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Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QAPI was out of compliance.

A-0283: Program Data. The hospital must use the data collected to - Identify opportunities for improvement and changes that will lead to improvement. Program Activities. The hospital must set priorities for its performance improvement activities that-- Focus on high-risk, high-volume, or problem-prone areas; Consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, patient safety, and quality of care. The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to problem-prone areas. Specifically, the facility's QAPI program, called the Performance Excellence Committee (PEC), failed to identify, track and trend, and implement preventive actions related to the facility's Sterile Processing Department (SPD).

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to problem-prone areas. Specifically, the facility's QAPI program, called the Performance Excellence Committee (PEC), failed to identify, track and trend, and implement preventive actions related to the facility's Sterile Processing Department (SPD).

Findings include:

Facility policies:

The Sterile Processing Policy read, the purpose of the policy was to provide a consistent and uniform understanding of the decontamination, clearing, inspection and quality control of critical and semi-critical instrumentation that require sterilization. Contamination is defined as a state of having been actually or potentially coming in contact with microorganisms. Periodic monitoring of quality control documentation should be done at least quarterly to ensure the sterile processing process and policy are being followed. The findings should be reported to the Care Site Infection Prevention Committee quarterly. This is to be done by the Manager of SPD. The infection prevention department shall perform periodic auditing, at least quarterly to ensure that the sterile processing policy is being followed.

The Safety Event Identification, Analysis, and Reporting policy read, the purpose was to identify, report and analyze actual and near-miss safety events. This policy applies to all associates. Associates shall report potential safety events via the PEARL event reporting system. Once an event has been reported, the care site risk manager and department lead will conduct an initial review and investigation of the event and complete follow-up. If the event is determined to be a precursor or near-miss safety event, the patient safety event should be trended.

Facility documents:

The Infection Preventionist Job Description read, the Infection Preventionist (IP) is responsible for assisting the program manager and the Sr. Director of Quality/Safety in the planning, implementation, and continuous evaluation of infection control programs at the facility. The IP provides support by identifying and implementing infection control processes related to surveillance, data analysis and reporting in order to eliminate potential infectious hazards. Additionally, the IP participates fully with teams around infection prevention regulatory requirements such as sterile processing.

The SPD Manager Job Description read, essential job duties include: possess knowledge to ensure compliance with regulatory standards; communicate with Senior leadership to include infection prevention and risk management; and performs other duties as assigned

The Infection Prevention and Control Risk Assessment and Plan for 2021 read, factors that increase risk of infection in the surgical services area include high volume of different surgeries and not sustained point of use instrument pre-cleaning after surgery. Factors that decrease the risk of infection in the surgical area include standardized SPD sterilization processes for all surgical areas and close monitoring of instrument cleaning. Additional factors to decrease infection include biweekly OR rounding with OR leaders to identify infection risks, action planning and improvement follow-up.

The Performance Excellence Plan 2021 read, the Performance Excellence Committee (PEC) obtains data through the safety event reporting program, associates with external review organizations and comparative databases. Major components of performance excellence include process outcomes and analysis. During this, data on critical processes and outcomes are collected and analyzed on a regular basis and appropriate action is taken as necessary.

Through proactive risk reduction activities, the facility identifies and attempts to improve the quality of care and reduce the risks to the safety of patients through proactive methods. These include associate interviews, environmental rounds, and process analysis.

1. The facility failed to ensure a consistent process was followed for staff to report variations in surgical instruments. Additionally, the facility failed to ensure audits were completed and followed up on in the sterile processing department.

A. Document review revealed occasional audits were completed by SPD but corrective action and preventive measures were not implemented by SPD, the Infection Control Committee (ICC) or the Performance Excellence Committee (PEC) based on the findings.

a. Review of events from January 1, 2021 to present, revealed there were six reported events where there was a potential contamination (potentially or actually coming in contact with infectious microorganisms) of surgical instruments or bioburden (potential bacteria on an area that has not been sterilized) was discovered on the instruments.

b. Review of the SPD instrument tray reprocessing data provided to the Infection Control Committee (IC Committee) from January 2021 to December 2021 was reviewed.

