HospitalInspections.org

The governing body, in accordance with hospital policy and procedures, failed to ensure that specific requirements for Infection Control oversight in the hospital's Surgical Processing Department and for cleaning of hospital equipment (Glucometer) used by multiple patients were met. The governing body in accordance with hospital policy and procedures failed to ensure that specific requirements for cleaning and processing of surgical equipment in the hospital's surgical processing department were met.

The findings are:

Cross Reference to A 0747: The hospital's Infection Control body failed to ensure a system for identifying, reporting, investigating, and documenting the monitoring of the high volume, high risk surgical sterile processing department and ensuring the competency of staff in the hospital's Surgical Processing Department for cleaning and disinfectant procedures for surgical equipment used in the hospital's surgical department and for disinfection procedures for 3 of 12 observations of glucometers used for multiple patients.

Cross Reference to A 0940: The hospital leadership failed to ensure that staff responsible for sterile processing procedures for Immediate Use Steam Sterilization (IUSS) performed those sterilization processing procedures followed accurate sterilization parameters for 4 of 4 surgical instruments, failed to ensure staff in the sterile processing department attached chemical indicator strips for 2 of 4 logs used to capture IUSS data, failed to ensure staff sterilized surgical instruments within the parameters for the manufacturer's Instructions For Use (IFU), failed to ensure documentation on the IUSS logs was accurately completed, failed to ensure the sterilization load printout data had the initials of the Sterile Processing Department staff validating the load met the appropriate cycle time and temperature parameters for sterilization, failed to ensure 2 of 2 staff were knowledgeable when pre- cleaning soiled surgical instruments accurately, and failed to ensure clarity in the hospital's policies for IUSS that also included what actions to take if there were discrepancies between the different manufacturers' instructions for use.

Four Standard Sterilzation Cycles:

Basic Cycles Description Typical Application/Load Type
Gravity The most basic sterilization cycle. Steam displaces air in the Glassware, unwrapped goods,
chamber by gravity (i.e. without mechanical assistance) waste, utensils, redbags
through a drain port.

Pre- Vacuum Air is mechanically removed from the chamber and load through Wrapped goods, packs, animal cage
and/or Post a series of vacuum and pressure pulses. This allows the steam to bedding, cages, porous materials
Vacuum penetrate porous areas of the load that couldn't otherwise be reached
with simple gravity displacement


Liquids A gravity cycle with a slower exhaust rate to minimize boil over. Media, Broth, water, etc

Flash High temperatur cycle (over 270 degrees Fahrenheit) for a shorter Unwrapped goods
(Healthcare period of time.
sterilizers only)

Based on observations, record reviews, interviews, hospital's policies and procedures reviews, and review of staff training in the surgery processing department, the hospital leadership in the Surgery Department and in Infection Control failed to ensure that its sterile processing department operated in a safe manner when cleaning and processing surgical equipment used during surgical procedures and failed to ensure accurate disinfection of the glucometer used by multiple patients for 3 of 12 observations in multiple units.

The findings are:

The hospital's failed to ensure that leadership responsible for Infection Control Program developed and implemented an active system for surveillance, documentation, and monitoring parameters for the high volume high risk surgical sterile processing department for sterilization procedures that included decontamination and sterilization procedures for surgical equipment and for disinfection procedures for 3 of 12 glucometers observed used for multiple patients.

The hospital leadership failed to ensure that staff responsible for sterile processing procedures for Immediate Use Steam Sterilization (IUSS) performed those sterilization processing procedures for accurate sterilization parameters for 4 of 4 surgical instruments, failed to ensure staff in the sterile processing department attached chemical indicator strips for 2 of 4 logs used to capture IUSS data, failed to ensure staff sterilized surgical instruments within the parameters for the manufacturer's Instructions For Use (IFU), failed to ensure documentation on the IUSS logs was accurately completed, failed to ensure the sterilization load printout data had the initials of the Sterile Processing Department staff validating the load met the appropriate cycle time and temperature parameters for sterilization, failed to ensure 2 of 2 staff were knowledgeable when pre- cleaning soiled surgical instruments accurately, and failed to ensure clarity in the hospital's policies for IUSS that also included what actions to take if there were discrepancies between the different manufacturers' instructions for use. Failure to accurately perform sterile processing procedures for surgical equipment used in the hospital's operating rooms has the potential to negatively affect any patient receiving surgical services.

On 3/17/2022 at 3:15 PM, Quality Manager #1 stated the Infection Preventionist Team conducts environmental rounds on the nursing units and in the Surgical Department to include the Operating Room. The team constantly rounds, observing, and talks to staff to identify concerns. The hospital failed to provide documentation related to the Infection Preventionist Team's environmental rounds on nursing units, nor the Surgical Departments to include the Operating Room. Quality Manager #1 verified there were no infection control audits or documentation by the Infection Preventionist Team.

On 3/17/2022 at 2:00 PM, the Sterile Processing Clinical Manager revealed he/she had performed some monitoring with the Sterile Processing Department staff for sterilization processes, but he/she had not documented the audits.

On 3/18/2022 at 4:06 PM, the Vice President of Quality and Patient Experience (VPQPE) and Director of Quality #1 revealed Infection Control personnel monitor glucose disinfection procedures and monitor sterilization procedures, but the hospital had no documentation of the monitoring.

Based on observations, record reviews, interviews, review of the hospital's policies and procedures, and review of staff training in the surgery processing department, the hospital failed to ensure that its sterile processing department operated in a safe manner when cleaning and processing surgical equipment used during surgical procedures and for 3 of 12 observations of inaccurate disinfection of the glucometer by staff.

The findings are:

Cross Reference to A 0747: The hospital's failed to ensure its leadership responsible for Infection Control Program developed and Implemented an active system for surveillance and documenting its monitoring parameters for the high volume high risk surgical sterile processing department for sterilization procedures that included decontamination and sterilization procedures for surgical equipment and for disinfection procedures for 3 of 12 glucometers observed used for multiple patients.

Cross Reference to A 0950: The hospital leadership failed to ensure its staff responsible for sterile processing procedures for Immediate Use Steam Sterilization (IUSS) performed those sterilization processing procedures followed accurate sterilization parameters for 4 of 4 surgical instruments, failed to ensure staff in the sterile processing department attached chemical indicator strips for 2 of 4 logs used to capture IUSS data, failed to ensure staff sterilized surgical instruments within the parameters for the manufacturer's Instructions For Use (IFU), failed to ensure documentation on the IUSS logs was accurately completed, failed to ensure the sterilization load printout data had the initials of the Sterile Processing Department staff validating the load met the appropriate cycle time and temperature parameters for sterilization, failed to ensure 2 of 2 staff were knowledgeable when pre- cleaning soiled surgical instruments accurately, and failed to ensure clarity in the hospital's policies for IUSS that also included what actions to take if there were discrepancies between the different manufacturers' instructions for use. Failure to accurately perform sterile processing procedures for surgical equipment used in the hospital's operating rooms has the potential to negatively affect any patient receiving surgical services.

Based on observations and interview, the hospital failed to ensure 1 of 1 sterilizer deemed inoperable was labeled and/or removed from potential staff access for 1 of 1 inoperable sterilizer unit observed in the orthopaedic surgery area.

The findings are:

On 3/15/2022 at 2:00 PM, observations on the first floor in the orthopaedic surgical area revealed a sterilizer unit that was inoperable and out of service per Director #1 who accompanied the surveyor. Director #1 reported the sterilizer unit was stuck in the charge cycle. The sterilizer unit had no sign or labeling on the sterilizer unit to alert the staff that the sterilizer unit was out of service. The finding was verified by Director #1 at 2:00 PM on 3/15/2022.

Based observations, record reviews, review of hospital sterilization logs, interviews, review of the hospital's policy , manufacturer's directions for use, and CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, the hospital's Infection Control body failed to ensure a system for identifying, reporting, investigating, and documenting the monitoring for the high volume high risk surgical sterile processing department and ensuring the competency of staff in the hospital's Surgical Processing Department for cleaning and disinfectant procedures for surgical equipment used in the hospital's surgical department and for disinfection procedures for 3 of 12 observations of glucometers used for multiple patients.

The findings are:

Cross Reference to A 0749: Based on a review of documentation related to Immediate Use Steam Sterilization (IUSS), Instrument Manufacturer's instructions for use, review of the hospital's policy, entitled, "Infection Prevention Plan", and interview, the hospital infection control body failed to ensure a system of auditing, monitoring, identifying, and investigation in the hospital's sterile processing department for oversight for the reprocessing of surgical instruments to ensure staff appropriately disinfected and sterilized surgical instruments to prevent potential surgical infections of all patients receiving services in the surgical department.

Cross Reference to A 0750: The hospital failed to ensure 1 of 1 Registered Nurses observed cleaning a glucometer (RN #7) and 2 of 2 Patient Care Technicians (PCT #1 and PCT #2) observed performing a fingerstick blood sugar on patients failed to ensure multiple-patient use glucometers remained wet with disinfectant for the full 2 minute wet contact time to ensure the effectiveness of the disinfectant in removal of potential blood borne pathogens from the glucometer surface. The hospital failed to ensure staff in the hospital's Sterile Processing Department followed the hospital's policies for cleaning and disinfecting surgical instruments prior to sterilization for 4 of 4 observations in the Sterilization Department.

Cross Reference to A 0770: The hospital's leadership responsible for Infection Control failed to ensure the hospital's Infection Control Program had an active system for identifying, reporting, documenting, and investigating risks in its high volume high risk surgical sterile processing department for cleaning and disinfectant procedures for surgical equipment used in the hospital's surgical department, and for ensuring glucometers used between patients were disinfected per the hospital's policies and procedures and accepted practices for disinfecting of glucometers.

Cross Reference to A 0773: The hospital's Infection Control Program Leadership failed to ensure oversight, assessment, monitoring, and documentation for infection control targets for sterilization procedures and for ensuring accurate disinfection for glucometers used for multiple patients throughout the hospital.

Based on a review of documentation related to Immediate Use Steam Sterilization (IUSS), Instrument Manufacturer's instructions for use, review of the hospital's policy, entitled,"Infection Prevention Plan", and interview, the hospital infection control body failed to ensure a system of auditing, monitoring, identifying, and investigation in the hospital's sterile processing department for oversight for the reprocessing of surgical instruments to ensure staff appropriately disinfected and sterilized surgical instruments to prevent potential surgical infections of all patients receiving services in the surgical department.


The findings included:

On 3/15/22 at 12:46 PM, review of the hospital's policy provided by the hospital, entitled, "Infection Prevention Plan", revealed in part, ".....policies and procedure outline the process for appropriate cleaning, disinfecting, and sterilizing of medical equipment, devices and supplies. Teammates follow standardized practices to minimize infection risks related to medical equipment, devices, and supplies. The hospital has implemented programs for infection prevention and control for the use of medical equipment, devices, and supplies." According to the policy, members of the Infection Prevention Team have begun to regularly attend the Operating Room monthly meetings to discuss surgical site infections (SSI) in a group setting with the staff on the types of SSI's that are occurring in their workspace and facilitates brainstorming to potential causes and solutions to help reduce the risk of occurrence for these type of infections. The Infection prevention program is reviewed and evaluated to prioritize risks to determine improvement needs, goals for success, results of surveillance findings, and analysis of opportunities...".

