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Based on review of facility policy, medical record review, review of 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 infection prevention for 2 patients (#1 and #3) who had surgical procedures utilizing nonsterile surgical equipment and 1 patient (#2) who had an expired surgical implant surgically placed, of 8 patients reviewed.

The findings included:

Patient #1 was admitted to the facility's Main Operating Room (OR) on 11/11/2022 for a revision on a nonunion (fractured bone that has not shown healing progression). The surgical procedure included the placement of orthopedic screws and hardware replacement. During the procedure, an additional "reamer device" (rotational cutting tool used in a variety of orthopedic surgeries) was used. The surgical procedure was completed, and the surgeon had exited the room. The OR team noticed the chemical indicators (indicators used to monitor whether the parameters to achieve sterilization were performed) had not changed, indicating the surgical equipment was not sterilized. The surgeon was notified and determined the surgical implant needed to be removed and replaced due to the potential of contamination of the equipment. The patient required a second surgical revision. Patient #1 was admitted as an inpatient to the facility and required an Infectious Disease consult with antibiotic prophylaxis treatment for infections. The unsterilized surgical equipment that was utilized in the OR had been placed in the storage area prior to having completed the full sterilization process. The equipment was brought into the OR by a vendor representative and placed on the sterile field for use. The OR staff failed to check the chemical indicators prior to the equipment being used for the patient.

Patient #3 was admitted to the facility's Day Surgery (outpatient surgery department for the facility) on 11/17/2022 for a laparoscopic robotic bilateral inguinal repair. The surgical procedure was completed without complications, and he was transferred to the Post Anesthesia Care Unit (PACU). During the cleaning of the OR, the staff observed the chemical indicators in the trash can. It was determined the chemical indicators had not changed, indicating the surgical equipment was not sterilized prior to being used on the patient. The surgical tray had been placed in the Day Surgery storage area prior to having completed a full sterilization process. The tray was brought into the OR by the OR staff and chemical indicator checks were not completed by the OR staff prior to placing the tray on the sterile field and before using the equipment on the patient.

Patient #2 was admitted to the facility's Main OR on 11/16/2022 for an Open Reduction and Internal Fixation (ORIF) of a left Jones Fracture nonunion (fracture of the bone on the 5th toe) and Osteotomy (surgical procedure involving cutting the bone to reshape or realign the bone). The surgical procedure was completed. After the surgical procedure, it was found the surgical implant expired on 10/31/2022. The expired implant was stored in the OR storage area. When the surgeon requested the implant during the procedure, a vendor representative retrieved the implant from the storage area, brought the implant into the OR, and handed the expired implant to a student scrub technician. The implant was placed on the sterile field for use. There was no communication by the OR staff regarding the expiration date.


Refer to A-0286

Based on review of facility policy, review of Association of Perioperative Registered Nurse (AORN) standards, review of job descriptions, medical record review, review of documentation of facility investigations, and interviews, the facility's Quality Assurance Performance Improvement (QAPI) failed to immediately identify, analyze the cause, and implement immediate preventive actions to ensure patient safety for the use of nonsterile equipment during surgical procedures for 2 patients (#1 and #3) and for 1 patient (#2) who had an expired surgical implant surgically placed of 8 patients reviewed.

The findings included:

Review of facility policy "Performance Improvement Policy" last revised 7/2020, showed "...Performance Improvement...promotes data-driven decision-making and initiate the continuous assessment and improvement of processes and services in a culture that supports the vision, mission, and strategic goals...has the responsibility for monitoring and improving the quality and safety of patient care in a clinically integrated fashion...data are collected and performance improvement opportunities are assessed for the following...Operative or other procedures that place patients at risk of disability or death...[2] Medical Staff Chairpersons are responsible for continuously assessing, improving, and maintaining the quality of care and services related to the professional performance of all department members with clinical privileges, including non-member practitioners...[3] leaders of the Centers of Excellence and Hospital Departments are responsible for participating in, encouraging, and implementing performance improvement activities within their areas of responsibility, including contractors, to meet organizational and departmental strategic objectives. Activities may include defining specific PI [Performance Improvement] initiatives and providing resources, identifying, and monitoring appropriate performance metrics, planning, designing, measuring, assessing, and improving processes supporting those activities...[5] Risk Management...reviews untoward events related to patient care and safety, works collaboratively with COEs [Centers of Excellence], departments, and committees to appropriately resolve issues and improve processes. Individual cases and aggregate reports identified through untoward event reporting may be provided through PI committees to determine the need for process and system redesign...[6] Patient Safety Council shares Patient Safety Council Scorecard with PIC [performance improvement council] and reports to Performance Improvement Committee of the Board and Board of Directors the results of Sentinel Event Root Cause Analysis and proactive risk reduction activities..."

Review of facility policy "Sentinel Event Report" last revised 11/2021, showed "...the Adverse Event Review process includes a review of the adverse event, any necessary background information, pertinent policies and procedures, staff interviews, completion of a root cause analysis, and corrective action plans to reduce the likelihood of a future similar occurrence...immediately upon discovery of an adverse event, staff should notify the unit/department manager, Risk Management...department manager/Risk Manager will ensure there is not an ongoing potential safety problem and direct actions as appropriate...make appropriate notifications...adverse event review will be conducted for any incident that meets the definition of a sentinel event, as well as other patient safety events deemed to be reviewable by the CMO [Chief Medical Officer] or adverse event core team...a formal Root Cause Analysis (RCA) will be conducted to identify underlying factors that contributed to the event. The VP [Vice President] for the area of occurrence is responsible for convening the review team, including appropriate disciplines and individuals..."

Review of facility policy "Vendor Management Policy" last revised 6/2021, showed "...for cases requiring vendor provided products, the clinical staff will inspect for sterility and integrity of package as well as an expiration date prior to opening any item on the sterile field...vendors must only handle their products. Vendors should not open products onto the sterile field..."

Review of the Association of Perioperative Registered Nurse (AORN) standard "Sterile Field-preparing, maintain, and monitoring" last revised 2018, showed "...perioperative team members will place sterile drapes on the patient, furniture, equipment in the sterile field and handle them in a manner that prevents contamination...only sterile items will come into contact with the sterile field...perioperative personnel will observe for, recognize, and immediately corrects breaks in sterile techniques when preparing, performing, or assisting with operative or other invasive procedures, and will implement measures to prevent future occurrences...when a break in sterile technique occurs, correction will be taken immediately..."

Review of a Surgical Technologist Job Description (no date) showed "...duties...[1] checks supplies and equipment for surgical procedure...[3] sets up sterile table with instruments, supplies, equipment...[8] maintains highest standard of sterile technique during procedure..." The Circulating Surgical Technologist "...[1] checks appropriate sterile and unsterile items for procedure..."

Review of a Circulating Nurse Job Description (no date) showed "...the circulating RN [Registered Nurse] is responsible for advocating for the surgical patient and ensuing a safe environment of care during surgery...collaboration with Pre-Op, anesthesia, surgeon, OR [Operating Room] staff, SPD [sterile processing department and PACU [post operative anesthesia care unit] is crucial to providing quality and safe patient care..."

Medical record review showed Patient #1 was admitted to the facility's Main OR on 11/11/2022 for a revision of a nonunion of left femur (fractured bone that has not shown healing progression). During the surgical procedure, the femur bone was reamed up to the size of 14 ½, a #13 nail was inserted, and interlocking screws were inserted. Fluoroscopy was obtained which showed alignment of the femur and the surgical procedure was completed. After the surgical procedure, the surgeon exited the room and was then informed by the OR staff the "reamer system" (rotational cutting tool used in a variety of Orthopedic surgeries) was possibly contaminated. The surgeon was informed chemical indicators (indicators used to monitor whether the parameters to achieve sterilization were performed) did not show the surgical equipment had been sterilized. This failure resulted in Patient #1 having a second surgery to remove the hardware, irrigation of the wound, and surgical implant replacement of the hardware. Empiric antibiotics (antibiotics to prevent infections from developing) were begun. Following the procedure, a discussion was conducted by the surgeon with the patient's husband regarding the incident and an Infectious Disease consult was initiated. The patient was admitted to the facility and discharged home on 11/12/2022. Infectious Disease evaluated the patient on 11/11/2022 at 4:53 PM where an exposure plan of care was implemented for the patient to include Hepatitis B vaccine, IVIG (Intravenous Immunoglobulin- therapy treatment for patients with antibody deficiencies) and antibiotics including Daptomycin and Meropenem for 48 hours. Patient #1 was started on Truvada and Raltegravir (medications to treat HIV exposure). On 11/12/2022 at 11:46 AM, the patient was continued on Descovy and Raltegravir (antiviral medications) for 4 weeks and was scheduled for follow-up with Infectious Disease in 4 weeks to repeat blood testing. The patient declined intravenous antibiotics at home, and the patient was sent home on oral Ceftriaxone (antibiotic) for 2 weeks.

