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Based on observation, documentation and interviews, it was determined that the hospital failed to maintain the condition of the environment to ensure the safety and well being of patients when the steam valve (humidifier) on a roof top air handling unit that was to remain open at all times, was turned off. When the valve was re-opened, an unpleasant odor (determined to be caused by an accumulation/high concentration of stabilizing chemicals in the humidifier while the valve was shut off) was noted in the medical Intensive Care Unit (ICU) and the out-patient Cardiac Clinic. This had the potential to affect all patients receiving services in the medical ICU and the out-patient Cardiac Clinic.

Findings include:

The hospital did not meet the Condition of Participation of Physical Environment at 42 CFR 482.41. See A701.

Based on observation, documentation and interviews, the hospital failed to maintain the overall hospital environment in such a manner that the safety and well being of all patients was assured, when the humidifier isolation valve on a roof top air handling unit, that was to remain open, was turned off. As a result, when the valve was re-opened after approximately ten minutes, an unpleasant odor (determined to be caused by an accumulation/high concentration of stabilizing/condensate corrosion inhibiting chemicals in the humidifier while the valve was shut off) was noted in the medical Intensive Care Unit (ICU) and the out-patient Cardiac Clinic which had the potential to affect all patients receiving services in the medical ICU and the out-patient Cardiac Clinic.

Based on observation, documentation and interviews, the hospital failed to maintain the overall hospital environment in such a manner that the safety and well being of all patients was assured, when the humidifier isolation valve on a roof top air handling unit, that was to remain open, was turned off. As a result, when the valve was re-opened after approximately ten minutes, an unpleasant odor (determined to be caused by an accumulation/high concentration of stabilizing/condensate corrosion inhibiting chemicals in the humidifier while the valve was shut off) was noted in the medical Intensive Care Unit (ICU) and the out-patient Cardiac Clinic which had the potential to affect all patients receiving services in the medical ICU and the out-patient Cardiac Clinic.

Findings include:
A timeline of events, dated 2/1/17, was provided to the investigator at the time of the site visit at Lakeview Memorial Hospital. The timeline indicated that on 2/1/17, at 12:50 p.m., staff reported that there were air quality issues (odor similar to anti-freeze) in the medical ICU. In response, an incident command was called, and a code red was initiated to further alert staff to the problem. The timeline indicated visitors were promptly moved from the ICU at the beginning of the incident, and the fire department and Fire Marshal (F) were called. At 1:00 p.m., physician (I) began ongoing monitoring of the thirteen patients in the medical ICU and reported that they were all doing well. At 2:24 p.m., on 2/1/17, eight patients were transferred to other units within the hospital, three patients were discharged from the hospital prior to the evacuation/transfer of patients, and one patient was transferred to another hospital per prior arrangements. The medical ICU, and the out-patient Cardiac Clinic were closed.

The timeline indicated that at 1:13 p.m., on 2/1/17, the hospital determined that the odor was caused by condensation from a closed air handler (Roof Top Unit 2) that had recently been re-opened by the maintenance department. The air handler released Handipack 109 chemicals that accumulated when the unit was closed, and the odor developed as a result. At 1:14 p.m., the odor began to dissipate. The air handler was turned off, the valve was purged to the outside of the hospital in order to flush any remaining contaminants out of the line, and the unit was turned to full exhaust to draw the odor out of the medical ICU, and out-patient Cardiac Clinic. At 3:14 p.m., the hospital contacted chemical hygienist (I) for assessment of the chemicals involved with the incident and further testing which was scheduled to occur on 2/2/17. At 4:00 p.m., chemical specialist (H) arrived at the hospital and provided an analysis of the situation and a recommendation. The recommendation was to replace the twelve N-95 Heppa filters in the affected areas with new filters in order to eliminate the odor. The Heppa filters were replaced on 2/2/17, and staff scrubbed and cleaned the ICU and Cardiac Clinic.

A Material Safety Data Sheet, dated 7/1/05, that described the product/chemical/Handi-Pak 109 was reviewed. The sheet indicated the product, Handi-Pak 109, contained two primary components which were identified as Cyclohexylamine and Diethyinoethanol. The sheet indicated the product is corrosive to the eyes and skin, and is moderately toxic. The routes of exposure are contact and ingestion. The flammable properties of the product were identified as follows: white solid product; product will melt and combustion may occur when exposed to fire; releases combustible amine vapors when heated to boiling; closed containers may rupture due to pressure build-up when exposed to extreme heat; avoid inhalation, contact, or ingestion.

The timeline indicated that seven staff were seen in the Emergency Department (ED) from 3:30 p.m. to 4:47 p.m. on 2/1/17 for symptoms such as headache and nausea, following the incident. Review of the ED records of the seven staff indicated they were promptly treated and symptom-free when they were discharged from the ED on 2/1/17.

Patients #1 and #2 were patients on the ICU at the time of the incident, and they were interviewed by the investigator on 2/2/17 at 12:15 p.m. Patient #1 stated she experienced a slight headache at approximately 2:30 p.m. on 2/2/17 following the incident and after she moved to another unit. The headache was relieved by Tylenol. Patient #2 denied having any symptoms following the incident.

Physician (I) stated on 2/2/17 at 9:30 a.m. that five of the eight patients who were evacuated/transferred from the medical ICU to other units on 2/1/17 were returned to the medical ICU during the afternoon of 2/2/17. The other three patients did not return to the ICU on 2/2/17 and were discharged from the hospital per prior arrangements.

The investigator toured the medical ICU and the out-patient Cardiac Clinic on 2/2/17 at 8:45 a.m. No chemical odors were noted at the time of the tour.

The Lakeview Hospital Indoor Air Quality Policy Eng-056, dated September 1998, was reviewed. The policy stated, "It is recognized that the control of air quality within the facility is crucial to the health and safety of patients, staff and employees. An effective indoor air quality (IQA) program is the result of proactive inspection and maintenance of systems that influence indoor air quality, the control of contaminants during renovation and construction and the implementation of controls for specific contaminants such as outdoor air contaminants and other hazards within the indoor environment."