On 3/17/22 and 3/18/22, review of IUSS documentation related to the Immediate Use Steam Sterilization for 4 of 4 "flashed" instruments in January 2022 and February 2022 revealed hospital staff did not follow the instruments' manufacturer instructions for use (IFU) related to the parameters for sterilization to include the cycle type and time for a Kolbel Retractor (orthopedic retractor), a Synthes Ball Spike, and a Bulldog (vascular clamp) and an ablation cord. Review on 3/17/22 and 3/18/22 of IUSS documentation related to the Immediate Use Steam Sterilization of 4 of 4 "flashed" instruments in January and February 2022 revealed hospital staff were not following the instrument manufacturer's instructions for use (IFU) related to the parameters for sterilization to include the cycle type and time for a Kolbel Retractor (orthopedic retractor), a Synthes Ball Spike, and a Bulldog (vascular clamp). On 3/17/22 at 10:20 AM, Operating Room Nurse #1 revealed the sterilizers used for these instruments had been configured to gravity prior to 3/10/22. Review of the load strips for the instruments revealed they had all undergone a "flash" sterilization cycle. On 3/18/22 at 3:32 PM, the Chief Administrative Officer verified the sterilizers used for these instruments had been configured to gravity prior to 3/10/22. Review of the load strips for the surgical instruments revealed the surgical instruments had all undergone a "flash" sterilization cycle.

On 3/17/22 at 2:00 PM, review with the DPS of the load printout strip for the Synthese Ball Spike along with the IUSS log dated 1/7/22 revealed log documentation indicating the instrument had been removed out of the sterilizer 55 minutes after the "flash" process had been completed. The IUSS log revealed an "In Time" of 8:08 AM, and an "Out Time" of 9:16 AM. The load printout strip of the "flash" cycle revealed the start time of 8:06 AM and an end time of 8:21 AM which indicated a delay of approximately 55 minutes in the removal of the instruments after the IUSS cycle. The finding was verified with the Director of Perioperative Services (DPS) during an interview on 3/17/21 at 2:05 PM. The Director of Perioperative Services stated that it was not good to leave the instrument in the sterilizer due to moisture buildup and infection control issues.

On 3/18/22 at 2:45 PM, review of a load printout strip with the Sterile Processing Department Clinic Manager (SPDCM) revealed a "flash" cycle was performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for the Kolbel Retractor on 2/21/22. When asked which parameters the retractor should have been processed under for with IUSS, the SPDCM stated the instrument manufacturer's IFU would be followed. Review of the Ortho Med (Kolbel Retractor device manufacturer's) IFU provided to the surveyor revealed under "Steam Sterilization" to "Use a validated, properly maintained and calibrated steam sterilizer. Functional vacuum method/pre-vacuum method or gravitational methods with sufficient drying of product. Maximum sterilization temperature 273 degrees F ...Sterilization time (exposure time at sterilization temperature) at least 5 minutes at 270 degrees F ...273 degrees F, Minimum drying time for wrapped instruments is 15 minutes and for wrapped containment devices is 30 minutes. The less effective gravitational method should only be used when the fractional vacuum/pre-vacuum method is unavailable ...". The information revealed, "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization, ...". Review of the load strip revealed the load had undergone a "flash" cycle and not a prevac cycle. After reviewing the load strip and the instrument manufacturer's IFU, the SPDCM verified the instrument manufacturer's IFU had not been followed. Interviews with Operating Room Nurse #1 on 3/17/22 at 10:20 AM and the CAO on 3/18/22 at 3:32 PM revealed the sterilizers used for these surgical instruments had been configured to gravity prior to 3/10/22. Review of the load strips for the surgical instruments revealed they had all undergone a "flash" sterilization cycle.

On 3/18/22 at 2:52 PM, review of a load printout strip with the Sterile Processing Department Clinical Manager revealed the Bulldog (Instrument) had been processed with a "flash" cycle under gravity configuration at a temperature of 270 degrees Fahrenheit (F), a control temp of 273 degrees F, a sterilization time of 3 minutes, and a dry time of 1 minute. When the SPDCM was asked if she/he were going to perform IUSS on the Bulldog (as in the instance of 1/13/22) which cycle, time, and temperature would she/he use, the SPDCM reported the instrument manufacturer's IFU says to process it on a Prevac cycle at 270 degrees F for 4 minutes. Review of the device manufacturer's (Boss Instruments) IFU provided to the surveyor revealed information under "Sterilization" to "Use a validated, properly maintained steam sterilizer. Always follow instructions of the machine manufacturer. Do not exceed ...284 degrees Fahrenheit during sterilization cycle. Effective sterilization can be achieved following the steam cycle listed below: Cycle type pre-vacuum, Minimum Temperature 270 degrees Fahrenheit, Minimum Exposure 4 minutes, Dry Time 20 minutes for metal or metal plastic trays and 45 minutes for all plastic trays. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable." The instrument manufacturer's instructions did not say anything about flash or Immediate Use Steam Sterilization. After reviewing the instrument manufacturer's IFU, the SPDCM verified the instrument manufacturer's IFU had not been followed.

On 3/18/22 at 3:00 PM, review of a load printout strip with the Sterile Processing Department Clinic Manager (SPDCM) revealed a "flash" cycle had been performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for a Synthes Ball Spike on 1/7/22. When asked which parameters the Synthes Ball Spike should have been processed under with IUSS, the SPDCM stated the instrument manufacturer's IFU would be followed. Review of the DePuy Synthes IFU provided to the surveyor for the Synthes Ball Spike revealed information that " ...The following are the recommendations for the sterilization of Synthes devices: Cycle Type- Prevacuum, Sterilization Exposure Time 4 minutes, Sterilization Exposure Temperature ...270 degrees Fahrenheit), Minimum Dry Time 20 minutes...". The device manufacturer's IFU did not include information that a gravity cycle was appropriate for the instrument, only Prevacuum. The information included that "Immediate Use Steam Sterilization is only intended for individual instruments and should only be considered under emergency conditions and when approved by local policies. Synthes does not support Immediate-Use Steam Sterilization of instrument sets, cases, or implants. The following steam sterilization cycle is an example of a validated cycle for individual instruments only. Unwrapped instruments ....270 degrees Fahrenheit for 4 minutes .....Immediate-Use Steam Sterilization should be performed in accordance with current AORN and AAMI recommendations ...". After reviewing the instrument manufacturer's IFU, the SPDCM verified the instrument manufacturer's IFU had not been followed.

On 3/18/22 at 12:45 PM, in an interview with Infection Preventionist #1 who is based outside of the hospital, and with Infection Preventionist #2, who is based out of another hospital in the system, they reported that someone on the team rounds in the surgical department and sterile processing area since they have multiple team members. When asked if there is monitoring by infection prevention team members of the hospital's sterilization equipment cycles or tests on the sterilizing equipment regarding the placement of testing devices, both infection control Preventionist stated the process would be observed if it was being while they were in the area. They verified they had not come in on any 11-7 shifts when daily testing of sterilizers would be done. They indicated they have not had training to determine if specialized procedures pertaining to sterilization were done done appropriately so this would be the responsibility of the Surgical Processing Department. They just observed general things like transport of supplies relative to any infection control issues .

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, reads, "Periodic infection control rounds to areas using sterilizers to standardize the sterilizer's use may identify correctable variances in operator competence; documentation of sterilization records, including chemical and biological indicator test results; sterilizer maintenance and wrapping; and load numbering of packs. These rounds also may identify improvement activities to ensure that operators are adhering to established standards."

Based on observations, interviews, review of the hospital's policy, entitled, "Bedside Glucose Monitoring-Accu-Chek Inform II", the glucose meter's manufacturer's instruction for cleaning and disinfection, and the General Guidelines for Use for the Super Sani-Cloth germicidal wipe, the hospital failed to ensure 1 of 1 Registered Nurses observed cleaning a glucometer (RN #7) and 2 of 2 Patient Care Technicians (PCT #1 and PCT #2) observed performing a fingerstick blood sugar on patients failed to ensure multiple-patient use glucometers remained wet with disinfectant for the full 2 minute wet contact time to ensure the effectiveness of the disinfectant in removal of potential blood borne pathogens from the glucometer surface. The hospital failed to ensure staff in the hospital's Sterile Processing Department followed the hospital's policies for cleaning and disinfecting surgical instruments prior to sterilization for 4 of 4 observations in the Sterilization Department.

The findings are:

Observations on 3/16/22 at 10:00 AM in the Cardiac Care Unit revealed Registered Nurse (RN) #7 demonstrated the procedures for a fingerstick blood sugar using a glucometer designated for multiple patient use. After demonstrating the fingerstick blood sugar procedure, RN #7 set the glucometer down, removed gloves, performed hand hygiene, and donned a clean pair of gloves. RN #7 removed a Super-Sanicloth wipe from the container and wiped the glucometer for 17 seconds. RN #7 stated the glucometer had to dry for 2 minutes before the next patient. Observations of the glucometer showed that within 45 seconds into the disinfection process, the disinfectant had evaporated, and the glucometer surface was dry. During an interview on 3/16/22 during the procedure, RN #7 verified the glucometer had not been wetted for the full 2 minutes. When RN #7 was asked if she/he was aware of the hospital's instructions for use for glucometer disinfection related to how to accurately clean glucometers, RN #7 stated that she/he was aware there had been instructions for accurately cleaning the glucometer, but was not aware those instructions were for the glucometers used at the nursing station.

Observations on 3/16/22 at 11:00 AM on the hospital's third floor nursing unit revealed PCT #2 transporting a glucometer into a patient room 3010 on the third floor. The glucometer is used for more than one patient. After checking the patient's blood sugar, PCT #2 removed gloves, performed hand hygiene, donned clean gloves, removed a Super-Sani-Cloth from the container, and wiped the glucometer surface with the Super - Sani - Cloth for a total of 15 seconds. PCT #2 set the glucometer down, removed gloves, and performed hand hygiene. PCT #2 placed the glucometer back in the holder at the nurse station after 1 minute time had elapsed. Observations with PCT #2 revealed the glucometer surface was dry when the glucometer was placed in the holder. The finding was verified with the PCT #2 during an interview on 3/16/22 at 11:12 AM.