Review of facility documentation (system investigation report) dated 11/11/2022 showed after the surgical procedure for Patient #1 was completed, the Certified Surgical Technician (CST) observed the "reamer device" had not been sterilized prior to use. The patient was still on the OR table. The CST notified the surgeon, and it was decided to remove the implant, irrigate the wound, and replace the hardware. Review of facility documentation showed during the 1st surgical procedure, the surgeon had requested a larger "reaming device" which was not present on the sterile field or in the OR. The vendor, who was in the room during the surgical procedure, exited the room, retrieved the reaming device from the equipment room, returned to the room with the equipment, and placed the non-sterile equipment on the table. The nonsterile equipment was opened and given to the CST for use, and the nonsterile equipment was used during the surgical procedure. The facility had not completed a thorough investigation into the causes of the adverse event.

During an interview on 11/16/2022 at 12:25 PM, CST #1 stated the surgeon had taken the nails out and after using the original reamer device, the surgeon had asked for a larger size which was not in the room. The vendor representative was in the room, exited the OR to get another tray, and brought the tray into the room. The vendor opened the nonsterile equipment and placed the equipment on the sterile field, and no one checked the equipment to determine if the equipment was sterilized. After the case was completed, CST #1 noticed the chemical indicators on the outside had not changed and there were no chemical indicators in the tray. The patient was still on the OR table. CST #1 asked CST #2 if "she checked it" and she said she did not check the tray for chemical indicators. The tray was not sterile, and the nonsterile reamer had been used on the patient. The surgeon determined he would have to remove the device, clean the wound out, and replace the implant. CST #1 confirmed the equipment was not checked for chemical indicators to confirm sterility of the equipment.

During an interview on 11/16/2022 at 12:45 PM, RN #1 confirmed the equipment was not checked for the chemical indicators to confirm sterility of the equipment.

During an interview on 11/16/2022 at 2:15 PM, Surgeon #1 stated "...the reamer was used; I needed a larger size reamer and had asked for the equipment. The reamer was brought into the room and a size #14.5 was used with successful enlargement to place the implant. The screws were secured and clamped, and the surgery was successfully completed. I had exited the room and the PA [Physician Assistant] was closing. A few minutes later, the CST came and told me the equipment had not been sterilized and there was possibly contamination. I was not sure how this happened, but I determined the only safe thing to do was to take the implant out, wash the wound, and replace the implant...there was no question what we had to do...I knew I could not take any chance with it. The patient was still under anesthesia, so we re-draped, changed the sterile field, washed the wound out, and replaced the implant..."

During an interview on 11/16/2022 at 3:15 PM, the Executive Director of Orthopedic Institute stated surgical equipment had gotten from the Sterile Processing Department to the OR "tool shed" (designated area where sterile supplies were stored in the OR), where the equipment was brought into the OR by a vendor representative, and then given to the CST. She confirmed the OR staff did not check the supplies for chemical indicators. She stated these three factors contributed to the nonsterile surgical equipment being available for use on a patient. She had been notified by the surgeon on 11/11/2022, a system investigation report had been completed, and she had contacted Risk Management. An inventory of surgical equipment was done but it was not documented. The facility had not completed an investigation to determine why the failures occurred.

During an interview on 11/17/2022 at 9:05 AM, the Vendor Representative stated "...I just grabbed the equipment and took the tray to the room, popped the lid from the tray, and placed the tray on the table for the CST. The scrubbed CST took the equipment to the sterile field and set it up for the case. I did not check for chemical indicators and after the case was finished, the OR staff discovered the tray had not been sterilized..." The vendor representative confirmed he did not have any conversation with the OR staff when the tray was brought in regarding chemical indicator checks; he did not check the tray for chemical indicators and obtaining OR supplies was not within his role while being in the OR.

During an interview on 11/17/2022 at 9:15 AM, CST #2 stated the vendor had brought the reamer into the room and she had gotten the reamer out of the tray and handed it the surgeon. CST #1 noticed the chemical indicator in the trash and noticed the indicator had not changed, indicating the tray was not sterilized. She asked me "...if I had checked the indicator and I told her I had not checked it prior to handing the reamer to the surgeon. I should have checked it prior to getting the reamer out the tray, but I did not. When she showed me the indicator it had not changed..."

Medical record review showed Patient #3 was admitted on 11/17/2022 at 9:32 AM to the Day Surgery department (outpatient surgery department of the facility) for a left and right laparoscopic inguinal hernia repair (surgical procedure performed in the abdomen or pelvis using small incisions with the aid of a camera). The surgical procedure was completed at 11:24 AM. Approximately 12:45 PM, the surgeon was notified by the OR staff of concerns the surgical equipment had not been sterilized. The chemical indicators for the equipment had not changed, indicating the equipment had not been sterilized. The surgeon informed Patient #3 after the patient's anesthesia had worn off. The patient was discharged home on 11/17/2022 and then readmitted on 11/18/2022 for an Infectious Disease Consult. Infectious Disease recommendations included Hepatitis B vaccine, postexposure prophylaxis with Descovy and Tivicay (antiviral medications) for 28 days, Cipro (antibiotic) and Linezolid (antibiotic), baseline Hepatitis B and C serology, and follow up with Infectious Disease on 11/21/2022. The patient was discharged home on 11/19/2022.

During an interview on 11/21/2022 at 9:15 AM, RN #3 stated CST #3 noticed the chemical indicators in the trash for the surgical tray were in the trash had not changed, indicating the surgical tray had not been sterilized. CST #3 then questioned CST #4 about the indictors. CST #4 stated she did not notice the chemical indicators had not changed. She stated "...the indicators should be checked prior to placing the sterile tray on the sterile field. This did not happen..."

During an interview on 11/21/2022 at 9:20 AM, CST #4 stated "...I can't explain why I didn't get indicators out. [CST #3] had seen them in the trash and noticed it...I thought they were okay and tossed them into the trash. The chemical indicators had not changed, and the checks did not happen...for some reason I didn't catch it. The surgical tray was in the OR storage room and was brought into the OR and I just didn't catch it..." She confirmed the chemical indicators had not changed indicating the surgical tray was not sterilized and the standard work process was not followed.

During an interview on 11/21/2022 at 11:00 AM, Surgeon #2 stated he was made aware of the unsterile equipment after the surgical procedure had been completed. He was informed by the OR staff the chemical indicators had not changed for the equipment used, indicating the equipment had not been sterilized. The OR staff were not sure how the equipment had gotten to the OR storage area without being sterilized. Infectious Disease was consulted and made recommendations for the patient.

Medical record review showed Patient #2 was admitted to the Main OR on 11/16/2022 for an outpatient surgical procedure including an Open Reduction and Internal Fixation (ORIF) of a left Jones Fracture nonunion (fracture of the bone on the 5th toe of the foot) and Osteotomy (surgical procedure involving cutting the bone to reshape or realign the bone). The surgical procedure was completed, and the OR staff observed the Orthopedic implant which was used for the patient had an expiration date of 10/31/2022. The Orthopedic surgeon made the decision to leave the expired implant in place and disclosed the expired implant to the patient. There was mutual agreement to leave the implant in place related to the difficulty of the surgical procedure and to monitor the patient. The patient was discharged home on 11/16/2022.

Review of a facility investigation dated 11/17/2022 showed the vendor representative was in the OR room during the procedure when the surgeon asked for another screw. The vendor went out of the room, retrieved the screw from the "tool shed", returned to the room with the screw, and gave the screw to a student surgical technician (ST) without the preceptor's knowledge. There was no communication with the OR staff to indicate the expiration date of the implant. The screw was given to the surgeon and was surgically implanted. After the surgical procedure was completed, the OR staff recognized the screw was expired. The facility had initiated an investigation on 11/17/2022 and confirmed an expired surgical implant was available in the OR for the use on the patient and was surgically implanted.

