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Based on document review and staff interview, the facility failed to implement a safe and effective system that assured staff met the emergency breathing needs of the Patients. The facility failed to ensure:

- Facility staff used 1 of 3 (PR Bennett ventilator) available and operational ventilators (a mechanical device used to breathe for a patient) for a patient who was unable to breathe on their own. (C-202)

- Inpatient and Emergency Department (ED) nursing staff were aware of the number and location of ventilators maintained in the facility. (C-204)

- Inpatient and ED staff had orientation, training, and verification of competency on the use of the PB Bennett ventilator. (C-204)

- The Respiratory Therapy (RT) staff and Biomedical Engineer maintained communication in a way that guaranteed RT staff knew whenever respiratory equipment, such as a ventilator, required service and may not be functional when needed. (C-204)

It is extremely important to provide emergency medical equipment, as well as, medical and nursing personnel knowledgeable of the equipment's location and qualified to operate the equipment, to meet the emergency medical needs anticipated by the facility in a safe manner. The facility identified 4 patients that required emergency mechanical ventilation, outside of surgery, in the prior 2 years. Additionally, the facility performed an average of 57 surgical procedures, requiring mechanical ventilation, each month.

The cumulative effect of these systemic failures and deficient practices resulted in the facility's inability to provide the emergency mechanical ventilation necessary to meet the needs of the CAHs patients.

Based on document review and staff interview, the facility failed to use 1 of 1 available emergency back-up mechanical ventilator (PR Bennett ventilator) for 1 of 1 Patient (Patient #1) that required emergency mechanical ventilation following surgery. The facility identified 4 patients that required mechanical ventilation in the prior 2 years.

The staff's failure to use the back-up ventilator in this emergent situation resulted in Patient #1's family not having sufficient time and information to make an informed decision before they elected to withdraw life support.

Findings include:

1. Review of Patient #1's medical record on 9/18/12 at 9:45 AM revealed the following:

- Registered Nurse (RN) A admitted Patient #1 to the facility's Emergency Department (ED) on 5/21/12 with a complaint of abdominal pain. RN A documented Patient #1 reported 7 out of 10 pain (severe) in the lower abdomen. ED Physician B examined Patient #1 at 11:59 AM, and ordered an x-ray of the Patient's abdomen.

- At 12:02 PM, Radiologist C interpreted the abdominal x-ray, contacted ED Physician B and requested an abdominal CT scan (a detailed x-ray to see all the structures in a patient's abdomen) to determine if Patient #1 had a hole in their bowel.

- At 12:25 PM, ED Physician B ordered a CT scan of the Patient's abdomen. At 12:33 PM, Radiologist C interpreted the abdominal CT scan, and documented the Patient had a hole in their small bowel, causing air in the abdomen.

- At 1:40 PM, ED Physician B requested that Surgeon E evaluate Patient #1 for possible emergency surgery.

- At 1:55 PM, Surgeon E examined Patient #1 in the ED and at 2:44 PM requested nursing staff prepare the Patient for emergency surgery.

- Certified Registered Nurse Anesthetist (CRNA) F documented the Patient's emergency surgery started at 3:37 PM, and ended at 4:58 PM. The surgery required general anesthesia (a medically induced coma that requires assistance with breathing via a tube placed through the patient's windpipe into the lungs, and then attached to a breathing machine). During the surgery, CRNA F placed a breathing tube in Patient #1.

- Patient #1 required continued emergency mechanical ventilation due to the Patient's inability to breathe independently following surgery ending at 4:58 PM on 5/21/12. Staff moved the Patient to the Special Care Unit (SCU) for continued respiratory support by ventilator. RT G set up an iVENT ventilator in the Patient's SCU room prior to the Patient arriving. However, when RT G attempted to use the ventilator for Patient #1, it failed and RT G was unable to get the ventilator to operate. Staff attempted to use a another ventilator (transport ventilator) but that ventilator was unable to meet the Patient's needs.

- CRNA F documented she removed the breathing tube in an attempt to allow the Patient to breathe on their own. The Patient was unable to breathe without mechanical assistance, and CRNA F re-inserted the breathing tube. CRNA F documented staff attempted to use another mechanical ventilator (transport ventilator), but the equipment did not allow CRNA F to adjust the settings on the mechanical ventilator, and the Patient did not tolerate this mechanical ventilator.

