scrub or participate in the procedure other than a service support role..."

Medical record review of a history and physical showed Patient #1 was admitted to the facility for a Left Computer Navigated Total Knee Arthroplasty (Knee replacement) on 10/31/2022. Patient #1's medical history included but was not limited to Anxiety, Arthritis, Chronic Obstructive Pulmonary Disease, Hypertension, and Obstructive Sleep Apnea.

Medical record review of an Intraoperative (during surgery) Record showed Patient #1's surgery start time on 10/31/2022 was 12:45 PM. The surgery stop time was 5:24 PM (4 hours 39 minutes after surgery start time). The following were present during Patient #1's surgical procedure: surgeon, 1 Circulating Registered Nurse (RN-responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery), 1 Certified Registered Nurse Anesthetist (CRNA-administers anesthesia), 3 Certified Surgical Technicians (CST- pass instruments, fluids and supplies to the surgeon and prepare and manage surgical equipment during surgery), and 1 vendor representative. Patient #1 was transferred to the recovery room on 10/31/2022 at 5:30 PM.

Medical record review of an operative report showed Patient #1 underwent a Left Computer Navigated Total Knee Arthroplasty. Review of the operative report showed "...Once the patella [kneecap] component [implant] was placed the leg was extended and axially loaded [to check for alignment] and at this point is when I [orthopedic surgeon] looked down and realized that there was a right femoral component [replaces the lower end of the thigh bone] in the left knee..." It took "...roughly 10 minutes..." to remove the right femoral component which resulted in loss of bone. Continued review showed "...Revision components were required given the patient's size...it was felt that revision total stabilized stem components [used when the remaining bone is insufficient to support the artificial joint] would be most appropriate given the slight bone loss...Unfortunately, the revision total knee components are not routinely at this facility...It took...93 minutes for those components to be brought to this facility..." Patient #1's surgery resumed after the needed components were brought to the facility. The patient was admitted to the facility for postoperative pain control and rehabilitation.

Review of a facility report showed the circulating RN reported the following on 10/31/2022 at 2:44 PM: During the procedure (Patient #1's Left Total Knee Replacement), the vendor showed the surgeon the implant components and the surgeon agreed it was the correct implants before the packages were opened. The femur implant was then implanted with cement. Approximately 5 minutes later, the surgeon noticed that the implant did not align well, and the implant looked like it was for the right knee instead of the left knee. The surgeon asked the vendor if it was a left or right femur implant. The vendor looked at the packaging and noticed the implant was for the right side and not the left. At that point, the surgeon tried to remove the implant, but the cement had already dried, and he had to use substantial force to remove the implant which "...appeared to remove excess bone from site..." The report showed there was deviation from the generally accepted performance standard and the deviation reached the patient. The documentation showed the deviation did not cause moderate to severe harm or death. Documentation showed the incident occurred in the OR on 10/31/2022 at 2:25 PM. The patient's surgeon (present) and the OR Nurse Manager were notified. The incident was documented as a "...Precursor Safety Event PSE 1: Minimal Permanent Harm-A deviation in GAPS resulting in minor harm with no expected change in clinical status; requires little or no intervention..."

Medical record review of a Post Anesthesia Care Unit (PACU-Recovery Room) record showed Patient #1 was transferred to the medical surgical floor on 10/31/2022 at 6:03 PM.

Medical record review of a discharge summary showed Patient #1 was discharged to home on 11/1/2022.

Review of Quality Improvement Monitoring Data for Safe Procedure Reviews for 11/2022 showed documentation for 1 observation for monitoring of Safe Procedure Review on 11/15/2022. There was no documentation to indicate other Safe Procedure Reviews were conducted during 11/2022. There were 7 orthopedic surgery observations from 12/8/2022-12/14/2022.

Patient #1 was contacted on 4/17/2023 at 9:19 AM. The patient confirmed he had a Left Total Knee Replacement performed at the facility on 10/31/2022. He stated the surgery was performed on the correct knee (left) but a "...right knee joint..." was put in his left knee "...He [surgeon] apparently didn't realize it until it was too late. He had already cemented it [implant] in. He couldn't get the cement loose and had to send to [named nearby city] to get a machine to get the cement out..."

During an interview on 4/17/2023 at 2:02 PM, in the conference room, CST #1 stated she was present when Surgeon #1 realized the wrong sided implant had been placed in Patient #1's knee. The CST reported Surgeon #1 tried to remove the implant, but the cement had already hardened "...It was harder to remove...", but he was able to get it out and replaced it with the correct sided implant.