During an interview on 11/18/2022 at 11:05 AM, the CMO stated the facility was made aware of the incident on 11/16/2022 and an investigation was initiated. The vendor representative retrieved the implant from the "tool shed", reentered the OR, pulled the bag open, and handed the implant to the student where the implant was surgically implanted. There were no discussions between the vendor, the OR team, and the surgeon regarding the expiration date of the implant and it was not noticed by the OR staff until after the surgical procedure was completed. The surgeon was made aware of the expired equipment and based on the surgical findings, made the decision the screw would not be removed. The CMO stated "...in this case, the vendor went and retrieved the screw and brought into the room. The vendor should have handed it off to the circulating nurse who should have been the designated person to hand the equipment to the sterile field. There should have been a verbal exchange between the OR staff and the surgeon related to the expiration date, which did not occur. This was not the normal procedure and given the gravity of the surgeon needing the screw immediately and quickly, the event escalated, and our normal procedures were not followed..."

During an interview on 11/18/2022 at 12:30 PM, the Infection Prevention Director confirmed the standard process was not followed for checking for expired surgical implants and the sterility of the surgical equipment.

During a telephone interview on 11/18/2022 at 12:55 PM, Surgeon #3 stated she had completed the surgery on 11/16/2022 when she was made aware one of the surgical implants had an expiration date of 10/31/2022. She stated "...given the fact that this surgical procedure was so complex, and the stability of the bone was achieved, I felt it was in the best interest of the patient to not remove the screw and place the patient at risk for an increased nonunion of this implant...I disclosed this to the patient and told him I felt this was the safest option and he agreed. I told him we would follow him closely..."

During an interview on 11/18/2022 at 1:30 PM, the CMO, the Vice President (VP) of Clinical Operations, the VP of Quality and Safety, the VP of Perioperative Services, the Executive Director of Orthopedic Institute, and the Executive Director of Orthopedic confirmed there had been process failures related to ensuring sterilization was completed prior to the use of the surgical equipment, confirmed chemical indicators were not checked prior to two surgical cases, and confirmed expired supplies were available for use. Interview revealed upon discovery of the incident with Patient #1, the facility had notified the Administrator on Call (AOC) and the VP of Risk Management, and the family was informed, however a complete Root Cause Analysis was not conducted until 11/16/2022 (5 days later). Two of the incidents had occurred in the main OR and one case occurred in the Day Surgery resulting in a system wide failure. Nonsterile equipment had been transported from the Sterile Processing Department (SPD) to the ORs and were available for use during surgical procedures; and expired surgical implants were stored in the equipment room in the OR. Vendor representatives had retrieved surgical equipment/implants, brought the equipment into the OR, and there was failure to check the equipment prior to the use on the patients.

Based on review of job descriptions, review of the Association of Perioperative Registered Nurse (AORN) standards, review of facility policy, medical record review, review of documentation of facility investigations, and interviews, the facility failed to follow infection prevention and control guidelines for 2 patients (#1 and #3) who had surgical procedures performed with unsterilized surgical equipment and failed to ensure expired equipment was not used for 1 patient (#2) of 8 patients reviewed.

The findings included:

Patient #1 was admitted to the facility's Main Operating Room (OR) on 11/11/2022 for a revision on a nonunion (fractured bone that has not shown healing progression). The surgical procedure included the placement of Orthopedic screws and hardware replacement. During the procedure, an additional "reamer device" (rotational cutting tool used in a variety of Orthopedic surgeries) was used. The surgical procedure was completed, and the surgeon exited the room. The OR team noticed the chemical indicators (indicators used to monitor whether the parameters to achieve sterilization were performed) had not changed, indicating the surgical equipment was not sterilized. The surgeon was notified and determined the surgical implant needed to be removed and replaced due to the possibility of contamination. Patient #1 required a second surgical revision. The patient was admitted to the facility and required an Infectious Disease consult with prophylaxis treatment for infections. It was determined the nonsterile surgical equipment had been brought from the Sterile Processing Department (SPD) to the OR storage area, placed on the shelf in the OR, and the equipment had not completed the sterilization process. The equipment was brought into the OR by a vendor representative and placed on the sterile field for use. The OR staff failed to check the chemical indicators prior to the equipment being used for the patient.

Patient #3 was admitted to the facility's Day Surgery (outpatient surgical department of the facility) on 11/17/2022 for a laparoscopic robotic bilateral inguinal repair (surgical procedure performed in the abdomen or pelvis using small incisions with the aid of a camera). The surgical procedure was completed without complications, and he was transferred to the Postoperative Anesthesia Care Unit (PACU). During the cleaning of the OR, the staff observed the chemical indicators in the trash can. It was determined the chemical indicators had not changed, indicating the surgical equipment was not sterilized prior to using the equipment on the patient. The nonsterile surgical equipment had been brought from the SPD to the OR storage area, placed on the shelf in the OR, and the equipment had not completed the sterilization process. The tray was brought into the OR by the OR staff and chemical indicator checks were not completed by the OR staff prior to placing the tray on the sterile field and prior to using the equipment on the patient.

Patient #2 was admitted to the facility's Main OR on 11/16/2022 for an Open Reduction and Internal Fixation (ORIF) of a left Jones Fracture nonunion (fracture of the bone on the 5th toe of the foot) and Osteotomy (surgical procedure involving cutting the bone to reshape or realign the bone). The surgical procedure was completed. After the surgical procedure it was found the surgical implant expired on 10/31/2022. The expired implant was stored in the facility's OR storage area. When the surgeon requested the implant during the procedure, a vendor representative retrieved the implant from the storage area, brought the implant into the OR, and handed the expired implant to a student scrub technician. The implant was placed on the sterile field for use. There was no communication by the OR staff regarding the expiration date.


Refer to A-0750

Based on review of job descriptions, review of the Association of Perioperative Registered Nurse (AORN) standards, review of facility policy, medical record review, review of documentation of facility investigations, and interviews, the facility failed to ensure surgical equipment was sterilized prior to use during surgical procedures for 2 patients (#1 and #3) and failed to ensure expired surgical implants were not used for 1 patient (#2) of 8 patients reviewed.

The findings included:

Review of a Surgical Technologist Job Description, not dated, showed "...possess expertise in the theory and application of sterile and aseptic technique...surgical procedures, and implementation and technologies to facilitate a physician's performance of invasive therapeutic and diagnostic procedure...duties are as follows: [1] checks supplies and equipment for surgical procedure...[3] sets up sterile table with instruments, supplies, equipment...[8] maintains highest standard of sterile technique during procedure..." The Circulating Surgical Technologist (CST) "...[1] checks appropriate sterile and unsterile items for procedure..."

Review of a Circulating Nurse Job Description, not dated, showed "...the circulating RN [Registered Nurse] is responsible for advocating for the surgical patient and ensuing a safe environment of care during surgery. Collaboration with Pre-Op, anesthesia, surgeon, OR (Operating Room) staff, SPD [sterile processing department] and PACU [post operative anesthesia care unit] is crucial to providing quality and safe patient care..."

Review of the Association of Perioperative Registered Nurse (AORN) standards "Sterile Field-preparing, maintain, and monitoring" last revised 2018, showed "...perioperative team members will place sterile drapes on the patient, furniture, equipment in the sterile field and handle them in a manner that prevents contamination...only sterile items will come into contact with the sterile field...perioperative personnel will observe for, recognize, and immediately corrects breaks in sterile techniques when preparing, performing, or assisting with operative or other invasive procedures, and will implement measures to prevent future occurrences...when a break in sterile technique occurs, correction will be taken immediately..."

Review of facility policy "Vendor Management Policy" last revised 6/2021, showed "...for cases requiring vendor provided products, the clinical staff will inspect for sterility and integrity of package as well as an expiration date prior to opening any item on the sterile field...vendors must only handle their products. Vendors should not open products onto the sterile field...if another manufacturer's product or a piece of equipment requires movement, a staff member must be contacted..."

