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Based on observations, review of facility documents, and medical records (MR), and interviews (EMP), it was determined the facility failed to ensure infection prevention processes were followed to prevent potential contamination of equipment.

This condition is not met as evidenced by:

Based on a review of an incident and facility investigation into same, it was determined that contaminated equipment was utilized on a patient, and the facility failed to thoroughly investigate and take immediate and appropriate corrective actions to prevent possible recurrence.

Findings include:

1. On October 20, 2021, it was identifed that endoscope #3433 had a clip lodged inside of the scope during the cleaning process. This clip was used from a previous case, and therefore was contaminated during use on a patient.

§482.42 (a)(2) Standard: Infection prevention and control program organization and policies. (A-0479)

2. During observations, document review, and interviews, it was determined the facility failed to ensure that a clean and sanitary environment to avoid sources and transmission of infection was maintained.

(A-750)

Based on review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to ensure endoscopes were processed to ensure contamination did not occur for one of one medical record (MR 2) reviewed.

Findings included:

On November 4, 2021, a review of the facility policy, "Reprocessing of Flexible Endoscopes with the OER-PRO, 3106," last revised December 1, 2019, revealed, "Administration...3. Point of Care Pre-cleaning: 1. Initiate immediately following completion of the endoscopic procedure at the point of use when the insertion tube is removed from the patient and prior to disconnecting from the power source. 2. Pre-cleaning will be done at the bedside using an enzymatic bedside cleaning kit, according to the manufacturers IFU. Immediately after removing the endoscope from the patient the pre-cleaning should be done. Flush air and water channels in accordance with the endoscope's manufacturer's instructions...Flush the auxiliary water channel per manufacturer's instructions...5. Pre-Cleaning...1. Fill the sink with water and appropriate flexible scope cleaning detergent...Immerse the endoscope...4. Brush the insertion tube portion of the suction channel. Repeat until all the debris is removed. 5. Brush the universal cord portion of the suction channel. Repeat until all debris is removed. Continue to brush ports until the brush comes out free of debris. 6. Brush the suction port and instrument port. Repeat until all debris removed....6. High Level Disinfection...1. Place endoscope in the OER-PRO using the proper manufacturer recommended connectors...4. Once the cycle is completed and a printout is obtained designating proper completion of the process, remove the scope from the processor...7. Drying Scopes...3. Forced Air will be inserted into the air/water, suction and biopsy channels."

On November 4, 2021, a review of facility incidents revealed, On October 20, 2021, A "Sterilization/Cleanliness Issue, Pt [MR# 2] had gastroscopy procedure with endoscopy scope #3433. After the case the scope was being processed and the endo tech found a clip inside of the scope during the cleaning process. No clips were used during this case. This clip was from previous clip case, that was lodged inside of scope. A boroscope was used to visualize the clip and it was dislodged...Because of the foreign object inside the scope, the scope should be considered contaminated."

A review of MR#2 was completed on November 4, 2021, and revealed this patient came to the GI Lab as an outpatient on October 20, 2021, for an upper GI endoscopy. The procedure was completed at 11:53 AM on October 20, 2021, and then the patient was discharged to home.

A letter sent from the facility to MR# 2 dated October 28, 2021, revealed, "When an unanticipated outcome occurs that requires the delivery of additional healthcare services to a patient, Pennsylvania law requires that the patient, or next of kin as appropriate, receive written notification. This letter is in follow-up regarding the potential improper sterilization of equipment that was utilized during your surgical procedure on October 20, 2021..."

During an interview on November 5, 2021, at 11:50 AM, EMP 2 confirmed that endoscope #3433 was found to be contaminated due to retention of a clip from a previous procedure. Further interview with EMP 2 confirmed that facility failed to conduct a thorough investigation into this incident.

During an interview on November 5, 2021, at 12:30 PM, EMP3 was asked to provide evidence that staff were re-educated and provide evidence of any other corrective actions that were implemented since the incident on October 20, 2021. Nothing was provided and EMP 3 confirmed staff were not re-trained prior to this survey.

Based on observations, review of facility documentation and interview, it was determined the facility failed to ensure that a clean and sanitary environment to avoid sources and transmission of infection was maintained.

Findings included:

On November 4, 2021, at 10:05 AM, a tour of the GI Lab was conducted. The scope processing room was set up with a dirty to clean flow, from the pass-thru window to the stainless sink, to the automatic Olympus OER-Pro scope processors, of which there were two. The clean scopes are then carried into the adjacent room to the Clean Scope Storage area where a Mass Medical Storage Unit for Olympus scopes stood along one wall. This dryer/storage cabinet was HEPA filtered and had roll down doors. After taking a tour of the GI Laboratory and having the endoscope cleaning process explained, further documents were requested and reviewed.

1. During an interview on November 5, 2021, at 1:30 PM, EMP 6 explained that the GI lab's two automated scope washers each contained a filtration system that included 6 filters. EMP 6 explained that the GI Lab staff were responsible for changing the three MAJ filters and they were to be changed monthly. A review of the log that EMP 6 provided verified that those filters were being changed monthly. Further interview with EMP 6 revealed that the three other filters, a 1.0 micron filter is required to be replaced every month, a .45 micron filter is required to be replaced every 6 months, and the MAJ-824 internal filter was required to be replaced every 6 months. EMP 6 stated these three filters were changed by the engineering department. A log for these filters was requested and provided for both of the automatic scope processors and revealed the following:

Processor tag #56:
July 2, 2020, All 3 filters were changed
November 21, 2020, the 1.0 micron and the internal filter was changed
March 4, 2021, the 1.0 and .45 micron filters were changed
November 4, 2021, ALL filters were changed.

Processor tag #57:
July 2, 2020, All 3 filters were changed
November 21, 2020, the 1.0 micron filter and the internal filter were changed
March 4, 2021, the 1.0 and the .45 micron filters were changed
June 16, 2021, the internal filter was changed
November 4, 2021, ALL filters were changed.


Further interview with EMP 6 confirmed the filters on both Olympus endoscope automated processors were not being changed with the required frequency.


2. During the above tour of the GI Lab, it was observed that the endoscope locker/dryer was used to store the scopes. This cabinet was blowing warm air during the observations. The manufacturer's literature was requested and provided:
This "scope locker" included a HEPA filter and the manufacturer's guidelines revealed, "Replacing the locker HEPA filter. MASS Medical Storage recommends changing the Locker HEPA filter every six months with continuous filtration."
During an interview on November 5, 2021, EMP 5 confirmed that she was unaware that the scope locker/dryer contained a HEPA filter and was unaware the frequency that it needed to be changed.
During an interview on November 5, 2021, at 1:30 PM, EMP 6 confirmed he was not aware of the GI Lab scope locker/dryer and stated he never changed a HEPA filter for that unit.