On 3/16/22 at 1:13 PM, observations revealed PCT #1 entering patient room 4031 on the fourth floor to do a blood sugar check. The glucometer used for the procedure is used for more than one patient. After checking the patient's blood sugar, PCT #1 removed gloves and performed hand hygiene. PCT #1 donned clean gloves, placed a paper towel on the counter, used a Super-Sani-Cloth and wiped the glucometer for 18 seconds, placed the glucometer on the towel and waited. The glucometer surface was not wet and /or damp after waiting 1 minute and 38 seconds into the disinfection process. While waiting, PCT #1 was asked what she/he was waiting for, and PCT #1 stated she/he was waiting for the 2 minutes timeframe. PCT #1 stated she/he didn't know how, but thought the glucometer should stay wet with disinfectant, but was unsure how to accomplish this. When asked, the PCT #1 stated she/he was unsure how much time had elapsed as she/he wasn't timing the 2 minutes. During an interview on 3/16/22 at 1:25 PM, PCT #1 verified the glucometer had not stayed wet for the full 2 minute contact time.

On 3/18/2022 at 4:06 PM, in an interview with the Vice President of Quality and Patient Experience (VPQPE) and Director Of Quality #1, they revealed Infection Control personnel monitor glucose cleaning on the nursing units and monitor the sterilization areas, but do not document the monitoring of the areas. The VPQPE stated, "It is an opportunity for us" at 4:06 PM on 3/18/2022.

On 3/16/22 at 11:13 AM, review of the hospital's policy, provided by the hospital, entitled, "Bedside Glucose Monitoring-Accu-Chek Inform II", revealed that an approved product for cleaning and disinfecting the glucometer was the PDI Super Sani-Cloth with Alcohol. "...(Gluco)Meters used with multiple patients require cleaning before, disinfecting after every use, and if there is obvious contamination...Disinfection kill times are listed on the individual wipe containers...Disinfecting destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms (e.g. bacterial spores). KILL TIMES MUST BE FOLLOWED TO ALLOW DISINFECTION OF THE METERS per manufacturer...".

On 3/16/22, review of the Roche Point of Care Accu-Chek Inform II guide for Cleaning and Disinfection provided by the hospital revealed to disinfect the glucometer, use an approved wipe. "...Disinfect by gently wiping outside of meter 3 times horizontally, then three times vertically, and carefully around test strip port. Allow the meter surface to remain damp for entire contact time with recommended disinfection solution for ...2 minute contact time with Super Sani-Cloth Germicidal Disposable Wipes..."

On 3/16/22, review of the instructions related to glucometer cleaning posted in the nursing stations revealed, "Low level Disinfection Process for all Multi-Patient use Equipment, Specifically, Accu-Chek Inform II Meter, 1. All Multi Use Patient Equipment must be disinfected after use and in between patients. This includes the Accu-Chek Inform II meter. 2. To disinfect the device: Wipe the entire surface of the Accu-Chek Inform II meter with a hospital approved disinfecting wipe such as -Super Sani Germicidal Wipe. This includes the front, back, sides, and test strip port (All Surfaces). Ensure the device remains wet for a full 2 minutes when using the Super Sani Germicidal Wipe. (Happy Birthday or ABC song-Repeated 4 times). Use as many wipes as necessary for the device to remain wet for a full 2 minutes...".

Review of a document submitted by the hospital that was identified as "Roper St. Francis Accucheck Mandatory", revealed, "Yearly competency is completed by: - Running both levels of controls on the meter within 30 days of the anniversary date of the initial training. - Completion of written in-line test in NetLearning. To review the policy, click on the link below. Accucheck (link). Please proceed to Take Test option located at the top of the screen."


41743

On 3/15/2022 at 10:27 AM, observations in the hospital's Sterile Processing Department (SPD) on the second floor revealed Sterile Processing Technician (SPT) #7 washing surgical equipment in a sink filled with water and surgical equipment. The water temperature in the sink was 69.2 degrees Fahrenheit(F) based on the temperature probe in the water in the sink. Observations of a sign located on the wall above the sink revealed, "Water temperature is to be between 80-110 degrees Fahrenheit. Equipment should soak in the wash sink for five minutes." Observations showed the surgical equipment had been in the washing sink for an undetermined amount of time. The finding was verified at 10:27 AM on 3/15/2022 by Sterile Processing Technician #7 who stated, "I didn't notice it. Must have just started this morning. We just keep going." When Sterile Processing Technician #7 was asked how long the surgical equipment had been soaking in the sink, he/she shrugged his/her shoulders and gave no verbal response.

On 3/15/2022 at 11:16 AM, observations of Engineering Personnel #1 revealed he/she checked the water temperature in the sink in the Disinfection/Cleaning Room #1 with a hand held digital immersion thermometer and determined the water temperature was 68.6 degrees Fahrenheit and verified the temperature probe in the sink reading 68.6 degrees Fahrenheit was accurate.

On 3/15/2022 at 11:20 AM, Engineering Personnel #1 traveled to Disinfection/Cleaning Room #2 and revealed the handheld digital immersion thermometer in the water in the cleaning sink was 71.2 degrees Fahrenheit, and the probe in the water in the sink showed the water temperature was 68.4 degrees Fahrenheit which was below the 80 degrees to 110 degrees F noted on the signage above the sink.

On 3/15/2022 at 11:25 AM, observations of Director #1 measured the amount of enzymatic cleaner dispensed into the five gallons of water in the sink. The machine dispensed five ounces of enzymatic cleaner into the five gallons of water into the sink. On 3/15/2022 at 11:25 AM, review of the instructions for the enzymatic cleaner revealed two and one-half ounces of enzymatic cleaner should be used for five gallons of water. Director #1 verified the machine was dispensing the wrong amount of enzymatic cleanser into the five gallons of water in the sink at 11:25 AM on 3/15/2022.

The hospital had documentation of training for the Sterile Processing Department staff in January 2022 and March 2022, but observations showed the staff were not able to demonstrate competency for required cleaning and disinfection procedures for glucometers and surgical equipment.

Review of the Centers Disease Control (CDC) Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, reads, "Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high- level disinfection and sterilization because inorganic and organic materials that remain on surfaces of instruments interfere with the effectiveness of these processes. Decontamination removes pathogenic microorganisms from objects so they are safe to handle, use, or discard."

Facility policy, titled, "Decontamination of Soiled Instruments and Devices", latest review/revision 09/20/2019, reads in part,
"Purpose: To establish protocols for the cleaning of surgical instrumentation and devised in preparation for high level disinfection or sterilization. To establish cleaning protocols which will assist in assuring sterility and provide for patient personnel safety."
"Policy: All instruments and devices shall be cleaned and/or decontaminated per the device manufacturer's written instructions. A copy of the cleaning instructions is maintained in the Decontamination Area for staff reference. The device manufacturer's current IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. All reusable surgical instruments and devices must be decontaminated, high level disinfected or sterilized before reuse. All used surgical instruments and devices are considered contaminated (Standard Precautions)."
"Procedure: .....6. Unless otherwise directed by the IFUs, items should be pretreated with an initial cold water rinse with running tap water or an initial soak in cool water and/or a clinical - soil- dissolving pretreatment product (e.g., an enzymatic cleaner or ph neutral detergent).
Procedure:6.h. Monitor the water temperature as required in the manufacturer's written IFU; and will prevent coagulation and thus assist in the removal of protein substances. NOTE - Lukewarm water and detergent solutions (at temperatures optimally in the range of 27 degrees C(centigrade) to 44 degrees C[80 degrees F(Fahrenheit), but not to exceed 60 C [140 degrees F]."



41879

On 03/18/2022 at 11:09 AM, observations in the Sterile Processing Decontamination and Pre-Clean area revealed Sterile Processing Technician #5 placed half of a large dirty metal tray into the water in a sink filled with other soiled surgical instruments. Half of the large soiled tray was submerged in the sink with the enzymatic cleaning solution while the other half of the soiled tray was not submerged. The other surgical instruments that were already in a tray in the sink were displaced out of the tray into the enzymatic water. Then observations showed Sterile Processing Technician #5 placed the large tray on the side of the sink, removed the surgical instruments from the sink, and placed the surgical instruments into the tray. On 3/18/2022 at 11:15 AM, observations showed the tray was over half filled with the surgical instruments that were in the water in the sink. Sterile Processing Technician#5 was asked about the other half of soiled tray that was not submerged in the water in the sink, Sterile Processing Technician #5 stated, "I'll go back and get to that."

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Table 10, Page 115, titled, "Factors affecting the efficacy of sterilization", reads, "(Factor) Cleaning 1, (Effect) Failure to adequately clean instruments results in higher bioburden, protein load, and salt concentration. These will decrease sterilization efficacy."

Facility policy, titled, Decontamination of Soiled Instruments and Devices", latest review/revision 09/20/2019, reads in part, "Purpose: To establish protocols for the cleaning of surgical instrumentation and devised in preparation for high level disinfection or sterilization. To establish cleaning protocols which will assist in assuring sterility and provide for patient personnel safety."
"Policy: All instruments and devices shall be cleaned and/or decontaminated per the device manufacturer's written instructions. A copy of the cleaning instructions is maintained in the Decontamination Area for staff reference. The device manufacturer's current IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. All reusable surgical instruments and devices must be decontaminated, high level disinfected or sterilized before reuse. All used surgical instruments and devices are considered contaminated (Standard Precautions)." 2. Separate utensils from instruments. NOTE: To prevent damage keep delicate items in specialty containers for reprocessing) if applicable. a. Remove trays from inside rigid containers but keep the instruments in protective holders for processing. b. Separate specialty and non - immersible items. i. Heavier instruments should be placed on the bottom and lighter instruments, more delicate instruments on top to prevent damage. "

Based on observations, record reviews, and review of the hospitals "Infection Prevention Plan", the hospital's leadership failed to ensure the hospital's Infection Control Program had an active Infection Control Program in place for identifying, reporting, documenting, and investigating potential risks in its high volume high risk surgical sterile processing department for cleaning and disinfectant procedures for surgical equipment used in the hospital's surgical department, and for ensuring glucometers used between patients were disinfected per the hospital's policies and procedures and accepted practices for disinfecting of glucometers.

The findings are:

On 3/15/22 at 12:46 PM, review of the hospital's "Infection Prevention Plan" policy revealed ,"Policies and procedures outline the process for appropriate cleaning, disinfecting, and sterilizing of medical equipment, devices and supplies. Teammates follow standardized practices to minimize infection risks related to medical equipment, devices, and supplies. The hospital has implemented programs for infection prevention and control for the use of medical equipment, devices, and supplies."

Review of the hospital's Infection Control Committee meeting minutes dated 2/18/2021, 4/15/2021, 5/20/2021, 6/17/2021, 9/18/2021, 10/21/2021, and 2/17/2022 revealed there was no documentation that showed the hospital's Infection Control Committee had collected data to show monitoring point of care devices (such as the glucometer for appropriate cleaning and disinfection) or any data collected and analyzed relating to the processes critical to infection control in the Operating Rooms/Surgical Processing Department (proper cleaning, disinfection, and sterilization procedures).

On 3/17/2022 at 3:15 PM, Quality Manager #1 stated the Infection Preventionist Team conducts environmental rounds on the nursing units and in the Surgical Department to include the Operating Room. The team constantly rounds, observing, and talks to staff to identify concerns, but the hospital had no documentation related to the Infection Preventionist Team's rounds or the findings. Quality Manager #1 verified there were no infection control audits or documentation by the Infection Preventionist Team.