Medical record review of Patient #1's Admission History and Physical (H&P) dated 11/10/2022 at 8:30 AM showed the patient had complaints of left knee pain and she was admitted for a revision of nonunion (fractured bone that has not shown healing progression) of the left femur. The H&P was updated on 11/11/2022 prior to the surgical procedure.

Medical record review showed Patient #1 was admitted to the Main OR on 11/11/2022 for a revision of nonunion of the left femur and was discharged home on 11/12/2022.

Medical record review of an Operative Report dated 11/11/2022 at 6:49 PM showed the patient had previously sustained a left atypical femur fracture and previously had hardware removal related to symptomatic dysfunction of distal interlocking screws. Ultimately Patient #1 developed a nonunion of the femur with shortening of the femoral shaft and nail encroaching the intra-articular (entry to the joint) surface of the knee. The patient's femur was reamed up to a size 14 ½ for placement of a size 13 nail. The distal interlocking screw was placed, the fracture was compressed, followed by proximal interlocking screw placement. Fluoroscopy was used to confirm appropriate hardware placement and alignment of the femur. The wounds were closed. At that point, the staff was informed of a sterile wrapped "reamer system" (rotational cutting tool used in a variety of orthopedic surgeries) that was possibly contaminated and used for intermedullary reaming of the femur. Since sterility could not be confirmed, the decision was made for removal and replacement of the sterile implants, debridement of the intermedullary canal, and extensive irrigation. Empiric antibiotics were begun. Following the procedure, the patient's husband was notified of the incident. An Infectious Disease consult was placed for recommendations following the possible use of a contaminated system. Patient #1 was admitted to the facility.

Medical record review of an Infectious Disease Consult dated 11/11/2022 at 4:53 PM showed "...consulted for surgical exposure to unknown source, discussed with family regarding HIV [human immunodeficiency virus-virus that attacks the body's immune system] and Hepatitis B prophylaxis [ppx]...if we cannot trace exposure, husband agrees for HIV post exposure ppx, will be starting tomorrow [within 72 hours], patient Hepatitis B non-immune, vaccine ordered, IVIG [Intravenous Immunoglobulin- therapy treatment for patients with antibody deficiencies] with pharmacy. Abx [antibiotics] broadened to Depto [daptomycin] and Mero [meropenem] for 48 hours, will also order tetanus shot..."

Medical record review of an Infectious Disease Progress Note dated 11/11/2022 at 9:19 PM showed a discussion was held with the patient and the patient's husband who were aware of the potential exposure to non-sterile hardware which had contact with the patient's skin, deep tissue, muscle, and contact with blood. It was "...immediately realized that hardware placed was non-sterile and was removed. New Femoral retrograde with proximal and distal locking screws were placed. Patient and husband are aware and want to be aggressive with post exposure prophylaxis...give Hep B vaccine and tetanus shot, started Daptomycin and Meropenem, will deescalate if remains stable...needs IVIG, discussed with pharmacy, Truvada and Raltegravir [medications to treat HIV exposure] x [times] 4 weeks..."

Medical record review of an Infectious Disease Progress Note dated 11/12/2022 at 11:46 AM showed "...continue Descovy and Raltegravir x 4 weeks 11/12/2022-12/10/2022...requested follow-up with my clinic in 4 weeks and repeat blood test...Dapto and Meropenem discontinued and started on Ceftriaxone [antibiotic]...no signs of sepsis at this time...I suggested patient to have antibiotic ppx with IV Ceftriaxone for 2 weeks-she is denying for any IV [intravenous] antibiotics...states she can take pills but no IV...recommend 2 weeks of oral Doxycycline [antibiotic] on discharge..."

Medical record review of a Discharge Summary dated 11/12/2022 at 4:17 PM showed "...pertinent events in the hospitalization include exposure to unsterile instruments in the operating room, Infectious Disease consulted...stable for discharge to home...follow-up in office in 2 weeks..."

Review of facility documentation (system investigation report) dated 11/11/2022 showed after the surgical procedure for Patient #1 was completed, the Certified Surgical Technician (CST) observed the "reamer device" had not been sterilized prior to use. The patient was still on the OR table. The CST notified the surgeon, and it was decided to remove the implant, irrigate the wound, and replace the hardware. Review of facility documentation showed during the 1st surgical procedure, the surgeon had requested a larger "reaming device" which was not present on the sterile field or in the OR. The vendor, who was in the room during the surgical procedure, exited the room, retrieved the reaming device from the equipment room, returned to the room with the equipment, and placed the non-sterile equipment on the table. The nonsterile equipment was opened and given to the CST for use, and the nonsterile equipment was used during the surgical procedure.

During an interview on 11/16/2022 at 12:25 PM, CST #1 stated she was precepting another CST. The precepting CST was scrubbed in assisting with the case. The surgeon had taken the nails out and after using the original reamer device, the surgeon had asked for a larger size, which was not in the room. The vendor representative was in the room, exited the OR to get another tray and brought the tray into the room. The vendor opened the nonsterile equipment and placed the equipment on the sterile field, and staff failed to check the equipment to determine if the equipment was sterilized. After the case was completed, CST #1 noticed the chemical indicators on the outside had not changed and there were no chemical indicators in the tray. Patient #1 was still on the OR table. CST #2 said she did not check the tray for chemical indicators. The tray was not sterile, and the nonsterile reamer had been used on the patient. The surgeon determined he would have to remove the device, clean the wound out, and replace the implant. CST #1 confirmed the equipment was not checked for chemical indicators to confirm sterility of the equipment.

During an interview on 11/16/2022 at 12:45 PM, RN #1 stated the surgeon had completed the case and had exited the room. CST #1 noticed the tray did not have chemical indicator changes, and she had questioned CST #2 if she had checked the chemical indicators. CST #2 stated she had not checked the chemical indicators and it was determined the tray was not sterilized. The surgeon came back into the room and stated he would have to remove the implant, wash the wound out, and replace the implant. The RN confirmed the equipment was not checked for the chemical indicators to confirm sterility for the equipment.

During an interview on 11/16/2022 at 2:15 PM, Surgeon #1 stated "...the reamer was used; I needed a larger size reamer and had asked for the equipment. The reamer was brought into the room and a size #14.5 was used with successful enlargement to place the implant. The screws were secured and clamped, and the surgery was successfully completed. I had exited the room and the PA [Physician Assistant] was closing. A few minutes later, the CST came and told me the equipment had not been sterilized and there was possibly contamination. I was not sure how this happened, but I determined the only safe thing to do was to take the implant out, wash the wound, and replace the implant...there was no question what we had to do...I knew I could not take any chance with it. The patient was still under anesthesia, so we re-draped, changed the sterile field, washed the wound out, and replaced the implant..."

During an interview on 11/16/2022 at 3:15 PM, the Executive Director of Orthopedic Institute stated the surgeon had texted her regarding the use of non-sterile equipment. The surgical equipment had gotten from the Sterile Processing Department (SPD) to the OR "tool shed" (designated area where sterile supplies were stored in the OR), where the equipment was brought into the OR by a vendor representative, and then given to the CST. She confirmed the OR staff failed to check the supplies for chemical indicators.

During an interview on 11/16/2022 at 4:15 PM, the Executive Director of Orthopedic Surgical Services confirmed the nonsterile equipment was in the OR "tool shed" and was available for use for Patient #1. The equipment was brought from the tool shed by the vendor representative where inspection of chemical indicators was not completed. Once the equipment was brought into the OR, the OR staff failed to inspect or confirm the chemical indicators prior to the reamer device being used during the surgical procedure.

During an interview on 11/17/2022 at 9:05 AM, the Vendor Representative stated the surgeon had asked for a "bigger reamer" device and he left the room and got the reamer from the "tool shed" room. He stated "...I just grabbed the equipment and took the tray to the room, popped the lid from the tray, and placed the tray on the table for the CST. The scrubbed CST took the equipment to the sterile field and set it up for the case. I did not check for chemical indicators and after the case was finished, the OR staff discovered the tray had not been sterilized..." The vendor representative confirmed he and the OR staff did not discuss chemical indicator checks when the tray was brought in. He did not check the tray for chemical indicators and confirmed obtaining OR supplies were not within his role while being in the OR.

