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I. Based on observation, staff interview, and document review, the Critical Access Hospital (CAH) surgical management staff failed to ensure surgical staff tested 2 of 2 disinfecting solutions for efficacy before each use, as required by the manufacturer. The CAH surgical staff identified an average of 15 endoscopic procedures per month, and each would require the use of the disinfecting solutions for cleaning after the procedure.

Failure to test the disinfecting solutions prior to each use could result in the disinfecting solution not containing a sufficient strength of the active ingredient to kill all microorganisms, potentially resulting in the spread of infectious microorganisms between patients.

Findings include:

A. Observations during a tour of the Operating Rooms Decontamination Area on 7/20/10 at 8:30 AM revealed a Medivator automated endoscope reprocessor machine for disinfecting endoscopes.

B. During an interview at the time of the tour, the Surgery and Infection Control Director revealed the surgical staff use Rapicide High Level Disinfectant in the Medivator endoscope reprocessor to disinfect the endoscopes. The Rapicide used glutaraldehyde as the active ingredient. Surgical staff tested the Rapicide High Level Disinfectant for the Minimum Effective Concentration (MEC) of glutaraldehyde once per day, and can use the solution up to 8 times per day.

C. Review of the "Medivator Log Sheet" found under the Medivator automated endoscope reprocessing machine revealed surgical staff only tested the Rapicide solution once per day.

D. Review of the Rapicide High Level Disinfectant solution's manufacturer's instructions, included as part of the surgical policy manual on cleaning endoscopes, revealed, "Directions for use. Monitor the... minimum recommended concentration (MRC) of glutaraldehyde in Rapicide High-Level Disinfectant... utilizing... Medivator Rapicide Glutaraldehyde Indicator Test Strips.... Monitor the glutaraldehyde concentration prior to each reprocessing cycle using Medivator Rapicide Glutaraldehyde Indicator Test Strips..."

E. Additionally, during an interview at the time of the tour, the Surgery and Infection Control Director revealed the surgical staff use Cidex Plus to disinfect surgical instruments an average of 1 day per month. The surgical staff may need to use the Cidex Plus to disinfect surgical instruments up to twice during the 1 day per month. The surgical staff do not test the Cidex Plus for the Minimum Effective Concentration (MEC) of glutaraldehyde.

F. Review of the manufacturer's directions for Cidex Plus, removed from the bottle of Cidex Plus in the operating room, revealed, "Efficacy of this product during its use-life must be verified by the Cidex Plus Solution Test Strips to determine that the solution is above the minimum effective concentration (MEC) of 2.1% glutaraldehyde. Use only Cidex Plus Solution Test Strips as they have been specifically designed to monitor Cidex Plus Solution MEC."

G. During an interview on 7/20/10 at 1:30 PM, the Surgery and Infection Control Director presented a revised log sheet for testing of Rapicide to indicate the need to test the solution before each use. The Surgery and Infection Control Director also presented a new log sheet for the Cidex Plus solution, indicating the need to test the Cidex Plus solution before each use. The Surgery and Infection Control Director stated the CAH purchasing staff would order Cidex Plus test strips.

Based on document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure qualified anesthesia staff evaluate 2 of 2 patients for recovery from anesthesia before discharge from the CAH. The CAH surgical staff identified an average of 10 procedures involving anesthesia per month.

Failure to evaluate each patient for recovery from anesthesia before discharge could potentially result in patients discharged with unrecognized complications of anesthesia.

Findings include:

A. Review of surgical medical records revealed:

1. Patient 11's medical record lacked evidence of a qualified anesthesia provider evaluating Patient 11 for recovery from anesthesia before nursing staff discharged Patient 11 home.

2. Patient 12's medical record lacked evidence of a qualified anesthesia provider evaluating Patient 12 for recovery from anesthesia before nursing staff discharges Patient 12 home.

B. Review of the policy, "[P]postoperative anesthesia care", updated 3/1/07, revealed, "At least one postanesthetic visit will be recorded, describing the presence or absence of anesthesia related complications..." "The attending anesthetist is responsible for postanesthesia care of all patients who have received anesthesia.... This includes documentation of all postanesthesia visits."

C. During an interview on 7/21/10 at 12:30 PM, the Surgery and Infection Control Director stated the anesthesia providers do not evaluate the patients after the patient moves to the post-anesthesia care unit. The anesthesia providers do not stay in the facility after the scheduled surgical procedures finish, and leave for another facility.