On 3/17/2022 at 2:00 PM, the Sterile Processing Clinical Manager revealed he/she had performed some monitoring with the Sterile Processing Department staff for sterilization processes, but he/she had not documented the audits.

On 3/18/2022 at 4:06 PM, the Vice President of Quality and Patient Experience (VPQPE) and Director Of Quality #1 revealed Infection Control personnel monitor glucose disinfection procedures and monitor sterilization procedures, but the hospital had no documentation of the monitoring.

Based record reviews and interview, the hospital's leadership team failed to ensure that their Infection Prevention policy was followed as evidenced by failing to maintain or provide documented audits of appropriate cleaning and disinfection of the glucometer devices. Additionally, the hospital failed to maintain documented audits to ensure the surgical instruments were properly cleaned, disinfected, and ensuring appropriate sterilization procedures for the operating room/surgical.

The findings are:

On 3/15/22 at 12:46 PM, review of the hospital's "Infection Prevention Plan" policies and procedures revealed "Policies and procedures outline the process for appropriate cleaning, disinfecting, and sterilizing of medical equipment, devices, and supplies. Teammates follow standardized practices to minimize infection risks related to medical equipment, devices, and supplies. The hospital has implemented programs for infection prevention and control for the use of medical equipment, devices, and supplies."

Review of the hospital's Infection Control Committee meeting minutes dated 2/18/2021, 4/15/2021, 5/20/2021, 6/17/2021, 9/18/2021, 10/21/2021, and 2/17/2022 revealed there was
no documentation to indicate the Infection Control Committee collected data to show monitoring point of care devices such as the glucometer for appropriate cleaning and disinfection or analyzed any data related to surgical sterile processing elements critical to an ongoing infection control program in the Operating Rooms/Surgical Processing Department for cleaning, disinfection, and sterilization procedures.

On 3/17/2022 at 3:15 PM, Quality Manager #1 stated the Infection Preventionist Team conducts environmental rounds on the nursing units and in the Surgical Department to include the Operating Room. Quality Manager #1 verified the hospital's Infection Preventionist Team has no documentation related to the Infection Preventionist Team's rounds within the hospital departments.

On 3/18/2022 at 12:45 PM, Infection Preventionist #1 and Infection Preventionist #2 revealed part of their job was to conduct unannounced rounding for infection prevention surveillance. Infection Preventionist #1 and #2 stated the team makes observational rounds on the nursing units and in the surgical areas, but did not document the data of any findings related to the observational rounding.

On 3/18/2022 at 2:30 PM, the Sterile Processing Clinical Manager revealed he/she had performed some observational audits with the Sterile Processing Department staff for sterilization processes, but he/she had not documented the audits.

On 3/18/2022 at the Director of Perioperative Services revealed he/she does not perform infection control audits.

On 3/18/2022 at 4:06 PM, the Vice President of Quality and Patient Experience and Director Of Quality #1 revealed the Infection Control staff stated the Infection Control Preventionist staff did not document the findings of the rounds the Infection Control Preventionist stated they conducted within the hospital departments.

Based on observations, review of the hospital's Immediate Use Steam Sterilization (IUSS) logs, review of the hospital's sterilization load printout strips, review of the manufacturer's Instructions For Use (IFU), review of the hospital's policies for sterilization procedures, and interviews, the hospital leadership failed to ensure its staff responsible for sterile processing procedures for Immediate Use Steam Sterilization (IUSS) performed those sterilization processing procedures followed accurate sterilization parameters for 4 of 4 surgical instruments, failed to ensure staff in the sterile processing department attached chemical indicator strips for 2 of 4 logs used to capture IUSS data, failed to ensure staff sterilized surgical instruments within the parameters for the manufacturer's Instructions For Use (IFU), failed to ensure documentation on the IUSS logs was accurately completed, failed to ensure the sterilization load printout data had the initials of the Sterile Processing Department staff validating the load met the appropriate cycle time and temperature parameters for sterilization, failed to ensure 2 of 2 staff were knowledgeable when pre- cleaning soiled surgical instruments accurately, and failed to ensure clarity in the hospital's policies for IUSS that also included what actions to take if there were discrepancies between the different manufacturers' instructions for use.

The findings are:

Observations
On 3/15/2022 at 10:27 AM, observations in the hospital's Sterile Processing Department (SPD) on the second floor revealed Sterile Processing Technician #7 washing surgical equipment in a sink filled with water and surgical equipment. The water temperature in the sink was 69.2 degrees Fahrenheit(F) based on the temperature probe in the water in the sink. Observations of a sign located on the wall above the sink revealed, "Water temperature is to be between 80-110 degrees Fahrenheit. Equipment should soak in the wash sink for five minutes." Observations showed the surgical equipment had been in the washing sink for an undetermined amount of time. The finding was verified at 10:27 AM on 3/15/2022 by Sterile Processing Technician #7 who stated, "I didn't notice it. Must have just started this morning. We just keep going." When Sterile Processing Technician #7 was asked how long the surgical equipment had been soaking in the sink, he/she shrugged his/her shoulders and gave no verbal response.

On 3/15/2022 at 11:16 AM, observations of Engineering Personnel #1 in Disinfection/Cleaning Room #1 revealed he/she checked the water temperature in the sink in Disinfection/Cleaning Room #1 with a hand held digital immersion thermometer and determined the water temperature was 68.6 degrees Fahrenheit and verified the temperature probe in the sink read 68.6 degrees Fahrenheit and the probe was accurate. Engineering Personnel #1 traveled to Disinfection/Cleaning Room #2 and revealed the handheld digital immersion thermometer in the water in the cleaning sink read 71.2 degrees Fahrenheit, and the probe in the water in the sink showed the water temperature was 68.4 degrees Fahrenheit which was below the 80 degrees to 110 degrees F noted on the signage above the sink.

On 3/15/2022 at 11:25 AM, observations of Director #1 as he/she measured the amount of enzymatic cleaner dispensed into the five gallons of water in the sink. The machine dispensed five ounces of enzymatic cleaner into the five gallons of water into the sink. On 3/15/2022 at 11:25 AM, review of the instructions for the enzymatic cleaner revealed two and one-half ounces of enzymatic cleaner should be used for five gallons of water. Director #1 verified the machine was dispensing the wrong amount of enzymatic cleanser into the five gallons of water in the sink at 11:25 AM on 3/15/2022.

Review of the Centers Disease Control (CDC) Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, reads, "Cleaning is the removal of visible soil (e.g., organic and inorganic material) from objects and surfaces and normally is accomplished manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential before high- level disinfection and sterilization because inorganic and organic materials that remain on surfaces of instruments interfere with the effectiveness of these processes. Decontamination removes pathogenic microorganisms from objects so they are safe to handle, use, or discard."

Record Reviews
On 3/18/2022 from 9:00 AM to 11:14 AM, review of random daily sterilizer test cycle strips and Load logs revealed the hospital staff responsible for the hospital's sterilizer processing procedures failed to document necessary data on the cycle strip read outs and on the Immediate Use Steam Sterilization (IUSS) logs on 2/1/2022, 2/8/2022, 2/16/2022, 3/5/2022, 3/10/2022, and 3/11/2022. On 3/17/2022 at 3:37 PM, the Administrator revealed, "The latest training for the Sterile Processing Department (SPD) staff was 3/10/2022 for new testing procedures. We averaged times out for equipment to 275 temp with 5 minutes exposure and 5 minutes dry. If staff need to change those for IUSS, they call the Sterile Processing Department Administrator(SPDA) or myself. We had a policy change in January 2022 and trained all Sterile Processing Department staff by 02/02/2022." Review of the hospital's training data showed 19 staff in the sterile processing department, but only 10 staff signatures were listed on the hospital's training form, titled, OR(Operating Room) Autoclave Testing, Roper SPD (Sterile Processing Department) In-service, dated 3/10/22.

IUSS
On 3/18/2022 at 10:15 AM, review of the hospital's Immediate Use Steam Sterilization(IUSS) log for the sterilization procedure performed on 1/3/2022 at 12:18 AM for an ablation cord revealed the manufacture's Instructions For Use for the surgical equipment, KARL STORZ, reads, "Has validated and approved steam sterilization using the fractionated pre-vacuum procedure for this device." Review of the load strip for the instrument revealed the instrument had undergone a "flash" sterilization cycle under a gravity cycle. Review of the hospital's Load log showed the log had no documentation if the cycle used was a pre-vacuum cycle or gravity cycle. There was no documentation of a Bowie-Dick. There was no Chemical Indicator (CI) attached to the log, no documentation for CI lot number, CI +/-, and CI time in and time out. The hospital's Load Log was missing the load number, Biological Indicator (BI) +/-, BI Lot #, BI time in and time out. There was no documentation that the surgical equipment was decontaminated prior to sterilization. On 3/18/2022 at 2:27 PM, the Chief Administration Officer (CAO) verified the finding.

Daily Testing Load Logs
On 3/18/2022 at 10:20 AM, review of the hospital's daily testing log for VAC 01 performed on 2/1/2022 at 12:17 AM revealed on the cycle strip attached was sterilization time of 4 minutes at 270 degrees F and 1 minute dry time. Review of the hospital's Load Log showed the following parameters were checked: 10 minutes@(at)270 F/1 m(minute)dry. The Load log had no documentation for BI +/-, of lot number and time in, time out. There was no documentation for CI of +/-, time in, time out. On 3/18/2022 at 2:31 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 10:24 AM, review of the hospital's daily testing log for VAC T1 performed on 2/8/2022 at 12:30 AM revealed on the cycle strip attached was no initials of the person performing the procedure, and a sterilization time of 4 minutes at 270 degrees F and 1 minute dry time. Review of the Load log revealed, no initials of the personnel who performed the procedure, no BI +/-, no lot number, or time in and time out, CI had no +/-, no time in or time out, and cycle parameters marked were for 10m@270F/1 m dry. On 3/18/2022 at 2:33 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 10:28 AM, review of the hospital's daily testing log for VAC 02 performed on 2/16/2022 at 12:56 AM revealed the cycle strip showed a sterilization time of 4 minutes at 270 degrees F and 1-minute dry time. Review of the hospitals's Load log showed no date, time, initials of who performed the procedure, no initiated by or retrieved by, no BI +/-, no lot number or time in and time out, CI had no +/-, no time in or time out, and cycle was marked 10m@270F/1 m dry. On 3/18/2022 at 2:35 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 11:00 AM, review of the hospital's daily testing log for VAC 00 performed on 3/5/2022 at 12:45 AM revealed the cycle strip showed there were no initials of the staff, sterilization time was 3 minutes at 270 degrees F and 1-minute dry time. Review of the hospital's Load log showed no time, no load number, no BI +/-, no lot number or time in and time out, CI has no +/-, no time in or time out, and cycle was marked 10m@270F/1 m dry. On 3/18/2022 at 2:36 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 11:05 AM, review of the daily testing log for VAC 04 performed on 3/10/2022 at 11:58 PM revealed the cycle strip showed sterilization time of 3.5 minutes at 270 degrees F and 1-minute dry time. The hospital's Load log had no time, no load number, no initiated by or retrieved by documentation, no documented gravity or pre-vacuum, no BI +/-, no lot number or time in and time out, no CI sticker for this load, no CI +/-, time in or time out, and cycle was not marked. There was a Bowie-Dick test attached with no Sterilizer number or Operator. On 3/18/2022 at 2:40 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 11:14 AM, review of the hospital's daily testing log for VAC 04 performed on 3/11/2022 at 12:26 AM revealed the cycle strip showed sterilization time of 5 minutes at 270 degrees F and 5 minute dry time. The hospital's Load log had no date, time, no load number, no initiated by or retrieved by documentation, marked as "GRAVITY", no BI +/-, no lot number or time in and time out, and no CI +/-, time in or time out. There was a Bowie-Dick test attached, but Bowie-Dick test would be done with pre-vacuum and not gravity. On 3/18/2022 at 2:41 PM, the Chief Administrative Officer verified the finding.

