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Based on observations, interviews, and record reviews, the facility failed to ensure surgical services were maintained when:

1. Black particles were observed in the dryer chamber of one of four big washers (Washer 1) in the Main Central Sterile Processing (CSP) Department. This failure had the potential for instruments which were sterilized in Washer 1 to be contaminated which had had the potential for patients in whom these instruments were used to be exposed to infection (Refer to A 0951); and

2. Unsterilized instruments were used during a surgical procedure, for one of 10 sample patients (Patient 3). This failure resulted in Patient 3 to be exposed to infection and/or blood-borne diseases (diseases caused by bacteria or viruses in the blood transmitted through contact with infected blood or body fluids) and had the potential to result in a delay in Patient 3's recovery and may prolong the patient's hospital stay (Refer to A 0951).

The cumulative effect of these failures had the potential for patients to exposed to bacteria, viruses, and/or fungi from the unsterilized instruments which could result in hospital acquired infections (infections that patients develop while receiving care in a hospital) for patients and prolonged hospital stay.

Based on observations, interviews, and record reviews, the facility failed to ensure surgical services were maintained when:

1. Black particles were observed in the dryer chamber of one of four big washers (Washer 1) in the Main Central Sterile Processing (CSP) Department. This failure had the potential for instruments which were sterilized in Washer 1 to be contaminated which had had the potential for patients in whom these instruments were used to be exposed to infection; and

2. Unsterilized instruments were used during a surgical procedure, for one of 10 sample patients (Patient 3). This failure resulted in Patient 3 to be exposed to infection and/or blood-borne diseases (diseases caused by bacteria or viruses in the blood transmitted through contact with infected blood or body fluids) and had the potential to result in a delay in Patient 3's recovery and may prolong the patient's hospital stay.

Findings:

1. On May 13, 2025, at 8:13 a.m., a tour of the Main CSP Department was conducted with the Associate Vice President of Surgical Services (AVP), the Chief Nursing Officer (CNO), the Quality Analyst (QA), the Central Services Manager (CSM) and the Director of Central Services (DCS).

On May 13, 2025, at 8:22 a.m., during the tour, an inspection of the Main CSP big washer was done and black particles were observed in the dryer compartment of the big washer.

On May 13, 2025, at 8:24 a.m., an interview was conducted with the CSM. The CSM stated there were black particles in the dryer compartment of the big washer. The CSM stated there should not be any black particle in the dryer compartment of the big washer. The CSM stated the dryer compartment of the washer should have been cleaned.

On May 13, 2025, at 4:50 p.m., an undated document titled, "Operator Manual," for the big washer, was reviewed. The document indicated, "...it is the responsibility of the customer to verify HEPA [High Efficiency Particulate Air] filter [a type of filter designed to remove airborne particles] condition to help ensure safe and reliable operation of filter...HEPA filter replacement should be carried out only by [Name of company] trained, qualified, facility service technicians or [Name of Company] service technicians..."

On May 13, 2025, at 4:50 p.m., an undated and untitled document was reviewed. The document indicated, "...May 13, 2025, at 9:36:45 [9:36 a.m.]...Subject...(Dry Chamber)...The dry chamber is an empty chamber that the washer rack will pass thru once the devices have been cleaned and thermally disinfected [a process that removes infections such as bacteria and viruses through the use of hot water]...There are HEPA filters that are changed...but end users do not do this only trained service team..."

There was no documented evidence the Operator Manual for the big washer contained instructions on what is to be done if there were black particles in the dryer chamber of the big washer.

On May 13, 2025, at 4:50 p.m., an interview was conducted with the DCS. The DCS stated they do not have a policy on the cleaning, testing, and maintenance of the washers in the CSP department. The DCS stated they follow the operator manual in the cleaning, testing, and maintenance of the big washer.

On May 14, 2025, at 8:48 a.m., an interview was conducted with the CSM. The CSM stated the Operator Manual for the big washer did not contain instruction regarding the cleaning of black particles in its dryer chamber. The CSM stated that the Operator Manual indicated the staff should have been checking the condition of the dryer compartment. The CSM stated there was no staff assigned to check the condition of the dryer compartment in the big washer.

2. On May 12, 2025, at 9:38 a.m., a tour of the Main CSP Department was conducted with the QOS, the AVP, the CNO, the QA, and the DCS. Two unlabeled carts were observed in front of Sterilizer (an equipment that kills bacteria, fungi [microorganism such as molds or yeasts] and spores [cell that bacteria or fungi produce to defend themselves against high temperatures or conditions])12.

On May 12, 2025, at 11 a.m., an interview was conducted with CSP Technician (CST) 1. CST 1 stated there were no labels on the two carts in front of Sterilizer 12. CST 1 stated the CSP personnel will check for the chemical test (CT, a test to ensure the instruments or trays are sterilized) on the trays on the carts to know which cart holds the sterilized trays and which cart holds the unsterilized trays.

On May 13, 2025, at 9:16 a.m., a review of the Quality Assurance testing (testing done to ensure equipment meet specified quality standards and requirements) for the equipment in the Main CSP Department was conducted with the Instrument Management Coordinator (IMC).

