HospitalInspections.org

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Based on medical record (MR) review, document review, and interview, the facility failed to fully investigate, identify, and evaluate an infection control issue.

This failure placed patients at increased risk of infection.

Findings:

The facility failed to:

- Identify that inspection and replacement of the internal transducer protectors was not performed on a hemodialysis machine used to treat a Hepatitis B virus positive patient, prior to the machine's use on non-Hepatitis B virus patients.
(See Tag A-0286)

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Based on medical record (MR) review, document review, and interview, the facility failed to identify that inspection and replacement of the internal transducer protectors was not performed on a hemodialysis machine used to treat a Hepatitis B virus positive patient, prior to the machine's use on non-Hepatitis B virus patients.

This failure placed all non-Hepatitis B virus hemodialysis patients at risk for exposure to the Hepatitis B virus.

Findings:

Review of Patient #1's medical record identified that Hemodialysis Machine #14 (a non-isolation designated machine) was used to treat Patient #1, a Hepatitis B Virus positive patient, on 3/8/2024.

The facility's Hemodialysis Treatment Sheets, dated from 3/8/2024 to 3/11/2024, verified that Patient #s 2 and 3 were subsequently dialyzed on Machine #14 since it's use on the Hepatitis B positive patient (Patient #1) on 3/8/2024.

Machine #14's Repair Log, dated 3/11/2024, identified that Machine #14 was terminally disinfected on 3/11/2024. There was no documented evidence that the internal transducer protectors were inspected and changed prior to Machine #14's return to general use on non-Hepatitis B virus patients.

During interview of Staff L (Biomedical Technician) on 4/4/2024 at 10:15 AM, Staff L confirmed they were not informed of the use of Machine #14 on a Hepatitis B Virus positive patient. Staff L also stated that if they had been notified of the exposure, they would have opened the machine and inspected/replaced the internal transducer protectors and disinfected the metal ports connecting the tubing. Although Staff L verbalized the steps they would follow had they been notified of an exposure, Staff L confirmed they did not inspect or replace the internal transducer protectors prior to returning hemodialysis Machine #14 to general use.

Confirmation and review of the facility's investigation revealed that the investigation did not identify the need to notify the Biomedical technician of the use of Machine #14 on a Hepatitis B positive patient, and the potential contamination of the machine's internal transducer protectors. Thus, Machine #14 was not inspected to verify there was no contamination to the internal transducer protectors, mitigating Hepatitis B exposure to non-immune patients.

During interview of Staff E (Chief of Nephrology) on 4/5/2024 at 9:30AM, Staff E confirmed the facility's investigation did not identify the need for Biomedical's physical inspection of the internal transducer protectors on Machine #14 to rule out cross-contamination, prior to returning the machine to use on the general hemodialysis population. Staff E acknowledged that the Biomedical technician should have been notified of the machine's use on a Hepatitis B virus positive patient.

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Based on document review and interview, the facility failed to maintain hemodialysis equipment to ensure patient safety.

Findings:

The facility failed to:

- Ensure electrical safety tests were performed and documented during preventative maintenance (PM), in accordance with manufacturers and the National Fire Protection Association's (NFPA) 99 (health care facilities code) recommendations.
(See Tag A-0724)

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Based on document review and interview, in eleven (11) of eleven (11) hemodialysis machines, the facility failed to ensure electrical safety tests were performed and documented during preventative maintenance (PM), in accordance with manufacturers and the National Fire Protection Association's (NFPA) 99 (health care facilities code) recommendations.

Findings:

The 2012 edition of the National Fire Protection Association (NFPA) 99 code 10.5.2.1.2 stated that "All patient care-related electrical equipment used in
patient care rooms shall be tested ... before being put into service for the first time and after any repair or modification that might have compromised electrical safety." In addition, Section 6.3.3.1 stated, " ...the effectiveness of the grounding system shall be determined by voltage measurements and impedance measurements."

