HospitalInspections.org

Based on investigative findings at the time of on-site visits of June 26, 2012 and July 2, 2012 to Prince Georges Hospital (PGH), it was determined that the hospital failed to provide a safe setting of care for patient's who required Vela Ventilator support:

On June 27, 2012 an initial site visit was made to PGH. At the time of the site visit interview was conducted with the hospital's Vice President of Facilities who informed the surveyor that at the time of the generator failure the on-duty engineer was unable to turn the generator back on. As a result the VP of Facilities was notified of the failure and inability to turnon the inoperable generator. The VP of Facilities subsequently traveled and arrived at the hospital approximately 45 minutes after the initial power failure to reset the generator.

According to the VP of Facilities when he arrived he turned the generator switch to the right (auto position) and the generator started. The VP of Facilities also informed the surveyor that the hospital's electrician had documented turning the switch back to the "ON" position but he (VP of Facilities) was 90% sure that it had likely been left in the "OFF" position after maintenance was perfromed earlier that day.

Interview was also held with the hospital's Clinical Engineering Supervisor to determine why the ventilator had failed. On June 26, 2012 when he was interviewed , the surveyor was informed by the supervisor that he did not know why the ventilator had failed; but it had been taken out of service. The surveyor then specifically asked about battery testing and was informed that the unit had not had a battery test at that time.

A copy of the maintenance record for the unit was reviewed showing that it passed testing as part of its preventive maintenance in January 2012 and was due again July 1, 2012. Further review of the documentation revealed that on June 26, 2012, it was determined that there was a report stating that the ventilator would not pass "leak test". The leak test is a minimum requirement for ventilator testing to ensure safe use of the ventilator.

During interview with the Director of Quality the surveyor was also informed that the manufacturer recommendation for battery replacement was every two years. However, at the time of the survey, there was no battery replacement history available for the surveyor to review. The Director of Quality did speak with the Clinical Engineering Supervisor and verified that the battery for the unit had never been replaced since the ventilator was purchased on February 2, 2008.

At the time of the second site visit on July 2, 2012, surveyors obtained additional information from the Clinical Engineering Supervisor in regards to maintenance of all ventilators currently at the hospital. During theJuly 2, 2012 interview, the supervisor verified that the batteries for multiple ventilator units had not been replaced since purchase. Review of the hospital's Ventilator Inventory Log on July 2, 2012 indicated that the hospital has a total of 29 Vela Ventilators, 25 of which had been purchased in February of 2008 and 4 which had been purchased in October of 2010. The batteries had not been replaced on any of the 29 ventilators in accordance with manufacturer's recommendations

There is no indication or documentation that the Clinical Engineering Supervisor had ever provided an alternative schedule for the technician to change the batteries, required the technician to provide documentation of the batteries having been changed or in any way provided oversight in regards to the technician completing the battery maintenance despite the potential for life threatening patient harm related to the ventilator batteries potential for failure.

Based on investigative findings it was determined that the hospital failed to utilize Quality Assessment and Performance Improvement standards to thoroughly investigate a serious adverse event involving failure of a ventilator to operate during the loss of emergency power on June 22, 2012 placing the patient at risk of harm as evidenced by:

On July 2, 2012 state surveyors made a visit to Prince Georges Hospital Center in response to a system wide power failure and ventilator failure while in patient use . At the time of the site visit surveyors conducted a tour of the CCC accompanied by the charge nurse.

Based on interview with the charge nurse, he informed the surveyors that Patient #1 was the patient who had been on a ventilator that failed to operate in battery back-up mode on June 22, 2012 during a power failure. According to the charge nurse, he observed Patient #1 being bagged (assisted respiration by Ambu bag) by the respiratory therapist. However, the charge nurse stated that he did not know how long Patient #1 was bagged because the next time he passed Patient #1's room he had been placed onto a new replacement ventilator.

Patient # 1 is a 46 year old male who had been brought to Prince Georges Hospital Center Emergency Department in May 2012 after being injured in a motorcycle accident. Patient #1 subsequently underwent surgery and was post operatively admitted to the Critical Care Center (CCC) on ventilator support.

Interview with the patient was subsequently conducted by the state surveyor. At that time Patient #1 was awake,alert,oriented and up in a chair without ventilator support. Based on interview with Patient #1, he indicated that he was doing much better, had no concerns at that time, and had no recollection of the ventilator event. Further review of Patient #1's medical record revealed no documentation of the ventilator event. At the time of the record review, the surveyor informed the CCC Charge Nurse and the Director of Quality that as part of the patient's treatment and care, the need to be bagged due to ventilator failure should have been documented in the medical record. .

