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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 §482.57, Respiratory Services was out of compliance.

(A-1160) - The equipment and facilities provided for respiratory care services shall be commensurate with the clinical procedures and programs of the hospital. Based on observation, interviews, and document review, the facility failed to ensure critical patient care equipment was maintained through a preventative maintenance program for all ventilators (a machine used to mechanically move air in and out of lungs) at the facility.

Based on observation, interviews, and document review, the facility failed to ensure critical patient care equipment was maintained through a preventative maintenance program for all ventilators (a machine used to mechanically move air in and out of lungs) at the facility.

Findings include:

Facility policies:

The Medical Equipment Inspection Policy read, both for owned and non-owned equipment, Biomed obtains and confirms that preventive maintenance is current and satisfies manufacturer's recommendations or an approved CHCO Alternate Equipment Management (AEM) Program. Additionally, the Medical Equipment Policy states all equipment included in the medical equipment management plan that requires scheduled service will receive such service and will be serviced based on the manufacturer's recommendations for service unless the equipment is otherwise subject to an approved AEM Program or if service is to be provided more frequently than per the manufacturer's recommendations.

The Clinical Equipment Preventive Maintenance Strategies Policy read, equipment on the Medical Equipment inventory will be evaluated in a risk assessment process and risk scored based on that evaluation to ensure appropriate maintenance procedures are performed at effective intervals to provide safe equipment and to maximize the equipment's useful life. The risk criteria will include equipment functional risk, probability of failure, impact of failure, and regulatory/accreditation requirements. Ventilators are considered high risk based on the risk assessment process.

The Medical Equipment-Expired, Defective, Malfunctioning, and-or Unsafe Policy read, Biomed is responsible for tracking preventative maintenance schedules for all medical equipment provided by CHCO for patient use during care at CHCO locations.

References:

According to the Director of Clinical Engineering job description, the Director of Clinical Engineering is responsible for providing oversight and governance over all functions related to safety testing, utilizing, repairing and maintaining of biomedical patient care equipment across the health system. According to the Biomedical Equipment Advanced Job Description, the Biomedical Equipment Advanced technician inspects and repairs sophisticated medical equipment for compliance to documented safety and performance standards. Manages, mentors and trains other team members on Biomedical devices.

According to the Draeger V500 Service Manual, routine maintenance (RM) is required every four weeks for ambient air filters and every three months for the internal battery (NiMH) and PS500 power supply unit (VRLA). The manual states the Draeger V500 ventilator must be inspected and serviced at the intervals specified by the manufacturer as device failure is possible due to wear or material fatigue of the components.

According to the Servo-u/Servo-n/Servo-u MR Ventilator Systems User Manual, preventive maintenance (PM) must be performed by authorized personnel at least once every year as long as the unit is not used more than normal. Normal operation during one year is estimated to correspond to approximately 5000 hours of operation.

According to the Trilogy 202 Ventilator User Manual by Philips, PM service is due every 10,000 hours or 24 months, whichever comes first depending on the usage of the device. Additionally, PM service is due every two weeks to inspect and clean the air inlet filter for proper operation of the ventilator.

According to the Trilogy EV300 Ventilator Service Manual RM to inspect and replace the air inlet filter and air particulate should occur every 250 hours to inspect for occlusions dirt, lint, or damage. The Trilogy EV300 Ventilator Service Manual states RM is important to help protect the patient and other internal components of the ventilator.

1. The facility failed to perform preventative maintenance (PM) on ventilators.

A. Observations and document review revealed ventilators were missing preventative maintenance (PM) required by manufacturer's instructions.

i. On 2/7/23 at 12:15 p.m., a tour was conducted with respiratory therapist (RT) #1 in a patient room. Observations in the room revealed a Servo-u ventilator. RT #1 displayed the system's general maintenance log on the machine's screen, which revealed the ventilator had been running for 42,793 operation usage hours.

The Master Equipment Report was reviewed, which was explained by Bio Med Technician (Tech) #2 in an interview on 2/7/23 at 10:40 a.m., as a report used to log when preventative maintenance was due for the Servo-u ventilator. The report revealed the Servo-u ventilator's last inspection was due on 1/6/2023 by 7:35 p.m. There was no evidence PM was conducted by the time frame indicated from the Master Equipment Report. In addition, there was no evidence of when the last PM was conducted for the Servo-u ventilator.

Review of the facility's overall Ventilator PM log, which was explained by Tech #2 on 2/7/23 at 10:40 a.m. the log to track PM schedules for all ventilators owned by the facility. Review of the log revealed the Servo-u ventilator was not listed in the log.

