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Based on observation, interview, record review and policy review, the hospital failed to ensure infection prevention policies were followed when:
- Staff failed to follow their policy regarding high humidity levels within the operating room (OR) and sterile processing areas when staff visualized wet sterile instruments and packages and did not dispose of contaminated items, leaving them available for use during sterile procedures. (A-749)
- Staff failed to follow manufactures recommendation for the re-use of surgical breast implants for one patient (#2) of five surgical procedures involving breast implants reviewed. (A-749)
- Staff failed to perform hand hygiene (washing hands with soap and water or alcohol-based hand sanitizer) prior to providing care for three patients (#4, #48 and #61) of 13 patient observed. (A-749)
- Staff failed to appropriately doff personal protective equipment (PPE, such as gloves, gowns, goggles and masks) after providing care for one patient (#66) of two patients observed in isolation. (A-749)
- Staff failed to properly date food items located in patient nutrition rooms, including the dry goods and refrigerated foods in 22 of 29 units. (A-750)
The hospital census was 488.

The severity and cumulative effects of these systemic practices resulted in the overall non-compliance with 42 CFR 482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs, which resulted in a condition of Immediate Jeopardy (IJ).

As of 08/25/23, the hospital had provided an immediate action plan sufficient to remove the IJ when the hospital implemented the following actions:
- The hospital removed and replaced all surgical instruments and supplies from the affected ORs.
- Materials Management provided an OR supply inventory to identify, remove and dispose of any product remaining from 07/31/23.
- Equipment carts containing instruments with compromised sterility were moved from the clean side to the decontamination side of the Sterile Processing Department.
- Infection Prevention will perform surveillance from surgeries performed from 07/31/23 through 08/25/23 during possible utilization of supplies in question.
- Administration revised the hospital's Utility Failure policy and plan.
- Hospital leadership communicated their actions to surgeons and surgery staff via huddles at the beginning of each shift to ensure staff were aware that patient safety was the priority and encouraged staff to speak up if they had concerns.

46856

Based on observation, interview, policy review and nationally-recognized standards, the hospital failed to ensure they followed infection prevention policies when:
- Staff failed to follow their policy regarding high humidity levels within the operating room (OR) and sterile processing areas when staff visualized wet sterile instruments and packages and did not dispose of contaminated items, leaving them available for use during sterile procedures.
- Staff failed to follow manufactures recommendation for the re-use of surgical breast implants for one patient (#2) of five surgical procedures involving breast implants reviewed.
- Staff failed to perform hand hygiene (washing hands with soap and water or alcohol-based hand sanitizer) when providing care for three patients (#4, #48 and #61) of 13 patients observed.
- Staff failed to appropriately doff personal protective equipment (PPE, such as gloves, gowns, goggles and masks) after providing care for one patient (#66) of two patients observed in isolation.

These failures had the potential to expose all patients, visitors and staff to cross contamination and increased the potential to spread infection. The hospital census was 488.

Findings included:

Review of the hospital's policy titled, "Infection Prevention IP Plan 2023," reviewed 02/20/23, showed the following were the responsibilities of the infection prevention program to reduce the risk of Healthcare Associated Infections and infectious diseases and, to protect the health of patients, staff and visitors through surveillance, prevention antibiotic stewardship and control of hospital acquired infections and infectious diseases in our patients, staff and visitors.
- Maintain a sanitary hospital environment to limit sources of transmission of infection and communicable disease.
- Ensure safe practices for cleaning and disinfecting environmental surfaces, carpeting and furniture.
- Ensure sanitary inpatient rooms, surgical areas, supply storage, treatment areas, labs, waiting rooms, meeting rooms and bathrooms.
- Promote utilization of alcohol-based hand sanitizers among physicians and all coworkers.
- Monitor compliance with policies, procedures, protocols and other infection prevention program requirements to ensure the safety of patients, visitors, and staff.
- Ensure the use of standard precautions, including the use of PPE, to reduce the infection transmission and exposure to staff, patients and visitors.
- Ensure transmission based precautions are in place in response to the suspected or identified pathogen. The precautions identified are droplet, airborne, contact, enteric or a combination of these precautions. Appropriate use and technique of PPE including gowns, gloves, masks, eye protection, and respirator as recommended by the Centers for Disease Control (CDC).

Review of the hospital's policy titled, "Incident Operations Plan - Surgery Participation," dated 03/04/21, showed that the Administrative Director of Surgical Services and charge nurse will be notified if an incident Alert is a drill or an actual emergency. When a disaster level has been activated and categorized, the charge nurse, or designee, in collaboration with Anesthesia, will determine which elective cases may proceed. Internal:
- An event at the hospital facilities that causes damage to one or more departments, which impairs these departments from normal operations.
- All departments will develop a contingency plan for the continuation of operations if an event causes damage to the hospital in general or their unit in particular. This plan will designate an area to which staff and equipment could be relocated in order to provide essential services.
- When an Incident Alert level has been activated and the nature of the disaster has been assessed, the charge nurse or designee is responsible for:
* Notifying the Administrative Director of Surgical Services, or the next person on the Emergency Call Tree, until the Management team has been notified;
* Maintain communication with Anesthesia Services, surgeons, Post Anesthesia Care Unit (PACU), and Sterile Processing Department (SPD);
* Determining the number of operating rooms available;
* Determining the number of personnel currently on duty;
* Assessing additional staffing needs based on number of injuries and injury types;
* Assessing current availability of supplies, equipment and instrumentation;
* Assessing additional supply, equipment, and instrumentation needs based on number of injuries and injury types. S
- Surgical Services personnel on duty will remain in the operating room during the disaster.

Review of the hospital's policy titled, "Utility Management Plan - Springfield Hospitals & Outpatient Services," dated 02/08/23, showed that air handling and filtration equipment designed to control airborne contaminants including vapors, biological agents, dust, and fumes are monitored and maintained by the Engineering Department. If system performance cannot be adjusted to meet code requirements or occupant needs, the Engineering, Infection Prevention departments and clinical staff develop appropriate temporary management practices.

Review of the hospital's policy titled, "Indoor Air Quality," dated 11/09/20, showed the HVAC systems at Cox Health facilities are designed to:
- Maintain the indoor air temperature and humidity at comfort levels for staff, patients and visitors;
- Remove contaminated air;
- Facilitate air-handling requirements to protect susceptible staff and patients from air borne healthcare-associated pathogens; and
- Minimize the risk of transmission of airborne pathogens from infected patients.
HVAC equipment that serves critical areas (e.g. operating rooms [ORs] and surgery) are supplied with emergency power. Contingency plans are also in place that address the possibility of disruptions to the HVAC equipment serving these areas.

Review of the hospital's document titled, "Humidity/Temperature Checks," dated 07/31/23, showed that ORs 1, 2, 3, 21, and 26 did not have humidity levels above 60%. The heart, neuro (relating to nerves or the nervous system), anesthesia, and vender supply rooms had humidity levels above 60%.

