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Based on the nature of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews and document review the facility failed to ensure a process was in place to ensure staff followed manufacturer's instructions for use (IFU) when sterilizing surgical instruments.

Based on observations, interviews and document review the facility failed to ensure a process was in place to ensure staff followed manufacturer's instructions for use (IFU) when sterilizing surgical instruments.

Findings include:

Facility policies:

The Sterile Processing Procedures policy read, to provide procedures for sterilizing items to be used in the surgical environment. One of the measures for preventing surgical site infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to cleaning, inspection and decontamination, followed by a sterilization process. Steam and low temperature sterilization methods that are used in our health care environment. Sterilization provides the highest level of assurance that surgical items are free of viable microbes. Pre-Cleaning, Decontamination and Sterilization processes will be performed in alignment with manufacturer Instructions for Use and follow evidence-based guidelines. Sterilization records will be maintained according to hospital/regulatory guidelines. Sterilizer quality control will be performed to monitor efficacy of the sterilization process. A manufacturer instruction database (One Source) will be accessible and utilized by staff to
reference handling, cleaning, sterile processing and storage of all devices. Steam under pressure is the preferred method of sterilization and is utilized for items and devices
that are heat and moisture tolerant as dictated by manufacturer's instructions. Cycle parameters will be based on manufacturer's instructions.

References:

The 2019 Association of PeriOperative Registered Nurses (AORN) Guidelines for Perioperative Practice pg. 404 Recommendation I read, all instruments and devices used in surgery should be cleared for use by the US Food and Drug Administration (FDA) for use in surgery and have written manufacturer validated cleaning and decontamination instructions for use. Manufacturers provided validated cleaning and decontamination instructions, items cannot be assumed to be clean, decontaminated or sterile unless the IFUs are derived from validation testing and the user has followed those instructions. IFUs provide users with validated techniques for processing instruments.

One Source overview read, healthcare product manufacturers are required to produce and provide Instructions for Use (IFU) documents for their reusable surgical instruments, medical devices and equipment and implantable biologics, materials and devices. To minimize healthcare-associated infections (HAIs) and adhere to accreditation standards, your Sterile Processing and Operating Room technicians continually refer to these documents as they maintain and prepare equipment. The first step in this process is to ensure validated IFUs are easily accessible to everyone throughout your facility who needs them. One source offers IFU-related databases.
Life Instruments IFU read, soak the instruments in a neutral enzymatic solution for five minutes. After following the cleaning procedure, effectively steam sterilize at 270 degrees for four minute exposure time and allow to dry for 20 minutes.

Vu a Pod Prime Nanometalene IFUs read, steam sterilize at 270 degrees for four minutes exposure time and allow to dry for 30 minutes.

Vu a Pod Prime Nanometalene Spin Plate Sergio instructions read, sterilize at 270 degrees for eight minutes and allow to dry for 45 minutes. The Sergio instructions did not match the IFUs.

SeaSpine Surgical Instruments IFU read, designed for use in orthopedic surgical procedures for implantation of devices manufactured by SeaSpine Orthopedics Corporation. Immerse the instruments in the cleaning solution and actuate all features so the enzymatic cleaner contacts all mated surfaces for 15 minutes. Sterilize at 270 degrees for eight minute exposure time.

SeaSpine Surgical Instruments for Intervertebral Disc Preparation IFU read, the Intervertebral Disc Prep Surgical Instruments are intended for use during surgical procedures for cutting, scraping, retracting, or similar procedures. Immerse the instruments in the cleaning solution and actuate all features so the enzymatic cleaner contacts all mated surfaces and soak for 15 minutes. Sterilize at 270 degrees for a four minute exposure time.


