HospitalInspections.org

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.41, PHYSICAL ENVIRONMENT, was out of compliance.

In addition, due to the nature of the survey findings, an Immediate Jeopardy was declared on 10/22/15 at 2:54 p.m. related to the Condition of Participation §482.41, PHYSICAL ENVIRONMENT. The facility failed to provide oversight of the physical environment by failing to ensure equipment used for emergent situations was safe and in working order.

A-0701 - Standard: Buildings - The facility failed to ensure equipment used for emergency situations was maintained according to manufacturer's instructions and facility policy in order to assure the safety of patients. This failure created the potential for patient harm or delay in care during an emergent situation.

A-0724 - Standard: Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality - The facility failed to implement actions to avoid reoccurrence of malfunctions in equipment used on patients in emergent situations. In addition, the facility failed to ensure equipment was used in accordance with manufacturer's instructions for use. This failure resulted in delays in patient care during emergent situations and could potentially result in negative patient outcomes.

Based on interviews and document review, the facility failed to ensure equipment used for emergency situations was maintained according to manufacturer's instructions and facility policy in order to assure the safety of patients for 11 of 46 patients who received treatment using an iNOMAX ventilator (Patients G, H, O, S, U, AA, CC, HH, JJ, LL and OO).

This failure created the potential for patient harm or delay in care during emergent situations.

Findings:

POLICY

According to the policy, Nitric Oxide: Set-up and Delivery of Inhaled Nitric Oxide, a pre-use checkout was to be performed prior to initiating the INO and a low range calibration was to be performed prior to initiation on a patient.

According to the policy, Inhaled Nitric Oxide, high range calibration should be completed every 30 days.

REFERENCE

According to the manufacturer's operation manual for INOMAX DSIR Plus, complete the initial connections and Pre-Use Checkout procedure before connecting the INOMAX DSIR into the patient's breathing circuit. The maintenance schedule stated a high calibration should be performed monthly.

1. The facility failed to ensure a Pre-Use Check and high range calibration procedure was performed on iNOMAX ventilators in accordance with manufacturer's instructions prior to patient use.

a) On 10/22/15 at 9:20 a.m., the Accreditation Specialist (Employee #12) supplied documents titled Standby iNOVent logs. Employee #12 stated the logs were included for all patients who used iNOMAX ventilators between 08/01/15 to 10/19/15. The log was used to document the Pre-Use Checkout procedure required by the manufacturer's instructions and facility policy prior to patient use.

Of the 46 patients who were placed on the iNOMAX ventilators between 08/01/15 to 10/19/15, the following discrepancies were revealed:

5 of 46 patients (Patient's O, S, AA, CC, and OO) documented as using iNOVENT ventilators during their length of stay had no corresponding log sheet to evidence the Pre-Use Checkout Procedure had been completed prior to patient initiation.

6 of the 41 log Sheets provided (Patient's G, H, U, HH, JJ, and LL) contained no documentation that a Pre-Use Checkout Procedure had been performed prior to initiation as required by manufacturer's instructions and facility policy.

b) On 10/27/15 at 1:15 p.m., a document review was conducted of INOMAX DSir PLUS Inventory Logs for the months of September and October of 2015. The log was used to document the high range calibration procedure required every 30 days by the facility policy. Of the 20 ventilators tracked on the log, 2 were documented as being returned. The following discrepancies were revealed of the remaining 18 ventilators:

The September Log listed the high calibration procedure for ventilator #DS20110149 was due on 09/30/15. No documentation was noted regarding if and when the calibration procedure was done. On the October Log, the same ventilator's high calibration procedure was due on 10/22/15. As of 10/27/15 no documentation was noted to show the procedure had been completed.

The September Log listed high calibration procedure for ventilators #DS20110114 and #DS20090628 were due on 09/30/15. The procedures were documented as completed on 10/05/15, which was 5 days past the due date.