During an interview on 11/17/2022 at 9:15 AM, CST #2 stated the vendor had brought the reamer into the room and the CST had gotten the reamer out of the tray and handed it the surgeon. After the case was completed, CST #1 noticed the chemical indicator in the trash had not changed, indicating the tray was not sterilized. CST #1 asked me "...if I had checked the indicator and I told her I had not checked it prior to handing the reamer to the surgeon. I should have checked it prior to getting the reamer out of the tray, but I did not. When she showed me the indicator, it had not changed..."

During an interview on 11/17/2022 at 11:25 AM, the Director of Infection Prevention confirmed the nonsterile surgical equipment was used for the patient, chemical indicators were not checked prior to the surgical procedure, and the facility failed to follow standards and policy.

Medical record review showed Patient #3 was admitted to the Day Surgery (outpatient surgical department for the facility) on 11/17/2022 for a left and right laparoscopic inguinal repair (operation performed in the abdomen or pelvis using small incisions with the aid of a camera). He was discharged on 11/17/2022 and readmitted on 11/18/2022 for an Infectious Disease Consult and discharged on 11/19/2022.

Medical record review of an H&P dated 11/17/2022 at 9:32 AM showed Patient #3 reported feeling discomfort in the pelvic region with bulging on the left side which was noticed 1 month prior to the assessment. The surgical procedure was discussed with the patient along with the risks and benefits of surgery and the patient signed a consent for a robotic assisted bilateral inguinal hernia repair.

Medical record review of an Operative Report dated 11/17/2022 at 11:24 AM showed a left and right laparoscopic inguinal repair was successfully performed.

Medical record review of a Physician's addendum note dated 11/17/2022 at 6:28 PM showed "...I was notified [about 12:45 PM] by the OR staff after completing the patient's case regarding concerns about an instrument tray used in surgery. They were concerned that though the tray was clean, but the internal indicators of complete sterility were not color change...I met with the patient regarding his potential risk for infection due to the use of a concerned tray. I explained that he was given a dose of antibiotics preoperatively, and I was not certain more antibiotics would be helpful...he will have close follow-up..."

Medical record review showed Patient #3 was readmitted to the facility on 11/18/2022 for follow-up of infection concerns and an Infectious Disease consult.

Medical record review of an Admission H&P dated 11/18/2022 at 2:42 PM showed the patient was postoperative 1 day after a robotic-assisted bilateral inguinal hernia repair. He was admitted for Infectious Disease consult and recommendations.

Medical record review of an Infectious Disease Consult dated 11/18/2022 at 5:20 PM showed Patient #3 was admitted after a surgical procedure and there were concerns the surgical tray used for his procedure did not have chemical indicators, indicating the surgical tray was not sterilized. There was no information of which patient the tray may have been previously used for. Recommendations by Infectious Disease were as follows:
1. Hepatitis B Vaccine and observe for Hepatitis C.
2. Postexposure prophylaxis with Descovy and Tivicay (antiviral medications) for 28 days.
3. Approach in a fashion similar as to what would be done for occupational exposure in consideration that this was a surgical tray content exposure.
4. Cipro (antibiotic) and Linezolid (antibiotic) to start in the hospital and prescriptions through 11/25/2022.
5. Follow-up with Infectious Disease in the clinic on 11/21/2022.
6. Baseline Hepatitis B and C serology was obtained.

Medical record review of a General Surgery Progress Note dated 11/19/2022 at 9:30 AM showed Patient #3 was cleared for discharge after the Infectious Disease consult was completed and medications started. He was discharged home with follow-up with General Surgery and Infectious Disease on 11/21/2022.

During an interview on 11/21/2022 at 9:15 AM, RN #3 stated CST #3 noticed the chemical indicators for the surgical tray in the trash had not changed, indicating the surgical tray had not been sterilized. CST #3 then questioned CST #4 about the indictors. CST #4 stated she did not notice the chemical indicators had not changed. RN #3 confirmed "...the indicators should be checked prior to placing the sterile tray on the sterile field. This did not happen..."

During an interview on 11/21/2022 at 9:20 AM, CST #4 stated "...I can't explain why I didn't get indicators out. [CST #3] had seen them in the trash and noticed it...I thought they were okay and tossed them into the trash. The chemical indicators had not changed, and the checks did not happen...for some reason I didn't catch it. The surgical tray was in the OR storage room and was brought into the OR and I just didn't catch it..." She confirmed the chemical indicators had not changed indicating the surgical tray was not sterilized and the standard work process was not followed.

During an interview on 11/21/2022 at 9:40 AM, RN #4 stated CST #3 noticed the chemical indicators were in the trash and the chemical indicator had not changed colors, indicating the tray was not sterilized. The surgeon was notified of the possibility the tray was not sterile.

During an interview on 11/21/2022 at 11:00 AM, Surgeon #2 stated he was made aware of the unsterile equipment after the surgical procedure had been completed. He was informed by the OR staff the chemical indicators had not changed, indicating the equipment used had not been sterilized.

During an interview on 11/21/2022 at 11:10 AM, CST #3 stated when he was cleaning the room, he noticed the chemical indicators in the trash, which had not changed. He spoke with CST #4 who had assisted and set-up the equipment for Patient #3's surgery. CST #4 told CST #3 she had not noticed the chemical indicators and did not catch the indicators had not changed colors at the time she was setting up the room. CST #3 confirmed the chemical indicators had not changed, indicating the equipment was not sterilized.

During an interview on 11/21/2022 at 3:30 PM, the Director of Infection Prevention confirmed the nonsterile surgical equipment was used for the patient, chemical indicators were not checked prior to the surgical procedure, and the facility failed to follow standards and policy.

Medical record review showed Patient #2 was admitted to the Main OR on 11/16/2022 for an outpatient surgical procedure including an Open Reduction and Internal Fixation (ORIF) of a left Jones Fracture nonunion (fracture of the bone on the 5th toe of the foot) and Osteotomy (surgical procedure involving cutting the bone to reshape or realign the bone).

Medical record review of an Admission H&P dated 11/16/2022 at 12:25 PM showed Patient #2 had previous left peroneal tendinitis (inflammation of tendons to the lower foot) with chronic instability, and nonunion. The patient had elected for surgical repair including ORIF with internal fixation of the left metatarsal (5th toe), repair of the tendon, graft reconstruction, osteotomy of the left lateral calcaneal (heel), left Plantar Fascia (connects the heel bone to the base of the toes) release, and possible left first metatarsal (bone behind the big 1st toe) osteotomy.

Medical record review of an Intra-operative Nursing report dated 11/16/2022 showed three of the five orthopedic screws were included in the surgical tray which had been sterilized for the surgery. The documentation showed the 4th screw, which was inserted and used for the patient, had an expiration date of 10/31/2022.

Medical record review of an Operative Report dated 11/16/2022 at 12:24 PM showed during the surgical procedure orthopedic screws were used for stabilization of the bones which were secured with internal sutures to the first metatarsal and the calcaneus. A reamer device was used to allow for the insertion of additional screws to the lateral ligaments. Review of the Operative Report showed "...did not have adequate enough fixation and secondary to the large size of the patient, decision was made to place further [named orthopedic screw] in the fibula and the hole was used to bring the graft from the posterior fibula out of the distal aspect and this was secured with good fixation. There was excellent stability of the ankle once this was complete. At the conclusion of the case it was noted that this last prescription placed had expired on October 31, 2022, however I felt that this was critical to stability of the ankle and removing it may create damage and negate the surgical repair and a decision was made to leave this in place. The patient's family was notified..."

Medical record review showed Patient #2 was monitored and was successfully awoken from anesthesia. He was discharged home on 11/11/2022 at 2:16 PM with appropriate follow-up scheduled.

Review of a facility investigation dated 11/17/2022 showed the vendor representative was in the OR during the procedure when the surgeon asked for another screw during the surgery procedure. It was found the vendor went out of the room, retrieved the screw from the "tool shed" (area in the OR where surgical equipment was stored), returned to the room with the screw, and gave the screw to a student surgical technician (ST) and the preceptor was unaware. There was no communication with the OR staff to indicate the expiration date of the implant. The screw was given to the surgeon and was surgically implanted. After the surgical procedure was completed, the OR staff recognized the screw was expired.