2. During interviews on 9/18/12 at 2:15 PM and 9/24/12 at 10:30 AM, respectively, Respiratory Therapist G (RT G) reported he attempted to place Patient #1 on a mechanical ventilator when the Patient arrived in the SCU. However, the mechanical ventilator did not work. RT G then placed Patient #1 on a mechanical transport ventilator designed to breathe for patients during transfer between hospitals. However, CRNA F did not want to continue with the Patient on the transport ventilator because she could not adjust the ventilator settings.

RT G said he informed Family Practice Physician D (Physician D) the facility had a back-up ventilator available for use. Physician D responded to RT G, stating he would speak with the Patient's family and find out if the Patient's family wanted to continue to use mechanical ventilation. Physician D then spoke with the Patient's family and reported the family did not wish to continue using a mechanical ventilator to breathe for Patient #1.

Respiratory Therapist G stated he did not obtain the back-up mechanical ventilator, and did not switch Patient #1 from the transport mechanical ventilator to the back-up mechanical ventilator, because Physician D was at the patient's bedside, and ordered RT G to not obtain the back-up mechanical ventilator. RT G stated he followed Physician D's orders.

RT G acknowledged the facility had the back-up mechanical ventilator at the facility when Patient #1 required emergency mechanical ventilation. RT G also said, to his knowledge, at the time Patient #1 required emergency mechanical ventilation, the back-up mechanical ventilator functioned fully, and had received all appropriate maintenance to ensure it functioned correctly. RT G further stated facility staff failed to ensure the Patient's family knew the facility had a back-up mechanical ventilator at the facility. RT G further acknowledged if the Patient's family did not know the facility had a back-up mechanical ventilator at the facility, they could not fully weigh all the options available to them about the Patient's care, and make a fully informed decision regarding the Patient's care and treatment.

- During an interview on 9/19/12 at 4:31 PM, Physician D said he could have been told about the back-up ventilator but did not recall knowing about the back-up ventilator until after the fact, a couple of weeks later. He only recalled knowing the ventilators were not working and said that he would have used the back-up ventilator had he known it was available. Physician D acknowledged he did not tell the Patient's family about the back-up ventilator because he did not know a third ventilator was available; his knowledge was that the ventilators were not working. Physician D reported he only presented the Patient's family with the options of transferring the Patient to a hospital over an hour away from the facility, or removing the breathing tube and allowing the Patient to die. Physician D further stated, if he had known the facility had the back-up ventilator, he would have requested to use the back-up ventilator for Patient #1.

I. Based on document review, observation, and staff interview, the facility failed to ensure the Respiratory Therapy staff, Physicians, Certified Registered Nurse Anesthetist (CRNA), inpatient nursing staff, and Emergency Department (ED) nursing staff was aware of and/or knew how to operate 1 of 3 mechanical ventilators (PR Bennett ventilator; a machine to mechanically assist or replace spontaneous breathing). The PR Bennett ventilator was readily available as an emergency back-up ventilator on 5/21/12. Problems identified with 1 of 1 patient (Patient #1) that required emergency mechanical ventilation, outside of surgery, during an incident that occurred on 5/21/12. The facility identified 4 patients that required emergency mechanical ventilation outside of surgery in the prior 2 years. Refer to C 202 for Patient information.

Failure to have a system in place to ensure staff know what to do in the event of ventilator failure; the nursing and medical staff know where all emergency medical equipment, including a back-up ventilator, is located; and know how to operate the ventilator resulted in the facility's inability to ensure all staff was aware of the emergency back-up ventilator so it could be used in an emergency. This resulted in the facility's failure to offer Patient #1's family the option of using the emergency back-up ventilator to provide respiratory support on 5/21/12.

Findings include:

1. Observations during a tour of the respiratory therapy supply closet on 9/25/23 at 2:00 PM, revealed a PR Bennett mechanical ventilator stored in the closet and available for patient use.