i. In March, the SPD department reported zero bioburden, two contaminations, two trays without indicators, (markers placed in trays used to confirm sterility) and two holes in the sterile wrapping. There was no documentation on the follow-up or actions implemented regarding the concerns identified.

ii. In May, the SPD department reported one bioburden, eight contaminations, six trays without indicators and six holes in the wrappers. There was no documentation provided on the follow-up or actions implemented regarding the concerns identified.

iii. In July, the SPD department reported one bioburden, eight contaminations, four instruments without indicators and five holes in the wrap. There was no documentation provided on the follow-up or actions implemented regarding the concerns identified.

iv. In September, the SPD department reported one bioburden, 11 contaminations, eight instruments without indicators and eight holes in wrap. There was no documentation provided on the follow-up or actions implemented regarding the concerns identified.

v. In December, the SPD department reported one bioburden, 11 instances of contamination, 15 instruments without indicators and 11 holes in wrap. There was no documentation provided on the follow-up or actions implemented regarding the concerns identified.

c. Review of the 2021 SPD Monthly Sterilization Tracer Breakdown report indicated audits were completed and reported to the infection control committee in February 2021 and March 2021. There was no reported data from April 2021 to December 2021 indicating the audits were completed and reported to the infection control committee.

A document provided by the facility dated May 7, 2020 indicated tracers were to be halted in March of 2020, however were to resume in May of 2020. The facility did not provide documentation tracers were halted in the year 2021.

d. Review of the Performance Excellence Committee Meeting Minutes for 2021 revealed in the months of February, April, June, August and November, the infection prevention committee meeting minutes were reviewed for the months prior. The meeting minutes were approved by the PEC however there was no indication SPD variations were discussed nor were preventative measures implemented to prevent reoccurrence.

B. Interviews revealed there was a lack of consistent process for collecting data for the tracking and trending of variations discovered in SPD.

a. On 12/15/21 at 9:30 a.m., an interview was conducted with SPD Technician (Tech) #1. Tech #1 explained when instruments were found to be contaminated or to contain bioburden, the OR would call the SPD department to collect the instruments and reprocess them. Tech #1 further stated the SPD tech who inspected the instruments prior to being sterilized was spoken to by the SPD manager regarding the issue. Tech #1 stated when he was made aware of tray contamination or bioburden on instruments, he did not file a PEARL (safety event) report.

b. On 12/15/21 at 10:00 a.m. an interview was conducted with Certified Surgical Technician (Tech) #8. Tech #8 stated her role in the OR was to set up the sterile field (where sterile drapes are placed for sterile instruments to be set upon during a procedure), ensure the sterile field was maintained and ensure all necessary surgical instrumentation was present. Tech #8 stated if she found contaminated surgical instruments or bioburden on instruments, she would notify the circulating nurse in the OR and the nurse would call the SPD department to come and collect the instruments to be reprocessed.

Tech #8 explained if bioburden or contamination was found on surgical instruments while she prepared the sterile field, the circulating nurse would potentially fill out a PEARL report. Tech #8 stated it was important for these reports to be completed so staff could be made aware and staff could prevent the scenario from occurring again. Tech #8 was unaware if the SPD department also completed PEARL reports when variations in instruments were discovered.

c. On 12/15/21 at 10:31 a.m., an interview was conducted with the Instrument Coordinator (Coordinator) #2. Coordinator #2 explained his role was to oversee instrumentation and place orders for additional instrumentation. Coordinator #2 stated he also sometimes assisted SPD as needed. Coordinator #2 stated if bioburden or contaminated instruments were discovered while a sterile field was being set up in the OR, the OR staff were responsible to complete a PEARL report and notify SPD of the event. Coordinator #2 stated it was important for bioburden and contamination to be tracked in order to identify patterns and make improvements.

d. On 12/15/21 at 12:17 p.m., an interview was conducted with Registered Nurse (RN) #7. RN #7 stated her role was a circulating nurse in the OR. RN #7 explained if bioburden or contamination was discovered on surgical instruments while setting up the sterile field, the SPD staff were notified to come and collect the instruments to be reprocessed. RN #7 stated a PEARL report was completed by OR staff only in certain situations. RN #7 stated if bioburden or contamination on an implant was discovered or the contamination or bioburden caused a delay and impacted the patient, she would fill out a PEARL report. RN #7 further explained she was unaware if the SPD department completed a PEARL report once notified of a contamination issue.

e. On 12/15/21 at 10:55 a.m., an interview was conducted with SPD Manager (Manager) #4. Manager #4 stated he oversaw the SPD department and the SPD staff. Manager #4 stated he would walk through the SPD area and observe processes being done; however, he did not document these audits. Manager #4 explained that if correct processes were not followed there was a risk for adverse effects on the patient.