During an interview on 11/18/2022 at 11:05 AM, the Chief Medical Officer (CMO) stated the facility was made aware of the incident on 11/17/2022 and an investigation was initiated. The vendor representative retrieved the implant from the "tool shed", reentered the OR, pulled the bag open, and handed the implant to the student where the implant was surgically implanted. There were no discussions between the vendor, the OR team, and the surgeon regarding the expiration date of the implant and it was not noticed by the OR staff until after the surgical procedure was completed.

During an interview on 11/18/2022 at 12:30 PM, the Infection Prevention Director confirmed the standard process was not followed for checking for expired surgical implants.

During a telephone interview on 11/18/2022 at 12:55 PM, Surgeon #3 stated she had completed the surgery on 11/16/2022 when she was made aware one of the surgical implants had an expiration date of 10/31/2022.

During an interview on 11/21/2022 at 9:58 AM, CST #5 stated "...the vendor brought the screw in the room and handed it to the student from the sterile package. The student took the screw out of the wrapper and handed it to the surgeon, but there was no conversation regarding the expiration date of the screw. At the conclusion of the case, another CST had noticed the implant had an expiration date of 10/31/2022..." CST #5 confirmed the facility's policy was not followed.

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 2 patients (#1 and #3) who had surgical procedures performed with unsterilized surgical equipment and failed to ensure expired equipment was not used for 1 patient (#2) of 8 patients reviewed.

The findings included:

Patient #1 was admitted to the facility's Main Operating Room (OR) on 11/11/2022 for a revision on a nonunion (fractured bone that has not shown healing progression). The surgical procedure included the placement of orthopedic screws and hardware replacement. During the procedure, an additional reamer device (rotational cutting tool used in a variety of orthopedic surgeries) was used. The surgical procedure was completed and the surgeon exited the room. The OR team noticed the chemical indicators (indicators used to monitor whether the parameters to achieve sterilization were performed) had not changed, indicating the surgical equipment was not sterilized. The surgeon was notified and determined the surgical implant needed to be removed and replaced due to the potential of contamination of the equipment. The patient required a second revision. Patient #1 was admitted to the facility and required an Infectious Disease consult with prophylaxis treatment with antibiotics for infections. The surgical equipment located in the OR had been placed in the storage area prior to having a completed full sterilization process. The equipment was brought into the OR by a vendor representative and placed on the sterile field for use. The OR staff failed to check the chemical indicators prior to the equipment being used for the patient.

Patient #3 was admitted to the facility's Day Surgery (outpatient surgical department for the facility) on 11/17/2022 for a laparoscopic robotic bilateral inguinal repair. The surgical procedure was completed without complications, and he was transferred to the Post Anesthesia Care Unit (PACU). During the cleaning of the OR, the staff observed the chemical indicators in the trash can. It was determined the chemical indicators had not changed, indicating the surgical equipment was not sterilized prior to using the equipment on the patient. The surgical tray was placed in the Day Surgery storage area prior to having a completed full sterilization process. The tray was brought into the OR by the OR staff and chemical indicator checks were not completed by the OR staff prior to placing the tray on the sterile field and prior to using the equipment on the patient.

Patient #2 was admitted to the facility's Main OR on 11/16/2022 for an Open Reduction and Internal Fixation (ORIF) of a left Jones Fracture nonunion (fracture of the bone on the 5th toe of the foot) and Osteotomy (surgical procedure involving cutting the bone to reshape or realign the bone). The surgical procedure was completed. After the surgical procedure it was found the surgical implant expired on 10/31/2022. The expired implant was stored in the facility's OR storage area. When the surgeon requested the additional equipment during the procedure, a vendor representative retrieved the implant from the storage area, brought the implant into the OR, and handed the expired implant to a student scrub technician. The implant was placed on the sterile field for use. There was no communication by the OR staff regarding the expiration date.

Refer to A-0951

Based on review of job descriptions, review of the Association of Perioperative Registered Nurse (AORN) standards, review of facility policy, medical record review, review of documentation of facility investigations, and interviews, the facility failed to ensure surgical equipment was sterilized prior to use during surgical procedures for 2 patients (#1 and #3) and failed to ensure expired surgical implants were not used for 1 patient (#2) of 8 patients reviewed.

The findings included:

Review of a Surgical Technologist Job Description, not dated, showed "...possess expertise in the theory and application of sterile and aseptic technique...surgical procedures, and implementation and technologies to facilitate a physician's performance of invasive therapeutic and diagnostic procedure...duties are as follows: [1] checks supplies and equipment for surgical procedure...[3] sets up sterile table with instruments, supplies, equipment...[8] maintains highest standard of sterile technique during procedure..." The Circulating Surgical Technologist (CST) "...[1] checks appropriate sterile and unsterile items for procedure..."

Review of a Circulating Nurse Job Description, not dated, showed "...the circulating RN [Registered Nurse] is responsible for advocating for the surgical patient and ensuing a safe environment of care during surgery. Collaboration with Pre-Op, anesthesia, surgeon, OR (Operating Room) staff, SPD [sterile processing department] and PACU [post operative anesthesia care unit] is crucial to providing quality and safe patient care..."

Review of Facility Policy "Vendor Management Policy" last revised 6/2021, showed "...for cases requiring vendor provided products, the clinical staff will inspect for sterility and integrity of package as well as an expiration date prior to opening any item on the sterile field...vendors must only handle their products. Vendors should not open products onto the sterile field...if another manufacturer's product or a piece of equipment requires movement, a staff member must be contacted..."

Review of the Association of Perioperative Registered Nurse (AORN) standards "Sterile Field-preparing, maintain, and monitoring" last revised 2018, showed "...perioperative team members will place sterile drapes on the patient, furniture, equipment in the sterile field and handle them in a manner that prevents contamination...only sterile items will come into contact with the sterile field...perioperative personnel will observe for, recognize, and immediately corrects breaks in sterile techniques when preparing, performing, or assisting with operative or other invasive procedures, and will implement measures to prevent future occurrences...when a break in sterile technique occurs, correction will be taken immediately..."

Medical record review of Patient #1's Admission History and Physical (H&P) dated 11/10/2022 at 8:30 AM showed the patient had complaints of left knee pain and she was admitted for a revision of nonunion (fractured bone that has not shown healing progression) of the left femur. The H&P was updated on 11/11/2022 prior to the surgical procedure.

Medical record review showed Patient #1 was admitted to the Main OR on 11/11/2022 for a revision of nonunion of the left femur and was discharged home on 11/12/2022.

Medical record review of an Operative Report dated 11/11/2022 at 6:49 PM showed the patient had previously sustained a left atypical femur fracture and previously had hardware removal related to symptomatic dysfunction of distal interlocking screws. Ultimately Patient #1 developed a nonunion of the femur with shortening of the femoral shaft and nail encroaching the intra-articular (entry to the joint) surface of the knee. The patient's femur was reamed up to a size 14 ½ for placement of a size 13 nail. The distal interlocking screw was placed, the fracture was compressed, followed by proximal interlocking screw placement. Fluoroscopy was used to confirm appropriate hardware placement and alignment of the femur. The wounds were closed. At that point, the staff was informed of a sterile wrapped "reamer system" (rotational cutting tool used in a variety of orthopedic surgeries) that was possibly contaminated and used for intermedullary reaming of the femur. Since sterility could not be confirmed, the decision was made for removal and replacement of the sterile implants, debridement of the intermedullary canal, and extensive irrigation. Empiric antibiotics were begun. Following the procedure, the patient's husband was notified of the incident. An Infectious Disease consult was placed for recommendations following the possible use of a contaminated system. Patient #1 was admitted to the facility.

Medical record review of an Infectious Disease Consult dated 11/11/2022 at 4:53 PM showed "...consulted for surgical exposure to unknown source, discussed with family regarding HIV [human immunodeficiency virus-virus that attacks the body's immune system] and Hepatitis B prophylaxis [ppx]...if we cannot trace exposure, husband agrees for HIV post exposure ppx, will be starting tomorrow [within 72 hours], patient Hepatitis B non-immune, vaccine ordered, IVIG [Intravenous Immunoglobulin- therapy treatment for patients with antibody deficiencies] with pharmacy. Abx [antibiotics] broadened to Depto [daptomycin] and Mero [meropenem] for 48 hours, will also order tetanus shot..."