Policies and Procedures
Hospital policy, entitled, "IMMEDIATE USE STEAM STERILIZATION", review 1/2022, revealed,
"Individual Load Records
1. For each individual IUSS load, maintain paper or electronic records of:
a. Identification or description of specific items/sets processed in each cycle
B. Initials or other identification of the sterilizer operator and load retriever
c. Number or other identification of the sterilizer
d. Type of cycle (pre-vacuum or gravity)
e. Date/time of cycle and cycle parameters (time and temperature)
f. Results of the Chemical Indicator (CI) and Biological Indicator (BI) (if applicable) along with physical CI and sterilizer printout
g. Traceability to the patient (e.g. patient medical record #)
h. Documentation item was decontaminated
i. Specific reason for IUSS"

Facility policy, titled, "Decontamination of Soiled Instruments and Devices", latest review/revision 09/20/2019, reads in part, "Purpose: To establish protocols for the cleaning of surgical instrumentation and devised in preparation for high level disinfection or sterilization. To establish cleaning protocols which will assist in assuring sterility and provide for patient personnel safety."
"Policy: All instruments and devices shall be cleaned and/or decontaminated per the device manufacturer's written instructions. A copy of the cleaning instructions is maintained in the Decontamination Area for staff reference. The device manufacturer's current IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. All reusable surgical instruments and devices must be decontaminated, high level disinfected or sterilized before reuse. All used surgical instruments and devices are considered contaminated (Standard Precautions)."
"Procedure: .....6. Unless otherwise directed by the IFUs, items should be pretreated with an initial cold water rinse with running tap water or an initial soak in cool water and/or a clinical - soil- dissolving pretreatment product (e.g., an enzymatic cleaner or ph neutral detergent).
Procedure:6.h. Monitor the water temperature as required in the manufacturer's written IFU; and will prevent coagulation and thus assist in the removal of protein substances. NOTE - Lukewarm water and detergent solutions (at temperatures optimally in the range of 27 degrees C(centigrade) to 44 degrees C[80 degrees F(Fahrenheit), but not to exceed 60 C [140 degrees F]."


41879

On 03/18/2022 at 11:09 AM, observations in the Sterile Processing Decontamination and Pre-Clean area revealed Sterile Processing Technician #5 placed half of a large dirty metal tray into the water in a sink filled with other soiled surgical instruments. Only half of the large soiled tray was submerged in the sink with the enzymatic cleaning solution while the other half of the soiled tray was not submerged. There were surgical instruments that were already in a tray in the sink that were displaced out of that tray into the enzymatic water when the large tray was placed into the sink . Observations showed Sterile Processing Technician #5 placed the large tray on the side of the sink, removed the surgical instruments from the sink, and placed the surgical instruments onto the tray. On 3/18/2022 at 11:15 AM, observations showed the tray was over half filled with the surgical instruments that were in the water in the sink. When Sterile Processing Technician #5 was asked about the other half of soiled tray that was never submerged in the water in the sink, Sterile Processing Technician #5 stated, "I'll go back and get to that."

Facility policy, titled, Decontamination of Soiled Instruments and Devices", latest review/revision 09/20/2019, reads in part,
"Purpose: To establish protocols for the cleaning of surgical instrumentation and devised in preparation for high level disinfection or sterilization. To establish cleaning protocols which will assist in assuring sterility and provide for patient personnel safety."
"Policy: All instruments and devices shall be cleaned and/or decontaminated per the device manufacturer's written instructions. A copy of the cleaning instructions is maintained in the Decontamination Area for staff reference. The device manufacturer's current IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. All reusable surgical instruments and devices must be decontaminated, high level disinfected or sterilized before reuse. All used surgical instruments and devices are considered contaminated (Standard Precautions)." 2. Separate utensils from instruments. NOTE: To prevent damage keep delicate items in specialty containers for reprocessing) if applicable. a. Remove trays from inside rigid containers but keep the instruments in protective holders for processing. b. Separate specialty and non - immersible items. i. Heavier instruments should be placed on the bottom and lighter instruments, more delicate instruments on top to prevent damage. "


28883

On 3/16/22, review of the hospital's processing sterilization load printout strips for Sterilizer #1, #2, and #3 located in the Sterile Processing Department (SPD) revealed the printout strips had no signature or initials of the SPD staff to ensure the sterilization parameters were reviewed as required to validate the sterile processing of the load had gone according to standards of practice. The following printout strips had no initials or signature to confirm validation:
Sterilizer #1: 01/04/22 - Load 1 (#1, #2, #3, #4)
Sterilizer #1: 02/19/22- Load 1 (#1 and #2)
Sterilizer #1: 03/08/22- Load 1 (#1, #2, #3, #5)

Sterilizer #2: 01/19/22- Load 2 (#1, #2, #3, #7)
Sterilizer #2: 03/08/22 -Load 2 (#1, #2, #7, and #8)

Sterilizer #3: 01/08/22- Load 3 (#1, #2, #3, #4)
Sterilizer #3: 03/16/22- Load 3 (#1, #2, #3)
On 3/16/22 at 2:30 PM, the findings were verified by the Sterile Processing Department Clinical Manager(SPDCM) during an interview and review of the printout strips.

On 3/17/22 and 3/18/22, review of the hospital's Sterile Processing Department 's IUSS (Immediate Use Steam Sterilization) documentation for 4 of 4 "flashed" instruments in January 2022 and February 2022 revealed the Sterile Processing Department (SPD) staff did not follow the instruments' manufacturer instructions for use (IFU) for the correct sterilizer configuration and cycle type as well as sterilization time parameters for the following instruments: Kolbel Retractor (orthopedic retractor), Synthes Ball Spike, and Bulldog (vascular clamp) and an ablation cord. Review of the Load strips for each of the instruments revealed all three instruments had undergone a "flash" sterilization cycle under a gravity cycle. Review of a Load printout strip with the Sterile Processing Department Clinic Manager (SPDCM) revealed a "flash" cycle was performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for the Kolbel Retractor on 2/21/22. Review of the Load strip documentation revealed the Kolbel instrument had undergone a "flash" cycle and not a prevac cycle. The Ortho Med's Kolbel Retractor device manufacturer instructions revealed, "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization .... ". On 3/17/22 at 10:20 AM, Operating Room Nurse #1 revealed the sterilizer used for the IUSS for the instruments was configured to gravity.

Review of the Ortho Med's (Kolbel Retractor device manufacturer) IFU revealed, under, "Steam Sterilization" to "Use a validated, properly maintained and calibrated steam sterilizer. Functional vacuum method/pre-vacuum method or gravitational methods with sufficient drying of product. Maximum sterilization temperature 273 degrees F..... Sterilization time (exposure time at sterilization temperature) at least 5 minutes at 270 degrees F..... 273 degrees F, minimum drying time for wrapped instruments is 15 minutes and for wrapped containment devices is 30 minutes. The less effective gravitational method should only be used when the fractional vacuum/pre-vacuum method is unavailable......". The IFU instructions, revealed, "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization." After reviewing the Load strip and the instrument manufacturer's IFU, the Sterile Processing Department Clinical Manager verified the instrument manufacturer's IFU was not followed.

On 3/17/22 at 1:25 PM, review of the hospital's IUSS logs and "flash" load printout strips for the Kobel Retractor, Synthes Ball Spike, and Bulldog for January 2022 and February 2022 with the instrument manufacturer's IFUs was conducted with the Director of Perioperative Services (DPS). The Director of Perioperative Services reviewed the device manufacturer's instructions for use (IFU) and stated, "The three instruments may not be the exact brand for the instrument/device used for the procedure, but is part of the same family or brand of devices that would have been used." The Director of Perioperative Services reported there was no way to track the brand name/manufacturer of the device without the serial number of the device, so the manufacturer's IFU that should have similar parameters for use for that type of instrument was provided. The Director of Perioperative Services reported the symmetry flash pak manufacturer's IFU should have been followed related to the IUSS of the 3 instruments. The Director of Perioperative Services reported that since the instrument manufacturer's IFU stated IUSS is not recommended or the instrument manufacturer will not give a recommendation due to liability concerns, staff would go by Association for the Advancement of Medical Instrumentation (AAMI) or (AORN) Association of Operating Room Nurses standards which indicated the flash pak manufacturer's IFU should be followed. When asked if this was specified in hospital policy, the Director of Perioperative Services stated she/he was unsure.

On 3/17/22 at 1:25 PM, review of the manufacturer's instructions with the Director of Perioperative Services revealed the manufacturer's instructions for use for the flash pak stated that nonporous instruments for gravity displacement sterilizers should have a minimum steam exposure time for 3 minutes at 270 degrees F, and porous/mixed (porous and nonporous) instruments should have a minimum steam exposure time of 10 minutes at a minimum temperature of 270 degrees F if using a gravity displacement sterilizer.

On 3/17/22 at 2:00 PM, review of the hospital's IUSS log documentation and the load printout strip dated 1/7/22 for the "flash" sterilization of the Synthese Ball Spike with the Director of Perioperative Services, he/she revealed information that indicated the instrument was removed out of the sterilizer 55 minutes after the "flash" process was completed. The IUSS log revealed an "In Time" of 8:08 AM, and an "Out Time" of 9:16 AM. The Load printout strip of the "flash" cycle revealed the start time of 8:06 AM, and an end time of 8:21 AM. This indicated a delay of approximately 55 minutes in the removal of the surgical instruments after the IUSS cycle. The finding was verified with the Director of Perioperative Services during an interview on 3/17/21 at 2:05 PM. The Director of Perioperative Services stated that it was not good to leave the surgical instrument in the sterilizer due to moisture buildup and infection control issues. Review of AAMI guidelines revealed that items processed by IUSS should be used immediately and not stored for later use or held from one procedure to another.

