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Based on interviews the Hospital failed to ensure that the hyper/hypothermia unit/blanket were removed from service in a timely manner to determine if the unit/blanket functioned properly.

Findings included:

Please refer to Standard A-0287 for details regarding use of the hyper/hypothermia unit.

Staff Nurse #1 was interviewed by telephone on 1/21/11 at 1:20 P.M.; Staff Nurse #2 was interviewed by telephone on 1/21/11 at 2:30 P.M., and CNA #2 was interviewed by telephone on 1/25/11 at 10:30 A.M.

Interviews determined that although the heating/cooling modes of the hyper/hypothermia unit were not in use after CNA #1 turned the unit off; the blanket was not removed from under the Patient.

The Risk Manager was interviewed throughout the survey. The Risk Manager said that on 1/2/11 he/she was notified of the incident at told the supervisor to take the unit and blanket out of service.

Based on interview and documentation review the LTAC Hospital failed to ensure that the circumstances surrounding Patient #1's burns was thoroughly investigated.

Findings included:

Medical Record documentation indicated that Patient #1 was admitted to the LTAC Hospital on 11/15/10. Diagnoses included: acute respiratory failure; status post septic shock (sepsis is an inflammatory response to an infection; can become severe with multiorgan failure and shock); acute coronary syndrome with myocardial ischemia; acute tubular necrosis (death of the tubules of the kidneys; causes include poor perfusion during shock); metabolic encephalopathy (syndrome that cause temporary or permanent damage to the brain; cause include diabetes, sepsis, acute renal failure); acute kidney injury; deep vein thrombosis (blood clot in the vein); atrial fibrillation (rapid heart rate); malnutrition, and diabetes. Patient #1 had a tracheostomy tube ( tube placed surgically directly into the trachea to provide an airway) and was on mechanical ventilation (machine that performs breathing for the patient through tubing connected to the tracheostomy) and had a feeding tube for nutrition. Patient #1 was nonverbal, was contracted in all four extremities and had multiple Stage II (loss of the top layer of skin such as with a blister or an abrasion), Stage IV (loss of multiple layers of tissue with exposed bone and/or tendon), and unstagable (ulcer is covered with black or yellow tissue that is dead; cannot stage until the dead tissue is removed to see the extent of damage underneath) pressure ulcers.

Medical record documentation, dated 11/16/10 to 11/21/10, indicated that Patient #1 had episodic increased temperatures. On 11/21/10 an order was written for a hypothermia blanket for a temperature greater than 102 degrees Fahrenheit.

Review of the operation manual for the hyper/hypothermia unit and observation of the unit indicated the following: the unit could be used to either increase or decrease a patient's temperature (by selecting cooling or heating). A physician's order was required for the blanket temperature setting and for continued use of equipment. The operator was responsible for setting the mode of operation of which there were 3: manual mode (blanket temperature control); auto mode (patient temperature control), and monitor mode (mode used to monitor patient temperature without use of the manual/auto modes) and for setting the desired blanket/patient temperatures through the set point. If the set point was not established, it would defer to the default settings. The default setting for the maximum water temperature was 107.7 F or 42 C (considered to be below the threshold for tissue injury). The patient and blanket temperatures and the set point were displayed on the panel of the unit. There were alarms to indicate if the temperatures were outside the set point. The heating/cooling blanket was connected to the unit via connector hoses and placed under the patient and covered with a sheet/blanket. When in the manual/auto mode water would flow through the blanket at the set temperature. A flexible rectal probe was inserted rectally and connected to the unit via a connector cord to measure patient temperature in any of the modes.

The operation manual had multiple warnings. One warning indicated that the patient's temperature and condition of the skin that came in contact with the blanket should checked at least every 20 minutes or as directed by the physician, and the blanket temperature had to be monitored especially for patients who were temperature-sensitive (such as those with impaired blood circulation or patients who were incapacitated). Failure to monitor the patient could result in skin damage or inappropriate patient temperature.