Review of the hospital's undated document titled, "Timeline of Critical Events During Power Outage/Severe Storms on July 30, 2023," showed the following:
- On 07/30/23 at 11:30 PM, Staff GGG, OR Charge RN, contacted Staff QQ, Manager, and sent photos of supplies, walls, flooring, and SPD department. Engineering was aware of the situation and actively working to resolve the issue. First case carts (carts containing surgical instruments and sterile single use disposable items for a specific patient or surgery) were not salvageable, second case carts were moved to Unit E, where the air handler units were functioning within normal humidity range. The hospital was put on Trauma/OR divert.
- On 07/31/23 at 12:49 AM, Staff QQ, Manager, called Staff Z, OR Nurse Manager, to discuss the issue. It was determined to call the administrator on call for further guidance.
- At 1:30 AM, Staff QQ, Manager, called the Nursing Administrator on call, who recommended calling Staff G, Vice President of Operations.
- At 1:38 AM, Staff G, Vice President of Operations, was called and made aware of the situation.
- At 1:40 AM, Staff QQ, Manager, spoke with Staff X, Administrative Director of OR, and discussed postponing the first scheduled OR cases until they had a better plan from engineering. Staff GGG, OR Charge RN, contacted patients to let them know not to come in at 5:30 AM, but that they would be updated as Cox staff were able to.
- At 2:45 AM, ORs 1, 2, 3, 21, and 26 were deemed functional, since they were never out of range.
- At 3:00 AM, OR and SPD began to level back out into normal range. SPD started re-sterilizing emergency sets.
- At 4:57 AM, Staff Z, OR Nurse Manager, spoke with Staff YY, SPD Manager, who was at Cox South. She contacted Infection Prevention and asked for them to be in as soon as possible to look at the supplies.
- At 6:00 AM, Staff Z, OR Nurse Manager, arrived at the OR front desk. All but five ORs were back in range. She spoke with Staff U, SPD Manager. Emergency trays were being sterilized to allow Cox South to come off of diversion.
- At 6:30 AM, Staff Z, OR Nurse Manager, Staff X, Administrative Director of OR, Staff G, Vice President of Operations, and Staff NNNN, Director of Infection Prevention, deemed that only urgent or emergent OR cases would be performed.
- At 7:00 AM, Incident Command was established.
- At 8:30 AM, The Trauma/OR diversion was discontinued.

Review of the hospital's undated document titled, "Milestones," showed the following:
- On 07/31/23 at 12:00 AM, 90% humidity was reported in SPD. Case carts were moved to the OR.
- At 12:51 AM, the generators were on. Air handlers/chillers were manipulated.
- At 1:50 AM, air handlers were functioning with a report of 67 degrees Fahrenheit in SPD.
- At 2:30 AM, OR returned case carts to SPD due to rising humidity.
- At 7:00 AM, Infection Prevention, OR leadership, Administration, and SPD met to discuss risk analysis.

Review of the hospital's document titled, "Incident Command - Weather Event," dated 07/31/23, showed the OR was on divert but urgent/emergent cases were going ahead. SPD was up and running, and 25 instrument sets were sent to Hospital B's SPD for sterilization to help with backlog. Infection Prevention had cleared the surgical packs for use once a risk assessment had been completed.

Review of the hospital's document titled, "Incident Command - Weather Event Agenda for PM Call", dated 07/31/23, showed the patients canceled on 07/31/23 were rescheduled. All cases were ready for 08/01/23.

Review of the hospital's document titled, "Real-World Notes," dated 08/01/23 at 9:00 AM, showed all three location ORs were "up and running as if yesterday had never happened. We have a full schedule for the next four days. We will keep an eye on SPD to make sure they can keep up." They planned to continue to use Hospital B's SPD to reprocess peel packs and items not used much.

Review of the hospital-provided electronic mail communication from Staff A, Administrative Director of Regulatory Affairs, to the State Department of Health and Senior Services Bureau of Hospital Standards (SA), dated 08/01/23, showed the following:
- On 07/31/23 at 9:11 AM, Staff A notified the SA that Cox Health was experiencing major power outages since 1:00 AM due to severe weather. Cox South SPD was reprocessing all surgical instruments due to the high humidity level for a sustained amount of time. They were on surgery and trauma diversion.
- At 12:07 PM, Staff A updated the SA that Cox South OR was now able to perform urgent emergent cases and would hopefully expand to elective cases later that day.
- On 08/01/23 at 9:34 AM, Staff A updated the SA that all operations were back to normal.

During an interview on 08/28/23 at 2:30 PM, Staff OOO, Director of Environmental Services (EVS), stated that he was not included in the emergency preparedness plan following the humidity event on 07/31/23.

Review of the hospital's policy titled, "Scope of Services - South Operating Room," dated 03/22/21, showed the Department of Surgical Services at Cox South offers comprehensive surgical services. Cox South surgical services are available 24 hour per day, seven days a week. The standards and practice guidelines the department follow include the Association of PeriOperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), Association of Professionals in Infection Control (APIC), and Centers for Disease Control and Prevention (CDC).

Review of the hospital's policy titled, "Scope of Services - Sterile Processing Department," dated 03/18/21, showed that the Sterile Processing Department (SPD) is a vital part of Surgical Services that provides all the processing needs for surgical instrumentation, cameras, scopes, loaner sets and other various items used during surgical procedures. The Sterile Processing Department at Cox South operates 24 hours a day, seven days a week.

Review of the hospital-provided document titled, "AORNeGuidelines+ Guidelines for Perioperative Practice: Design and Maintenance (NEW)," dated 07/20/23, showed the following:
- A systematic process for resolving unintentional variances in the surgical suite (e.g. temperature and humidity outside of heating ventilation and air conditioning (HVAC) parameters for any amount of time) includes steps to take when a disruption is initially noticed; escalation and communication with the OR and Health Care Organization (HCO) chain of command; and the team that will conduct the risk assessment and determine the necessary steps to mitigate associated risks including delays and cancellations.
- The effect of the HVAC system parameters falling out of range is variable. Maintaining backups and taking immediate steps to restore fixed ventilation systems in emergencies facilitates a safe surgical suite.
- Elements of the risk assessment may include the duration and magnitude of the variation in temperature and humidity (if any); evidence of condensation, dampness, water drips, or water damage; concern for compromise of supply sterility; the risk profile of the potentially affected supplies; the Instructions for Use (IFU) regarding supply storage; the level of gross contamination (e.g. water intrusion level); the presence of dirt, debris, and dust on surfaces, walls, or ceilings; and the presence or possibility of environmental fungi or pathological bacteria.
- Based on the risk assessment, corrective measures may include sequestering and relocating supplies, restoring OR and HVAC functionality, and monitoring for additional adverse effects; rescheduling or redirecting procedures to areas of the surgical suite where the HVAC system is functioning in accepted parameters; delaying elective procedures; limiting surgical procedures to emergency procedures only; or closing the affected OR(s).
-Based on the risk assessment, measures taken to restore the surgical suite to full functionality after the HVAC system variance has been corrected may include reprocessing according to manufacturer's IFU or discarding any supplies with packaging that may have been compromised; and inventorying discarded, damaged supplies for insurance claim purposes and to assist with obtaining replacements.