During a telephone interview on 4/18/2023 at 10:15 AM, Surgeon #1 stated Patient #1 had End Stage Chronic Obstructive Pulmonary Disease and confirmed a Left Total Knee Replacement was performed for the patient. Surgeon #1 stated the vendor said "...7 left...and I thought I saw left...I put it in and said 'Oh my God this is a right', and the rep [vendor] looked and said 'oh my God it is'...I [Surgeon #1] immediately removed the component and replaced with the correct one..." Surgeon #1 stated the patient needed stems (used for revisions) for additional support which were not available at the facility. He had to wait for a stem component to be brought from another facility, about 20 minutes away, which increased the case time. Surgeon #1 stated he was not involved in any type of investigation related to the incident.

During an interview on 4/18/2023 at 10:50 AM, in the conference room, the OR Director stated the process for implant verification when the incorrect implant was placed in Patient #1 was: the vendor retrieved the implant and brought the implant to the room. The vendor verified the implant information with the surgeon and the vendor would open the implant if the nurse was busy. The OR Director stated she thought the facility's Quality Manager and Regional Surgery Director completed an investigation and RCA, but she was not involved.

During a telephone interview on 4/18/2023 at 11:09 AM, RN Circulator #1 stated he recalled the incident with Patient #1's surgery. RN Circulator #1 stated the vendor grabbed what the surgeon wanted and read off the size and side of the implant to the surgeon. RN Circulator #1 said it was a pretty busy day for the surgeon "...It appeared [Surgeon #1] was in a hurry. He had asked for the implants, she [vendor] showed him, he said 'okay', then said 'let's go, let's go'..." Surgeon #1 noticed it was the wrong side and yelled out '...this is the wrong implant'..." RN Circulator #1 stated it was "...very stressful...didn't have all the pieces we needed so it made it even harder..." RN Circulator #1 confirmed the vendor opened the package and put the implant on the table.

During a telephone interview on 4/18/2023 at 11:39 AM, CST #3 stated the incision and bone cutting was going great for Patient #1's surgery. The vendor said it was a left implant. Surgeon #1 did not turn around to look back and make sure everything was correct. CST #3 stated he put the implant on the handle, the surgeon took the implant and placed the implant in the patient. Surgeon #1 realized it was the wrong implant when he was washing it out with all the hardware in place and cementing had occurred. CST #3 stated the surgeon asked the vendor about the implant, the vendor checked the packaging and discovered she had given a right implant instead of the left. The incorrect implant was removed, and the correct side was placed. CST #3 stated the cement had hardened which made it difficult to remove the implant. Surgeon #1 had to do a revision on the femur, and the correct implant was placed. CST #3 stated they had to wait "...maybe 45 minutes..." to get an instrument that was needed from a different facility before the surgery could be completed.

During a telephone interview on 4/18/2023 at 1:25 PM, Orthopedic Vendor #1 stated her role in the OR was to help the CST's in surgery with knowing what type of instrumentation to use and to ensure implants are available at the facility prior to the procedure. Orthopedic Vendor #1 stated she "...grabbed a right [implant], showed [Surgeon #1], he looked at it..." Orthopedic Vendor #1 stated she verbally said the side and size of the implant and Surgeon #1 looked at the implant and agreed it was the correct implant.

During an interview on 4/19/2023 at 10:00 AM, in the conference room, the Director of Quality and Risk stated she was unable to locate documentation to show a RCA had been completed for the incorrect implant placement for Patient #1. The Director of Quality and Risk, who had been in this role for 1 week, was not aware of why the adverse event with Patient #1 was not considered a Serious Safety Event nor did she know why a RCA was not conducted. The Director of Quality and Risk stated the safe procedure observation validation report enabled all facility leadership and corporate leadership to review monitoring data. The Director of Quality and Risk confirmed the only monitoring data for safe procedure observations for 11/2022 was 1 observation performed on 11/15/2022 and confirmed there was no further documentation of safe procedure observation validations for orthopedic surgery except those (7 orthopedic surgery cases) conducted between 12/8/2022-12/14/2022.