2. Review of facility policy "PR Bennett Ventilator," effective 10/01, showed the facility had a third ventilator identified as their "Back up" ventilator. According to the policy, RT staff stored the PR Bennett Ventilator in the supply closet. The policy included the operational procedures, such as how to turn the machine on and connect the oxygen supply. It also included detailed instructions for the recommended ventilator settings, as well as, monitoring, and cleaning procedures.

- Review of Respiratory Therapist (RT) G's job description revised 3/2012, showed RT G was responsible for major Respiratory Care functions including setting up and operating the PR Bennett mechanical ventilator. RT G's job description also included providing education efforts within the department, presenting case studies and in-services to staff including competency training: orient/train, assign, schedule, direct, and supervise department staff; provide education and training to staff; direct and supervise maintenance of department facilities, equipment, and supplies; plans, directs, facilitates, and evaluates clinical services provided by the respiratory care department; and participate in physician education, equipment evaluation, and repair.

3. During an interview on 9/24/12 at 10:30 AM, RT G stated he maintained the PR Bennett mechanical ventilator for emergency use only. RT G stated he did not train the nurses in the inpatient unit or ED on how to use the PR Bennett mechanical ventilator because, if an emergency arose and they needed to use the PR Bennett he wanted staff to call him to come set up and operate the ventilator. If the nurses needed to use the PR Bennett mechanical ventilator, they would need to call either RT G, or the on-call anesthesia provider (CRNA F) to set up the mechanical ventilator.

- During an interview on 9/19/12 at 4:31 PM, Physician D said he could have been told about the back-up vent but did not recall knowing about the back-up ventilator until after the fact, a couple of weeks later. He only recalled knowing the ventilators were not working and said that he would have used the back-up ventilator had he known it was available.

- During an interview on 9/24/12 at 6:45 PM, Certified Registered Nurse Anesthetist (CRNA) F (a nurse with additional training in the administration of anesthesia) stated she provided on-call anesthesia coverage to the facility 3 out of 4 weeks per month. CRNA F had provided on-call anesthesia coverage to the facility since 1/12. CRNA F stated she did not know the facility had the PR Bennett mechanical ventilator until 6/12. CRNA F stated if nursing staff called her about the PR Bennett mechanical ventilator, she could not assist them with the ventilator. CRNA F stated she had never used the PR Bennett mechanical ventilator.

- During an interview on 9/20/12 at 11:20 AM, RN J stated she worked in the ED. RN J stated if she needed a mechanical ventilator, she would obtain an iVENT from the inpatient unit. RN J knew the facility had the PR Bennett mechanical ventilator as a back-up ventilator. However, RN J did not know how to operate the PR Bennett mechanical ventilator. If RN J needed to operate the PR Bennett mechanical ventilator, she would call RT G. If she could not reach RT G, she would call the on-call anesthesia provider (CRNA F).

- During an interview on 9/20/12 at 10:45 AM, Registered Nurse (RN) H stated she worked on the inpatient-nursing unit, and provided care to patients in the Special Care Unit (SCU). SCU patients included patients that needed mechanical ventilation. RN H stated the facility had 2 iVENT brand mechanical ventilators but did not know the facility had the PR Bennett ventilator. If RN B needed a back-up mechanical ventilator, she would call the nurse in the ED to locate a back-up ventilator, since the ED nurses had additional training using the ventilators.

- During an interview on 9/20/12 at 10:55 AM, RN I stated she worked on the inpatient nursing unit, and also provided care to patients in the SCU, which could include patients requiring mechanical ventilation. RN I stated the facility only had 2 mechanical ventilators, the iVENTs. RN I did not know the facility had the PR Bennett Ventilator. In the event RN I needed a back-up mechanical ventilator, she stated she would call the nurse working in the ED to locate a back-up ventilator, since the ED nurses had additional training using the ventilators.


II. Based on document review and staff interview, the facility failed to ensure a system was in place to notify 1 of 1 respiratory therapist (Respiratory Therapist G) of mechanical problems with the facility's ventilators (a machine used to mechanically assist or replace spontaneous breathing). Problems identified with 1 of 3 ventilators available for patient use that failed to operate when 1 of 1 patient (Patient #1) needed emergency mechanical ventilation, outside of surgery, on 5/21/12. The facility owned 4 (3 were at the facility and 1 was off-site for repair) mechanical ventilators and identified 4 patients that required mechanical ventilation following surgery during the prior 2 years. Refer to C 202 for Patient information.