Review of the hospital's policy titled, "Packaging and Shelf-Life of Sterile Supplies and Instruments," dated 08/15/23, showed that the shelf life of products processed in Sterile Processing was determined to event related sterility. An event related to shelf life is linked to events that would compromise the sterility of the package such as dirt, ripped packaging, dust, broken seals, etc. Single-use disposable items may be marked with an expiration date by the manufacturer. This date is acceptable as long as the package has not been damaged. Damage consists of visible package altering such as: dust, dirt, water spots, tearing, and broken seals. Single use disposable items with no expiration date are considered sterile until the package is damaged or opened. In the event of a rapid change in temperature and/or humidity or prolonged exposure to humidity conditions outside the range, the Department of Surgical Services will consult with Infection Prevention and American National Standards Institute (ANSI)/AAMI guidelines for mitigation of temperature and humidity will be followed.

Review of the hospital's policy titled, "Environmental/Infection Control for Cleaning, Disinfection, Sterilization, Transportation," dated 03/27/23, showed that storage of clean and sterilized items shall be in well-ventilated, limited access areas with controlled temperature and humidity. Sterile items shall be stored away from water, windows, doors, exposed pipes and vents.

Review of the hospital-provided document titled, "Management and Mitigation of Temperature and Humidity Events in the Perioperative Setting," dated 2021, showed the following:
- Extreme temperature and humidity variations that persist for extended periods in perioperative areas can increase the risk to patient safety.
- Condensation events may compromise the sterility of surgical supplies as a result of water intrusion and the subsequent proliferation of waterborne bacteria or medically relevant fungi, thereby increasing the risk of patient infection.
- Clean and sterile supplies may become contaminated if moisture penetrates an item's protective covering or packaging. The item can then become a source of infection when placed on the sterile field, used for patient care, or implanted as part of a procedure. Many pathogenic microbes thrive in elevated relative humidity, especially if the conditions are prolonged.
- If damage to supplies and equipment goes undetected and results in poor patient outcomes, the harm and longitudinal effects of postoperative infections could be substantial.
- For a rapid increase in humidity, if any visible dampness is found, do not start any new operative or other invasive procedures until the humidity level no longer causes condensation. Exceptions may be made to proceed with emergent surgeries only after a terminal cleaning (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) and ideally using surgical supplies from an area unaffected by the humidity event. Consider any internally reprocessed wrapped, peel packaged, or containerized sterile items with evidence of moisture as contaminated and fully reprocess. Do not use single use sterile products until infection control staff members can make additional assessments in conjunction with perioperative staff members and manufacturers.
- When assessing supplies, perioperative personnel should consider the type of supply and packaging materials, visible evidence of contamination, and the risk of contamination transfer from the compromised supplies to the patient. They should also review the manufacturer's IFU, or, if necessary, consult the manufacturer directly to determine the expected performance of the product and packaging. Perioperative staff members should individually inspect all supplies for contamination because not all supplies may need to be discarded.
- Multidisciplinary collaboration and research on infection control implications for out-of-range temperatures and humidity parameters are needed from regulatory organizations.

Review of the hospital-provided document titled, "Restoring Office-Based Surgical Facility Function Post-Hurricane Irma: Lessons Learned From Multiple Facilities," dated 2019, showed the following:
-Moisture in contact with a sterile package is considered a contaminating event and therefore the AORN (2019) recommends that the facility reprocess or discard any sterile items with condensation or suspected water damage.
- An example facility affected by Hurricane Irma was advised by AORN to reprocess all items that were not commercially sterilized and to contact the manufacturers as to whether the items could be returned to stock or whether they needed to be discarded. The manufacturers agreed that unless the item had been in direct contact with water or other contamination, it was not necessary to discard it.

Review of the hospital's document titled, "Risk Assessment - Sterile Processing and Surgery," dated 07/31/23, showed the following:
- Sterile and non-sterile products were stored in a non-controlled environment from 1:57 AM to 7:25 AM (six hours and 28 minutes).
- For humidity out of recommended range, mitigation actions included performing visual and tactile inspection of water droplets on walls, surfaces, and products. If water was present, every product was assessed. Sterile items became damp with the humidity reaching 90%. Damp supplies were considered contaminated if wet or torn per CDC and AORN. AORN recommended a multidisciplinary risk assessment for events such as this. AORN stated that humidity higher than 60% for greater than 18 hours increases risk to patient safety.
- For the integrity of in house sterile processed instruments, mitigation actions included visual and tactile inspection. There was no evidence of moisture. All instruments (wrapped, peel packs and pans) were reprocessed since the packaging was not as robust as commercially manufactured sterile consumable supplies.
- For the integrity of commercially sterilized supplies/implants compromised, mitigation actions included visual and tactile inspection. There was no evidence of moisture. All instrument packs were reprocessed per policy.
- For package permeability, mitigation actions included inspection. Packages were dry to touch. Some steam indicator tape was noted to be peeling. Steam sterilization strips from known high humidity exposure and towel packs were exposed to boiling water and cold water and allowed to stand for five minutes on a paper towel to check moisture permeability. There was no evidence of moisture permeability on package strips. The outer wrapping of the sterile item was not compromised by moisture when exposed to boiling water tests performed on manufactured major extremity packs.
- For the integrity of peel pack items inside plastic containers, mitigation actions included visual and tactile inspection. No visible moisture was present, and they were dry to touch. The container was an additional exterior barrier that was resistant to moisture. No moisture was visible.
- For the integrity of commercially sterilized supplies and implants compromised, mitigation actions included visual and tactile inspection. There was no evidence of moisture. All instrument packs were reprocessed per policy. The internal sterile packaging of commercially manufactured sterile disposable items was surrounded by secondary and tertiary packaging resistant to moisture and physical damage.
- For high humidity in the surgery suites, mitigation actions included delayed or canceled cases until rooms were in range or emergent cases arose. Surgery was on divert. Only urgent or emergent cases were performed when instruments were reprocessed.
- For surgery supplies/consumables exposed to high humidity, mitigation actions included inspecting first case cart supplies stored in surgery suites during the high humidity event. Wrapped, pan and peel pack instruments were reprocessed. Manufactured sterile consumable supplies were assessed, retained, and used. Obtaining replacement sterile consumable supplies would have taken an extended period of time and could have affected patient mortality. These were manufacturer sterilized, single use disposable items. These packages had secondary and tertiary wrappings and were not found to be compromised.

During an interview on 08/28/23 at 3:35 PM, Staff NNN, Physician, stated that he was in the OR during the humidity event on 07/31/23, and he saw physical moisture on the floors and walls.

Review of the hospital's document titled, "7/31/23 Products Removed from service," dated 07/31/23, showed a list of items that were discarded. The total number of items discarded was 123.