The Servo-u Ventilator IFUs required PMs to be conducted yearly as long as the unit was not used more than normal. Normal operation during one year was estimated to correspond to approximately 5000 hours of operation. This was in contrast to observations which revealed the Servo-u ventilator had been running for 42,793 usage hours without evidence of PM.

ii. According to the Ventilator PM log, there were 100 Trilogy 202 Ventilators listed in the Ventilator PM log scheduled for yearly PM service intervals. The Ventilator PM log provided information about specific maintenance and part replacements performed during scheduled annual PM. The Ventilator PM log did not show maintenance for Trilogy 202 Ventilators based on usage hours.

This was in contrast with the Trilogy 200 IFUs which required PM to be conducted every 10,000 hours or 24 months, whichever was first depending on the usage of the device.

B. Interviews revealed staff were unaware of the requirements for ventilator PMs.

i. On 2/8/2023 at 7:32 a.m., an interview was conducted with Tech #2. Tech #2 stated his role was to maintain and monitor maintenance for all ventilators owned by the hospital. Tech #2 stated PM was scheduled and performed every six months for all ventilators owned by the hospital. Tech #2 stated he was unaware of additional PM requirements based on usage hours. Tech #2 did not complete PM based on usage hours and had not since the start of his employment in 1995.

ii. On 2/8/23 at 12:23 p.m., an interview was conducted with the Director of Respiratory Therapy (Director) #3. Director #3 stated Respiratory Therapy managed all leased ventilators and was responsible for ensuring machines functioned properly. The medical equipment companies who provided leased ventilators were responsible for PM on all leased ventilators. Director #3 stated the leased ventilators received PM every six months and the leasing companies did not perform checks or maintenance based on hours used. Director #3 stated it was important all ventilators were maintained at recommended times because ventilators were life sustaining and a malfunction could put a patient at risk of death.

iii. On 2/9/23 at 11:58 a.m., an interview was conducted with the Clinical Specialty Coordinator (Clinical Coordinator) #4. Clinical Coordinator #4 lead the ventilator process and quality improvement, program development, care coordination, education for staff and families. The Clinical Coordinator #4 stated the ventilators were a life sustaining piece of equipment which made identifying and trending issues key to help guard against unchecked adverse patient events. Clinical Coordinator #4 stated the Quality and Safety Review System (QSRS) tracked ventilator maintenance errors in connection with patient events for review.

2. The facility failed to perform routine maintenance (RM) with part inspection and replacement as part of their preventative maintenance (PM) program on ventilators.

A. Observations and document review revealed ventilators were missing routine maintenance (RM) for parts and components required by manufacturer's instructions.

i. On 2/7/23 at 12:22 p.m., a tour was conducted with respiratory therapist (RT) #1 in a patient room. Observations in the room revealed a Draeger V500 Ventilator. RT #1 displayed the system status maintenance log on the machine, which revealed the ventilator was due for service by 1/2/23. The maintenance log revealed the PS500 power supply unit (VRLA) was installed on 2/14/22.

Review of the Master Equipment Report revealed the Draeger V500 Ventilator's last PM was due by 2/28/22. The Master Equipment Report revealed a yearly PM schedule for the Draeger V500 Ventilator with the first scheduled PM date of 2/1/24. RM part inspection for the Draeger V500 Ventilator was not present in The Master Equipment Report or the Ventilator PM log.

This was in contrast with the Draeger V500 Ventilator IFUs, which required RM of the ambient air filter every four weeks. In addition, the Draeger V500 Ventilator IFUs required RM every three months to test capacity and replace if necessary for the internal battery (NiMH) and PS500 power supply unit (VRLA).

ii. According to the Ventilator PM log, PM was scheduled yearly for the Trilogy EV300 Ventilators. The Ventilator PM log did not show evidence of RM in addition to scheduled yearly PM for the inspection of parts for the Trilogy EV300. In an interview on 2/7/23 at 10:40 a.m., Tech 2# explained he was unaware of the additional RM part inspection requirements and had not completed RM on Trilogy EV300 ventilators owned by the hospital.

This was in contrast to the Trilogy EV300 Ventilator IFUs, which required RM to be performed monthly and between patients for the particulate filter and every 250 hours for the air inlet foam filter.

B. Interviews revealed staff were unaware of the requirements for ventilator RM with part inspection and replacement.

i. On 2/8/2023 at 7:32 a.m., an interview was conducted with Tech #2. Tech #2 stated PM is scheduled and performed every six months for all ventilators owned by the hospital. Tech #2 stated he was unaware of additional PM requirements to check and replace certain parts every four weeks to three months. Tech #2 did not complete RM or check and replace parts for ventilators with service intervals less than six months, and had not since the start of his employment in 1995.