1. The facility failed to ensure staff followed IFUs for instrument sterilization.

a. According to policy, the facility would determine how to sterilize an instrument based on the manufacturer's IFU. According to the AORN guidelines, items could not be assumed clean without following the IFUs.

b. Observations and interviews during the tour of the sterile processing department (SPD) department revealed staff followed the instructions produced by the Sergio computer system (Sergio) and did not validate those instructions with the IFU prior to sterilization of instruments.

i. On 7/2/21 at 9:15 a.m., an observation of the SPD was conducted. Sterile Processing Technician (SPT) #1 was interviewed. SPT #1 showed the process in which instruments were sterilized in the autoclave (a machine which sterilized with elevated temperature and pressure in relation to ambient pressure/temperature). SPT #1 explained the instrument trays were selected in Sergio which would produce a sticker which contained the instructions for how to sterilize the instruments. The sticker was scanned when the instruments were placed in the autoclave. The instructions contained how long the instruments were required to be exposed in the autoclave (to heat and pressure). SPT #1 printed the sticker for the Vu a Pod Prime Nanometalene Spin plate (surgical instrument) which read it required an eight minute exposure time. SPT #1 printed the IFU for the instrument which read, it required a four minute exposure time. SPT #1 stated even though the IFUs differed from the sticker instructions, she would follow the sticker instructions instead of the IFUs. She stated she would not normally look at the IFUs for the instruments, and would follow the printed sticker instructions.

ii. During the observation, SPT #2 was interviewed. She stated she had been employed for less than a month and was trained to determine how long to sterilize instruments based on what the Sergio computer system instructed her. She stated she chose the instrument in Sergio and a sticker was produced and placed on the wrapped instrument. Once the instrument load was ready to be placed in the autoclave, the sticker was scanned and those settings were used to set the autoclave for exposure time.

iii. SPT #9 was interviewed in the decontamination area. Observations revealed specialty curettes (surgical instruments). SPT #9 stated the specialty curettes should soak in an enzymatic solution for 15 minutes because they were difficult to clean. She stated she logged into the Sergio system to get the instrument IFUs to know how to clean and sterilize the instrument. SPT #9's process was different from the IFUs.

c. Interviews revealed process gaps with staff and leadership in using the correct IFUs.

i. On 7/8/21 at 7:57 a.m., Lead SPT (SPT) #6 was interviewed. SPT #6 stated she was a lead SPT and one of her roles was to input sterilization and instrument set information into Sergio, so instruments could be tracked and scanned. She stated the Sergio information helped staff know how to decontaminate and sterilize instruments. She stated it was a manual process to load information into Sergio. SPT #6 stated she typed in a vendor code and the instrument would appear on the screen to be selected or she would type in the manufacturer IFU manually. SPT #6 stated most instruments came with an IFU. SPT #6 stated if instruments did not come with an IFU she could look them up on One Source (IFU database).

SPT #6 stated there was confusion over which IFUs to use for SeaSpine instruments and also which instruments to place in the sets together. She stated the instruments sets have been separated to have eight minutes exposures separated from four minute exposures. SPT #6 stated the exposure time is what the manufacturer determined was the time needed to kill germs. She stated an instrument which needed eight minutes could not only be exposed for four minutes and kill the germs. SPT #6 stated as of 7/8/21, there was still confusion about which IFUs to use with SeaSpine instruments and was unsure which IFU was correct in Sergio.

SPT #6 stated the staff had been working on the IFU confusion for "a while". SPT #6 stated the process was when it was identified while processing an instrument that the staff was using the incorrect IFU, she or the SPD manager would input the correct information into Sergio.

SPT #6 stated the facility had not verified all the IFUs for all instruments used by the facility were correct in Sergio. SPT #6 stated the only way to know if an instrument was cleaned properly would be to follow the IFUs.

ii. On 7/2/21 at 9:54 a.m., an interview with the Infection Program Manager (IP) #3 was conducted who had done an investigation into IFUs used by the SPD staff. IP #3 stated AORN guidelines required staff to use the manufacture IFU to ensure instruments were clean and sterilized for patient use.

IP #3 discussed his investigation and stated the investigation was conducted to identify the correct IFUs for SeaSpine instruments. The investigation, revealed non-specialized IFUs were used which required a 5 minute pre-soak and a 4 minute exposure time for the SeaSpine instruments. According to IP #3, these were incorrect because the instruments were curated. According to IP #3, curated instruments, meant staff had to follow the specialty IFU which required a 15 minute soak time an 8 minute exposure time.