Medical record documentation, dated 11/21/10 to 12/30/10, indicated that Patient #1 was followed by medicine, pulmonary, physiatry, the wound nurse, therapies, infectious diseases, and the dietician. The Wound Nurse did weekly rounds to monitor Patient #1's progress, the last being 12/28/10. Patient #1 continued to have episodes of elevated temperatures which the origin, despite multiple tests, was unable to be determine and was attributed to autonomic dysreflexia (loss of control of such functions as blood pressure and temperature; the most common cause is spinal cord injury however; a variety of disease processes and side effects of medication are contributing factors). Patient #1 continued with fragile skin, pressure ulcers, and contractures requiring frequent turning and repositioning.

The staffing schedules and assignment sheets for 12/30/10 to 12/31/10 were reviewed and the following staff were interviewed: the Nursing Supervisor was interviewed on 1/21/11 at 2:05 P.M.; Agency Nurse #1 was interviewed on 1/21/11 at 8:30 A.M. and intermittently throughout the survey; Staff Nurse #1 was interviewed on 1/21/11 at 1:20 P.M.; Agency Nurse #2 was interviewed on 1/21/11 at 2:20 P.M.; Staff Nurse #2 was interviewed on 1/21/11 at 2:30 P.M.; Agency Nurse #3 was interviewed on 1/27/11 at 12:10 P.M.; Certified Nurse Aide (CNA) #1 was interviewed on 1/21/11 at 12:40 P.M., and CNA #2 was interviewed on 1/25/11 at 10:30 A.M. Interviews were as follows:

Staff Nurse #2 was assigned to Patient #1 from 7:00 P.M. to 11:00 P.M. on 12/30/10. Staff Nurse #2 said Patient #1 spiked a temperature greater than 102 and toward the end of the shift (exact time unknown) the hyper/hypothermia unit was activated as ordered. Staff Nurse #2 reported having knowledge and experience with hyper/hypothermia units in other facilities however; this was a different type of unit so the Nursing Supervisor was called to assist with the set-up. Staff Nurse #2 said the instructions were located on the unit. Staff Nurse #2 said the unit was set to cooling in the auto mode and the blanket temperature was set to 100 degrees to prevent rapid cool down. Staff Nurse #2 said the unit was checked to be sure all parts were functional, the water level was appropriate, and the probe was in place.

The Supervisor said he/she could not remember the specifics about assisting Staff Nurse #2 with the hyper/hypothermia unit.

Review of Staff Nurse #2's medical record entries, dated 12/30/10, indicated that activation of the hyper/hypothermia unit was not documented.

Staff Nurse #2 said report was given to the oncoming nurse (Agency Nurse #3) who was told the hyper/hypothermia unit was activated. Staff Nurse #2 said Agency Nurse #3 did not ask any questions.

Agency Nurse #3 said he/she was familiar with hyper/hypothermia unit but it was the first instance with the unit used for Patient #1. Agency Nurse #3 said report did not include information that Patient #1 had developed an increased temperature or that the hyper/hypothermia unit was activated. Agency Nurse #3 said that at approximately 12:00 A.M. the hyper/hypothermia unit was observed to be activated and the readings were found to be within acceptable parameters. Agency Nurse #3 said Patient #1 was not turned to visualize all areas of skin, the blanket was not felt, and probe placement was not checked. Agency Nurse #3 reported making rounds every 2 hours throughout the shift and each time checked the tube feeding, looked and the hyper/hypothermia unit, but did not conduct a full body assessment. Agency Nurse #3 said that at approximately 6:00 A.M. the CNA (later identified as CNA #1) reported that the cooling blanket temperature was up to 107 F and was told to pull the plug and turn the blanket off. Agency Nurse #3 said he/she went in after and hung tube feeding and noted the unit was off but did not examine Patient #1. Agency Nurse #3 said Patient #1 was observed to have been repositioned every 2 hours however; CNA #1 never reported any skin issues.

Review of Agency Nurse #3's medical record documentation for Patient #1 dated/timed 12/31/10, 4:59 A.M., 5:08 A.M., and 7:08 A.M., indicated that Patient #1 had a full assessment sometime prior to 4:59 A.M. that included a skin assessment. An entry at 5:08 A.M. indicated that hypothermia blanket for temperature greater than 102 degrees was executed as ordered. There was no additional documentation regarding the issues with the blanket.