During an interview on 4/20/2023 at 9:00 AM, in the conference room, the OR Director stated she was made aware of the event on 10/31/2022 at 2:13 PM and the vendor notified her supervisor simultaneously. She stated Patient #1's original surgical plan did not include a stem implant for stabilization. According to the OR Director, a stem was used more for revisions and was not required for regular total knee replacement. A stem was needed due to bone loss that occurred when the incorrect implant and cement was removed. The OR Director confirmed the stem implant was not available at the facility and had to be brought to the OR from another facility. The expected process at the time of the incident with Patient #1 was for the vendor to show the implant package to the surgeon and read what was on the package to the surgeon. The nurse was supposed to review what was on the package, open the package, and maintain sterility while placing the implant on the sterile table. The OR Director confirmed the vendor showed the implant box to Surgeon #1, read the information to the surgeon, and verbalized it was a left sided implant, even though it was actually a right sided implant. The vendor then opened the implant and placed the implant on the sterile table/field "...A rep [vendor] should never open anything onto a sterile field..." The OR Director's understanding was that risk management/quality were investigating and obtaining witness statements regarding the incorrect implant being placed in Patient #1. The OR Director stated she did not know why the incident with Patient #1 was not considered a serious safety event. No changes were made in relation to the vendor's role in the OR except reinforcement that they were to never open a package and place on the sterile field. The OR Director confirmed the OR staff did not follow the facility's policy for safe procedure review and implant verification in relation to Patient #1's surgical procedure. In another interview on 4/20/2023 at 2:40 PM, the OR Director stated a computer navigated total knee replacement typically took 2 ½ hours-3 hours depending on the size of the patient. She again confirmed the needed implant device was not available at the facility and had to be brought from another facility. The implant was requested at 2:13 PM and arrived at the facility at 3:20 PM which prolonged the length of surgery and anesthesia time over 1 hour.

During an interview on 4/20/2023 at 2:04 PM, in the conference room, the former Director of Quality and Risk stated he was notified of the incident regarding Patient #1's surgical procedure on 10/31/2022. The former Director of Quality and Risk had reached out to corporate on 11/1/2022 to notify them of the event that occurred with Patient #1. He stated he received an email response from corporate that indicated the event with Patient #1 would be considered a precursor event and not a serious safety event because it was discovered while the patient was still in the OR and the incision had not been closed. The former Director of Quality and Risk stated corporate had the final say as to whether an event is classified as a serious safety event. He stated interviews with the surgeon and the vendor revealed the implant verification process in place at the time of the incident with Patient #1 included only the vendor and the surgeon. Once the implant was verified with the surgeon, the vendor placed the implant on the sterile field/table. The former Director of Quality and Risk confirmed an RCA was not conducted in relation to the incorrect implant placement for Patient #1.

Based on review of facility policy, medical record review, facility documentation, and interviews the facility failed to ensure a Registered Nurse (RN) supervised an implant (artificial joint) verification (correct implant, size, side, and expiration date) in the Operating Room (OR) for 1 orthopedic surgical patient (Patient #1) of 8 orthopedic surgical patients reviewed.

The findings include:

Patient #1 underwent a surgical procedure on 10/31/2022 for a Left Computer Navigated Total Knee Arthroplasty (Total Knee Replacement). A right femoral (thigh bone) component (artificial implant) was placed in the patient's left knee after a vendor (individuals who sell, distribute, or train for use of a product or service) retrieved the incorrect implant from the supply cart and took into the Operating Room (OR) Suite. The vendor and the surgeon verbally reviewed the implant. The OR nursing staff failed to ensure the implant verification process was followed. The vendor opened the incorrect sided implant onto the sterile table. The implant was then placed and cemented in the patient. The surgeon realized a right femoral component had been placed after the patella (kneecap) component had been placed and the patient's leg was extended. This resulted in removal of the implant with bone loss of the patient's femur, replacement of the implant, and the patient being under anesthesia longer than anticipated. The vendor's retrieval of the incorrect implant, failure to perform a thorough implant verification with the surgeon, and lack of the circulating nurses' (RN responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery) management of the implant verification process placed all orthopedic surgical patients at risk for placement of incorrect implants.

Refer to A-0395.

Based on review of facility policy, medical record review, facility reports, and interviews the Operating Room (OR) Circulating Registered Nurse (RN-responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery) failed to ensure the facility's implant (artificial joint) verification (correct implant, size, side, and expiration date) process was followed for 1 orthopedic surgical patient (Patient #1) of 8 orthopedic surgical patients reviewed.

The findings include:

