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A. Based on document review, observations and staff interviews it was determined that infection control failed to ensure that all single patient use devices such as insulin pens are used according to the Center for Disease Control (CDC) recommendations that requires insulin pens to be used only on a single patient and not shared among multiple patients. Additionally, they failed to follow the manufacturer guidance that specifies that insulin may be withdrawn from the cartridge system only if there is a failure. When single patient use insulin pens are used to withdraw doses for multiple patients can result in contamination of the solution with resulting patient infections or adverse events.

Findings include:

The following is in part current CDC Recommendations for insulin pens.
Insulin pens containing multiple doses of insulin are meant for use on a single person only, and should never be used for more than one person, even when the needle is changed.
Insulin pens should be clearly labeled with the person 's name or other identifying information to ensure that the correct pen is used only on the correct individual. Hospitals and other facilities should review their policies and educate their staff regarding safe use of insulin pens and similar devices.

The following in part is the manufacture's recommendation for both SoloStar Lantus and Apridra cartridge systems: If the delivery device malfunctions the Apridra or Lantus may be drawn from the cartridge into a U-100 syringe and injected.

1. On 7/9/12 at 1450 hours Registered Nurses (RN) 1 and RN 2 were interviewed in the medication room on unit 3. Both nurses were questioned about multidose medication vials for insulin and they both said they use the insulin pens for drawing up Lantis and Aprida for different patients. They demonstrated with an insulin pen how they enter the cartridge with a clean syringe and needle to withdraw insulin for multiple patients. They asserted they always use individual needles and syringes for the different patients but do use the pen like a multidose vial.

2. The hospital pharmacist was interviewed on 7/9/12 at 1530 hours. She stated they do use insulin pens to withdraw Apridra and Lantus insulin doses for multiple patients. When questioned if this practice followed CDC or Food and Drug Administration (FDA) standards for single patient use devices she stated the practice was approved by Pharmacy and Therapeutics Committee.


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B. Based on observation on 7/9/12 at 12:45 p.m. the hospital staff failed to maintain a sterile environment during a liver biopsy performed in the ultra sound procedure room. This has the potential to cross contaminate the patient and staff with any possible disease process.

Findings include:

1. During direct observation of a liver biopsy, the assisting X-ray Technician scrubbed and donned gloves and helped prepare the patient for the procedure. The Technician then returned to the computer without removing her gloves. She then returned to continue assisting with the patient while using the same gloves. This was observed two separate times during the procedure.

2. This observation was discussed with the Director of QA/PI on 7/10/12 at approximately 2:00 p.m. and she agreed this action caused a break in the sterile surgical environment.

Based on staff interview and review of meeting minutes, it was determined the hospital failed to ensure that problems identified in the infection control program are addressed in the hospital Quality Assessment Performance Improvement (QAPI) program. This failure has the potential to adversely impact the quality of services provided to all patients.

Findings include:

1. Joint interview with the Infection Control Coordinator and Director of Performance Improvement was conducted at 0900 hours on 7/10/12. Both indicated that multiple infection control problems were identified in the past year. These problems included, but were not limited to a lack of any respirator fit testing being conducted for years and a low percentage of staff who received flu vaccinations.

2. Review of both the Infection Control Committee and QAPI Committee meeting minutes for the past year revealed no mention of these problems or any development and implementation of corrective interventions related to these problems.

3. Both the Infection Control Coordinator and Director of Performance Improvement acknowledged these minutes failed to reference these problems, the development and implementation of corrective interventions related to these problems or any on-going evaluation of interventions implemented for both success and sustainability.