On May 13, 2025, at 9:48 a.m., an untitled and undated facility document was reviewed. The document indicated, "...[Name of Sterilizer]...Site: MAIN...Date opened: 1/7/2025 [January 7, 2025] 2:14 AM [a.m.]...Contents...Neuro [neurology, branch of medicine specializing on the diagnosis and treatment of disorders of the brain and spinal cord] Spine Tray 1 Item Index [a unique identifier used to track and manage individual instruments] 001...Biologicals [a test system used to verify the effectiveness of sterilization (a process that destroys bacteria, viruses, fungi, and spores) ...]...Test...Chemical...Result...Fail...Date Recorded 1/7/2025 4:20 AM..."

On May 13, 2025, at 10:02 a.m., an untitled and undated facility document was reviewed. The document indicated, "...Date...1/7/2025 2:14 AM...[Name of CST 2] ...Neuro Spine Tray 1...[Name of Sterilizer 12]...QTY [Quantity]1...1/12/2025 [January 12, 2025] 7:03 AM...Tray 1...Case Cart-010 ...01/12/2025 3:29 PM...Washer 1...1/13/2025 [January 13, 2025] 1:29 AM...Tray 1...Sterilizer 12..."

On May 13, 2025, at 10:11 a.m., an undated facility document titled, "Case Cart Details," was reviewed. The document indicated, "...Case Number n2061440...1/12/2025 7:30 AM...Main OR [operating room, room number]...[Name of MD]...Neuro Spine Tray # [number]1...Date Added to Cart 1/12/2025 7:03 AM..."

On May 13, 2025, at 10:25 a.m., an interview with the IMC was conducted. The IMC stated the chemical test for Sterilizer 12 failed. The IMC stated Neuro Spine Tray 1 was not re-sterilized on January 7, 2025. The IMC stated Neuro Spine Tray 1 should have been re-sterilized on January 7, 2025. The IMC stated Tray 1 was used for a surgical procedure on January 12, 2025, at 7:30 a.m.

On May 13, 2025, at 10:35 a.m., an interview was conducted with the CSM. The CSM stated the chemical test for Sterilizer 12 failed. The CSM stated the instruments or trays in Sterilizer 12 were not sterile. The CSM stated Neuro Spine Tray 1 should have been re-sterilized. The CSM stated Neuro Spine Tray 1 should not have been used on a surgical procedure since it was not sterilized.

On May 13, 2025, at 3:12 p.m., a review of Patient 3's medical record was conducted with the Manager Perioperative Informatics and Education (MPI). Patient 3 was admitted to the facility on January 7, 2025, for back and leg pain.

On May 13, 2025, at 3:18 p.m., an undated facility document titled, "Verification of Informed Consent," was reviewed. The document indicated, "...your physician [Name of MD]...has recommended the following surgery...Signature [Signature of Patient 3]...1/9/25 [January 9, 2025]...1342 [1:42 p.m.]..."

On May 13, 2025, at 3:19 p.m., an undated and untitled document was reviewed. The document indicated, " ...Care Timeline ...01/12 [January 12, 2025] Lumbar Three Lumbar Four Lumbar Five [bones in the lower portion of the spine] Decompression Fusion [a surgical procedure used to address back pain and nerve compression] ..."

On May 14, 2025, at 9:14 a.m., an interview was done with the CSM. The CSM stated the facility policy titled, "Recall of Hospital Sterilized Items," was not implemented for Neuro Spine Tray 1. The CSM stated everything that was supposed to be done in the policy should have been followed.

On May 14, 2025, at 9:32 a.m., an interview was done with the Quality Analyst (QA). The QA stated the Neuro Spine Tray 1 was used for Patient 3's surgery.

On May 14, 2025, at 10:23 a.m., an interview was conducted with the Infection Preventionist (IP). The IP stated the facility policy titled, "Recall of Hospital Sterilized Items," should have been followed for Neuro Spine Tray 1. The IP stated she was not informed an unsterile tray was used during Patient 3's surgery. The IP stated she should have been informed so the patient could be monitored for infection and complications of surgery. The IP stated it is important to recall the unsterilized items to keep unsterile packs or instruments from being used on a patient and to prevent infection.

On May 14, 2025, at 10:33 a.m., a document tiled, "[Name of Company] Attest Steam Chemical Integrators 1243A and 1243B," was reviewed. The document indicated, "...Directions for Use ...After processing, the dark color should have entered the green ACCEPT window...If the dark color has not entered the green ACCEPT window, a red REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to sufficient steam sterilization conditions. These items should be returned for reprocessing..."

A facility policy titled, "Recall of Hospital Sterilized Items," dated June 21, 2005, was reviewed. The policy indicated, "...if a biological culture is positive or a sterilizer has malfunctioned a recall shall be initiated...notify the central sterile processing director who will notify the Surgical Services Director and infection preventionist...Identify and Retrieve items from the load not in use...If suspected items have been used, the Central Sterile Processing Director and the Infection Preventionist will notify the physicians and supply patient names for proper treatment and follow up...Administrative Director of Surgical Services shall be notified of the above when a recall is initiated..."

The facility Infection Control Plan titled, "Infection Prevention and Epidemiology (the study of the distribution and control of health-related events or diseases) Program Plan 2024 Evaluation 2025 Goals," was reviewed. The plan indicated, "...Mission...The infection prevention program is in place to reduce the incidence of preventable...infections...conduct ongoing surveillance (the ongoing systematic collection, analysis, and interpretation of health-related data) and analysis...to recognize trans and address issues in a timely manner...protect patients...by reducing risks of healthcare associated infections (infections acquired by patients while receiving care in a health facility)...and providing timely exposure follow up and management..."