Review of the corporate policy "Safe Procedure Review Policy Version: 4" dated 3/8/2022 showed "...The purpose of this policy is to prevent procedures on the wrong patient, wrong site or side, wrong level and wrong procedures by using multi-layered checks and verifications during scheduling and pre-procedure [before procedure] testing, procedure preparation, intra- [during surgery] and post- [after procedure] procedural patient care and to promote consistent procedural verification and readiness, site-marking, time-out, and care team communication in a safe and reliable culture...All disciplines involved in operative, invasive, and bedside procedures will perform the following required action steps of Safe Procedure Review during the scheduling, pre-procedure testing, pre-procedure verification and site-marking, pre-procedure preparation, pre-procedure brief and time-out, and post-procedure debriefing...Procedure Briefing [actively communicate patient specific information related to safety and the plan for the procedure] (before induction or sedation)...Procedure team discusses plan and concerns before the patient enters the room which may include (some items below may be inapplicable for the procedure/surgery being performed)...Verifies the required implants, supplies, and instruments are available...Procedure Time-out and Intra-procedure...Additional Timeout Required...Implant verification-prior to opening any implant verify size, expiration date, type and side, if applicable with the Surgeon or Proceduralist..." Review of additional guidance included in the policy showed "...The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating/procedure nurse, operating room/procedure room technician and other active participants who will be participating in the procedure from the beginning...Vendors [individuals who sell, distribute, or train for use of a product or service] and equipment representatives ARE NOT included in time-out...Visual Inspection and verbal verification of the implant information is used to ensure the procedure and/or surgical team is implanting the correct device..."

Review of the facility's policy "Safe Procedure Review" dated 10/26/2022 showed the facility's policy did not address a process for implant verification (process to verify correct type of implant, correct size, correct side right or left, and expiration date).

Review of the facility's policy "Vendor Relations Policy" dated 12/6/2022 showed "...Vendor sales representatives are sometimes required to participate in surgical and patient care procedures through direct involvement, such as programming a Cardiac pacemaker, or indirect involvement, such as making recommendations to the surgeon about which appliance to use. When this should occur, the facility shall follow these guidelines for vendors under these circumstances...During each visit to the Department of Surgery each vendor will adhere to the following rules...Vendors are not allowed direct patient contact in the Operating Room...The Health Care Industry Rep. [representative] is not ever to be considered part of the surgical team and will not be requested to perform tasks that are not part of his/her role as an industry representative...Vendors do not open sterile packages nor enter the sterile field...Vendors will not be allowed to scrub or participate in the procedure other than a service support role..."

Medical record review of a history and physical showed Patient #1 was admitted to the facility for a Left Computer Navigated Total Knee Arthroplasty (Knee replacement) on 10/31/2022. Patient #1's medical history included but was not limited to Anxiety, Arthritis, Chronic Obstructive Pulmonary Disease, Hypertension, and Obstructive Sleep Apnea.

Medical record review of an Intraoperative (during surgery) Record showed Patient #1's surgery start time on 10/31/2022 was 12:45 PM. The surgery stop time was 5:24 PM (4 hours 39 minutes after surgery start time). The following were present during Patient #1's surgical procedure: surgeon, 1 Circulating Registered Nurse, 1 Certified Registered Nurse Anesthetist (CRNA-administers anesthesia), 2 Certified Surgical Technicians (CST- pass instruments, fluids and supplies to the surgeon and prepare and manage surgical equipment during surgery), and 1 vendor representative. Patient #1 was transferred to the recovery room on 10/31/2022 at 5:30 PM.

Medical record review of an operative report showed Patient #1 underwent a Left Computer Navigated Total Knee Arthroplasty "...Once the patella [kneecap] component [implant] was placed the leg was extended and axially loaded [to check for alignment] and at this point is when I [orthopedic surgeon] looked down and realized that there was a right femoral component [replaces the lower end of the thigh bone] in the left knee..." It took "...roughly 10 minutes..." to remove the right femoral component which resulted in loss of bone. Continued review of the operative report showed "...Revision components were required given the patient's size...it was felt that revision total stabilized stem components [used when the remaining bone is insufficient to support the artificial joint] would be most appropriate given the slight bone loss...Unfortunately, the revision total knee components are not routinely at this facility...It took...93 minutes for those components to be brought to this facility..." Patient #1's surgery resumed after the needed components were brought to the facility. The patient was admitted for postoperative pain control and rehabilitation.

Review of a facility report showed the circulating RN reported the following on 10/31/2022 at 2:44 PM: During the procedure (Patient #1's Left Total Knee Replacement), the vendor showed the surgeon the implant components and the surgeon agreed it was the correct implants before the packages were opened. The femur implant was then implanted with cement. Approximately 5 minutes later, the surgeon noticed that the implant did not align well, and the implant looked like it was for the right knee instead of the left knee. The surgeon asked the vendor if it was a left or right femur implant. The vendor looked at the packaging and noticed the implant was for the right side and not the left. At that point, the surgeon tried to remove the implant, but the cement had already dried, and he had to use substantial force to remove the implant which "...appeared to remove excess bone from site..." The report showed there was deviation from the generally accepted performance standard and the deviation reached the patient. The documentation showed the deviation did not cause moderate to severe harm or death. Documentation showed the incident occurred in the OR on 10/31/2022 at 2:25 PM. The patient's surgeon (present) and the OR Nurse Manager were notified. The incident was documented as a "...Precursor Safety Event PSE 1: Minimal Permanent Harm-A deviation in GAPS resulting in minor harm with no expected change in clinical status; requires little or no intervention..."

