HospitalInspections.org

Based on observation, interview, and policy review, the provider failed to ensure intravenous (IV) and irrigation solutions stored in two of two solution warmers were maintained according to the manufacturer's specifications. Findings include:

1. Observation on 12/13/11 at 10:00 a.m. in the hallway outside the emergency room revealed a two compartment warming cabinet. One compartment contained blankets, and the other held IV and irrigation solutions. The compartment containing the solutions:
*Had a temperature setting of 121 degrees Fahrenheit (F).
*Had a thermometer inside the warming cabinet showing a temperature of 115 degrees F.
*Held three 1000 milliliter (ml) IV lactated ringers solution bags.
*Held one 1000 ml IV normal saline solution bag.
*Held one 500 ml bottle of sterile water for irrigation.
The above solution bags and bottle had not been marked with a date when they had been placed in the warming cabinet or with a date when they should have been removed.

Interview at the above time with the pharmacy director revealed:
*She was not aware of the manufacturer's storage requirements for warmed IV and irrigation solutions.
*The provider did not have a policy for storing warmed IV and irrigation solution.
*The provider was in the process of purchasing a warming cabinet specific for solutions.

Review of an e-mail received 12/13/11 from the manufacturer of the IV solutions revealed IV solutions in plastic flexible containers, in their overwraps:
*Could have been warmed at a temperature not to exceed 104 degrees F for a period no longer than fourteen days.
*Should have been removed from the warming cabinet after fourteen days.
*Could have been used after removal from the warming cabinet if marked with a revised expiration date obtained by deducting fifty-six days from the original expiration date of the solution.
*Should not have been re-warmed after they had been warmed previously.

Review of an e-mail received 12/14/11 from the manufacturer of the irrigation solution revealed irrigation solutions in plastic pour bottles:
*Could have been warmed at a temperature not to exceed 104 degrees F for a period no longer than fourteen days.
*Should have been removed from the warming cabinet after fourteen days.
*Could have been used after removal from the warming cabinet if marked with a revised expiration date obtained by deducting eight weeks from the original expiration date of the solution.
*Should not have been re-warmed after they had been warmed once.
*Could also have been warmed at a temperature not to exceed 150 degrees F for a period no longer than fourteen days. Once removed from the warming cabinet the solutions warmed to this temperature should have been used within twenty-four hours or discarded.




26691

2. Observation on 12/13/11 from 8:00 a.m. until 9:15 a.m. of the operating room (OR) suite revealed a fluid warmer built into the wall across the hall from the OR. The fluid warmer had:
*A temperature adjustment knob on the inside with settings of low, medium, and high. The knob was set at high.
*A thermometer showing a temperature of 110 degrees F.
*Three 1000 ml IV normal saline solution bags. One of those three bags was not marked with a date when it was placed in the warmer or with a date when it should have been removed.
*One 3000 ml normal saline for irrigation bag.
Posted on the outside of the door of that fluid warmer were temperature logs for November 2011 and December 2011. The documented temperatures for November ranged from 100 to 120 degrees F except for November 27, 2011. On that date the temperature was documented as 140 degrees F. The documented temperature ranges through December 13, 2011 were 105 to 110 degrees F. Those temperature logs also stated the staff were to report any temperature above 150 degrees F and refer to the provider's policy.

Interview on 12/13/11 at 2:40 p.m. with the OR supervisor revealed:
*The fluids placed in that OR fluid warmer were used for irrigation only.
*All fluids placed in that warmer should have been marked with a date when it was placed in the warmer.
*The fluids were only good for thirty days after the date they had been placed in the warmer.
*After the thirty days they were discarded.
*The temperature inside the fluid warmer should not have been above 120 degrees F.
*The temperature of the warmer had been 140 degrees F on November 27, 2011 but after rearranging the fluids in the warmer the temperature had came down to below 120 degrees F.
*There was no surgical policy and procedure related to the fluid warming cabinet or for the storage requirements of warmed IV and irrigation solutions.