Manager #4 stated when an instrument in the OR was discovered to be contaminated or contain bioburden, a Lead SPD tech would recover the instrument from the OR and bring it to the decontamination area to be reprocessed. Manager #4 explained he was able to identify who reprocessed the instrument sets based on the initials documented on the tag applied to the tray during the sterilization process. Manager #4 further explained once he identified who had reprocessed the instruments, he would speak to the staff member regarding the contamination or bioburden discovered. Manager #4 stated he typically received PEARL reports from the OR circulating nurse or scrub tech but was uncertain who was responsible to complete the PEARL report for contaminated instruments or bioburden found on instruments. Manager #4 stated it was important for PEARL reports to be completed so events could be tracked and trended to identify areas of improvement.

f. On 12/15/21 at 11:35 a.m., an interview was conducted with Infection Preventionist (IP) #6. IP #6 stated SPD audits were to be completed by the SPD department. She stated she did not personally conduct audits in the decontamination and sterilization area. IP #6 stated the Infection Prevention department should conduct audits in the SPD area in order to keep a broader pulse of variations in the area and to gain a better understanding of potential causes of surgical site infections (SSIs).

IP #6 stated for the year 2021, there was only one report entered into the PEARL system regarding bioburden. IP #6 stated Manager #4 completed the investigation and action plan in regards to this event. The bioburden event and follow-up was requested from the facility, however the facility was unable to provide documentation of the event and the actions taken to prevent reoccurrence.

The responsibility of who was to enter a PEARL report was discussed with IP #6. IP #6 stated the person who discovered the error or concern was the person who should enter in a PEARL report. IP #6 stated any minor deviation was expected to be reported by staff. The PEARL was to include but not be limited to: an indicator missing from a tray of instruments, a hair found on an instrument, and bioburden.

g. On 12/15/21 at 1:01 p.m., an interview was conducted with the Director of the Perioperative Department (Director) #3. Director #3 stated the SPD department received incident reports in regards to contamination and bioburden and the head of the SPD department would follow up. Director #3 stated there was not a lot of instruction given for when and who should complete a PEARL in the SPD area. Director #3 stated if staff working in the OR discovered bioburden on an instrument, a PEARL should be completed.

h. On 12/15/21 at 12:27 p.m., an interview was conducted with the Director of Quality and Safety (Director) #5. Director #5 stated she oversaw various different departments to include risk, infection prevention and safety. Director #5 stated a PEARL was the facility's internal reporting system for events that occurred. Director #5 stated it was the responsibility of any staff member who sees a variation in a process to complete a PEARL report.

Based on the manner and degree 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-0772 The infection preventionist(s)/infection control professional(s) is responsible for: The development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines.

Based on interviews and document review, the facility's infection preventionist (IP) failed to ensure the oversight of the facility's Sterile Processing Department (SPD). Specifically, the IP did not ensure a process was in place to have oversight of the SPD area and did not ensure sterilization breaches were investigated to prevent recurrence.

Based on interviews and document review, the facility's infection preventionist (IP) failed to ensure the oversight of the facility's Sterile Processing Department (SPD). Specifically, the IP did not ensure a process was in place to have oversight of the SPD area and did not ensure sterilization breaches were investigated to prevent recurrence.

Findings Include:

Facility policy:

The Sterile Processing Policy read, the purpose of the policy was to provide a consistent and uniform understanding of the decontamination, cleaning, inspection and quality control of critical and semi-critical instrumentation that require sterilization. Contamination is defined as a state of having been actually or potentially coming in contact with microorganisms. Periodic monitoring of quality control documentation should be done at least quarterly to ensure the sterile processing process and policy are being followed. The findings should be reported to the Care site Infection Prevention Committee quarterly. This is to be done by the Manager of SPD. The infection prevention department shall perform periodic auditing, at least quarterly to ensure that the sterile processing policy is being followed.

