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Based on staff interviews, observations and record reviews, it was determined the facility failed to ensure one liquid nitrogen storage container LN2 Tank (Container #1) used for egg and embryo storage was inspected and maintained. (A0724) This affected 930 patients and involved a sum total of 2,751 eggs and embryos.

Based on staff interviews, observations and record reviews, the facility failed to ensure one liquid nitrogen storage container LN2 Tank (Container #1) used for egg and embryo storage was inspected and maintained. This affected 930 patients and involved a sum total of 2,751 eggs and embryos.

Findings include:

1. Observation of the fertility clinic with Staff A on 03/12/18 between 3:58 PM and 4:32 PM revealed a liquid nitrogen storage container (Container #2) in the invitro laboratory area (Cryo room) which was being used to store eggs and embryos. Staff A stated this was a loaner tank which was put into use after the other liquid nitrogen storage container (Container #1) malfunctioned on 03/03/18 and was discovered on 03/04/18. Container #1 was observed beside Container #2 and was not currently in use to store eggs and embryos. Staff A also identified an additional smaller liquid nitrogen storage container (Container #3) that was in use to hold eggs and embryos which had not been transferred into the larger storage tank. Staff A stated after the storage container (Container #1) malfunctioned all the eggs and embryos were moved from Container #1 and placed into the loaner container (Container #2).

Containers #1, #2, the andrology container (for sperm storage) and the holding container were all observed with an electronic alarm device on the outside of the containers.

Staff A stated storage Containers #1 and #2 were each equipped with two sensors (one placed higher and one placed lower) inside the container which monitored temperatures inside the unit. Staff A stated in the event the alarm tripped, an audible alarm would sound on the container and the alarm would also be electronically submitted to a remote monitoring company in an offsite location, and the monitoring company would then notify the designated facility contact person via a robocall or email of the triggered alarm.

Staff A confirmed the liquid nitrogen level should be between 10-23 inches inside the storage container to maintain proper internal temperature and the local and remote alarms would sound if the temperature rose greater than -160 degrees Celsius (C.).

2. On 03/13/18 between 4:37 PM and 5:30 PM, an interview was conducted with Staff C regarding the malfunctioning liquid nitrogen storage container (#1). Staff C stated the container had been used to store eggs and embryos until after a temperature malfunction occurred inside the container and the manual fill technique continued to be practiced until this same container malfunctioned due to increased internal temperatures on 03/03/18 and 03/04/18.

Staff C stated in January 2018 he/she was physically present in the facility when the local alarm sounded on Container #1. The alarm was due to a malfunctioning autofill sensor for the nitrogen level inside the container. Staff C stated the manufacturer was notified and staff were instructed to manually fill the container with liquid nitrogen due to the malfunctioning sensor.

Staff C stated he/she was not notified of the electronically submitted alarm by the remote outside service company for the malfunction of Container #1's autofill sensor in January 2018, or when the temperatures increased to an unacceptable level inside Container #1 on 03/03/18. Staff C denied being present in the facility when the malfunction occurred inside Container #1 in March 2018. Staff C stated he/she should have been notified for these two events due to being the only designated contact person for those alarms.

Staff C denied any of the facility staff had contacted the outside remote monitoring company to question why the designated contact person did not receive the alarm in January 2018. There was no documented evidence provided by hospital staff of investigation as to why the designated contact person failed to receive notification of the automatic alarm in January 2018 when the autofill sensor alarm failed, and prior to the malfunction of the container related to increased temperatures inside the tank on 03/03/18.

Staff C stated on 03/04/18 he/she was not present in the facility when Staff E arrived and discovered a high unacceptable temperature of -37 degrees Celsius on the outside display panel of Container #1, which revealed the internal tank temperature. Staff C stated acceptable temperature inside the liquid nitrogen container should have remained between -160 degree Celsius (C.) and -180 degrees Celsius. Staff C stated -140 C is considered a safe temperature but -150 C and below is the desired temperature. Staff C stated "If alarm sounds and somebody responds, I would say they would have a couple hours to respond and the upper alarm tells the levels have exceeded temperatures."

Staff C stated he/she was contacted on 03/04/18 by Staff F and Staff B of the unacceptable temperature. Staff C confirmed he/she again did not receive notification from the remote outside monitoring company of the alarm and stated he/she should have been notified of the alarm due to being the sole designated contact person.

Staff C stated the remote alarms for the liquid nitrogen containers were tested last March or April 2017; however, as of 03/14/18 the facility failed to provide documented evidence of this test.

Staff C stated he/she was onsite nine days a month and in other states the rest of the month.

3. On 03/12/18 at 1:30 PM, Staff L confirmed after the malfunction on 03/03/18, the facility staff contacted the outside remote monitoring company to investigate why the designated contact person was not notified about the unacceptable high temperature level inside Container #1 on 03/03/18. Staff L stated the alarm was received by the remote monitoring company; however, the alarm was not transmitted to the facility's sole designated contact person.

4. On 03/13/18 between 11:40 PM and 12:10 PM an interview was conducted with Staff E, who discovered the local audible alarm and increased unacceptable temperature inside the nitrogen storage Container #1 the morning of 03/04/18.