IP #3 stated the facility was unsure who manufactured the instrument prior to his investigation and assumed it was SeaSpine so SeaSpine instrument IFUs were used for non-curated instruments but during his investigation the staff switched to specialized instrument IFUs under the assumption SeaSpine curated and manufactured the instruments. According to IP #3, the facility bought the instrument from SeaSpine, who the facility later found out, obtained the instrument from Life Instruments who had actually manufactured the instruments. The IFU for Life instrument IFU had a five minute soak and four minute exposure time, which was in contrast to the SeaSpine IFU which required a 15 minute soak and an eight minute exposure time.

IP #3 stated it was not until the facility validated the manufacture did the facility realize they had then used the incorrect IFU of 15 minute soak and eight minute exposure IFU from SeaSpine when in fact the five minute soak and four minute exposure time originally used was correct for the IFUs for Life Instruments.

IP #3 the investigation revealed the facility struggled to ensure SPD staff had the ability to follow manufacture IFUs and the inability to ensure staff had the accurate IFUs for all facility instruments used during patient care. IP #3 stated the staff at the time of survey could not ensure SPD staff had accurate IFUs for all instruments used and identified there was a risk to patient safety if IFUs were not followed.

iii. On 7/7/21 at 3:03 p.m., the Interim Director of Surgery (Director) #5 was interviewed. Director #5 stated her role was to oversee all surgical operations to ensure they met the standards of AAMI and AORN. Director #5 stated the information which was in Sergio was all placed manually by SPD staff. She stated the information in Sergio contained what the instruments looked like, what was in a set, how to wash and decontaminate. She stated staff would upload the IFU from the manufacturer's website into Sergio. Director #5 stated staff would print a sticker from Sergio to scan so they could document the settings the autoclave was run on.

Director #5 stated in April 2021, the leadership agreed to change multiple four minute exposure times to eight, since there was confusion over the specialty curette IFU exposure time of eight minutes versus four minutes. She stated the change was a safety gap to ensure staff were not under exposing instruments. Director #5 stated if an instrument required eight minute exposure time and only received four minutes of exposure, they would be half sterilized. She stated it was an unknown risk to patients if instruments were not correctly sterilized.

Director #5 stated staff had been educated to go into Sergio to look up IFUs. She stated the IFUs had been manually uploaded from the manufactures websites and was still being built at the time of the survey. Director stated even though an issue was identified, the biggest focus of the SPD was to hire staff and get them competent and trained.

Director #5 stated the Vu a Pod Sergio sticker and IFUs were different because the Vu a Pod was part of a spine set. Director #5 stated due to the IFU confusion, the decision had been made to run all spine sets at eight minute exposure instead of four minutes. She stated they had reviewed the SeaSpine IFUs, but were not ready to change the exposure time yet.

Director #5 stated she had been working on a list of instruments which truly required an eight minute exposure time for the past three days. Director #5 stated she had identified two instrument sets which required an eight minutes exposure and were run on a four minute exposure, but she needed to verify. She stated the list of instruments which required an eight minute exposure time was very long and included instruments she knew only needed four minutes of exposure time. Additionally, she stated her primary concern was the SeaSpine instruments since some required an eight minute exposure and some required a four minute exposure time. Director #5 stated she was unable to provide an accurate list of instruments which required an eight minute exposure time to perform an audit to determine if instruments were ran on the correct autoclave cycle.

Director #5 was unable to verify if staff had and were following the correct IFUs for surgical instruments being used during surgical procedures at the facility.

iv. On 7/7/21 at 1:45 p.m., the director of quality and patient safety officer (Director) #7 was interviewed. Director #7 stated the facility staff was currently performing audits to determine if the correct IFUs were in Sergio. Director #7 stated she had not been informed prior to the interview there were still variations in Sergio from the Manufactures IFUs. Director #7 stated it was important to follow IFUs to ensure sterilization was appropriate and if it was not completed per the IFUs, there could be a risk of blood borne pathogens to patients

d. Document review

i. On 7/6/21 at 12:53 p.m., the facility sent an email with the IFU for the specialty curettes. The facility sent two IFUs. Both IFUs were from Life Instruments one read general instrument reprocessing and one read curettes. Both read there should be a four minute exposure.

ii. On 7/8/21 at 4:38 p.m., the facility emailed their audit of instruments which required eight minutes exposure time compared to the loads they were run on and compliance to the exposure.