The Fresenius 2008 T Hemodialysis Machine Manufacturer's Instructions for Use (IFU) (reviewed on 4/4/2024), directed staff to " ...measure the resistance...[and] verify the resistance is less than 0.2 ohm...[and that the] electrical chassis leakage [does] not exceed 100 microamperes." The Instructions for Use also directed staff to " ...record the measured values on either the 6-month ...or Annual Preventative Maintenance Checklist ...depending upon which is being performed..."

Review of the facility's 2023-2024 Preventive Maintenance (PM) Records for the 2008 T Hemodialysis Machines identified that no electrical safety test results were documented during the annual or semi-annual preventive maintenance. In addition, the work performed by the Biomedical staff during preventive maintenance was documented as "Pass." There was no documented evidence that impedance and voltage measurements were obtained and documented.

The instructions on the facility's Preventive Maintenance Work Orders for 2024 directed biomedical technicians to, " ...perform electrical safety ONLY if potential unsafe condition exists, is suspected, or repair(s) have been made, in accordance with NFPA 99 and ...policies ..." The instructions lacked guidance directing staff to perform and document the required electrical leakage and impedance measurements during the machines' annual or semi-annual preventive maintenance.

During interview of Staff L (Biomedical Technician) on 4/4/2024 at 10:15 AM, Staff L confirmed that the line voltage, ground resistance, and leakage measurements/results were not documented in the preventive maintenance records. In addition, Staff L was not able to confirm that these measurements had been obtained during the machines' annual preventive maintenance.

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Based on document review and interview, the facility failed to ensure staff complied with standards of infection control practices to avoid potential sources of cross contamination.

This failure placed patients at risk for exposure to infectious diseases.

Findings:

The facility failed to:

- Ensure preventive measures were implemented after a non-isolation designated hemodialysis machine (a machine used to treat non-isolation dialysis patients) was used to treat a Hepatitis B Virus positive patient.
(See Tag A-0750)

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Based on document review and interview, the facility failed to ensure preventive measures were implemented after a non-isolation designated hemodialysis machine (a machine used to treat non-isolation dialysis patients) was used to treat a Hepatitis B Virus positive patient.

This failure placed all hemodialysis patients at risk for infection due to cross-contamination.

Findings:

Review of Patient #1's medical record identified that Hemodialysis Machine #14 (a non-isolation designated machine) was used to treat Patient #1, a Hepatitis B Virus positive patient, on 3/8/2024.

Review of Machine #14's Repair Log, dated 3/11/2024, identified no documented evidence that the internal transducer protectors were inspected or replaced after the machine's repair, and before the return of Machine #14 to treat the general non-isolation hemodialysis population (non-Hepatitis B Virus positive patients).

During interview of Staff L (Biomedical Technician) on 4/4/2024 at 10:15 AM, Staff L confirmed they were not informed of the use of Machine #14 on a Hepatitis B Virus positive patient. Staff L also stated that if they had been notified of the exposure, they would have opened the machine and inspected/replaced the internal transducer protectors and disinfected the metal ports connecting the tubing. Although Staff L verbalized the steps they would follow had they been notified of an exposure, Staff L confirmed they did not inspect or replace the internal transducer protectors prior to returning dialysis Machine #14 to general use.

Upon request, the facility could not provide a written policy, procedure, instructions, or guidance directing staff of the actions to take when non-isolation machines were used to treat Hepatitis B Virus positive patients. In addition, the facility could not furnish written guidance directing staff of the steps to follow when blood or saline passes through the external tubing and transducer protectors.

Upon request, the facility could not provide documented evidence of staff education and/or guidance directing nursing staff to notify Biomedical staff of Hepatitis B cross-contamination to hemodialysis machines after use on Hepatitis B positive patients, and the need to inspect/replace internal transducer protectors, prior to returning non-isolation designated machines to general use.

During interview of Staff E (Chief of Nephrology) on 4/5/2024 at 9:30AM, Staff E confirmed no physical inspection of the internal transducer protectors was performed on hemodialysis Machine #14. Staff E also confirmed there was no written guidance directing nursing staff to notify Biomedical staff of Hepatitis B Virus-contaminated machines/equipment, or the steps staff should follow if cross-contamination occurred.