On 3/17/22 at 5:15 PM, review of information provided by the hospital, entitled, "ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities", revealed on page 63, under 10.2.2 Sterilization cycles, "The sterilizer manufacturer's written IFU (Instructions For Use) should be followed for operation of the sterilizer and indications for use. a) Differences between the programmed cycle and the cycle parameters recommended by the device manufacturer should be investigated and, if possible, reconciled before the items are sterilized. If differing instructions cannot be resolved, the device (instrument) manufacturer's written IFU should be followed. b) If a rigid sterilization container system or a sealed containment device designed for IUSS is used as packaging, the container system manufacturer's written IFU regarding exposure time should be consulted and reconciled with that of the sterilizer manufacturer.

On 3/18/22 at 2:30 PM, the Sterile Processing Department Clinical Manager (SPDCM) and the Chief Administrative Officer (CAO) were asked about which manufacturer's instructions for use to follow to determine how to process an instrument for IUSS. They reported staff would need to follow the instrument manufacturer's IFU when determining which cycle, time, and temperature for IUSS. The Sterile Processing Department Clinical Manager reported different instruments in the same family are processed similarly. The instrument manufacturer's instructions for use take priority, and not the flash-pak manufacturer's IFU.

On 3/18/22 at 2:45 PM, review of a Load printout strip with the Sterile Processing Department Clinic Manager (SPDCM) revealed a "flash" cycle was performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for the Kolbel Retractor on 2/21/22. Review of the Load strip documentation revealed the Kolbel instrument had undergone a "flash" cycle and not a prevac cycle. The Ortho Med's Kolbel Retractor device manufacturer instructions revealed "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization .... ". After reviewing the Load strip and the instrument manufacturer's IFU, the Sterile Processing Department Clinical Manager verified the instrument's manufacturer IFU had not been followed. When the Sterile Processing Department Clinical Manager was asked which parameters the Kolbel retractor should have been processed with IUSS, the SPDCM stated the instrument manufacturer's Instructions For Use should be followed.

On 3/18/22 at 2:45 PM, review of the hospital's IUSS log dated 2/21/22 for the Kolbel Retractor with the Surgical Processing Department Clinical Manager (SPDCM) revealed missing documentation on the IUSS log. The log had blanks and did not include documentation of the dates/times/load # for the daily check or the IUSS load. It did not include the initials/name of the operator who initiated and retrieved the daily test, or the operator who retrieved the IUSS load. The missing information was verified by the Sterile Processing Department Clinical Manager. Further review revealed a Bulldog was processed by "flash" sterilization on 1/13/22. The IUSS log did not include a time the Bulldog was removed out of the sterilizer. The log documentation related to cycle sterilization time was not accurate, indicating the sterilization cycle was 10 minutes instead of the 3 minutes as documented on the printout strip. The log did not indicate the cycle used. A chemical indicator strip was not attached to the IUSS logs for the Bulldog and Synthes Ball Spike to indicate a chemical indicator was placed in the load with the surgical instruments and had passed per the hospital's IUSS policy. The findings were verified with the SPDCM.

On 3/18/22 at 2:52 PM, review of a load printout strip with the Sterile Processing Department Clinical Manager revealed the "Bulldog: (Instrument) was processed with a "flash" cycle under gravity configuration at a temperature of 270 degrees Fahrenheit (F), a control temp of 273 degrees F, a sterilization time of 3 minutes, and a dry time of 1 minute. When asked if the Sterile Processing Department Clinical Manager was going to perform IUSS on the Bulldog (as in the instance of 1/13/22) which cycle, time, and temperature would she/he use, the Sterile Processing Department Clinical Manager responded, "The instrument manufacturer's IFU says to process it on a Prevac cycle at 270 degrees F for 4 minutes." Review of the device manufacturer's (Boss Instruments) IFU provided to the surveyor revealed information under "Sterilization" to "Use a validated, properly maintained steam sterilizer. Always follow instructions of the machine manufacturer. Do not exceed ...284 degrees Fahrenheit during sterilization cycle. Effective sterilization can be achieved following the steam cycle listed below: Cycle type prevacuum, Minimum Temperature 270 degrees Fahrenheit, Minimum Exposure 4 minutes, Dry Time 20 minutes for metal or metal plastic trays and 45 minutes for all plastic trays. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable." The instrument manufacturer's instructions did not say anything about flash or Immediate Use Steam Sterilization. After reviewing the instrument manufacturer's IFU, the Sterile Processing Department Clinical Manager verified the instrument manufacturer's IFU was not followed.

On 3/18/22 at 3:00 PM, review of a load printout strip with the Sterile Processing Department Clinic Manager (SPDCM) revealed a "flash" cycle had been performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for a Synthes Ball Spike on 1/7/22. When asked which parameters the Synthes Ball Spike should have been processed under with IUSS, the Sterile Processing Department Clinical Manager stated the instrument manufacturer's IFU would be followed. Review of the DePuy Synthes IFU provided to the surveyor for the Synthes Ball Spike revealed, " ...The following are the recommendations for the sterilization of Synthes devices: Cycle Type- Prevacuum, Sterilization Exposure Time 4 minutes, Sterilization Exposure Temperature ...270 degrees F(Fahrenheit), Minimum Dry Time 20 minutes...". The device manufacturer's IFU did not include information that a gravity cycle was appropriate for the instrument, only Prevacuum. The IFU stated, "Immediate Use Steam Sterilization is only intended for individual instruments and should only be considered under emergency conditions and when approved by local policies. Synthes does not support Immediate-Use Steam Sterilization of instrument sets, cases, or implants. The following steam sterilization cycle is an example of a validated cycle for individual instruments only. Unwrapped instruments ....270 degrees Fahrenheit for 4 minutes .....Immediate-Use Steam Sterilization should be performed in accordance with current AORN and AAMI recommendations ...". After reviewing the instrument manufacturer's IFU, the Sterile Processing Department Clinical Manager verified the instrument manufacturer's IFU had not been followed.

On 3/18/22 at 3:32 PM, the Chief Administrative Officer (CAO) revealed the hospital believed the sterilizers used for IUSS prior to 3/10/22 had all been gravity.

Hospital policy, titled, "Immediate Use Steam Sterilization", dated 1/2022, revealed on page 1, under Policy Statement , " ...2. IUSS will only be performed on those devices whose manufacturer has provided specific cleaning and IUSS sterilization instructions to RSFH (hospital name) ...5. Items processed in immediate use steam sterilization will be used immediately." On page 5 under Cycle Selection, revealed, " ...1. The IUSS cycle type (pre-vacuum or gravity displacement) and parameters (time and temperature) shall be selected from written instructions provided by the device manufacturer. 2. Power and specialty equipment may require special exposure times. Always consult the device manufacturer for cycle times and temperatures." On page 6 under "Removal from Sterilizer and Completion of IUSS Load Record" revealed information that " ...2. After every successful IUSS cycle, the sterilizer operator shall perform the following: a) Sign and date the sterilizer printout to indicate that all parameters for sterilization were met. b) Attach the CI (Chemical Indicator) to the IUSS Load Log form in the appropriate location and complete the rest of the IUSS Load Log Form. c) Attach the sterilizer printout to the completed IUSS Load Log Form." On page 6 under Individual Load Records revealed information that paper or electronic records for each IUSS load should include "a) Identification or description of specific items/sets processed in each cycle, b) Initials or other identification of the sterilizer operator and load retriever, c)Number or other identification of the sterilizer, d)Type of cycle (pre-vacuum or gravity), e) Date/time of cycle and cycle parameters (time and temperature), f) Results of CI and BI (if applicable) along with physical CI and sterilizer printout, g) Traceability to the patient (e.g. patient medical record #), h) Documentation item was decontaminated, i) Specific reason for IUSS ...". On page 7 under "Responsibilities" revealed "1. Organizational lead responsibilities for implementation of this IUSS policy are as follows: a) Equipment monitoring (chemical and biological monitoring)- SPD (Sterile Processing Department), ...e)Performance of IUSS (transport, loading, cycle selection, removal)- SPD, f) Validation of IUSS results (sterilizer printout, CI accept, BI (Biological Indicator) accept)-SPD, g) Completion of IUSS load records (IUSS log form record, CI, sterilizer printout)-SPD, h)Periodic sterilizer records reviews- SPD ...".

Sterilizer, gravity - displacement type: type of steam sterilizer in which incoming steam displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber. Typical operating temperatures are 121 - 123 degrees Centigrade (C) (250 - 254 degrees Fahrenheit (F)) and 132 - 135 degrees Centigrade (270 - 275 degrees F).

Sterilizer, pre-vacuum type: Type of steam sterilizer that depends on one or more pressure and vacuum excursions at the beginning of the cycle to remove air. This method of operation results in shorter cycle times for wrapped items because of the rapid removal of air from the chamber and the load by the vacuum system and because of the usually higher op

Based on record reviews, interviews, review of the surgical instruments manufacturer's Instructions For Use (IFU), and review of the hospital's policies and procedures for the Sterile Processing Department, the hospital's surgical department's leadership failed to ensure its staff adhered to the hospital's sterilization policies and procedures for Immediate Use Steam Sterilization (IUSS), failed to follow the manufacturer's Instructions for Use (IFU) for surgical instruments undergoing IUSS, and failed to ensure staff followed the hospital's policies and procedures for accurate completion of documentation for sterilizer cycle strips and for the Sterile Processing Department's testing Load logs.

The findings are:

On 3/16/22, review of the hospital's processing sterilization Load printout strips for Sterilizer #1, #2, and #3 located in the Sterile Processing Department (SPD) revealed the printout strips had no signature or initials to validate the sterilization parameters were reviewed as required to verify the Sterile Processing Department staff validated the sterile processing of the Load had gone according to standards of practice. The following printout strips had no initials or signature to confirm validation:
Sterilizer #1: 01/04/22 - Load 1 (#1, #2, #3, #4)
Sterilizer #1: 02/19/22- Load 1 (#1 and #2)
Sterilizer #1: 03/08/22- Load 1 (#1, #2, #3, #5)

Sterilizer #2: 01/19/22- Load 2 (#1, #2, #3, #7)
Sterilizer #2: 03/08/22 -Load 2 (#1, #2, #7, and #8)

Sterilizer #3: 01/08/22- Load 3 (#1, #2, #3, #4)
Sterilizer #3: 03/16/22- Load 3 (#1, #2, #3)
On 3/16/22 at 2:30 PM, the findings were verified by the Sterile Processing Department Clinical Manager during an interview and review of the printout strips.