Instrument list:

AWL and TAP combo set 001 58% ran correctly, AWL and TAP combo set 002 56% correctly, Lateral Disc Prep Instrument Set 001 29% correctly, Posterior Decompression Instrument set 001 90% correctly, Rapid Graft Delivery system set 001 40% correctly, Rapid Graft Delivery system set 002 40% correctly, specialty curettes set 001 30% correctly and 002 67% correctly. There was a note on the audit which read, waiting for a response from SeaSpine for instrument validation, data may change once response received.

iii. On 7/13/21 at 2:03 p.m., the facility emailed an updated audit of instruments which required eight minutes exposure time compared to the loads they were run on and compliance to the exposure.

Instrument list:

AWL and TAP combo set 001 32% ran correctly, AWL and TAP combo set 002 43% correctly, Lateral Disc Prep Instrument Set 001 46% correctly, Posterior Decompression Instrument set 001 50% correctly, Rapid Graft Delivery system set 001 50% correctly, Rapid Graft Delivery system set 002 43% correctly, specialty curettes set 001 and 002 0% correctly. There was a note on the audit which read, waiting for a response from SeaSpine for instrument validation, data may change once response received.

iv. On 7/13/21 at 7:09 a.m., the facility emailed Sergio autoclave instructions for the instruments audited above. The instructions included the Posterior disc Prep instruments which were to be exposed for four minutes. This was in contrast to the audit above which implied they should have been run on an eight minute exposure cycle.

v. On 5/18/21 there was a report in which the operating room (OR) staff opened a suction instrument which was assembled when the pack was opened. The OR staff was concerned because this set had been usually packaged disassembled. The staff reviewed the IFUs with the SPD manager and determined the IFUs were followed by the SPD staff in this case. There was no follow up as to why the instrument was previously packaged unassembled.

vi. On 6/8/21 there was a report in which bioburden was found on a graft delivery system and removed prior to reaching the patient. The graft delivery system was the same instrument listed in the audits above which were inconsistent with compliance. The load information was requested from the facility. The facility provided two different load data. One load was processed for eight minutes and one was processed for four minutes.

e. Subsequent interviews were conducted

i. On 7/13/21 at 3:42 p.m., Regulatory Affairs Program Manager (Manager) #8 was interviewed. Manager #8 stated the load data was unable to determine if the facility correctly sterilized the graft delivery system. Manager #8 stated it would be difficult to determine compliance with an IFU if there was a discrepancy over which IFU to follow. She stated if the manager would have dug deeper in June, the IFU could have been clarified sooner.

ii. On 7/13/21 at 8:29 a.m., an additional interview was conducted with Director #5. Director #5 stated the initial audit which was provided regarding the eight minute exposure accuracy was incorrect. Therefore, the facility was still trying to determine what the correct IFUs for some instruments were and if the instruments were run on the correct cycle for sterilization. Director #5 stated the facility had been sterilizing two different types of instruments with different exposure times together which caused confusion with the SPD staff as to whether the combined sets required four or eight minutes of exposure. She stated the set was combined in the past year. Director #5 stated the facility was not aware the setting in Sergio was incorrect until the time of the survey. She stated they had reached out to the specialty curette vendor to get an engineering analysis to determine the correct IFU. Director #5 stated the confusion was with SeaSpine brand instruments and until they were confident on how long to process the instruments, they were exposing all the SeaSpine instruments to eight minutes. Director #5 stated the list which listed the instruments that required eight minutes was incorrect.

Director #5 stated they found the information in Sergio was different from the manufacturer's IFUs. She stated the facility had identified some manual entries into Sergio were incorrect and there was no double check in place to verify the information which was added to Sergio.

Director #5 stated SPD staff sterilized instruments according to what the system told them, therefore if the information in the system was incorrect, staff sterilized incorrectly.