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Based on record review and interviews it was evident that the governing body failed to provide a level of oversight of policies, procedures and activities.

Findings include:

The facility failed to provide surgical services in a safe manner. Specifically, the hospital failed to formulate and implement a policy and procedure to govern the safe storage of tissues used in transplants. See Tag A940

Based on medical records and other documents reviewed it was determined that the facility failed to ensure that patients received care in a safe setting.

Findings include:

Review on 11/30/12 of the liquid nitrogen freezer log dated 2/12/12 noted that the temperature was -110C at about 2:00am and -45C at 2:13pm. The tissue (allografts) were stored at warmer than recommended temperatures for approximately 12 hours. The staff failed to maintain the temperature at the manufacturer's recommended range (-196C to -135C).
The compromised tissues (allografts) were not discarded as per the facility's policy but were later used for transplantation in 12 patients (MR ' s #1- #12) from 2/13/12 to 5/21/12. In addition, there was a delay in communicating with the Tissue Compliance Officer, staff of other departments and patients/patients' representatives regarding the temperature excursion of 2/12/12.

Based on review of the LifeNet and the CyroLife freezer temperature log it was determined that the facility staff failed to maintain equipment and medical supplies as per manufacturer recommendations.

Specifically, there was no evidence that the infection control and QAPI program identified potential infection control problems in the management of tissue storage.

Findings include:

Review on 11/30/12 of the liquid nitrogen freezer log for 2/12/12 noted that the temperature was -110C at about 2:00am and -45C at 2:13pm. The staff failed to maintain the temperature at the recommended range (-196C to -135C) as per the manufacturer recommendation. The compromised tissues (allografts) were not discarded as per the facility's policy but were later used from 2/13/12 to 5/21/12 for 12 patients (MR's #1-12).

This incident represented deficiencies in the oversight of storage of human tissues by infection control staff.

Based on record review and interviews it was determined that the facility failed to provide surgical services in a safe manner.

Specifically, the hospital failed to formulate and implement a policy and procedure to govern the safe storage of tissues used in transplants.

Findings include:

Review of documents and QA summaries on 11/30/12 found that the hospital implanted compromised tissues into 12 patients between 2/13/12 and 5/21/12 . These tissues were rendered unsatisfactory when they were stored for 12 hours starting on 2/12/12 at temperatures that exceeded the hospital's policy and the recommendation by the manufacturer. Nursing staff who were aware of the incorrect temperature limited their actions to making e-mail notifications to persons who were either off duty or on vacation.

There was no followed up when staff became aware that although the temperatures were restored to the correct range, there was a period when the integrity of the tissues were violated and the tissues were rendered unsafe for use.

There is no evidence that the surgeons were notified in advance of planned surgeries. Interviews with quality managment staff on 11/30/12 found that the surgeons were not advised until after a scheduled survey for regulatory compliance.

There was no evidence of a system to ensure the safe storage of tissues within the cryofreezer or an escalation to upper levels of management when it is determined that an emergency exists that may jepordize the welfare and safety of patients. There was no reference in policy that the tissue compliance officer was on the chain of command to be notified of any out of range temperature excursion.

There was no co-ordinated plan to address this emergency and insufficient oversight of the clinical staff in their responses to it. According to the procedure for the cryofreezer, nursing staff have the reponsibility to ensure the integrity of the transplant tissues.

As a result, over a 3 month period, patients recieved tissue that was stored in an unsafe manner. It was stated by Risk Management staff that the director of perioperative services made the decision not to notify leadership of this issue and did not remove the tissues. Furthermore, nursing staff who were aware of this unsafe storage failed to follow up with nursing leadership when they were aware that no tissues were disposed of.

There was no evidence that any of that staff made formal notification of this event to their supervisors. Review of the facility policy and procedure states that tissues stored at temp excursions beyond range require disposal.

The cryofreezer low level of LN2 alarm was on from 2/10/12to 2/12/12 and were audible by facility staff. The facility management was unable to report if the alarms were intentionally disabled or automatically shut off . Furthermore, there was evidence in documentation that nursing staff had with management that they recognized that the temperatures were out of range.