On 3/17/22 and 3/18/22, review of the hospital's Sterile Processing Department's IUSS (Immediate Use Steam Sterilization) documentation for 4 of 4 "flashed" instruments in January 2022 and February 2022 revealed the Sterile Processing Department staff did not follow the instruments' manufacturer Instructions for Use (IFU) for the correct sterilizer configuration and cycle type as well as sterilization time parameters for the following instruments: Kolbel Retractor (orthopedic retractor), Synthes Ball Spike, and Bulldog (vascular clamp) and an ablation cord. Review of the load strips for each of the instruments revealed all three instruments had undergone a "flash" sterilization cycle and not a pre-vac cycle. Review of a load printout strip with the Sterile Processing Department Clinic Manager revealed a "flash" cycle was performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for the Kolbel Retractor on 2/21/22. Review of the load strip documentation revealed the Kolbel instrument had undergone a "flash" cycle and not a pre-vac cycle. The Ortho Med's Kolbel Retractor device manufacturer instructions revealed, "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization .... ". On 3/17/22 at 10:20 AM, Operating Room Nurse #1 revealed the sterilizers used for the IUSS for the instruments was configured to gravity.

Review of the Ortho Med's (Kolbel Retractor device manufacturer) IFU revealed under, "Steam Sterilization" to "Use a validated, properly maintained and calibrated steam sterilizer. Functional vacuum method/pre-vacuum method or gravitational methods with sufficient drying of product. Maximum sterilization temperature 273 degrees F..... Sterilization time (exposure time at sterilization temperature) at least 5 minutes at 270 degrees F..... 273 degrees F, minimum drying time for wrapped instruments is 15 minutes and for wrapped containment devices is 30 minutes. The less effective gravitational method should only be used when the fractional vacuum/pre-vacuum method is unavailable......". The instructions revealed "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization." After reviewing the load strip and the instrument manufacturer's IFU, the Sterile Processing Department Clinical Manager verified the instrument manufacturer's IFU was not followed.

On 3/17/22 at 1:25 PM, review of the hospital's IUSS logs and "flash" load printout strips for the Kobel Retractor, Synthes Ball Spike, and Bulldog for January 2022 and February 2022 with the instrument manufacturer's IFUs was conducted with the Director of Perioperative Services. The Director of Perioperative Services reviewed the device manufacturer's Instructions for Use (IFU), and stated, "The four instruments may not be the exact brand for the instrument/device used for the procedure, but is part of the same family or brand of devices that would have been used." The Director of Perioperative Services reported there was no way to track the brand name/manufacturer of the device without the serial number of the device, so the manufacturer's IFU that should have similar parameters for use for that type of instrument was provided. The Director of Perioperative Services reported the symmetry flash pak manufacturer's IFU should have been followed related to the IUSS of the 3 instruments. The Director of Perioperative Services reported that since the instrument manufacturer's IFU stated IUSS is not recommended or the instrument manufacturer will not give a recommendation due to liability concerns, staff are to go by the Association for the Advancement of Medical Instrumentation (AAMI) or (AORN) Association of Operating Room Nurses standards which indicated the flash pak manufacturer's IFU should be followed. When asked if this was specified in hospital policy, the Director of Perioperative Services stated she/he was unsure.

On 3/17/22 at 1:25 PM, review of the manufacturer's instructions with the Director of Perioperative Services revealed the manufacturer's instructions for use for the flash pak stated that nonporous instruments for gravity displacement sterilizers should have a minimum steam exposure time for 3 minutes at 270 degrees F and porous/mixed (porous and nonporous) instruments should have a minimum steam exposure time of 10 minutes at a minimum temperature of 270 degrees F if using a gravity displacement sterilizer.

On 3/17/22 at 2:00 PM, review of the hospital's IUSS log documentation and the load printout strip dated 1/7/22 for the "flash" sterilization of the Synthese Ball Spike with the Director of Perioperative Services revealed information that indicated the instrument had been removed out of the sterilizer 55 minutes after the "flash" process had been completed. The IUSS log revealed an "In Time" of 8:08 AM, and an "Out Time" of 9:16 AM. The load printout strip of the "flash" cycle revealed the start time of 8:06 AM, and an end time of 8:21 AM. This indicated a delay of approximately 55 minutes in the removal of the instruments after the IUSS cycle. The finding was verified with the Director of Perioperative Services during an interview on 3/17/21 at 2:05 PM. The Director of Perioperative Services stated that it was not good to leave the instrument in the sterilizer due to moisture buildup and infection control issues. A review of AAMI guidelines revealed that items processed by IUSS should be used immediately and not stored for later use or held from one procedure to another.

On 3/17/22 at 5:15 PM, review of information provided by the hospital, entitled, "ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities" revealed on page 63 under 10.2.2 Sterilization cycles, "The sterilizer manufacturer's written IFU (Instructions For Use) should be followed for operation of the sterilizer and indications for use. a) Differences between the programmed cycle and the cycle parameters recommended by the device manufacturer should be investigated and, if possible, reconciled before the items are sterilized. If differing instructions cannot be resolved, the device (instrument) manufacturer's written IFU should be followed. b) If a rigid sterilization container system or a sealed containment device designed for IUSS is used as packaging, the container system manufacturer's written IFU regarding exposure time should be consulted and reconciled with that of the sterilizer manufacturer.

On 3/18/22 at 2:30 PM, the Sterile Processing Department Clinical Manager (SPDCM) and the Chief Administrative Officer (CAO) were asked about which manufacturer's Instructions for Use to follow to determine how to sterilize an instrument for IUSS. They reported staff would need to follow the instrument's manufacturer Instructions For Use when determining which cycle, time, and temperature for IUSS. The Sterile Processing Department Clinical Manager reported different instruments in the same family are processed similarly. The instrument manufacturer's instructions for use take priority; not the flash-pak manufacturer's Instructions For Use.

On 3/18/22 at 2:45 PM, review of a load printout strip with the Sterile Processing Department Clinic Manager revealed a "flash" cycle was performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for the Kolbel Retractor on 2/21/22. Review of the load strip documentation revealed the Kolbel instrument had undergone a "flash" cycle and not a pre-vac cycle. The Ortho Med's Kolbel Retractor device manufacturer instructions revealed, "The rapid sterilization method is generally not permitted. Also do not use any hot air sterilization .... ". After reviewing the load strip and the instrument manufacturer's Instructions For Use, the Sterile Processing Department Clinical Manager verified the instrument manufacturer's Instructions For Use had not been followed. When the Sterile Processing Department Clinic Manager was asked which parameters the Kolbel retractor should have been processed with IUSS, the Sterile Processing Department Clinical Manager stated the instrument's manufacturer Instructions For Use should be followed.

On 3/18/22 at 2:45 PM, review of the hospital's IUSS log dated 2/21/22 for the Kolbel Retractor with the Surgical Processing Department Clinical Manager (SPDCM) revealed missing documentation on the IUSS log. The log had blanks and did not include documentation of the dates/times/load # for the daily check or the IUSS load. It did not include the initials/name of the operator who initiated and retrieved the daily test, or the operator who retrieved the IUSS load. The missing information was verified by the Sterile Processing Department Clinical Manager. Further review revealed a Bulldog had been processed by "flash" sterilization on 1/13/22. The IUSS log did not include a time the Bulldog was removed out of the sterilizer. The log documentation related to cycle sterilization time was not accurate and indicated the sterilization cycle was 10 minutes instead of the 3 minutes documented on the printout strip. The log did not indicate the cycle used. A chemical indicator strip was not attached to the IUSS logs for the Bulldog and Synthes Ball Spike to indicate a chemical indicator was placed in the load with the instrument and had passed per the hospital's IUSS policy. The findings were verified with the Sterile Processing Department Clinical Manager.

On 3/18/22 at 2:52 PM, review of a load printout strip with the Sterile Processing Department Clinical Manager revealed the "Bulldog: (Instrument) was processed with a "flash" cycle under gravity configuration at a temperature of 270 degrees Fahrenheit (F), a control temp of 273 degrees F, a sterilization time of 3 minutes, and a dry time of 1 minute. When asked if the Sterile Processing Department Clinical Manager was going to perform IUSS on the Bulldog (as in the instance of 1/13/22) which cycle, time, and temperature would she/he use, the Sterile Processing Department Clinical Manager responded, "The instrument's manufacturer Instructions For Use says to process it on a Pre-vac cycle at 270 degrees F for 4 minutes." Review of the device's manufacturer (Boss Instruments) Instruction For Use provided to the surveyor revealed information under "Sterilization" to "Use a validated, properly maintained steam sterilizer. Always follow instructions of the machine manufacturer. Do not exceed ...284 degrees Fahrenheit during sterilization cycle. Effective sterilization can be achieved following the steam cycle listed below: Cycle type pre-vacuum, Minimum Temperature 270 degrees Fahrenheit, Minimum Exposure 4 minutes, Dry Time 20 minutes for metal or metal plastic trays and 45 minutes for all plastic trays. AAMI/AORN steam sterilization cycles with longer times than those listed are also acceptable." The instrument's manufacturer instructions did not say anything about flash or Immediate Use Steam Sterilization. After reviewing the instrument's manufacturer Instructions For Use, the Sterile Processing Department Clinical Manager verified the instrument's manufacturer Instructions For Use was not followed.

On 3/18/22 at 3:00 PM, review of a load printout strip with the Sterile Processing Department Clinic Manager (SPDCM) revealed a "flash" cycle had been performed under gravity configuration at 270 degrees F (Fahrenheit) for 10 minutes for a Synthes Ball Spike on 1/7/22. When asked which parameters the Synthes Ball Spike should have been processed under with IUSS, the Sterile Processing Department Clinical Manager stated the instrument's manufacturer Instructions For Use(IFU) would be followed. Review of the DePuy Synthes IFU provided to the surveyor for the Synthes Ball Spike revealed, " ...The following are the recommendations for the sterilization of Synthes devices: Cycle Type- Pre-vacuum, Sterilization Exposure Time 4 minutes, Sterilization Exposure Temperature ...270 degrees F(Fahrenheit), Minimum Dry Time 20 minutes...". The device manufacturer's IFU did not include information that a gravity cycle was appropriate for the instrument; only Pre-vacuum. The IFU stated, "Immediate Use Steam Sterilization is only intended for individual instruments and should only be considered under emergency conditions and when approved by local policies. Synthes does not support Immediate-Use Steam Sterilization of instrument sets, cases, or implants. The following steam sterilization cycle is an example of a validated cycle for individual instruments only. Unwrapped instruments ....270 degrees Fahrenheit for 4 minutes .....Immediate-Use Steam Sterilization should be performed in accordance with current AORN and AAMI recommendations ...". After reviewing the instrument manufacturer's IFU, the Sterile Processing Department Clinical Manager verified the instrument manufacturer's IFU had not been followed.

On 3/18/22 at 3:32 PM, the Chief Administrative Officer (CAO) revealed the hospital believed the sterilizers used for IUSS prior to 3/10/22 had been gravity.