Staff E stated the following: He/she was the first person to arrive on 03/03/18 and 03/04/18. He/she arrived to the fertility lab on 03/04/18 around 7:12 AM, went into the Cryo room (Used to house Container #1) at approximately 7:20 AM and observed an audible local alarm sounding on Container #1 and an internal temperature reading of -32 degrees C. Staff E shut off the audible alarm and notified Staff F by phone of the alarm and increased temperature. Staff B (physician) was informed as he/she was onsite who then notified Staff C (designated contact person) by phone. Staff E stated on the previous day on 03/03/18, he/she went into the Cryo room and observed the temperature prior to leaving around 1:20 PM, and stated the temperature reading was appropriate and denied hearing an audible alarm.

Review of the temperature logs revealed two internal temperature sensors (Sensor A and Sensor B). The temperature began rising inside Container #1 on 03/03/18 beginning at 2:00 PM. The internal temperature rose to -32 degrees C on Sensor A and -34 degrees C. on Sensor B. The internal undesired elevated temperature rise continued until 03/04/18 at 3:00 PM at which time Sensors A and B were -185 degrees Celsius. The liquid nitrogen level inside the container was 13 inches at 2:00 PM on 03/03/18 when Sensor B was at -160 degrees C. The level dropped to 1 inch on 03/04/18 at 2:00 PM when the temperature inside the tank was -100 degrees C. on both Sensors A and B. Staff E confirmed prior to the malfunction of Container #1 on 03/03/18 and 03/04/18, the temperature readings were only recorded upon arrival to the facility in the morning and did not list a time of the recordings.

5. On 03/13/18 between 12:11 PM and 12:54 PM Staff F stated Staff E sent a text picture to Staff F on 03/04/18 after 7:30 AM. Staff F stated the text picture was a temperature reading of -37 degrees C. on the digital control screen on top of Container #1. Staff F stated he/she arrived at 7:57 AM and confirmed the temperature reading on the digital gauge was too high. Staff F stated staff were trained to check an automatic digital screen on the outside of the nitrogen storage container which contained information for the temperature and liquid nitrogen fill level inside the storage container. Staff F also stated staff were to inspect the inside of the container for vapors by opening the top of the container. Staff F stated after receiving the text picture from Staff E on 03/04/18, upon arrival on that same date, there were no vapors present when the Container #1 was opened for inspection. Staff F stated the presence of vapors would indicate the presence of liquid nitrogen inside the storage container.

6. On 03/13/18 a review was conducted of the manufacturer's for use manual (Container 1). This manual contained the following:

"Prepare a contact list. Have at least 3 people on your contact list with Home, Cell and Pager Number. Review the list regularly for accuracy and changes."

"Recommended Best Practices. Secondary or backup alarm. It is strongly recommended to have, at a minimum, an independent temperature alarm for each LN2 freezer."

"Keep a daily log. Track temperatures daily. Record fill intervals and amount of LN2 filled into vessel (manual or pour-fill freezer or dewar). This information should be documented daily and reviewed monthly to foresee and prevent future problems such as temperature fluctuations and varying liquid levels."

"Remote Alarm Connection to your Delta Room, Facility Monitoring Station or Remote Auto Dialer
Q. Why should I use my remote alarm feature or connection?
A. If an alarm occurs after hours, on a weekend or holiday the remote alarm connection will alert you to a problem and let you address it quickly."

"Check unit daily to ensure proper operation and safety of the stored samples. For the V series units (type used in facility), it is essential to lift the lid each day and check for vapor and signs of proper freezing."

"Cleaning and Maintenance. System Check.
1. Test all alarm functions for proper operation.
2. Check any connected Remote Alarms or Automatic Dialing systems to ensure proper operation. See page 26 (of manual) for detailed instructions on how to manually cause a HIGH ALARM or LOW ALARM to test the remote alarm contacts.
3. Check for leaks at all connection points of the liquid nitrogen lines.
4. Be sure that all electrical wires are free of damage and plugs are firmly in place."

Until the malfunction of Container #1 was discovered on 03/04/18 by staff physically present in the room, the monitoring logs failed to indicate the amount of liquid in the storage tank or the presence/absence of vapors. Staff began logging observation of vapors and liquid nitrogen levels on 03/06/18.

There was no documented evidence of cleaning or inspection of Container #1 which included calibrating and testing of HIGH and LOW alarms, checking for leaks at all connection points of liquid nitrogen lines, or of the electrical wires to ensure they remained free of damage and plugs were firmly in place.

It was confirmed through staff interviews (Staff A, B, C, and H) prior to 03/03/18, there was only one sole designated contact person to receive notification of the remote electronic offsite alarm in the event of liquid nitrogen storage tank malfunction instead of three contacts recommended by the manufacturer's instructions.

7. During an interview with Staff H on 03/14/18 at 10:51 AM, Staff H verified there was no policy for notification of a designated person in relation to remote alarms for equipment (including nitrogen tank storage containers). Staff H stated the autofill issue on Container #1 was on or around 02/01/18 and confirmed the sole designated contact person (Staff C) did not receive notification of the remote alarm.

8. On 03/14/18 between 8:45 AM and 9:15 AM, Staff D, H, J, and L were made aware of the aforementioned concerns and no further information was provided at that time.