The September Log listed the high calibration procedure for ventilator #DS20090483 was due on 09/30/15. There was no documentation to show the calibration procedure was completed. On the October Log, the same ventilator's high calibration procedure was documented as completed on 10/05/15, which was 5 days past the due date.

The October Log listed the high calibration procedure for ventilators #DS20100528, #DS20110181, #DS20110118, and #DS20111242 was due on 10/11/15. The procedures were documented as completed on 11/11/15, which was a date which had not yet occurred and was 14 days after the log was reviewed on 10/27/15.

c) On 10/22/2015 9:37 a.m., an interview with the Director of Respiratory Care (Employee #8) was conducted. Employee #8 stated the expectation was for staff to perform a Pre-Use Check prior to patient use. Employee # 8 further stated s/he was unaware of the discrepancies found on the logs and that no one looked at the forms to ensure completeness.

Based on observation, interviews, and document review, the facility failed to implement actions to avoid reoccurrence of malfunctions in equipment used on patients in emergent situations. In addition, the facility failed to ensure equipment was used in accordance with manufacturer's instructions for use.

This failure resulted in delays in patient care during emergent situations and could potentially result in negative patient outcomes.

Findings:

FACILITY POLICY

According to the policy Inhaled Nitric Oxide, place an iNOMAX cylinder on the DSIR cart and check for correct identity labels, concentration (800ppm), and expiration date.

According to the policy Equipment, Defective and/or Unsafe, for emergency procedures in the event of equipment failures on high priority equipment, contact the department/manager who is responsible for locating backup equipment and training staff as well as implementing contingency plans for patient care in the absence of the equipment.

According to the policy Major Incident and/or Sentinel Event, a sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. The Major Event Review Team will initiate any immediate organizational actions and/or steps needed to protect patient safety.

REFERENCE

According to the manufacturer's operation manual for INOMAX DSIR Plus, load two INOMAX drug cylinders onto cart and check for correct product identity labels, cylinder concentration (800 ppm) and expiration date.

1. The facility did not follow manufacturer's instructions for operation of the iNOMAX ventilator, failed to investigate an equipment failure which occurred during an emergent situation and failed to initiate changes to decrease the likelihood of a similar failure.

a) Medical record review revealed Patient #3 arrived at the facility on 09/15/15 at 4:45 p.m. via air transport with a diagnosis of septic shock. At 6:03 p.m. on 09/15/15, Patient #3 experienced respiratory distress and a code blue response was initiated. At 6:20 p.m., anesthesia staff began attempting intubation of Patient #3. At 7:07 p.m. (approximately 37 minutes after intubation had been initiated) , inhaled nitric oxide treatment was initiated via an iNOMAX ventilator. Despite resuscitation efforts, Patient #3 expired at 7:21 p.m.

b) On 10/21/15 at 9:34 a.m., an interview with Respiratory Therapist #1 (RT) was conducted. During the interview, RT #1 described the code blue incident that occurred with Patient #3 on 09/15/15. RT #1 revealed that during the code it was determined an iNOMAX ventilator was needed. RT #1 stated the iNOMAX ventilator initially brought to the code blue was not working and a different ventilator had to be set up and brought to the patient's room, which took approximately 10 minutes to initiate.

i) On 10/22/15 at 9:37 a.m., an interview with the Director of Respiratory Care (Employee #8) was conducted. Employee #8 explained the inhaled nitric oxide treatment dispersed from the iNOMAX ventilator was used in emergent situations primarily to treat pulmonary hypertension in patients who were severely hypoxic and refractory to oxygen. Employee #8 further explained that if the inhaled nitric oxide treatment failed to improve patients' outcomes, the only other option available for patient survival would be to initiate Extracorporeal Membrane Oxygenation (ECMO).

ii) On 10/21/15 at 12:07 p.m., an interview with the Associate Respiratory Therapy Clinical Manager (Employee #11) was conducted. Employee #11 stated s/he was notified of the iNOMAX malfunction the day after the incident occurred and began investigating the incident. Employee #11 stated s/he believed the malfunction involved an infrared sensor on the nitric oxide cylinder not being recognized by the ventilator. Employee #11 stated the manufacturer had been notified of the failure and picked up the equipment; however no changes had been made as to how the remaining iNOMAX ventilators would be operated.