During an interview on 08/24/23 at 12:35 PM, Staff GG, Director of Infection Prevention, stated that a risk assessment began in the OR four hours after the humidity event happened. For the risk assessment they tested one sterile instrument and didn't find any wetness, none of the bins were wet. They did not see wetness anywhere when they did their assessment. All supplies that had wetness were either reprocessed or thrown out

During an interview on 08/22/23 at 11:15 AM, Staff A, Administrative Director of Regulatory Affairs, stated that on 07/31/23 there was a storm that caused a massive power outage. The temperature and humidity in areas of the hospital got too high. The hospital had to go on surgical diversion. Infection Prevention went in for an assessment, and any items that could get damp were thrown away and anything that could be was reprocessed. On 08/01/23 by noon the hospital was back to normal.

During an interview on 08/23/23 at 2:00 PM and 08/24/23 at 12:30 PM, Staff CCC, Infection Prevention Coordinator, stated that on 07/31/23, they performed their assessment of the supplies and carts on 07/31/23 from around 7:00 AM to 11:00 AM. They looked at the case carts and assessed for dampness and condensation. They looked in the supply bins in the trauma ORs. They assessed trauma OR 12 and did not find any condensation. OR 12 was chosen because it had lots of supplies and had been affected. They looked at all the supplies and bins. They opened sterile packs that had been in SPD and the OR with high humidity and found that there was no condensation or dampness in any of the sterile packs they opened. They did not dispose of 100% of the items. Staff was told to use their judgement on any questioned items and to ask their managers. They pulled a set that was wrapped in plastic off of one of the case carts. They opened it up and all the supplies inside it were dry. They also took a pack of sterile OR towels, dumped boiling water on the paper part of the packaging and let it sit for about five minutes. They opened the package and there was no strikethrough (unintended penetration of a fluid or liquid and contamination of a sterile field when fluid soaks through a barrier material, allowing microbes [microorganism, especially a bacterium causing disease] access to the sterile field). They only tested one towel package. They inspected the SPD bins and basins for storage, and they were dry, not damp to touch. The disposable items had packaging that had to withstand shipping and maintain sterility, and they felt that the packaging protected the supplies enough so they were not affected and were okay to use. Manufacturer IFUs did not normally have instructions specific to the humidity event situation. Staff CCC had no concerns for using the supplies on patients.

During an interview on 08/24/23 at 12:30 PM, Staff LLL, Infection Preventionist, stated that manufacturer's IFUs give general guidelines. They "put the ball back in your court to do your own risk assessment." Infection Prevention had been checking for any additional anomalies for all patients who had surgery two weeks after 07/31/23.

Review of the hospital's document titled, "2023 Springfield Weekly SSI Report," dated 08/10/23, showed no surgical site infections (SSI) were identified from surgeries performed from 07/31/23 onward.

Review of the hospital-provided electronic mail communication from Staff X, Administrative Director of OR to Staff A, Administrative Director of Regulatory Affairs, dated 08/10/23, showed that one of the quality nurses had voiced some concerns how things were handled. The nurse had examples or concerns about the OR supply rooms. The Neuro supply room was deemed not safe and the items were reprocessed. The Urology, ENT and Ortho supply rooms were deemed safe since the humidity stayed within range. Her concern was "what if." Staff X worked with Staff U, SPD Manager, and the supply room peel packs and instruments were to have been reprocessed too, to be safe.

During an interview on 08/23/23 at 2:00 PM, Staff BBB, Administrator for Quality and Safety, stated that there had been no increase in surgical site infections since the humidity event on 07/31/23. She did not think the OR kept a list of disposable items that were discarded.

Review of Patient #5's medical record showed that he was a 39-year-old male who was admitted to Cox Medical Centers South on 07/29/23 after a crush injury to his right chest. He had multiple surgeries throughout his hospitalization. An exploratory laparotomy (surgery to look inside the abdomen to diagnose or treat abdominal health conditions) surgery started on 07/31/23 at 6:07 AM and ended at 6:35 AM.

During an interview on 08/28/23 at 1:00 PM, Staff MMM, Physician, stated that Patient #5 had abdominal compartment syndrome (emergency condition where the pressure inside the abdomen abnormally increases to dangerous levels and can cause organ failure) and needed surgery on 07/31/23. Abdominal compartment syndrome can kill bowel in 20 to 30 minutes; there was no time to transfer him. Patient #5 needed the procedure done to save his life. Staff MMM found out about the sterility issues in the OR after Patient #5 had surgery. He was not concerned about the sterility of the equipment used, his only concern was the amount of sterile equipment available. No staff had shared concerns with him regarding equipment or supply use on patients since 07/31/23.

During an interview on 08/24/23 at 8:30 AM, Staff GGG, OR Charge RN, stated that on 07/30/23, SPD called and told Staff GGG that the humidity was "through the roof." SPD staff used the freight elevators to bring case carts up from SPD to protect them from the high humidity. Staff GGG called Staff QQ, Manager, and asked her to call in the on call OR team. She told him to hold off on calling in the on call team. Staff GGG and the other OR staff got the case carts to the OR. They brought up extra case carts for the scheduled cases that morning and placed them in Unit E, which was not affected by the humidity, due to being on a different air handler. Staff GGG notified the trauma surgeon of the humidity problems, and the trauma surgeon told Staff GGG that Patient #5 needed emergent surgery. Patient #5 had abdominal compartment syndrome. They did have enough sterile supplies to do the surgery and place a wound vacuum assisted closure (wound VAC, a device that decreases air pressure on a wound to help it heal more quickly). Staff GGG had enough instruments that had not been compromised that were pieced together for surgery. All trauma ORs had instruments removed. The neuro supply room had instrument sets with tape peeling off of them, which indicated that they needed to be reprocessed. The heart supply room's instruments were all contaminated. Around 4:30 AM or 5:00 AM, the humidity finally started coming down in SPD. Their plan was to process emergency instrument sets, such as a trauma set and a heart set, as soon as the temperature and humidity were back in range and they could wrap the instruments without fear of contamination. Any carts with tape peeling on the instrument sets were sent down to SPD. Everything in the rooms and on the carts, including disposable items, had water droplets on the packaging, which meant they were contaminated. If it was wet and on the case carts, Staff GGG and the OR staff sent the whole case carts down to SPD, including the disposable items on the cart. There was no way to track what was being sent back down to SPD. Management did come in to help. When management got there, things had already started to dry out. When he came back on shift the following Friday, he heard that people from Infection Prevention and Administration came in to inspect the ORs. There was a staff meeting where Management were talking about the contaminated items. They told staff "when in doubt, throw it out," and if any instruments were questionable, to send the instruments back down to SPD.