Medical record review of a Post Anesthesia Care Unit (PACU-Recovery Room) record showed Patient #1 was transferred to the medical surgical floor on 10/31/2022 at 6:03 PM.

Medical record review of a discharge summary showed Patient #1 was discharged to home on 11/1/2022.

Patient #1 was contacted during the investigation. The patient confirmed he had a Left Total Knee Replacement performed at the facility on 10/31/2022. He stated the surgery was performed on the correct knee (left) but a "...right knee joint..." was put in his left knee. Patient #1 stated "...He [surgeon] apparently didn't realize it until it was too late. He had already cemented it [implant] in. He couldn't get the cement loose and had to send to [named nearby city] to get a machine to get the cement out..."

During an interview on 4/17/2023 at 2:02 PM, in the conference room, CST #1 stated she was present when Surgeon #1 realized the wrong sided implant had been placed in Patient #1's knee. The CST reported Surgeon #1 tried to remove the implant, but the cement had already hardened. CST #1 stated "...It was harder to remove..." but he was able to get it out and replaced it with the correct sided implant.

During a telephone interview on 4/18/2023 at 10:15 AM, Surgeon #1 stated Patient #1 had End Stage Chronic Obstructive Pulmonary Disease and confirmed a Left Total Knee Replacement was performed for the patient. Surgeon #1 stated the vendor said "...7 left...and I thought I saw left...I put it in and said 'Oh my God this is a right', and the rep [vendor] looked and said 'oh my God it is'...I [Surgeon #1] immediately removed the component and replaced with the correct one..." Surgeon #1 stated the patient needed stems (used for revisions) for additional support which were not available at the facility. He had to wait for a stem component to be brought from another facility, about 20 minutes away, which increased the case time.

During an interview on 4/18/2023 at 10:50 AM, in the conference room, the OR Director stated the process for implant verification when the incorrect implant was placed in Patient #1 was: the vendor retrieved the implant and brought the implant to the room. The vendor verified the implant information with the surgeon and the vendor would open the implant if the nurse was busy.

During a telephone interview on 4/18/2023 at 11:09 AM, RN Circulator #1 stated the vendor grabbed what the surgeon wanted and read off the size and side of the implant to the surgeon. RN Circulator #1 stated it was a pretty busy day for the surgeon and "...It appeared [Surgeon #1] was in a hurry. He had asked for the implants, she [vendor] showed him, he said 'okay', then said 'let's go, let's go'..." Surgeon #1 noticed it was the wrong side and yelled out "...this is the wrong implant..." RN Circulator #1 stated it was "...very stressful...didn't have all the pieces we needed so it made it even harder..." RN Circulator #1 confirmed the vendor opened the package and put the implant on the table/sterile field.

During a telephone interview on 4/18/2023 at 11:39 AM, CST #3 stated the incision and bone cutting was going great for Patient #1's surgery. The vendor said it was a left implant. Surgeon #1 did not turn around to look back and make sure everything was correct. CST #3 stated he put the implant on the handle, the surgeon took the implant and placed the implant in the patient. Surgeon #1 realized it was the wrong implant when he was washing it out with all the hardware in place and cementing had occurred. CST #3 stated the surgeon asked the vendor about the implant, the vendor checked the packaging and discovered she had given a right implant instead of the left. The incorrect implant was removed, and the correct side was placed. CST #3 stated the cement had hardened which made it more difficult to remove the implant. Surgeon #1 ended up doing a revision on the femur, and the correct implant was placed. CST #3 stated they had to wait "...maybe 45 minutes..." to get an instrument that was needed from a different facility before the surgery could be completed.

During a telephone interview on 4/18/2023 at 1:25 PM, Orthopedic Vendor #1 stated her role in the OR was to help the CSTs in surgery with knowing what type of instrumentation to use and to ensure implants are available at the facility prior to the procedure. Orthopedic Vendor #1 stated she "...grabbed a right [implant], showed [Surgeon #1], he looked at it..." Orthopedic Vendor #1 stated she verbally said the side and size of the implant and Surgeon #1 looked at the implant and agreed it was the correct implant.