Employee #11 stated once the first iNOMAX ventilator failed during the code blue, a second iNOMAX ventilator had to be obtained from another unit within the hospital. Employee #11 concluded the total delay in care due to the ventilator failure was approximately 15 to 20 minutes.

Additionally, Employee #11 reported the iNOMAX ventilators were used several times per week and they would not sit in storage for more than a week due to their frequent use.

c) On 10/21/15 at 1:53 p.m., a tour of the facility revealed 17 iNOMAX ventilators. Each ventilator was equipped with two holders for nitric oxide cylinders; however, only 1 cylinder was observed on each ventilator. This was in contrast with the manufacturer's instructions for use which instructed the facility to load 2 iNOMAX drug cylinders (nitric oxide) onto the cart.

During the tour, the Director of Respiratory Care stated the facility always loaded only 1 nitric oxide cylinder on each iNOMAX ventilator, although the manufacturer of the iNOMAX ventilator stated 2 nitric oxide cylinders should be loaded.

There was no documentation to show the facility contacted the manufacturer to ascertain if the safe operation of the iNOMAX ventilator would be compromised by only loading 1 cylinder instead of 2 cylinders as identified in the manufacturer's operation manual.

i) On 10/21/15 at 4:43 p.m., an interview with Respiratory Therapist #2 (RT #2) was conducted. RT #2 stated s/he was not notified or aware of any incidents regarding the failure of an iNOMAX ventilator or nitric oxide cylinder. RT #2 stated there used to be 2 nitric oxide cylinders loaded in the iNOMAX ventilators but it was changed to 1 cylinder approximately 1 to 2 years ago.

ii) On 10/22/15 at 11:50 a.m., an interview with RT #3 was conducted. RT #3 stated s/he was not notified or aware of any recent incidents regarding issues with nitric oxide cylinders on iNOMAX ventilators. RT #3 stated that although it was suggested to use 2 cylinders on the iNOMAX ventilators, there was always only 1 loaded on the ventilator at a time.

iii) During the interview, on 10/22/15 at 9:37 a.m., Employee #8 stated the reason why only 1 nitric oxide cylinder was utilized on the iNOMAX ventilator was because the facility misinterpreted National Fire Protection Association (NFPA) guidelines regarding medical gas storage and thought they could only have 1 cylinder on each ventilator. Employee #8 then stated there had been no investigation since the malfunction of the iNOMAX ventilator, during Patient #3's code blue, on whether or not having a 2nd nitric oxide cylinder in place would have saved time during the incident.

iv) On 10/27/15 at 10:41 a.m., an interview with the Medical Director of Respiratory Care (Physician #9) was conducted. Physician #9 stated it probably would have saved time during the code blue incident if 2 cylinders had been on the ventilator but s/he wasn't sure if the outcome would have changed. Physician #9 further stated if emergency equipment was not available at the bedside, a delay in care could occur.

2. The facility did not investigate a malfunction of an iNOMAX ventilator, during a code blue, in order to determine if the equipment was defective or unsafe for operation and to determine if changes in practice needed to occur.

a) On 10/22/15 at 9:37 a.m. the Director of Respiratory Care (Employee #8) stated nothing had been changed since the incident (Patient #3's code blue on 09/15/15) to ensure it wouldn't happen again as the facility was waiting to hear back from the manufacturer. Additionally, s/he stated the failure to have a second cylinder on the ventilator had not been investigated to see if it would have saved time during the code blue situation. Employee #8 acknowledged that as of this date (10/22/15) the facility still used a single cylinder with the iNOMAX ventilators instead of 2 pursuant to manufacturer's instructions.

