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Based on observation, interview, and document review, the facility failed to ensure point of care glucometer quality control solutions were dated when opened.

The failure created the potential for patient harm related to inadequate glucometer quality control, which could result in inaccurate blood glucose measurement and inappropriate treatment.

POLICY

According to facility policy, Nova Stat Strip Blood Glucose Monitoring, All Nova Stat Strip vials will be labeled with the date on opening. Nova Stat Strips are expired 30 days post opening of vial(s). All quality control reagents will be labeled upon opening. Reagent is expired 30 days post opening of vial(s).

1. The facility failed to label Nova Stat Strips and quality control reagents with the date they were opened.

a) On 08/26/14 at 10:45 a.m., a tour of the facility's emergency department was conducted with the facility's Director of Nursing. A glucometer with one bottle of high quality control reagent, one bottle of low quality control reagent, and one bottle of Nova Stat Strips was found. All bottles were open and not dated.

b) On 08/26/14 at 11:05 a.m., a tour of the facility's inpatient unit was conducted with the facility's Director of Nursing and Nursing Service Manager. A glucometer with one bottle of high quality control reagent, one bottle of low quality control reagent, and one bottle of Nova Stat Strips was found. All bottles were open and not dated.

c) On 08/26/14 at 11:20 a.m., an interview with the facility's Director of Nursing was conducted. S/he stated it was the expectation that staff write the date the controls and test strips were opened on the bottle. S/he also stated the reason that dates had not been written on the bottles was unknown.

Based on observation, interview, and a review of documents, the facility failed to monitor the temperature of a fluid warming cabinet and to ensure intravenous and irrigation fluids were stored in a manner consistent with manufacturer recommendations.

The failure created the potential for patient harm related to administration of intravenous (IV) fluids and/or irrigation fluids whose product integrity could have been compromised.
REFERENCE

According to Baxter Healthcare Corporation's manufacturer's instructions, December 12, 2013, regarding intentional warming of intravenous solutions, while stored under the stated conditions, product remains pharmaceutically acceptable. Prolonged storage at higher temperatures may accelerate concentration and pH changes in the final product. IV solutions of volumes 150mL or greater can be warmed in their plastic overpouches to temperatures not exceeding 40C (104F), and for a period no longer than 14 days. Solutions for irrigation may be warmed for up to 60 days at no more than 150 Fahrenheit and may not be replaced in the warmer once removed.

FINDINGS

1. The facility failed to monitor the temperature of an Olympic Warmette fluid warmer, located in the facility's obstetrical department, and failed to date bottles of irrigation solution placed in the warmer, as well as normal saline for IV use placed in an emergency department warmer.

a) A tour of the facility's obstetrical department, on 8/26/14 at 11:37 a.m., with the facility's Director of Nursing (DON) was conducted. An Olympic Warmette fluid warmer was observed with a manual dial set at 150 degrees Fahrenheit . No means to monitor the accuracy of the temperature setting was in place, no temperature logs were found, and three out of three 500cc bottles of Baxter Healthcare Corporation normal saline for irrigation were found in the warmer without dates. When asked, the DON stated that no daily logs of the warmer temperature were kept.

b) A tour of the facility's emergency department, on 8/26/14 at 12:38 p.m., with the facility's DON revealed a liter of normal saline IV solution with no date in a single-liter warming device. When asked, Registered Nurse #7 (RN) could not state when the liter had been placed in the warmer.