During an interview on 4/20/2023 at 9:00 AM, in the conference room, the OR Director stated Patient #1's original surgical plan did not include a stem implant for stabilization. According to the OR Director, a stem implant was used more for revisions and was not required for regular total knee replacement procedure. A stem was needed for Patient #1 due to bone loss that occurred when the incorrect implant and cement was removed. The OR Director confirmed the stem implant was not available at the facility and had to be brought to the OR from another facility which prolonged the length of the patient's surgery and anesthesia time over 1 hour. The OR Director stated the expected process for implant verification at the time of Patient #1's surgery was for the vendor to show the implant package to the surgeon and read what was on the package to the surgeon. The RN Circulator was expected to review what was on the package, open the package, and maintain sterility while placing the implant on the sterile table. The OR Director confirmed the vendor showed the implant box to Surgeon #1, read the information to the surgeon, and verbalized it was a left sided implant, even though it was actually a right sided implant. The vendor then opened the implant and placed the implant on the sterile table/field. The OR Director stated "...A rep [vendor] should never open anything onto a sterile field..." The OR Director confirmed the RN Circulator was not involved in the implant verification process and confirmed the OR staff did not follow the facility's policy for safe procedure review and implant verification in relation to Patient #1's surgical procedure.

Based on review of facility policy, medical record review, review of facility documentation, and interviews the facility failed to provide organized surgical services in accordance with acceptable standards of practice for 1 patient (Patient #1) who had an incorrect implant (artificial joint) placed during an orthopedic surgical procedure of 8 orthopedic surgical patients reviewed.

The findings include:

Patient #1 underwent a surgical procedure on 10/31/2022 for a Left Computer Navigated Total Knee Arthroplasty (Total Knee Replacement). A right femoral (thigh bone) component (artificial implant) was placed in the patient's left knee after a vendor (individuals who sell, distribute, or train for use of a product or service) retrieved the incorrect implant from the supply cart and took into the Operating Room (OR) Suite. The vendor and the surgeon verbally reviewed the implant. The OR nursing staff failed to ensure the implant verification process was followed. The vendor opened the incorrect sided implant onto the sterile table. The implant was then placed and cemented in the patient. The surgeon realized a right-sided femoral component had been placed after the patella (kneecap) component had been placed and the patient's leg was extended. This resulted in removal of the implant with bone loss of the patient's femur, replacement of the implant, and the patient being under anesthesia longer than anticipated. The vendor's retrieval of the incorrect implant, failure to perform a thorough implant verification with the surgeon, and lack of the circulating nurses' (RN responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery) involvement with the implant verification process placed all orthopedic surgical patients at risk for placement of incorrect implants.

Refer to A-0951.

Based on review of facility policy, medical record review, review of facility documentation, and interview the facility failed to follow policy and procedures for the verification of a surgical implant (artificial joint) and process of placing implants on a surgical field for 1 orthopedic surgical patient (Patient #1) of 8 orthopedic surgical patients reviewed.

The findings include:

Review of the corporate policy "Safe Procedure Review Policy Version: 4" dated 3/8/2022 showed "...The purpose of this policy is to prevent procedures on the wrong patient, wrong site or side, wrong level and wrong procedures by using multi-layered checks and verifications during scheduling and pre-procedure [before procedure] testing, procedure preparation, intra- [during surgery] and post- [after procedure] procedural patient care and to promote consistent procedural verification and readiness, site-marking, time-out, and care team communication in a safe and reliable culture...All disciplines involved in operative, invasive, and bedside procedures will perform the following required action steps of Safe Procedure Review during the scheduling, pre-procedure testing, pre-procedure verification and site-marking, pre-procedure preparation, pre-procedure brief and time-out, and post-procedure debriefing...Procedure Briefing [actively communicate patient specific information related to safety and the plan for the procedure] (before induction or sedation)...Procedure team discusses plan and concerns before the patient enters the room which may include (some items below may be inapplicable for the procedure/surgery being performed)...Verifies the required implants, supplies, and instruments are available...Procedure Time-out and Intra-procedure...Additional Timeout Required...Implant verification-prior to opening any implant verify size, expiration date, type and side, if applicable with the Surgeon or Proceduralist..." Review of additional guidance included in the policy showed "...The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating/procedure nurse, operating room/procedure room technician and other active participants who will be participating in the procedure from the beginning...Vendors [individuals who sell, distribute, or train for use of a product or service] and equipment representatives ARE NOT included in time-out...Visual Inspection and verbal verification of the implant information is used to ensure the procedure and/or surgical team is implanting the correct device..."

Review of the facility's policy "Safe Procedure Review" dated 10/26/2022 showed the facility's policy did not address a process for implant verification (process to verify correct type of implant, correct size, correct side right or left, and expiration date).