On 10/21/15 at 12:07 p.m., during an interview with the Associate Respiratory Therapy Clinical Manager (Employee #11), s/he stated respiratory staff received updates and education through monthly emails, meetings or huddles. Employee #11 stated respiratory staff had not been notified of the iNOMAX ventilator failure because the facility was waiting to hear from the manufacturer regarding the cause of the malfunction.

Additionally, there was no documentation to show the facility investigated the standard practice of operating the iNOMAX ventilator with 1 cylinder instead of 2 cylinders, pursuant to manufacturer's instructions to determine if it played a role in the delay of care caused by the ventilator failure.

i) On 10/27/15 at 9:50 a.m., an interview with the Biomed Manager (Employee #6) and the Director of Facility Operations (Employee #5) was conducted. Employee #6 stated s/he was made aware of the malfunction of the iNOMAX ventilator from Employee #4 and that Employee #4 stated the manufacturer of the ventilator was going to look at the cause of the ventilator malfunction. Employee #6 stated that the Biomed department had no further involvement with investigating the malfunction of the iNOMAX.

Employee #6 stated the Biomed Department would usually be enlisted by the Patient Safety Department to follow up with the manufacturers of malfunctioning equipment; however, no follow up was done with the iNOMAX failure. Employee #6 stated the reason for not following up with the iNOMAX ventilator malfunction was because the Biomed Department was never enlisted by the Patient Safety Department to do so. Employee #6 stated s/he was unsure as to why the Biomed Department was never enlisted to follow up with the iNOMAX ventilator malfunction.

ii) On 10/27/15 at 12:46 p.m., an interview with the Patient Safety Manager (Employee #7) was conducted. Employee #7 stated the iNOMAX ventilator malfunction had been discussed at a weekly Safety Review Committee meeting, which was attended by staff from the Patient Safety Department and Risk Management, as well as physicians, nursing and pharmacy staff.

Employee #7 stated the understanding from the meeting was that the iNOMAX ventilator had been appropriately maintained and the committee was unable to assign specific causal outcome with the patient. Employee #7 then stated that due to this understanding, s/he did not feel the need to gather any further information about the malfunction. Employee #7 further stated s/he was unaware of any follow up being done regarding the iNOMAX malfunction after the Safety Review Committee meeting.

There was no representation from the respiratory department, who operated and maintained the iNOMAX ventilators, during the safety review.

iii) On 10/22/15 at 9:37 a.m., an interview with the Director of Respiratory Care (Employee #8) was conducted. Employee #8 was asked what had been done since the incident of the iNOMAX ventilator failure to avoid a reoccurrence. Employee #8 stated that nothing had been put in place because they were waiting to hear back from the manufacturer as to the cause of the malfunction. Employee #8 further stated that s/he had not been involved in any follow up analysis or discussion with the Risk or Quality Departments.

There was no evidence the facility assessed the standard practice of operating the iNOMAX ventilator with 1 cylinder instead of 2 to determine if changes were needed to ensure patient safety and a delay of care in emergent situations.

iv) On 10/27/15 at 10:41 a.m., an interview with the Medical Director of Respiratory Care (Physician #9) was conducted. Physician #9 stated s/he was not notified of the iNOMAX ventilator malfunction that occurred on 09/15/15. Physician #9 stated if s/he had been notified of the malfunction s/he could have worked with the Director of Respiratory Care to ensure issues were addressed to avoid future error or harm, assess if changes were needed, and notify Medical Staff of the malfunction.

v) On 10/27/15 at 11:49 a.m., an interview with the Chief of Quality and Safety (Employee #10) was conducted. Employee #10 stated the iNOMAX ventilator failure had been discussed at a meeting on 09/24/15 involving leadership employees from the Patient Safety Department, Risk Management and the Medical Staff. Employee #10 stated the attendees at the meeting concluded there had not been a deviation from the facility's policy regarding the usage of the ventilator and the delay in care that resulted from the malfunction did not contribute to the patient outcome from the incident. S/he further stated because of the conclusions made from the meeting, further investigation of the malfunction was not done. Employee #10 stated the incident should have been escalated to include a cause analysis.