Failure to have a system in place that ensures the RT staff knows when a ventilator has or may have a mechanical problem resulted in the facility's inability to ensure they had adequate mechanical ventilator equipment available to provide emergency respiratory support, when needed, for Patient #1 on 5/21/12.

Findings include:

1. Review of Respiratory Therapist (RT) G's job description revised 3/2012, showed RT G was responsible for major Respiratory Care functions including, to direct and supervise maintenance of department equipment, and supplies and participate in equipment evaluation and repair.

2. Review of the facility's contract with Biomedical Service L, effective 9/1/11, showed the contract stipulated that biomedical staff would take ventilators to their shop to make repairs too complex to perform at the facility. However, the contract did not include a process for biomedical staff to notify facility staff when they identified mechanical problems they felt did not need immediate attention and/or removed equipment for repair or, the estimated time the equipment would remain off-site for repairs.

3. Review of a written statement prepared and signed by Respiratory Therapist (RT) G on 9/20/12 revealed, Biomedical staff had taken 1 of the facility's 2 iVENTs back to their shop for repairs which left the facility with 1 iVENT that Biomedical Engineer (BE) K said, was in working order. On May 21, 2012, RT G put the remaining iVENT into service (for Patient #1); it failed to function and sounded a service alarm. RT G took the iVENT out of service and telephoned BE K the next business day. During the phone conversation, regarding the iVENT that remained at the facility, BE K reported that he had noticed that an "O-Ring" needed replaced but stated the iVENT passed calibration. RT G wrote, "I feel that he should of communicated this to me when he noticed that the O-Ring needed replaced and I would of taken the vent out of service, notified the physicians that we did not have vent coverage, or would of used our old ventilator on the patient [Patient #1] if desired."

4. During an interview on 9/20/12 at 7:00 AM, RT G said BE K had told him he was taking one of the iVENTs to the shop for repair so he knew he only had 1 iVENT available at the time of the incident on 5/21/12 involving Patient #1. RT G said BE K had not told him about the O-Ring and stated; he wished he had known. If RT G had known the O-Ring was bad, he would have just used the back-up vent.

- During an interview on 9/19/12 at 2:00 PM, Biomedical Engineer K stated he performed routine maintenance on the iVENTs at the facility on 4/26/12. During the routine maintenance, he discovered the battery had died on 1 of the iVENTs, and took the equipment to their maintenance shop at another hospital an hour away from the facility to replace the battery. Biomedical Engineer K stated he returned the iVENT to the facility on 5/24/12. Biomedical Engineer K reported he left 1 iVENT at the facility that passed all tests but did have a crack in the O-Ring.

Based on observation, document review, and staff interview, the facility failed to ensure surgical services staff members wrote the shortened date of expiraton on 1 of 1 vial of succinylcholine and 1 of 1 vial of rocuronium in the anesthesia cart. The facility administrative staff members identified an averge of 12 surgical procedures per month that involved succinylcholine and rocuronimum.

Failure to write the shortened expiration date on the medication vials could potentially result in the medication lacking potency, and the patient potentially failing to recive the desired theraputic effect of the medication.

Findings include:

1. Observations during a tour of the Operating Rooms on 9/17/12 at 2:00 PM revealed an anesthesia cart located in the main surgical hallway. Further observations in the cart's room temperature medication storage drawer revealed 1 of 1 200 mg/10 mL vial of succinylcholine (a short acting medication to relax muscles during surgery) lacked documentation of the date the surgical services staff members removed the succinylcholine from refrigerated storage. Additionally, 1 of 1 50 mg/5mL vial of rocuronium (a long acting medication to relax muscles during surgery) lacked documentation of the date the surgical services staff members removed the rocuronium from refrigerated storage.

2. Review of the manufacturer's directions for succinylcholine, revised 9/10, revealed in part, "Store in refrigerator ... vials are stable for up to 14 days at room temperature without significant loss of potency."

3. Review of the manufacturer's directions for rocuronium, revised 1/11, revealed in part, "Rocuronium ... should be stored in a refrigerator.... Upon removal from refrigeration to room temperature storage conditions ... use Rocuronium ... within 60 days."