Policies and Procedures
Hospital policy, entitled, "IMMEDIATE USE STEAM STERILIZATION", review 1/2022, revealed,
"Individual Load Records
1. For each individual IUSS load, maintain paper or electronic records of:
a. Identification or description of specific items/sets processed in each cycle
B. Initials or other identification of the sterilizer operator and load retriever
c. Number or other identification of the sterilizer
d. Type of cycle (pre-vacuum or gravity)
e. Date/time of cycle and cycle parameters (time and temperature)
f. Results of the Chemical Indicator (CI) and Biological Indicator (BI) (if applicable) along with physical CI and sterilizer printout
g. Traceability to the patient (e.g. patient medical record #)
h. Documentation item was decontaminated
i. Specific reason for IUSS"

Hospital policy, titled, "Immediate Use Steam Sterilization", dated 1/2022, revealed on page 1, under Policy Statement , " ...2. IUSS will only be performed on those devices whose manufacturer has provided specific cleaning and IUSS sterilization instructions to RSFH (hospital name) ...5. Items processed in immediate use steam sterilization will be used immediately." On page 5 under Cycle Selection, revealed, " ...1. The IUSS cycle type (pre-vacuum or gravity displacement) and parameters (time and temperature) shall be selected from written instructions provided by the device manufacturer. 2. Power and specialty equipment may require special exposure times. Always consult the device manufacturer for cycle times and temperatures." On page 6 under "Removal from Sterilizer and Completion of IUSS Load Record" revealed information that " ...2. After every successful IUSS cycle, the sterilizer operator shall perform the following: a) Sign and date the sterilizer printout to indicate that all parameters for sterilization were met. b) Attach the CI (Chemical Indicator) to the IUSS Load Log form in the appropriate location and complete the rest of the IUSS Load Log Form. c) Attach the sterilizer printout to the completed IUSS Load Log Form." On page 6 under Individual Load Records revealed information that paper or electronic records for each IUSS load should include "a) Identification or description of specific items/sets processed in each cycle, b) Initials or other identification of the sterilizer operator and load retriever, c)Number or other identification of the sterilizer, d)Type of cycle (pre-vacuum or gravity), e) Date/time of cycle and cycle parameters (time and temperature), f) Results of CI and BI (if applicable) along with physical CI and sterilizer printout, g) Traceability to the patient (e.g. patient medical record #), h) Documentation item was decontaminated, i) Specific reason for IUSS ...". On page 7 under "Responsibilities" revealed "1. Organizational lead responsibilities for implementation of this IUSS policy are as follows: a) Equipment monitoring (chemical and biological monitoring)- SPD (Sterile Processing Department), ...e)Performance of IUSS (transport, loading, cycle selection, removal)- SPD, f) Validation of IUSS results (sterilizer printout, CI accept, BI (Biological Indicator) accept)-SPD, g) Completion of IUSS load records (IUSS log form record, CI, sterilizer printout)-SPD, h)Periodic sterilizer records reviews- SPD ...".

Sterilizer, gravity - displacement type: type of steam sterilizer in which incoming steam displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber. Typical operating temperatures are 121 - 123 degrees Centigrade (C) (250 - 254 degrees Fahrenheit (F)) and 132 - 135 degrees Centigrade (270 - 275 degrees F).

Sterilizer, pre-vacumn type: Type of steam sterilizer that depends on one or more pressure and vacuum excursions at the beginning of the cycle to remove air. This method of operation results in shorter cycle times for wrapped items because of the rapid removal of air from the chamber and the load by the vacuum system and because of the usually higher operating temperature (132 - 135 C[270 - 275 F]; 141 - 144 C[285 - 291 F]. This type of sterilizer generally provides for shorter exposure time and accelerated drying of fabric loads by pulling a further vacuum at the end of the sterilizing cycle.

Flash Sterilization: process designed for the steam sterilization of unwrapped patient care items for immediate use (or placed in a specially designed, covered, rigid container to allow for rapid penetration of steam).





41743

On 3/18/2022 from 9:00 AM to 11:14 AM, review of random daily sterilizer test cycle strips and the Sterile Processing Department's load logs revealed the hospital staff responsible for the hospital's sterilizer procedures failed to document the necessary data on the cycle strip read outs and/or on the Immediate Use Steam Sterilization (IUSS) logs on 2/1/2022, 2/8/2022, 2/16/2022, 3/5/2022, 3/10/2022, and 3/11/2022. On 3/17/2022 at 3:37 PM, the Administrator revealed, "The latest training for the Sterile Processing Department (SPD) staff was 3/10/2022 for new testing procedures. We averaged times out for equipment to 275 degrees Fahrenheit temp with 5 minutes exposure and 5 minutes dry. If staff need to change those for Immediate Use Steam Sterilization, staff can call the Sterile Processing Department Administrator or myself. We had a policy change in January 2022 and trained all Sterile Processing Department staff by 02/02/2222."

On 3/18/2022 at 10:15 AM, review of the hospital's Immediate Use Steam Sterilization(IUSS) log for the IUSS sterilization procedure performed on 1/3/2022 at 12:18 AM on an ablation cord revealed the manufacture of the equipment, KARL STORZ, reads, "Has validated and approved steam sterilization using the fractionated pre-vacuum procedure for this device." Review of the load strips for the instruments revealed the instrument had undergone a "flash" sterilization cycle under a gravity cycle. Review of the hospital's Load log for this sterilization procedure showed the Load log had no documentation of the sterilizer cycle used was a pre-vacuum cycle or a gravity cycle. There was no Chemical Indicator (CI) attached to the log, no documentation for CI lot number, CI +/-, and CI time in and time out. The hospital's load log was missing the load number, Biological Indicator (BI) +/-, BI Lot #, BI time in and time out. There was no documentation that the surgical equipment was decontaminated prior to the IUSS sterilization procedure. On 3/18/2022 at 2:27 PM, the Chief Administration Officer verified the finding.

Daily Sterilizer Testing Logs
On 3/18/2022 at 10:20 AM, review of the hospital's daily testing log for VAC 01 performed on 2/1/2022 at 12:17 AM revealed on the cycle strip attached: sterilization time of 4 minutes at 270 degrees F and 1 minute dry time. Review of the hospital's Load log showed the following parameters were checked: 10 minutes@(at)270 F (Fahrenheit)/1 m(minute)dry. The Load log had no documentation for BI +/-, of lot number and time in, time out. There was no documentation for CI of +/-, time in, time out. On 3/18/2022 at 2:31 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 10:24 AM, review of the hospital's daily testing log for VAC T1 performed on 2/8/2022 at 12:30 AM revealed on the cycle strip attached: no initials of the person performing the procedure, and a sterilization time of 4 minutes at 270 degrees F and 1 minute dry time. Review of the Load log revealed, no initials of the personnel who performed the procedure, no BI +/-, no lot number, or time in and time out, CI had no +/-, no time in or time out, and cycle parameters marked were for 10m@270F/1 m dry. On 3/18/2022 at 2:33 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 10:28 AM, review of the hospital's daily testing log for VAC 02 performed on 2/16/2022 at 12:56 AM revealed the cycle strip showed a sterilization time of 4 minutes at 270 degrees F and 1-minute dry time. Review of the hospitals's Load log showed no date, time, initials of who performed the procedure, no initiated by or retrieved by, no BI +/-, no lot number or time in and time out, CI had no +/-, no time in or time out, and cycle was marked 10m@270F/1 m dry. On 3/18/2022 at 2:35 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 11:00 AM, review of the hospital's daily testing log for VAC 00 performed on 3/5/2022 at 12:45 AM revealed the cycle strip showed there were no initials of the staff, sterilization time was 3 minutes at 270 degrees F and 1-minute dry time. Review of the hospital's Load log showed no time, no load number, no BI +/-, no lot number or time in and time out, CI has no +/-, no time in or time out, and cycle was marked 10m@270F/1 m dry. On 3/18/2022 at 2:36 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 11:05 AM, review of the daily testing log for VAC 04 performed on 3/10/2022 at 11:58 PM revealed the cycle strip showed sterilization time of 3.5 minutes at 270 degrees F and 1-minute dry time. The hospital's Load log had no time, no load number, no initiated by or retrieved by documentation, no documented gravity or pre-vacuum, no BI +/-, no lot number or time in and time out, no CI sticker for this load, no CI +/-, time in or time out, and cycle was not marked. There was a Bowie-Dick test attached with no Sterilizer number or Operator. On 3/18/2022 at 2:40 PM, the Chief Administrative Officer verified the finding.

On 3/18/2022 at 11:14 AM, review of the hospital's daily testing log for VAC 04 performed on 3/11/2022 at 12:26 AM revealed the cycle strip showed sterilization time of 5 minutes at 270 degrees F and 5 minute dry time. The hospital's Load log had no date, time, no load number, no initiated by or retrieved by documentation, marked as "GRAVITY", no BI +/-, no lot number or time in and time out, and no CI +/-, time in or time out. There was a Bowie-Dick test attached, but Bowie-Dick test would be done with pre-vacuum and not gravity. On 3/18/2022 at 2:41 PM, the Chief Administrative Officer verified the finding.

Policies and Procedures
Hospital policy, entitled, "IMMEDIATE USE STEAM STERILIZATION", review 1/2022, revealed,
"Individual Load Records
1. For each individual IUSS load, maintain paper or electronic records of:
a. Identification or description of specific items/sets processed in each cycle
B. Initials or other identification of the sterilizer operator and load retriever
c. Number or other identification of the sterilizer
d. Type of cycle (pre-vacuum or gravity)
e. Date/time of cycle and cycle parameters (time and temperature)
f. Results of the Chemical Indicator (CI) and Biological Indicator (BI) (if applicable) along with physical CI and sterilizer printout
g. Traceability to the patient (e.g. patient medical record #)
h. Documentation item was decontaminated
i. Specific reason for IUSS"

Facility policy, titled, "Decontamination of Soiled Instruments and Devices", latest review/revision 09/20/2019, reads in part, "Purpose: To establish protocols for the cleaning of surgical instrumentation and devised in preparation for high level disinfection or sterilization. To establish cleaning protocols which will assist in assuring sterility and provide for patient personnel safety."
"Policy: All instruments and devices shall be cleaned and/or decontaminated per the device manufacturer's written instructions. A copy of the cleaning instructions is maintained in the Decontamination Area for staff reference. The device manufacturer's current IFU should be accessible, reviewed, and followed. If there are no specific written IFU in the labeling, then the manufacturer should be contacted and requested to provide a documented method of cleaning. All reusable surgical instruments and devices must be decontaminated, high level disinfected or sterilized before reuse. All used surgical instruments and devices are considered contaminated (Standard Precautions)."
"Procedure: .....6. Unless otherwise directed by the IFUs, items should be pretreated with an initial cold water rinse with running tap water or an initial soak in cool water and/or a clinical - soil- dissolving pretreatment product (e.g., an enzymatic cleaner or ph neutral detergent).
Procedure:6.h. Monitor the water temperature as required in the manufacturer's written IFU; and will prevent coagulation and thus assist in the removal of protein substances. NOTE - Lukewarm water and detergent solutions (at temperatures optimally in the range of 27 degrees C(centigrade) to 44 degrees C[80 degrees F(Fahrenheit), but not to exceed 60 C [140 degrees F]."