However, on July 16, 2012 the surveyor received notification from the Director of Quality that on July 11, 2012 after returning from vacation the Director of the Critical Care Center had made the Chief Nursing Officer and the Director of Quality aware that Patient #1 had been incorrectly identified to the state surveyors as the patient on the failed ventilator.

According to the Director of Quality, the involved patient (Patient #2) was not in the CCC on July 2, 2012 but had been transferred to a medical/surgical unit on June 30, 2012 and subsequently discharged to a nursing home on July 3, 2012.

On July 20, 2012 the surveyors obtained and reviewed the records for Patient #2. Review of pertinent portions of Patient #2's medical record, specifically, the Critical Care Flowrecord and the Physician, Nurses and Para Medical progress notes, revealed that there was no documentation by the attending RN or the Respiratory Therapist indicating that Patient #2 required manual ventilation (bagged) to maintain her respiratory status due to the failure of the ventilator to operate in battery mode. There was also no documentation in the medical record of the length of time Patient #2 was bagged, what her status was at the time she was bagged or at what time she was placed onto a different ventilator.

Further, it was later determined that despite manufacturer's recommendations that the ventilator battery be changed every 2 years, the ventilator's battery had never been changed since its purchase in February of 2008. The records also revealed that the hospital did not have any additional batteries in stock to replace the failed battery nor had the hospital ever purchased batteries for routine maintenance within the required 2 year time frame that the batteries would need to be changed.

During the July 2, 2012 survey, the surveyors obtained additional information from the Clinical Engineering Supervisor in regards to maintenance of all ventilators currently used by the hospital. At that time the supervisor verified that the batteries for multiple units had not been replaced since purchase. Ventilator Inventory Logs indicates that the hospital has a total of 30 Vela Ventilators, 25 of which had been purchased in February of 2008. Review of a purchase order dated June 26, 2012 indicated that on this date the hospital had authorized purchase of 29 batteries for the vela ventilators.

There was also no evidence that the hospital Quality Assurance Performance Improvement program had reviewed this incident, performed a root cause analysis or investigated the event in any manner to prevent its recurrence and make necessary corrections.

Based on the review of the medical records of patient #2 it was determined that the hospital failed to maintain a complete medical record for this patient that documented the course of the patient's care as evidenced by:
Patient #2 is a 52 year old female who was admitted to Prince Georges Hospital Center on June 17, 2012 after having a sudden syncopal episode with aphasia and right sided facial drooping. On examination Patient #2 was found to have right sided weakness. A CT scan of the brain was completed and results were positive for a left sided pontine hemorrhage. A pontine hemorrhage is a stroke within the brain stem due to a hemorrhage or bleeding of the blood vessels in this portion of the brain. An MRI was also positive for several acute ischemic infarcts. Patient #2 was also found to have a very elevated blood pressure. She was subsequently intubated for airway protection, placed on ventilator support, and admitted to the CCC.

On the evening of June 22, 2012 the hospital had a power failure. As a result 4 of 5 of the hospital's generators took over as the power source. However, 1 generator failed to come on. This particular generator provides power to the CCC, ED, and OR's. During that time Patient #2's ventilator failed to go into back-up battery mode and Patient #2 had to be bagged (assisted respiration by Ambu bag) by the respiratory therapist and RN to maintain her breathing.

On July 20, 2012 the hospital provided the surveyors with the medical records for Patient #2. Review of pertinent portions of Patient #2's medical record, specifically, the Critical Care Flowrecord and the Physician, Nurses and Para Medical, progress notes, revealed that there was no documentation by the attending RN or the Respiratory Therapist indicating that Patient #2 required manual ventilation (bagged) to maintain her respiratory status due to the failure of the ventilator to operate in battery mode. There was also no documentation in the medical record of the length of time Patient #2 was bagged, what her status was at the time she was bagged or at what time she was placed onto a different ventilator.