Medical record review of an Infectious Disease Progress Note dated 11/11/2022 at 9:19 PM showed a discussion was held with the patient and the patient's husband who were aware of the potential exposure to non-sterile hardware which had contact with the patient's skin, deep tissue, muscle, and contact with blood. It was "...immediately realized that hardware placed was non-sterile and was removed. New Femoral retrograde with proximal and distal locking screws were placed. Patient and husband are aware and want to be aggressive with post exposure prophylaxis...give Hep B vaccine and tetanus shot, started Daptomycin and Meropenem, will deescalate if remains stable...needs IVIG, discussed with pharmacy, Truvada and Raltegravir [medications to treat HIV exposure] x [times] 4 weeks..."

Medical record review of an Infectious Disease Progress Note dated 11/12/2022 at 11:46 AM showed "...continue Descovy and Raltegravir x 4 weeks 11/12/2022-12/10/2022...requested follow-up with my clinic in 4 weeks and repeat blood test...Dapto and Meropenem discontinued and started on Ceftriaxone [antibiotic]...no signs of sepsis at this time...I suggested patient to have antibiotic ppx with IV Ceftriaxone for 2 weeks-she is denying for any IV [intravenous] antibiotics...states she can take pills but no IV...recommend 2 weeks of oral Doxycycline [antibiotic] on discharge..."

Medical record review of a Discharge Summary dated 11/12/2022 at 4:17 PM showed "...pertinent events in the hospitalization include exposure to unsterile instruments in the operating room, Infectious Disease consulted...stable for discharge to home...follow-up in office in 2 weeks..."

Review of facility documentation (system investigation report) dated 11/11/2022 showed after the surgical procedure for Patient #1 was completed, the Certified Surgical Technician (CST) observed the "reamer device" had not been sterilized prior to use. The patient was still on the OR table. The CST notified the surgeon, and it was decided to remove the implant, irrigate the wound, and replace the hardware. Review of facility documentation showed during the 1st surgical procedure, the surgeon had requested a larger "reaming device" which was not present on the sterile field or in the OR. The vendor, who was in the room during the surgical procedure, exited the room, retrieved the reaming device from the equipment room, returned to the room with the equipment, and placed the non-sterile equipment on the table. The nonsterile equipment was opened and given to the CST for use, and the nonsterile equipment was used during the surgical procedure.

During an interview on 11/16/2022 at 12:25 PM, CST #1 stated she was precepting another CST. The precepting CST was scrubbed in assisting with the case. The surgeon had taken the nails out and after using the original reamer device, the surgeon had asked for a larger size, which was not in the room. The vendor representative was in the room, exited the OR to get another tray and brought the tray into the room. The vendor opened the nonsterile equipment and placed the equipment on the sterile field, and staff failed to check the equipment to determine if the equipment was sterilized. After the case was completed, CST #1 noticed the chemical indicators on the outside had not changed and there were no chemical indicators in the tray. Patient #1 was still on the OR table. CST #2 said she did not check the tray for chemical indicators. The tray was not sterile, and the nonsterile reamer had been used on the patient. The surgeon determined he would have to remove the device, clean the wound out, and replace the implant. CST #1 confirmed the equipment was not checked for chemical indicators to confirm sterility of the equipment.

During an interview on 11/16/2022 at 12:45 PM, RN #1 stated the surgeon had completed the case and had exited the room. CST #1 noticed the tray did not have chemical indicator changes, and she had questioned CST #2 if she had checked the chemical indicators. CST #2 stated she had not checked the chemical indicators and it was determined the tray was not sterilized. The surgeon came back into the room and stated he would have to remove the implant, wash the wound out, and replace the implant. The RN confirmed the equipment was not checked for the chemical indicators to confirm sterility for the equipment.

During an interview on 11/16/2022 at 2:15 PM, Surgeon #1 stated "...the reamer was used; I needed a larger size reamer and had asked for the equipment. The reamer was brought into the room and a size #14.5 was used with successful enlargement to place the implant. The screws were secured and clamped, and the surgery was successfully completed. I had exited the room and the PA [Physician Assistant] was closing. A few minutes later, the CST came and told me the equipment had not been sterilized and there was possibly contamination. I was not sure how this happened, but I determined the only safe thing to do was to take the implant out, wash the wound, and replace the implant...there was no question what we had to do...I knew I could not take any chance with it. The patient was still under anesthesia, so we re-draped, changed the sterile field, washed the wound out, and replaced the implant..."

During an interview on 11/16/2022 at 3:15 PM, the Executive Director of Orthopedic Institute stated the surgeon had texted her regarding the use of non-sterile equipment. The surgical equipment had gotten from the Sterile Processing Department (SPD) to the OR "tool shed" (designated area where sterile supplies were stored in the OR), where the equipment was brought into the OR by a vendor representative, and then given to the CST. She confirmed the OR staff failed to check the supplies for chemical indicators.

During an interview on 11/16/2022 at 4:15 PM, the Executive Director of Orthopedic Surgical Services confirmed the nonsterile equipment was in the OR "tool shed" and was available for use for Patient #1. The equipment was brought from the tool shed by the vendor representative where inspection of chemical indicators was not completed. Once the equipment was brought into the OR, the OR staff failed to inspect or confirm the chemical indicators prior to the reamer device being used during the surgical procedure.

During an interview on 11/17/2022 at 9:05 AM, the Vendor Representative stated the surgeon had asked for a "bigger reamer" device and he left the room and got the reamer from the "tool shed" room. He stated "...I just grabbed the equipment and took the tray to the room, popped the lid from the tray, and placed the tray on the table for the CST. The scrubbed CST took the equipment to the sterile field and set it up for the case. I did not check for chemical indicators and after the case was finished, the OR staff discovered the tray had not been sterilized..." The vendor representative confirmed he and the OR staff did not discuss chemical indicator checks when the tray was brought in. He did not check the tray for chemical indicators and confirmed obtaining OR supplies were not within his role while being in the OR.

During an interview on 11/17/2022 at 9:15 AM, CST #2 stated the vendor had brought the reamer into the room and the CST had gotten the reamer out of the tray and handed it the surgeon. After the case was completed, CST #1 noticed the chemical indicator in the trash had not changed, indicating the tray was not sterilized. CST #1 asked me "...if I had checked the indicator and I told her I had not checked it prior to handing the reamer to the surgeon. I should have checked it prior to getting the reamer out of the tray, but I did not. When she showed me the indicator, it had not changed..."

Medical record review showed Patient #3 was admitted to the Day Surgery (outpatient surgical department for the facility) on 11/17/2022 for a left and right laparoscopic inguinal repair (operation performed in the abdomen or pelvis using small incisions with the aid of a camera). He was discharged on 11/17/2022 and readmitted on 11/18/2022 for an Infectious Disease Consult and discharged on 11/19/2022.

Medical record review of an H&P dated 11/17/2022 at 9:32 AM showed Patient #3 reported feeling discomfort in the pelvic region with bulging on the left side which was noticed 1 month prior to the assessment. The surgical procedure was discussed with the patient along with the risks and benefits of surgery and the patient signed a consent for a robotic assisted bilateral inguinal hernia repair.

Medical record review of an Operative Report dated 11/17/2022 at 11:24 AM showed a left and right laparoscopic inguinal repair was successfully performed.

Medical record review of a Physician's addendum note dated 11/17/2022 at 6:28 PM showed "...I was notified [about 12:45 PM] by the OR staff after completing the patient's case regarding concerns about an instrument tray used in surgery. They were concerned that though the tray was clean, but the internal indicators of complete sterility were not color change...I met with the patient regarding his potential risk for infection due to the use of a concerned tray. I explained that he was given a dose of antibiotics preoperatively, and I was not certain more antibiotics would be helpful...he will have close follow-up..."

Medical record review showed Patient #3 was readmitted to the facility on 11/18/2022 for follow-up of infection concerns and an Infectious Disease consult.

Medical record review of an Admission H&P dated 11/18/2022 at 2:42 PM showed the patient was postoperative 1 day after a robotic-assisted bilateral inguinal hernia repair. He was admitted for Infectious Disease consult and recommendations.