During a telephone interview on 08/24/23 at 9:15 AM, Staff HHH, Surgical Technician, stated that on 07/31/23 SPD had issues with humidity, and Staff GGG, OR Charge RN, said SPD was sending everything they could from downstairs to try to save as many carts as they could. The case carts were brought to the OR. Then, they noticed that the OR humidity levels were getting bad. They started pulling the case carts into Unit E, which was still at a good humidity level. The walls and floor of the ORs were visibly wet. The papers on the case carts were wet, so she assumed all the disposables with paper packaging were contaminated. She did not throw anything away or bag any disposable items up. The case carts had a mix of disposable items and instruments. If there was tape peeling on the cart, she did not sort through the cart; the whole cart was held back. Staff GGG went around and kept checking the humidity levels, and he called the supervisor. OR staff were in a holding pattern for several hours waiting on instructions from Management. The trauma surgeon called and was told that they did have a backup room and some instruments. Staff HHH assumed everything in SPD and most of the ORs were not sterile. There were "tens of thousands of items in SPD." They did have enough instruments and supplies to do an exploratory laparotomy. She did not feel that they ever got a plan from Management. They were told to cancel everything, and at some point, the early case patients were called and told to come in

Based on observation, interview, and policy review, the hospital failed to ensure they followed infection prevention policies when staff failed to properly date food items located in patient nutrition rooms, including the kitchen refrigerated items and dry goods, in 22 out of 29 units that had a patient nutrition area.

These failures had the potential to expose all patients, visitors and staff to cross contamination and increased the potential to spread infection. The hospital census was 488.

Findings included:

Review of the hospital's policy titled, "Infection Prevention IP Plan 2023," reviewed 02/20/23, showed that ensuring the safe techniques for food sanitation including food storage were the responsibilities of the infection prevention program to reduce the risk of Healthcare Associated Infections and infectious diseases and, to protect the health of patients, staff and visitors through surveillance, prevention antibiotic stewardship and control of hospital acquired infections and infectious diseases in our patients, staff and visitors.

Observations on 22 of 29 units at Cox Medical Centers South, Meyer Orthopedic and Rehabilitation and Cox North showed food items including graham crackers, saltine crackers, single packets of peanut butter, packets of sugar, creamer, salt, and refrigerated butter had no date of use by or expiration date on them, or the container they were stored in.

During an interview on 08/28/23 at 2:30 PM, Staff OOOO, Administrative Director of Food and Nutrition Services, stated that staff did not have a system for tracking when certain food items in patient nutrition rooms, including refrigerated and dry goods were placed, or expired.


46856

Based on interview, record review, and policy review, the hospital failed to:
- Ensure terminal cleaning (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) of multiple areas in the surgical suite and operating rooms (OR) was performed prior to performing a surgical procedure for one current Patient (#5), after a humidity disaster event on 07/31/23 when moisture on the walls and floors was visualized by OR staff. (A-0951)
- Properly execute informed consent forms, prior to surgery were completed for six patients (#2, #5, #25, #26, #27 and #52) of 34 records reviewed. (A-0955)
- Provide an immediate postoperative report for one current patient (#5), and nine discharged patients (#6, #15, #16, #19, #23, #33, #35, #41 and #52) of 23 patient records reviewed. (A-0959)

These failed practices had the potential to compromise the safety and health of all patients undergoing surgeries at the hospital. The hospital, through three seperate campuses, performed a total of approximately 2,984 surgeries per month. The hospital census was 488.

The cumulative effect of these failures resulted in non-compliance with 42 CFR 482.51 Condition of Participation: Surgical Services.

Based on observation, interview, record review, policy review, and nationally-recognized standards, the hospital failed to ensure that terminal cleaning (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) of multiple areas in the surgical suite and operating rooms (OR) was performed prior to performing a surgical procedure for one current Patient (#5), after a humidity disaster event on 07/31/23, when moisture on the walls and floors was visualized by OR staff.

This failed practice had the potential to compromise the safety and health of all patients undergoing surgeries at the hospital after a disaster event.

Findings included:

Review of the hospital's policy titled, "Scope of Services - South Operating Room," dated 03/22/21, showed the Department of Surgical Services at Cox South offers comprehensive surgical services. Cox South surgical services are available 24 hours per day, seven days a week. The standards and practice guidelines the department follow include the Association of PeriOperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), Centers for Medicare and Medicaid Services (CMS), Association of Professionals in Infection Control (APIC), and Centers for Disease Control and Prevention (CDC).

Review of the hospital-provided document titled, "AORNeGuidelines+ Guidelines for Perioperative Practice: Design and Maintenance (NEW)," dated 07/20/23, showed the following:
- A systematic process for resolving unintentional variances in the surgical suite (e.g. temperature and humidity outside of heating, ventilation and air conditioning (HVAC) parameters for any amount of time) includes escalation and communication with the OR and Health Care Organization (HCO) chain of command; and the team that will conduct the risk assessment and determine the necessary steps to mitigate associated risks including delays, cancellations, and no action.
- The effect of the HVAC system parameters falling out of range is variable. Maintaining backups and taking immediate steps to restore fixed ventilation systems in emergencies facilitates a safe surgical suite.
- Elements of the risk assessment may include evidence of condensation, dampness, water drips, or water damage; concern for compromise of equipment function sterility; the level of gross contamination (e.g. water intrusion level); the presence of dirt, debris, and dust on surfaces, walls, or ceilings; and the presence or possibility of environmental fungi or pathological bacteria.
- Based on the risk assessment, corrective measures may include restoring OR and HVAC functionality, and monitoring for additional adverse effects; rescheduling or redirecting procedures to areas of the surgical suite where the HVAC system is functioning in accepted parameters; delaying elective procedures; limiting surgical procedures to emergency procedures only; or closing the affected OR(s).
-Based on the risk assessment, measures taken to restore the surgical suite to full functionality after the HVAC system variance has been corrected may include terminally cleaning when there is evidence of contamination on surfaces.

Review of the hospital's policy titled, "Environmental Controls - Surgery," dated 08/09/23, showed that if any environmental monitoring shows the operating rooms out of range, the room will be taken out of service until corrective action can be taken and it is back within range. The humidity level of the operating rooms will be maintained within a range of 30-60 percent. In the event of rapid change in temperature and/or humidity or prolonged exposure to humidity conditions outside the range, the Department of Surgical Services will consult Infection Prevention to initiate a risk assessment and corrective actions to mitigate risk as recommended by AORN guidelines and AAMI standards.

Review of the hospital's policy titled, "Environmental/Infection Control for Cleaning, Disinfection, Sterilization, Transportation," dated 03/27/23, showed that counter tops, sinks, and other surfaces located in patient care areas or areas used to prepare patient items are to be cleaned with a hospital approved cleanser daily or when visibly soiled.

Review of the hospital's undated policy titled, "Surgical Areas Cleaning - Environmental Services," showed that when daily OR schedule is completed, OR rooms should be re-cleaned. Clean and disinfect waste containers and re-line. Clean and disinfect surgical lights and high equipment/surfaces. Disassemble OR table, damp wipe/disinfect surfaces and allow to dry. Reassemble when dry. Damp wipe and disinfect all horizontal and vertical surfaces, including walls, OR tables, kick buckets, equipment, chairs, doors, cabinets, etc. Damp wipe and disinfect scrub sink areas related to the OR suite and replenish all supplies. Wet mop floors, pulling debris to doorway to be collected after mopping is completed. Wet vacuum floor surfaces. Clean and disinfect associated sub-sterile room and ancillary areas. Document cleaning on OR Terminal Cleaning Completion Log. Clean and disinfect corridors, storage areas, instrument clean-up rooms, sterile storage rooms.