Based on the following maintenance problems cited at A0724, it was determined that the hospital failed to maintain the to ensure the safety of patients as evidenced by:

During a June 27 and July 2, 2012 , investigation of a power outage and emergency generator failure that occurred on June 22,2012, it was determined that the on duty hospital maintenance staff lacked the training and expertise to start the emergency generator. The generator was later started by senior staff who returned to the facility. Investigation by the facility determined that the generator failure was likely due to a switch being left in the manual mode during routine maintenace earlier that day. However the responsible staff on duty during the power outage lacked adequate training to place the switch in the correct automatic position for operation during a power outage.

Further during the power outage a patient on a ventilator in the CCC required manual ventilation (bagged) for respiratory support when the ventilator failed to operate in the battery mode. Subsequent maintenance performed by the facility revealed that the battery on the ventilator required replacement. Although the unit had undergone regular preventive maintenance the battery had remained in the unit for four years , two years longer than the manufacturer's recommended replacement time. Further review of Maintenance records revealed that there were 29 other ventilators purchased at the same time with batteries that were four years old.

Based on these issues it was determined that the hospital failed to have a systemin place to ensure the operation of equipment critical to patient care and services

Based on investigative findings at the time of on-site visits of June 26, 2012 and July 2, 2012 to Prince Georges Hospital (PGH), it was determined that the hospital failed to maintain critical patient care equipment in opertional condition according to manufacturers' recommended standards and failed to have staff on duty trained to perform basic evaluation and trouble shoot ing of the emergency generator when it failed to operate as evidence by:

On June 27, 2012 an initial site visit was made to PGH. At the time of the site visit interview was conducted with the hospital's Vice President of Facilities who informed the surveyor that at the time of the generator failure the on-duty engineer was unable to turn the generator back on. As a result the VP of Facilities was notified of the failure and inability to turnon the inoperable generator. The VP of Facilities subsequently traveled and arrived at the hospital approximately 45 minutes after the initial power failure to reset the generator.

According to the VP of Facilities when he arrived he turned the generator switch to the right (auto position) and the generator started. The VP of Facilities also informed the surveyor that the hospital's electrician had documented turning the switch back to the "ON" position but he (VP of Facilities) was 90% sure that it had likely been left in the "OFF" position after maintenance was perfromed earlier that day.

Interview was also held with the hospital's Clinical Engineering Supervisor to determine why the ventilator had failed. On June 26, 2012 when he was interviewed , the surveyor was informed by the supervisor that he did not know why the ventilator had failed; but it had been taken out of service. The surveyor then specifically asked about battery testing and was informed that the unit had not had a battery test at that time.

A copy of the maintenance record for the unit was reviewed showing that it passed testing as part of its preventive maintenance in January 2012 and was due again July 1, 2012. Further review of the documentation revealed that on June 26, 2012, it was determined that there was a report stating that the ventilator would not pass "leak test". The leak test is a minimum requirement for ventilator testing to ensure safe use of the ventilator.

During interview with the Director of Quality the surveyor was also informed that the manufacturer recommendation for battery replacement was every two years. However, at the time of the survey, there was no battery replacement history available for the surveyor to review. The Director of Quality did speak with the Clinical Engineering Supervisor and verified that the battery for the unit had never been replaced since the ventilator was purchased on February 2, 2008.

At the time of the second site visit on July 2, 2012, surveyors obtained additional information from the Clinical Engineering Supervisor in regards to maintenance of all ventilators currently at the hospital. During a July 2, 2012 interview, the supervisor verified that the batteries for multiple ventilator units had not been replaced since purchase. Review of the hospital's Ventilator Inventory Log on July 2, 2012 indicated that the hospital has a total of 29 Vela Ventilators, 25 of which had been purchased in February of 2008 and 4 which had been purchased in October of 2010.

Based on the documentation during the July2, 2012 survey, nine Vela Ventilators were currently in use by patients but only one battery was current and the other eight ventilators had not had the battery changed since purchase. Five other Vela Ventilators were already out of service including the ventilator that had failed while in use by the patient during the power outage.

Based on interviews with the Clinical Engineering Supervisor and the Biomedical Equipment Technician on July 2, 2012, it was determined that the hospital does not have a system or schedule in place to flag ventilator batteries due for replacement. According to the Clinical Engineering Supervisor, the Biomedical Equipment Technician just "knows" it needs to be done.

However, there is no indication or documentation that the Clinical Engineering Supervisor had ever provided a schedule for the technician to change the batteries, required the technician to provide documentation of the batteries having been changed or in any way provided oversight in regards to the technician completing the battery maintenance despite the potential for life threatening patient harm related to the ventilator batteries potential for failure.