Review of the facility's policy "Vendor Relations Policy" dated 12/6/2022 showed "...Vendor sales representatives are sometimes required to participate in surgical and patient care procedures through direct involvement, such as programming a Cardiac pacemaker, or indirect involvement, such as making recommendations to the surgeon about which appliance to use. When this should occur, the facility shall follow these guidelines for vendors under these circumstances...During each visit to the Department of Surgery each vendor will adhere to the following rules...Vendors are not allowed direct patient contact in the Operating Room...The Health Care Industry Rep. [representative] is not ever to be considered part of the surgical team and will not be requested to perform tasks that are not part of his/her role as an industry representative...Vendors do not open sterile packages nor enter the sterile field...Vendors will not be allowed to scrub or participate in the procedure other than a service support role..."

Medical record review of a history and physical showed Patient #1 was admitted to the facility for a Left Computer Navigated Total Knee Arthroplasty (Knee replacement) on 10/31/2022. Patient #1's medical history included but was not limited to Anxiety, Arthritis, Chronic Obstructive Pulmonary Disease, Hypertension, and Obstructive Sleep Apnea.

Medical record review of an Intraoperative (during surgery) Record showed Patient #1's surgery start time on 10/31/2022 was 12:45 PM. The surgery stop time was 5:24 PM (4 hours 39 minutes after surgery start time). The following were present during Patient #1's surgical procedure: surgeon, 1 Circulating Registered Nurse (RN-responsible for managing all nursing care within the operating room, observing the surgical team from a broad perspective, and assisting the team to create and maintain a safe, comfortable environment for the patient's surgery), 1 Certified Registered Nurse Anesthetist (CRNA-administers anesthesia), 2 Certified Surgical Technicians (CST- pass instruments, fluids and supplies to the surgeon and prepare and manage surgical equipment during surgery), and 1 vendor representative. Patient #1 was transferred to the recovery room on 10/31/2022 at 5:30 PM.

Medical record review of an operative report showed Patient #1 underwent a Left Computer Navigated Total Knee Arthroplasty. Review of the report showed "...Once the patella [kneecap] component [implant] was placed the leg was extended and axially loaded [to check for alignment] and at this point is when I [orthopedic surgeon] looked down and realized that there was a right femoral component [replaces the lower end of the thigh bone] in the left knee..." It took "...roughly 10 minutes..." to remove the right femoral component which resulted in loss of bone. Continued review showed "...Revision components were required given the patient's size...it was felt that revision total stabilized stem components [used when the remaining bone is insufficient to support the artificial joint] would be most appropriate given the slight bone loss...Unfortunately, the revision total knee components are not routinely at this facility...It took...93 minutes for those components to be brought to this facility..." Patient #1's surgery resumed after the needed components were brought to the facility. The patient was admitted for postoperative pain control and rehabilitation.

Review of a facility report showed the circulating RN reported the following on 10/31/2022 at 2:44 PM: During the procedure (Patient #1's Left Total Knee Replacement), the vendor showed the surgeon the implant components and the surgeon agreed it was the correct implants before the packages were opened. The femur implant was then implanted with cement. Approximately 5 minutes later, the surgeon noticed that the implant did not align well, and the implant looked like it was for the right knee instead of the left knee. The surgeon asked the vendor if it was a left or right femur implant. The vendor looked at the packaging and noticed the implant was for the right side and not the left. At that point, the surgeon tried to remove the implant, but the cement had already dried, and he had to use substantial force to remove the implant which "...appeared to remove excess bone from site..." The report showed there was deviation from the generally accepted performance standard and the deviation reached the patient. The documentation showed the deviation did not cause moderate to severe harm or death. Documentation showed the incident occurred in the OR on 10/31/2022 at 2:25 PM. The patient's surgeon (present) and the OR Nurse Manager were notified. The incident was documented as a "...Precursor Safety Event PSE 1: Minimal Permanent Harm-A deviation in GAPS resulting in minor harm with no expected change in clinical status; requires little or no intervention..."

Medical record review of a Post Anesthesia Care Unit (PACU-Recovery Room) record showed Patient #1 was transferred to the medical surgical floor on 10/31/2022 at 6:03 PM.

Medical record review of a discharge summary showed Patient #1 was discharged to home on 11/1/2022.

Patient #1 was contacted during the investigation. The patient confirmed he had a Left Total Knee Replacement performed at the facility on 10/31/2022. He stated the surgery was performed on the correct knee (left) but a "...right knee joint..." was put in his left knee. Patient #1 stated "...He [surgeon] apparently didn't realize it until it was too late. He had already cemented it [implant] in. He couldn't get the cement loose and had to send to [named nearby city] to get a machine to get the cement out..."