4. During an interview at the time of the tour, the Surgical Services Manager acknowledged the vials lacked documentation of the date when the surgical services staff members had removed the vials from refrigerated storage.

Based on document review and staff interview, the facility failed to ensure staff completed an "Event Reporting" form for 1 of 1 mechanical ventilator that failed to operate, when needed on 5/21/12, and investigate the causes of the equipment failure as required by the Quality Management policies. The facility identified 4 patients that required mechanical ventilation in the prior 2 years. Refer to C 202 for Patient information,

Failure to complete an event report and investigate the failure of a mechanical ventilator compromised the facility's Quality Services Committee's ability to identify and analyze all factors involved in the equipment failure in order to take appropriate steps towards preventing a similar incident in the future.

Findings include:

1. Review of the policy "Event Reporting," revised 7/11, revealed in part, "The purpose of event reporting is to track ... processes to ensure quality patient care. Each report is a factual account of an event and provides ... a means for an investigation of causes.... an event is an instance that is not consistent with the routine care of a patient, routine services of a department, or routine operations of the Health Center....All completed event reporting forms will be forwarded to the Medical Staff Quality Management/Risk Management committee for review on a monthly basis...."

- Review of 104 Event Reporting forms dated from 9/11 to 7/12 lacked evidence facility staff submitted an Event Reporting form regarding an iVENT mechanical ventilator (a device used to breathe for a patient) equipment failure on 5/21/12 that involved Patient #1.

- Review of the Event Reporting forms involving Patient #1 revealed the forms only reported Patient #1's death, and did not include the fact the iVENT failed when staff attempted to use the iVENT on Patient #1.

2. During an interview on 9/19/12 at 11:15 AM, Respiratory Therapist G (RT G) stated he did not complete an Event Reporting form specifying the iVENT malfunctioned during ventilation of Patient #1 on 5/21/12. RT G stated he knew the facility's policies and procedures for completing event reports, and in this case "I should have [completed an event report about the failure of the iVENT.]"

- During an interview on 9/19/12 at 10:05 AM, the Quality Services Director acknowledged the respiratory services staff failed to complete an Event Reporting form that identified the iVENT equipment malfunction on 5/21/12. The Quality Services Director stated the staff should have completed an Event Reporting form according to the facility's policy.

3. Review of the Quality Management Policies and Procedures, dated 6/12, revealed in part, "Quality assessment and management activities should be organized around the flow of patient care and be coordinated across disciplines and departments...Responsibility for the oversight of the Quality Management plan has been delegated to the Quality Management Committee of the medical staff...." The policy lists actual performance evaluation measures that include the following, in part. safety of the care environment, what does of does not happen after a patient care function is performed or not performed, desired outcomes, and standards of care.

- Review of the "Quality Management" committee meeting minutes from 5/15/12 to 7/17/12 revealed the meeting minutes lacked evidence the committee reviewed or investigated the iVENT equipment failure that involved Patient #1 on 5/21/12.

- Review of the "Quality Assurance Meeting" minutes, dated 6/19/12, revealed the meeting minutes lacked evidence the committee reviewed or investigated the iVENT equipment failure that involved Patient #1 on 5/21/12.

- Review of the "Quality Management Quarterly Indicator Report" of the Respiratory Department from 4/12 to 6/12 revealed the report lacked evidence the department reported the iVENT equipment failure that involved Patient #1 on 5/21/12, or investigated the failure of the equipment.

4. During an interview on 9/25/12 at 10:00 AM, RT G acknowledged the Quality Management Quarterly Indicator Reports lacked documentation of the iVENT equipment failure that occurred on 5/21/12 and involved Patient #1. RT G stated he was currently working to perform a follow-up investigation after the iVENT equipment failure on 5/21/12. However, RT G acknowledged he had not documented the investigation, or reported the results to the Quality Management committee.

- During an interview on 9/25/12 at 9:40 AM, the Quality Services Director stated the Quality Services staff members failed to investigate the iVENT equipment failure on 5/21/12. The Quality Services Director acknowledged the Quality Services staff members failed to identify problems related to the equipment failure, and refer the problem to the Medical Staff committee, as required by the facility's policies.