Review of the hospital-provided document titled, "Management and Mitigation of Temperature and Humidity Events in the Perioperative Setting," dated 2021, showed the following:
- Extreme temperature and humidity variations that persist for extended periods in perioperative areas can increase the risk to patient safety.
- If damage to supplies and equipment goes undetected and results in poor patient outcomes, the harm and longitudinal effects of postoperative infections could be substantial.
- For a rapid increase in humidity, if any visible dampness is found, do not start any new operative or other invasive procedures until the humidity level no longer causes condensation. Exceptions may be made to proceed with emergent surgeries only after a terminal cleaning and ideally using surgical supplies from an area unaffected by the humidity event
- After the temperature and humidity of the environment have been restored to recommended levels, environmental cleaning services personnel should perform terminal cleaning in the affected areas. Surgeons should notify any affected patients about the potential risks and instruct them to monitor themselves for signs of infection.
- Multidisciplinary collaboration and research on infection control implications for out-of-range temperatures and humidity parameters are needed from regulatory organizations.

Review of the hospital's undated document titled, "Timeline of Critical Events During Power Outage/Severe Storms on July 30, 2023," showed the following:
- On 07/30/23 at 11:30 PM, Staff GGG, OR Charge RN, contacted Staff QQ, Manager, and sent photos of supplies, walls, flooring, and SPD department, Engineering was aware of the situation and actively working to resolve the issue. The hospital was put on Trauma/OR divert.
- On 07/31/23 at 12:49 AM, Staff QQ, Manager, called Staff Z, OR Nurse Manager, to discuss the issue. It was determined to call the administrator on call for further guidance.
- At 1:30 AM, Staff QQ, Manager, called the Nursing Administrator on call, who recommended calling Staff G, Vice President of Operations.
- At 1:38 AM, Staff G, Vice President of Operations, was called and made aware of the situation.
- At 1:40 AM, Staff QQ, Manager, spoke with Staff X, Administrative Director of OR, and discussed postponing the first scheduled OR cases until they had a better plan from engineering. Staff GGG, OR Charge RN, contacted patients to let them know not to come in at 5:30 AM, but that they would be updated as Cox staff were able to.
- At 2:45 AM, ORs 1, 2, 3, 21, and 26 were deemed functional, since they never were out of range.
- At 3:00 AM, OR and SPD began to level back out into normal range. SPD started re-sterilizing emergency sets.
- At 6:00 AM, Staff Z, OR Nurse Manager, arrived at the OR front desk. All but five ORs were back in range.
- At 6:30 AM, Staff Z, OR Nurse Manager, Staff X, Administrative Director of OR, Staff G, Vice President of Operations, and Staff NNNN, Director of Infection Prevention, deemed that only urgent or emergent OR cases would be performed.
- At 8:30 AM, The Trauma/OR diversion was discontinued.

Review of the hospital's document titled, "Humidity/Temperature Checks," dated 07/31/23, showed that ORs 1, 2, 3, 21, and 26 did not have humidity levels above 60%. The heart, neuro, anesthesia, and vender supply rooms had humidity levels above 60%.

Review of the hospital's document titled, "EVS Terminal Clean Log," dated 07/31/23, showed no documentation that terminal cleans were performed in OR 12 or the storerooms prior to surgeries after the humidity event.

Review of the hospital-provided electronic mail communication from Staff A, Administrative Director of Regulatory Affairs, to the State Department of Health and Senior Services Bureau of Hospital Standards (SA), dated 08/01/23, showed the following:
- On 07/31/23 at 9:11 AM, Staff A notified the SA that Cox Health was experiencing major power outages since 1:00 AM due to severe weather. They were on surgery and trauma diversion.
- At 12:07 PM, Staff A updated the SA that Cox South OR was now able to perform urgent emergent cases and would hopefully expand to elective cases later that day.
- On 08/01/23 at 9:34 AM, Staff A updated the SA that all operations were back to normal.

Review of Patient #5's medical record showed the following:
- He was a 39-year-old male who was admitted to Cox Medical Centers South on 07/29/23 after a crush injury to his right chest. He had multiple surgeries throughout his hospitalization.
- An exploratory laparotomy (surgery to look inside the abdomen to diagnose or treat abdominal health conditions) surgery started on 07/31/23 at 6:07 AM and ended at 6:35 AM.
- The surgery was performed in OR 12.

During an interview on 08/23/23 at 2:00 PM, Staff A, Administrative Director of Regulatory Affairs, stated that there was one emergent surgery on 07/31/23, but the surgery was performed in an OR room that was not impacted by the humidity event.

During an interview on 08/23/23 at 2:00 PM, Staff CCC, Infection Prevention Coordinator, stated that on 07/31/23, they assessed trauma OR 12 for moisture and condensation. OR 12 was chosen because it had a large quantity of supplies and was affected by the humidity event, thus providing a large sample size of potentially wet instruments and supplies. No condensation or moisture was found in OR 12.
(Note: This OR was utilized on 07/31/23 at 6:00 AM for a surgical procedure, prior to the Infection Prevention assessment from 7:00 AM to 11:00 AM.)

During a telephone interview on 08/24/23 at 9:15 AM, Staff HHH, Surgical Technician, stated that on 07/31/23 around 12:00 AM, the power flickered and the generators started working. SPD had issues with humidity. Then, OR staff noticed that the OR humidity levels were getting bad. The walls and floor of the ORs were visibly wet. Staff GGG went around and kept checking the humidity levels, and he called the supervisor. OR staff were in a holding pattern for several hours waiting on instructions from Management. The trauma surgeon called and was told that they did have a backup room and some instruments. They did have enough instruments and supplies to do an exploratory laparotomy. They did not do a terminal clean on the OR prior to Patient #5's surgery; they wiped down the OR with wipes and mopped the floor. She did not feel that they ever got a plan from Management. They were told to cancel everything, and at some point, the early case patients were called and told to come in around 12:00 PM instead of 5:30 AM.

During an interview on 08/24/23 at 8:30 AM, Staff GGG, OR Charge RN, stated that on 07/30/23, a storm came through and knocked out the power at Cox South. SPD called and told Staff GGG that the humidity was "through the roof." Staff GGG notified the trauma surgeon of the humidity problems, and the trauma surgeon told Staff GGG that Patient #5 needed emergent surgery. Patient #5 had abdominal compartment syndrome (emergency condition where the pressure inside the abdomen abnormally increases to dangerous levels and can cause organ failure). Staff GGG had enough instruments that had not been compromised that were pieced together for surgery. They did have enough sterile supplies to do the surgery and place a wound vacuum assisted closure (wound VAC, a device that decreases air pressure on a wound to help it heal more quickly). They did not do a terminal clean on the OR in which the patient had surgery. They did wipe down all flat surfaces and the bed prior to the surgery.