During an interview on 4/17/2023 at 2:02 PM, in the conference room, CST #1 stated she was present when Surgeon #1 realized the wrong sided implant had been placed in Patient #1's knee. The CST reported Surgeon #1 tried to remove the implant, but the cement had already hardened. CST #1 stated "...It was harder to remove..." but he was able to get it out and replaced it with the correct sided implant.

During a telephone interview on 4/18/2023 at 10:15 AM, Surgeon #1 stated Patient #1 had End Stage Chronic Obstructive Pulmonary Disease and confirmed a Left Total Knee Replacement was performed for the patient. Surgeon #1 stated the vendor said "...7 left...and I thought I saw left...I put it in and said 'Oh my God this is a right', and the rep [vendor] looked and said 'oh my God it is'...I [Surgeon #1] immediately removed the component and replaced with the correct one..." Surgeon #1 stated the patient needed stems (used for revisions) for additional support which were not available at the facility. He had to wait for a stem component to be brought from another facility, about 20 minutes away, which increased the case time.

During an interview on 4/18/2023 at 10:50 AM, in the conference room, the OR Director stated the process for implant verification when the incorrect implant was placed in Patient #1 was: the vendor retrieved the implant and brought the implant to the room. The vendor verified the implant information with the surgeon and the vendor would open the implant if the nurse was busy.

During a telephone interview on 4/18/2023 at 11:09 AM, RN Circulator #1 stated the vendor grabbed what the surgeon wanted and read off the size and side of the implant to the surgeon. RN Circulator #1 said it was a pretty busy day for the surgeon. RN Circulator #1 stated "...It appeared [Surgeon #1] was in a hurry. He had asked for the implants, she [vendor] showed him, he said 'okay', then said 'let's go, let's go'..." Surgeon #1 noticed it was the wrong side and yelled out "...this is the wrong implant..." RN Circulator #1 stated it was "...very stressful...didn't have all the pieces we needed so it made it even harder..." RN Circulator #1 confirmed the vendor opened the package and put the implant on the table/sterile field.

During a telephone interview on 4/18/2023 at 11:39 AM, CST #3 stated the incision and bone cutting was going great for Patient #1's surgery. The vendor said it was a left implant. Surgeon #1 did not turn around to look back and make sure everything was correct. CST #3 stated he put the implant on the handle, the surgeon took the implant and placed the implant in the patient. Surgeon #1 realized it was the wrong implant when he was washing it out with all the hardware in place and cementing had occurred. CST #3 stated the surgeon asked the vendor about the implant, the vendor checked the packaging and discovered she had given a right implant instead of the left. The incorrect implant was removed, and the correct side was placed. CST #3 stated the cement had hardened which made it harder to remove the implant. Surgeon #1 ended up doing a revision on the femur, and the correct implant was placed. CST #3 stated they had to wait "...maybe 45 minutes..." to get an instrument that was needed from a different facility before the surgery could be completed.

During a telephone interview on 4/18/2023 at 1:25 PM, Orthopedic Vendor #1 stated her role in the OR was to help the CSTs in surgery with knowing what type of instrumentation to use and to ensure implants are available at the facility prior to the procedure. Orthopedic Vendor #1 stated she "...grabbed a right [implant], showed [Surgeon #1], he looked at it..." and she verbally said the side and size of the implant and Surgeon #1 looked at the implant and agreed it was the correct implant.

During an interview on 4/20/2023 at 9:00 AM, in the conference room, the OR Director stated Patient #1's original surgical plan did not include a stem implant for stabilization. According to the OR Director, a stem was needed for Patient #1 due to bone loss that occurred when the incorrect implant and cement was removed. She stated a stem implant was used more for revisions and was not required for regular total knee replacement. The OR Director confirmed the stem implant was not available at the facility and had to be brought to the OR from another facility which prolonged the length of the patient's surgery and anesthesia time over 1 hour. The OR Director stated the expected process for implant verification at the time of Patient #1's surgery was for the vendor to show the implant package to the surgeon and read what was on the package to the surgeon. The RN Circulator was expected to review what was on the package, open the package, and maintain sterility while placing the implant on the sterile table. The OR Director confirmed the vendor showed the implant box to Surgeon #1, read the information to the surgeon, and verbalized it was a left sided implant, even though it was actually a right sided implant. The vendor then opened the implant and placed the implant on the sterile table/field. The OR Director stated "...A rep [vendor] should never open anything onto a sterile field..." The OR Director confirmed the RN Circulator was not involved in the implant verification process and confirmed the OR staff did not follow the facility's policy for safe procedure review and implant verification in relation to Patient #1's surgical procedure.