Review of the manufacturer's recommendation finds that the temperature must be maintained at ranges of -196 C to - 135 C. Review of the temperature log ( Lifenet and Cryolife Freezer temperarure log ) for that date (2/12/12 ) finds that the Cryopro VWR cryofreezer , Model - AF series auto-fill tank Catolog AF 20PS was at -45 C. at 2:13 PM. The cryofreezer alarms indicating low levels of liquid nitrogen were trigerred from 2/10/12 to 2/12/12.

On 2/7/12 the scheduled weekly delivery of liquid nitrogen (LN2) tanks did not occur. It was determined that no staff was " availabe to sign." On 2/10/12 between 7pm and 12 midnight it was noted by a nurse that the cryofreezer low level of LN2 alarm was activated . The cryofreezer temperature was noted at -182 C. Both LN2 tanks were noted to be empty.

Manual check of the LN2 level inside the freezer was deferred in an effort to " preserve any remaining LN2 ." Throughout 2/11/12 unsatisfactory efforts were made by nursing staff to address this emergency. An E-mail to the Perioperative services supervisor at 0210 was sent informing that person that the freezer was alarming since 2/12/12 and that the cryofreezer temperature had increased from -182 C to -162 C and requesting that the LN2 vendor be contacted for a replacement tank for 2/11/12. There was no response from the Supervisor.

Further review of documents found that the RN made efforts to find alternate supply of LN2 within the hospital but there were no extra LN2 tanks that were compatible with the cryofreezer were stored onsite. On 2/11/12 at 0200 hours the night shift RN found the temp to be at -110 C and made efforts to procure a new LN2 tank including contacting other facilities and left a " voicemail " with the LN2 vendor requesting emergency delivery of LN2 tank.
On 2/12/12 :LN2 tanks arrived at 2:15 PM and the temp was documented at -45 C, which was out of range and rendered any tissues unusable that were exposed to that temperature excursion.

Review of the facility policy and procedure found that it did not specify how and by whom the tissues could be removed. The accountability tree does not specifically address the perioperative director role. At interview with the Risk Manager on 11/30/12 it was stated that the facility would not want the peri-operative director to unilaterally dispose of the tissues. During an interview with the attending surgeon on 11/29/12, he stated that there could be a small chance of infection even though the tissue had quite a cold temperature.

The cryofreezer is located in the OR at Morgan - Stanley Childrens Hospital and is not under the control of any certified laboratory staff. As a result, lab techncians who are expert in the areas of tissue storage were not involved in the process and were not notified by nursing staff of the issues.

Accountability is in the hands of the peri-operative director who is neither an RN or lab tech. The laboratory has 24 hour coverage and policies and procedures that are reviewed periodically and are subject to a QA review. The facility failed to incorporate the facility Tissue Compliance Officer in any notifications where there is an alarm in the system.

The log in use during the incident did not record the " exact " temp but only ranges of 20 C. There is no system in effect that measures temperatures on a continuous basis so that a retrospective review of temps on a more frequent intervals can be made. Furthermore, this temperature was checked only every 24 hours and intervals of excursion during the 24 hour period are not noted.

There was no documentation of any QA monitoring of the 12 patients referenced in MR#1, 2,3,4,5,6,7,8,9,10, 11 and 12 who recieved tissue grafts that were not properly stored and should have been disposed of to ensure that any possible clinical effects of this incident were measured on an ongoing basis. The facility in its own literature review found that such improper storage can lead to HIV, Hepatitis B and C.

Given the risks of infection, they are subject to the infection control standards of blood banks. There was no evidence of an individualized assessment of each patient's type of tissue transplanted, risks and other factors for the purpose of ongoing evaluation of the patient's risk of complication after having recieved unsafe tissues.

Review of an addendum to the policy for tissue storage for the cryopro fill tank referred to the high temperature alarm - 130 C and low temperature alarm - 195 C. At interview with the Risk Manager on 12/1/12 it was stated that she did not know if there was any difference in the alarm sounds.