During an interview on 08/28/23 at 3:35 PM, Staff NNN, Physician, stated that he was in the OR during the humidity event on 07/31/23, and he saw physical moisture on the floors and walls.

During an interview on 08/28/23 at 1:00 PM, Staff MMM, Physician, stated that Patient #5 had abdominal compartment syndrome and needed surgery on 07/31/23. Abdominal compartment syndrome can kill bowel in 20 to 30 minutes; there was no time to transfer him. Patient #5 needed the procedure done to save his life. Staff MMM found out about the sterility issues in the OR after Patient #5 had surgery. He was not concerned about the sterility of the equipment used, his only concern was the amount of sterile equipment available. No staff had shared concerns with him regarding equipment or supply use on patients since 07/31/23.

During an interview on 08/28/23 at 2:35 PM, Staff W, EVS Supervisor for OR/SPD, stated that on 07/31/23, after the OR temperature and humidity levels decreased, EVS staff did a full terminal clean. She did not believe EVS staff scrubbed the ORs with their deep cleaning machine. Terminal cleanings were done once per day, unless there was an isolation surgical case. EVS staff do occasionally clean the OR supply rooms, the anesthesia techs take care of their own rooms. Staff W would not have been surprised if the OR supply rooms were affected due to their close proximity. There was no documentation of the OR supply rooms being cleaned after the humidity event on 07/31/23.

During an interview on 08/28/23 at 2:30 PM, Staff OOO, Director of Environmental Services, stated that EVS performed terminal cleaning in the OR daily and he had staff dedicated to the OR only. The only time EVS staff did not clean OR rooms was overnight, then the OR nurses cleaned the rooms. He was not included in the emergency preparedness plan following the humidity event on 07/31/23.

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Based on interview, record review, and policy review, the hospital failed to ensure that a properly executed informed consent form was completed prior to surgery for six patients (#2, #5, #25, #26, #27 and #52) of 34 records reviewed.

This failure had the potential to place all surgical patients at risk when necessary information was not provided to them before agreeing to the surgery. The hospital census was 488.

Findings included:

Review of the hospital's policy titled, "Consent to Surgery or Other Procedure," dated 02/04/22, showed the following:
- The signed consent shall include documentation of the date and time the consent signatures or telephone consent is obtained.
- Abbreviations may not be used on a consent form.
- The signed consent form obtained during the inpatient admission is valid throughout the hospital stay for the completion of the designated surgery/invasive or other procedure. This includes consents signed before admission (i.e. during preadmission process) or prior to the procedure within the clinic, ambulatory and outpatient setting.
- The primary purpose of the informed consent process is to ensure that the patient or the patient's alternate decision maker is provided information necessary to enable him/her to evaluate a proposed surgery/invasive or other procedure prior to consent.
- The properly executed consent form reflects the patient's informed consent to the ordered surgery, procedure, or treatment.
- The informed consent process includes a discussion about potential benefits, risks, and side effects of the patient's proposed care, treatment and services and any potential problems that might occur during recuperation. The informed consent process also includes a discussion about reasonable alternatives to the patient's proposed care, treatment, and services.

Review of Patient #2's medical record showed the following:
- She was a 58-year-old female who presented to Cox Surgery Center on 02/27/23 for a left capsulectomy (a surgical procedure to remove the layer of thickened scar tissue, from around a breast implant) with implant exchange-gel.
- A history and physical exam showed that she had a capsulectomy and implant exchange in 06/2022, and then had a recurrent contracture to the left breast. The left breast was firm, hard and much higher than the right.
- The consent form, signed and dated on 02/27/23 at 11:30 AM by Patient #2 and Staff LL, Physician, showed that the patient consented to have a left capsulectomy with implant exchange. A discussion included risks and benefits to the procedure, along with the risk for bleeding, infection, etc.
- Staff LL, Physician, documented that a complete capsulectomy and implant removal was performed. Antibiotic irrigation was obtained, and the implant was placed back into the pocket. The incision was closed and the patient was taken to a recovery room in stable condition.
- She was discharged home on 02/27/23 at 2:02 PM.

During a telephone interview on 06/26/23 at 1:20 PM, Patient #2, stated that she presented to Cox Surgery Center for what she believed to be a left capsulectomy with an implant exchange. Instead the physician removed the implant, irrigated it with an antibiotic solution and inserted the same implant back into her. The implant would have been replaced by the manufacturer free of charge. Doing this voided her warranty with the manufacturer.

During an interview on 08/23/23 at 9:55 AM, Staff SS, Registered Nurse (RN), stated that if it was a possibility to put an existing implant back into a patient instead of putting in a new one, that would need to be included on the informed consent.

During an interview on 08/23/23 at 10:50 AM, Staff QQ, Director of Procedure Operations, stated that it was not common to put the same breast implant back into a patient. Breast implants were all single use items. She would have to look at the manufacturer's instructions for use (IFU) for the implant. If the surgeon intended to put the same implant back into the patient, or if it was even a possibility then that should have been discussed with the patient prior to the surgery.

During an interview on 08/23/23 at 2:00 PM, Staff MM, Physician, stated that he would not discuss putting the same implant back into the patient because he would never do that. There would be no reason not to replace it with a new one as the new one would be covered by the manufacturer's warranty.

During an interview on 08/23/23 at 3:00 PM, Staff LL, Physician, stated that he and Patient #2 discussed the possibility of placing her existing breast implant back in if it looked ok, to save her money. He believed there was documentation in Patient #2's medical record regarding these discussions. Replacing the existing breast implant did void Patient #2's warranty with the manufacturer of the breast implant.

Review of the medical record of Patient #2's showed there was no documentation of discussions regarding placing existing breast implant back into her instead of replacing it with a new one.

Review of Patient #5's medical record showed the following:
- He was a 39-year-old male who was admitted to Cox Medical Centers South on 07/29/23 after a crush injury to his right chest. He had multiple surgeries throughout his hospitalization.
- His wife signed the consent for surgery on 07/31/23 at 05:11 AM. The procedure was listed as an "ex-lap" (abbreviation for exploratory laparotomy [surgery to look inside the abdomen to diagnose or treat abdominal health conditions]). There was no provider listed for the surgery. There was no time by the witness signature.
- His wife signed the consent for a chest tube insertion. There was no provider listed.
- His wife signed the consent for Continuous Renal Replacement Therapy (CRRT, non-stop, 24 hour dialysis (process that removes excess water and toxins from the blood when the kidneys can no longer perform these functions] therapy). There was no provider listed for the procedure. There was no date or time by his wife's signature. There was no witness signature, date or time on the form.