Medical record review of an Infectious Disease Consult dated 11/18/2022 at 5:20 PM showed Patient #3 was admitted after a surgical procedure and there were concerns the surgical tray used for his procedure did not have chemical indicators, indicating the surgical tray was not sterilized. There was no information of which patient the tray may have been previously used for. Recommendations by Infectious Disease were as follows:
1. Hepatitis B Vaccine and observe for Hepatitis C.
2. Postexposure prophylaxis with Descovy and Tivicay (antiviral medications) for 28 days.
3. Approach in a fashion similar as to what would be done for occupational exposure in consideration that this was a surgical tray content exposure.
4. Cipro (antibiotic) and Linezolid (antibiotic) to start in the hospital and prescriptions through 11/25/2022.
5. Follow-up with Infectious Disease in the clinic on 11/21/2022.
6. Baseline Hepatitis B and C serology was obtained.

Medical record review of a General Surgery Progress Note dated 11/19/2022 at 9:30 AM showed Patient #3 was cleared for discharge after the Infectious Disease consult was completed and medications started. He was discharged home with follow-up with General Surgery and Infectious Disease on 11/21/2022.

During an interview on 11/21/2022 at 9:15 AM, RN #3 stated CST #3 noticed the chemical indicators for the surgical tray in the trash had not changed, indicating the surgical tray had not been sterilized. CST #3 then questioned CST #4 about the indictors. CST #4 stated she did not notice the chemical indicators had not changed. RN #3 confirmed "...the indicators should be checked prior to placing the sterile tray on the sterile field. This did not happen..."

During an interview on 11/21/2022 at 9:20 AM, CST #4 stated "...I can't explain why I didn't get indicators out. [CST #3] had seen them in the trash and noticed it...I thought they were okay and tossed them into the trash. The chemical indicators had not changed, and the checks did not happen...for some reason I didn't catch it. The surgical tray was in the OR storage room and was brought into the OR and I just didn't catch it..." She confirmed the chemical indicators had not changed indicating the surgical tray was not sterilized and the standard work process was not followed.

During an interview on 11/21/2022 at 9:40 AM, RN #4 stated CST #3 noticed the chemical indicators were in the trash and the chemical indicator had not changed colors indicating the tray was not sterilized. CST #3 discussed this with CST #4, and it was confirmed the indicators were not changed. The surgeon was notified of the possibility the tray was not sterile.

During an interview on 11/21/2022 at 11:00 AM, Surgeon #2 stated he was made aware of the unsterile equipment after the surgical procedure had been completed. He was informed by the OR staff the chemical indicators had not changed for the equipment that was used, indicating the equipment had not been sterilized. The OR staff were investigating how the equipment had gotten to the OR storage area without being sterilized. He stated "...I did question the staff as to how this occurred, and I would have to inform the patient and the family regarding the use of nonsterile equipment...I did disclose to the patient and the family of the incident and told them I was not sure of the sterility of the equipment and if he would be subject to an infection...I spoke with our Infectious Disease, and it was agreed the patient needed antivirals, antibiotics, and have preliminary labs drawn...the next morning, I spoke with the patient, and we agreed that he would come back to the facility for admission and for an Infectious Disease consult..."

During an interview on 11/21/2022 at 11:10 AM, CST #3 stated when he was cleaning the room, he noticed the chemical indicators in the trash, which had not changed. He spoke with CST #4 who had assisted and set-up the equipment for Patient #3's surgery. CST #4 told CST #3 she had not noticed the chemical indicators and did not catch the indicators had not changed colors at the time she was setting up the room. CST #3 confirmed the chemical indicators had not changed, indicating the equipment was not sterilized.

Medical record review showed Patient #2 was admitted to the Main OR on 11/16/2022 for an outpatient surgical procedure including an Open Reduction and Internal Fixation (ORIF) of a left Jones Fracture nonunion (fracture of the bone on the 5th toe of the foot) and Osteotomy (surgical procedure involving cutting the bone to reshape or realign the bone).

Medical record review of an Admission H&P dated 11/16/2022 at 12:25 PM showed Patient #2 had previous left peroneal tendinitis (inflammation of tendons to the lower foot) with chronic instability, and nonunion. The patient had elected for surgical repair including ORIF with internal fixation of the left metatarsal (5th toe), repair of the tendon, graft reconstruction, osteotomy of the left lateral calcaneal (heel), left Plantar Fascia (connects the heel bone to the base of the toes) release, and possible left first metatarsal (bone behind the big 1st toe) osteotomy.

Medical record review of an Intra-operative Nursing report dated 11/16/2022 showed three of the five orthopedic screws were included in the surgical tray which had been sterilized for the surgery. The documentation showed the 4th screw, which was inserted and used for the patient, had an expiration date of 10/31/2022.

Medical record review of an Operative Report dated 11/16/2022 at 12:24 PM showed during the surgical procedure orthopedic screws were used for stabilization of the bones which were secured with internal sutures to the first metatarsal and the calcaneus. A reamer device was used to allow for the insertion of additional screws to the lateral ligaments. Review of the Operative Report showed "...did not have adequate enough fixation and secondary to the large size of the patient, decision was made to place further [named orthopedic screw] in the fibula and the hole was used to bring the graft from the posterior fibula out of the distal aspect and this was secured with good fixation. There was excellent stability of the ankle once this was complete. At the conclusion of the case it was noted that this last prescription placed had expired on October 31, 2022, however I felt that this was critical to stability of the ankle and removing it may create damage and negate the surgical repair and a decision was made to leave this in place. The patient's family was notified..."

Medical record review showed Patient #2 was monitored and was successfully awoken from anesthesia. He was discharged home on 11/11/2022 at 2:16 PM with appropriate follow-up scheduled.

Review of a facility investigation dated 11/17/2022 showed the vendor representative was in the OR during the procedure when the surgeon asked for another screw during the surgery procedure. It was found the vendor went out of the room, retrieved the screw from the "tool shed" (area in the OR where surgical equipment was stored), returned to the room with the screw, and gave the screw to a student surgical technician (ST) and the preceptor was unaware. There was no communication with the OR staff to indicate the expiration date of the implant. The screw was given to the surgeon and was surgically implanted. After the surgical procedure was completed, the OR staff recognized the screw was expired.

During an interview on 11/18/2022 at 11:05 AM, the Chief Medical Officer (CMO) stated the facility was made aware of the incident on 11/17/2022 and an investigation was initiated. The vendor representative retrieved the implant from the "tool shed", reentered the OR, pulled the bag open, and handed the implant to the student, and the implant was surgically implanted. There were no discussions between the vendor, the OR team, and the surgeon regarding the expiration date of the implant and it was not noticed by the OR staff until after the surgical procedure was completed. The surgeon was made aware of the expired equipment and made the decision based on the surgical findings, the screw would not be removed. The CMO stated "...in this case, the surgeon had the correct position for the screw, and she had the CST and the PA holding the site to place the screw. The vendor went and retrieved the screw and brought it into the room. He should have handed it off to the circulating nurse who should have been the designated person to hand the equipment to the sterile field. There should have been a verbal exchange between the OR staff and the surgeon related to the expiration date which did not occur. This was not the normal procedure and given the gravity of the surgeon needing the screw immediately and quickly, the event escalated, and our normal procedures were not followed..."

During an interview on 11/18/2022 at 12:30 PM, the Infection Prevention Director confirmed the standard process was not followed for checking for expired surgical implants.

During a telephone interview on 11/18/2022 at 12:55 PM, Surgeon #3 stated she had completed the surgery on 11/16/2022 when she was made aware one of the surgical implants had an expiration date of 10/31/2022. She stated "...given the fact that this surgical procedure was so complex, and the stability of the bone was achieved, I felt it was in the best interest of the patient to not remove the screw and place the patient at risk for an increased nonunion of this implant...I disclosed this to the patient and told him I felt this was the safest option and he agreed. I told him we would follow him closely..."

During an interview on 11/21/2022 at 9:58 AM, CST #5 stated the vendor brought the screw in the room and handed it to the student ST from the sterile package. The student took the screw out of the wrapper and handed it to the surgeon, but there was no conversation regarding the expiration date of the screw. At the conclusion of the case, another CST had noticed the implant had an expiration date of 10/31/2022. CST #5 stated normally the circulating nurse would have gotten the screw, checked the expiration date, and placed it on the sterile tray or handed it to the CST or the surgeon. At that time there should have been discussion regarding the expiration date between the OR staff and the surgeon. CST #5 confirmed the facility's policy was not followed.