CNA #1 said the following occurred: CNA #1 said Patient #1 was first seen at approximately 11:30 P.M. The hyper/hypothermia unit was observed and it was blinking (not alarming) and the blanket temperature was fluctuating between 107-108 F (default setting is 107.7 F). CNA #1 felt Patient #1 and the cooling blanket; neither feel hot. CNA #1 then took an axillary temperature and compared it to the temperature reading on the unit; there was only a 1/10th of a degree difference. CNA #1 went to Agency Nurse #3 and reported the unit reading to which Agency Nurse #3 said okay. CNA #1 went into Patient #1 approximately 3-4 times and repositioned Patient #1 every 2-2.5 hours. Each time it was noted the probe was in place. CNA #1 did not notice any issues with Patient #1's skin. CNA #1 looked at the unit temperature readings each time (fluctuated between 107-108 F and at one time read 44 F) and reported the findings to Agency Nurse #3. Another nurse heard CNA #1 speak with Agency Nurse #3. CNA #1 last saw Patient #1 at approximately 6:00 A.M. CNA #1 told the oncoming CNA (CNA #2) about the temperature fluctuations with the hyper/hypothermia unit.

Staff Nurse #1 said during shift report Agency Nurse #3 reported the hyper/hypothermia unit was not working correctly. Staff Nurse #1 reported asking him/her what had been done and was told the unit had been turned off and placed on the monitor mode (to monitor Patient #1's temperature; all other modes were off). Staff Nurse #1 said that at approximately 9:00 A.M. the CNA assigned to Patient #1 (CNA #2) reported Patient #1's burns.

CNA #2 said he/she received report from CNA #1 and was told that the cooling blanket was too hot which was reported to Agency Nurse #3 and CNA #1 turned the blanket off. CNA #2 said the unit was checked and it was set to the monitor mode (mode to monitor patient temperature only). CNA #2 said that at approximately 9:00 A.M. CNA #2 noted Patient #1's back was red with a blister and reported it to Staff Nurse #1 immediately.

Staff Nurse #1 said when Patient #1 was examined there areas on Patient #1's back elbow, and foot that appeared to be burns. Staff Nurse #1 said the Physician Assistant on duty, the Wound Nurse, the covering supervisor, and the family were notified. Staff Nurse #1 said after the hyper/hypothermia unit was used only in the monitor mode to monitor Patient #1's temperature. Staff Nurse #1 said staff caring for Patient #1 were notified not to use the unit only in the monitor mode. Staff Nurse #1 said the blanket had not been and was not removed.

The Risk Manager was interviewed throughout the survey. The Risk Manager said the hyper/hypothermia unit/blanket was removed from service, was inspected by a service representative and there were no problems with the unit/blanket's function (document provided). The Risk Manager said the investigation did not include determining who activated the unit prior to the event and did not include a demonstration as to how the unit was programmed to ensure the unit was properly activated.

Based on interviews and documentation review the Long Term Acute Care (LTAC) Hospital failed to ensure that all aspects of the corrective action plan were developed/implemented in a timely manner.

Findings included:

Please refer to A-0287 for information.

Review of the Root Cause Analysis indicated that findings included the following issues: physician orders only included parameters for use and not specifications for use; frequency of assessment/reassessment; documentation, and agency staff were not trained on the specific piece of equipment.

The corrective action plan included: immediate action was taken to determine if any other patients had orders for or were using a hyper/hypothermia unit (there were none); identifying patients with orders for the hyper/hypothermia unit was added to morning report; the agency and the Board of Registration in Nursing were notified of the incident; education for nursing and agency staff was initiated on use of the hyper/hypothermia unit and included components on assessment and documentation (started 1/4/11 and to be completed by 1/31/11); An order set were created (1/21/11) that required physicians to order specifications for use, set-up, and frequency of assessment. The order set, once entered into the electronic medical record system, would automatically kick over to nursing interventions and require nursing to complete each component as ordered. Failure to do so would be identified as an overdue order which was going to be monitored by administration; educate the medical staff regarding the orderset followed by audits of all orders for 3 months (to be completed by 1/31/11), and agency staff would no longer be allowed to care for patients on the hyper/hypothermia unit. A notice was sent to all nursing supervisors on 1/21/11.

As of the survey corrective action was in various stages of development and implementation but had not been completed.