Facility Documents:

The Infection Prevention and Control Risk Assessment and Plan for 2021 read, factors that increase risk of infection in the surgical services area include high volume of different surgeries and not sustained point of use instrument pre-cleaning after surgery. Factors that decrease the risk of infection in the surgical area include standardized SPD sterilization processes for all surgical areas and close monitoring of instrument cleaning. Additional factors to decrease infection include biweekly OR rounding with OR leaders to identify infection risks, action planning and improvement follow-up.

The Infection Prevention and Control Specialist Job description read, the IP is responsible for assisting the Program Manager and the Sr. Director of Quality/Safety in the planning, implementation and continuous evaluation of infection control programs. The IP provides support by identifying and implementing infection control processes related to surveillance, data analysis and reporting in order to eliminate potential infection hazards. The IP participates and collaborates fully with teams around infection prevention/control regulatory requirements, including Sterile Processing.

1. The facility's IP failed to ensure audits were completed and followed up on in the SPD.

A. Review of the 2021 SPD Monthly Sterilization Tracer Breakdown report showed audits were completed and reported to the infection control committee in February 2021 and March 2021. There was no reported data available from April 2021 to December 2021.

B. A document provided by the facility dated May 7, 2020 indicated tracers were to be halted in March of 2020, however were to resume in May of 2020. The facility did not provide documentation tracers were halted in the year 2021.

C. Interviews revealed there was a lack of oversight to SPD for Infection Control tracking and trending.

i. On 12/15/21 at 10:00 a.m., an interview was conducted with Certified Surgical Technician (Tech) #8. Tech #8 stated her role in the OR was to set up the sterile field (where sterile drapes are placed for sterile instruments to be set upon during a procedure), ensure the sterile field was maintained and ensure all necessary surgical instrumentation were present. Tech #8 stated if she found contaminated surgical instruments or bioburden (the number of bacteria on area that has not been sterilized) on instruments, she notified the circulating nurse in the OR and the nurse called the SPD to come and collect the instruments to be reprocessed.

Tech #8 stated it was important to track bioburden to make staff aware and prevent it from happening again.

ii. On 12/15/21 at 9:30 a.m. an interview was conducted with SPD Technician (Tech) #1. Tech #1 stated when instruments were found to be contaminated or to contain bioburden, the OR would call the SPD department to collect the instruments and reprocess them. Tech #1 stated the initials on the tray identified the tech who sterilized the instruments and they were made aware of the contamination and were retrained if needed.

iii. On 12/15/21 at 10:55 a.m., an interview was conducted with SPD Manager (Manager) #4. Manager #4 stated he oversaw the SPD department and the SPD staff. Manager #4 stated he did audits as he walked through the SPD area and observed equipment being processed, however he did not document these audits. Manager #4 stated that if correct processes were not followed there was a risk for adverse effects on the patient.

Manager #4 stated when an instrument in the OR was discovered to be contaminated or contain bioburden, a Lead SPD tech recovered the instrument from the OR and brought it to decontamination to be reprocessed. Manager #4 explained he was able to identify who reprocessed the instrument sets based on the initials documented on the tag applied to the tray during the sterilization process. Manager #4 further explained once he identified who had reprocessed the instruments, he spoke to the staff member regarding the contamination or bioburden discovered; however, he did not document the training.

Manager #4 stated it was important to provide oversight for contaminated instruments so events could be tracked and trended to identify areas of improvement.

iv. On 12/15/21 at 11:35 a.m., an interview was conducted with Infection Preventionist (IP) #6. IP #6 stated that SPD audits were completed by the SPD. IP #6 confirmed the last SPD audit had been done March 2021. IP #6 stated she did not conduct audits in SPD, however, she stated it would be a support to SPD if she assisted with audits because the SPD would gain a better understanding of potential causes of surgical site infections.

IP #6 stated for the year 2021, there was only one report entered into the PEARL (event reporting) system regarding bioburden. IP #6 stated Manager #4 completed the investigation and action plan in regards to this event.

The bioburden event and follow-up was requested from the facility, however the facility was unable to provide documentation of the event and the actions taken to prevent reoccurrence.