Review of Patient #25's medical record showed the following:
- He was an 80-year-old male admitted to Cox Medical Centers South on 01/30/23 after a fall with head injury.
- His wife signed consent on 02/05/23. Patient #25's name was not listed on the form in the designated area. The procedure was listed as an exploratory lap.
- His wife signed the consent on 02/15/23 for burr holes (surgery where one or more small holes are drilled in the skull and a flexible rubber tube is inserted to drain blood or fluid). The form was missing the provider name and the facility where the procedure was performed.
- His wife signed the consent on 02/22/23 for percutaneous endoscopic gastrostomy (PEG, a tube inserted through a person's abdomen directly into the stomach to provide a means of feeding when oral intake is not possible) tube placement. The form was missing the provider name and the facility where the procedure was performed.

Review of Patient #26's medical record showed he was a 76-year-old male admitted on 02/11/23 for a blood clot in his leg. On 02/24/23 he signed the consent for cardiac catheterization (a procedure where a long, thin tube is inserted in a large blood vessel that leads to the heart to diagnose or treat certain heart conditions). Patient #26's name was not listed on the form in the designated area.

Review of Patient #27's medical record showed he was a 58-year-old male admitted on 01/04/23 for a stroke. An operative report showed that a PEG tube was placed on 01/27/23. The consent for PEG tube placement was missing the provider name, the facility where the procedure was performed, patient signature with date and time, and witness signature with date and time.

Review of Patient #52's medical record showed he was a 46-year-old male admitted to Cox Medical Centers South on 07/17/23 after a motorcycle collision. His informed consent form for surgery on 08/11/23 did not have a witness signature, a time by his signature, or a time by where the witness signature would have been.

Based on policy review and record review, the hospital failed to provide an immediate postoperative report for one current patient (#5) and nine discharged patients (#6, #15, #16, #19, #23, #33, #35, #41 and #52) of 23 patient's records reviewed.
This failure placed all surgical patients at risk for their safety when operative findings were not immediately accessible in the event of emergent transfer. The hospital census was 488.

Findings included the following:

Review of the hospital's document titled, "Cox Medical Centers Medical staff Rules - Regulations," dated 06/14/23, showed that an operative report must be written or dictated immediately following surgery and signed by the surgeon.

Review of Patient #5's medical record showed the following:
- He was a 39-year-old male who was admitted to Cox Medical Centers South on 07/29/23 after a crush injury to his right chest. He had multiple surgeries throughout his hospitalization.
- A laparotomy (surgery to look inside the abdomen to diagnose or treat abdominal health conditions) surgery started on 08/09/23 at 10:18 AM and ended at 10:56 AM. The operative report was not dictated. It was written and signed on 08/09/23 at 5:07 PM, over six hours after the surgery ended.
- A laparotomy surgery started on 08/18/23 at 8:00 AM and ended at 8:41 AM. The operative report was not dictated. It was written and signed on 08/18/23 at 3:27 PM, over six hours after the surgery ended.

Review of Patient #6's medical record showed the following:
- She was an 84-year-old female admitted to Meyer Orthopedic and Rehabilitation Hospital on 07/17/23 for a right total knee replacement surgery.
- The surgery started on 07/17/23 at 11:18 AM and ended at 12:25 PM.
- The operative report was not dictated. It was written and signed on 07/18/23 at 12:04 PM, almost 24 hours after the surgery ended.

Review of Patient #15's medical record showed the following:
- She was a 36-year-old female admitted to Cox Surgery Center on 03/27/23 for cosmetic breast surgery.
- The surgery started on 03/27/23 at 7:23 AM and ended at 8:16 AM
- The operative report was dictated on 03/27/23 at 4:33 PM, over eight hours after the surgery ended, and signed 03/27/23 at 7:30 PM.

Review of Patient #16's medical record showed the following:
- She was an 84-year-old female admitted to Cox Surgery Center on 04/10/23 for cosmetic breast surgery.
- The surgery started on 04/10/23 at 1:10 PM and ended at 1:32 PM.
- The operative report was dictated on 04/11/23 at 8:14 AM, 19 hours after the surgery ended, and signed on 04/12/23 at 7:02 AM.

Review of Patient #19's medical record showed the following:
- She was a 46-year-old female admitted to Cox Surgery Center on 07/12/23 for cosmetic breast surgery.
- The surgery started on 07/12/23 at 1:45 PM and ended at 2:16 PM.
- The operative report was not dictated. It was written and signed on 07/12/23 at 6:19 PM, four hours after the surgery ended.

Review of Patient #23's medical record showed the following:
- She was a 41-year-old female admitted to Cox Surgery Center on 07/28/23 for cosmetic breast surgery.
- The surgery started on 07/28/23 at 11:09 AM and ended at 12:48 PM.
- The operative report was dictated on 07/30/23 at 1:47 AM, one day and 13 hours after the surgery ended, and signed on 08/10/23 at 9:56 AM.

Review of Patient #33's medical record showed the following:
- She was admitted to Cox Medical Centers South on 06/02/23 for cosmetic breast surgery.
- The surgery started on 06/02/23 at 10:48 AM and ended at 1:45 PM.
- The operative report was not dictated. It was written and signed on 06/02/23 at 6:12 PM, over four hours after the surgery ended.

Review of Patient #35's medical record showed the following:
- She was an 81-year-old female admitted to Meyer Orthopedic and Rehabilitation Hospital on 03/17/23 for hip surgery.
- The surgery started on 03/17/23 at 12:34 PM and ended at 1:22 PM.
- The operative report was dictated on 03/21/23 at 8:35 AM (three days and 19 hours after the surgery ended) and signed on 03/21/23 at 12:39 PM.

Review of Patient #41's medical record showed the following:
- She was a 73-year-old female admitted to Cox Medical Centers South on 08/01/23 for heart surgery.
- The surgery started on 08/01/23 at 7:51 AM and ended at 10:13 AM.
- The operative report was dictated on 08/02/23 at 6:13 AM, 20 hours after the surgery ended, and signed on 08/02/23 at 7:37 AM

Review of Patient #52's medical record showed the following:
- He was a 46-year-old male admitted to Cox Medical Centers South on 07/17/23 after a motorcycle collision. He had multiple surgeries throughout his hospitalization.
- Left leg irrigation and debridement (I&D, procedure where a liquid solution is poured over an open wound to make it easier to see the wound with removal of infected or diseased tissue to promote wound healing) surgery was started on 07/31/23 at 10:09 AM and ended at 12:04 PM. The operative report for the I&D surgery was not dictated. It was written and signed on 08/02/23 at 10:26 AM, one day and 22 hours after the surgery ended.
- Left foot open reduction internal fixation (ORIF, surgery to fix severely broken bones) surgery was started on 08/17/23 at 3:00 PM and ended at 6:27 PM. The operative report for the ORIF surgery was not dictated. It was written and signed on 08/18/23 at 12:06 PM, almost 18 hours after the surgery ended.

During a telephone interview on 08/29/23 at 4:15 PM, Staff PP, Physician, stated that the operative report was dictated when the patient was waking up from anesthesia. The operative report was then transcribed, and it would pop up on the computer within a few days for a signature.



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