HospitalInspections.org

Based on observation, interview and record review the facility failed to provide care in a safe environment when the facility's transvaginal probe was not sanitized according to the manufacturer's instructions, placing patients at risk for infections.

Findings include:

Review of the facility provided Wavicide-01 Package Insert (undated) reflected, "... HIGH LEVEL DINFECTANT: WAVICIDE-01 solution is a high level disinfectant when used according to directions at full strength.... with an immersion time of at least 45 minutes.... The user MUST adhere to the Directions for Use since any modification will affect the safety and effectiveness of the germicide. The reusable device manufacturer should provide the user with a validated reprocessing procedure for that device using WAVICIDE-01 solution.... Directions for Use...Record the date of use at the beginning of a reuse period and calculate expiration date in advance by adding 30 days. Expiration date should be recorded on the space provided on the WAVICIDE-01 Solution label or on a log book. Do not rely solely on days of used.... Do not use beyond 30- days even if the concentration of the glutaraldehyde is above the minimum effective concentration...."

An observation made on the afternoon of 8/20/18, in the facility's radiology department, revealed (4) bottles of Wavicide-01 with an expiration date of 4/30/18. The facility provided patient list, dated from 5/1/18 to 8/20/18, revealed the facility performed (52) transvaginal procedures after the Wavicide-01 had expired.

Review of the facility provided WAVACIDE [sic] LOG reflected the Wavicide-01 had been changed out on 5/3/18 and 6/6/18, based on the manufacturer's instructions the Wavicide needed to be replaced on 6/3/18. The Wavicide had been changed out on 7/13/18, based on the manufacturer's instructions the Wavicide needed to be replaced on 7/6/18.

During a telephone interview on the afternoon of 8/20/18, Staff #8, Ultrasound Technician stated, "...I change the Wavicide every 30 days.... I soak the probe for at least 30 minutes."

During an interview on the afternoon of 8/20/18, in the Radiology department, Staff #6, Radiology Director stated, "...We use high level disinfecting.... We don't have a written procedure." Staff #6 confirmed the findings.

Based on interview and record review the facility's Infection Control Program failed to ensure the development, implementation and enforcement of adequate infection control policies and procedures for the facility's transvaginal probe to prevent possible cross contamination.

Findings include:

Review of the facility provided Wavicide-01 Package Insert (undated) reflected, "... HIGH LEVEL DINFECTANT: WAVICIDE-01 solution is a high level disinfectant when used according to directions at full strength.... with an immersion time of at least 45 minutes.... The user MUST adhere to the Directions for Use since any modification will affect the safety and effectiveness of the germicide. The reusable device manufacturer should provide the user with a validated reprocessing procedure for that device using WAVICIDE-01 solution.... Directions for Use...Record the date of use at the beginning of a reuse period and calculate expiration date in advance by adding 30 days. Expiration date should be recorded on the space provided on the WAVICIDE-01 Solution label or on a log book. Do not rely solely on days of used.... Do not use beyond 30- days even if the concentration of the glutaraldehyde is above the minimum effective concentration...."

An observation made on the afternoon of 8/20/18, in the facility's radiology department, revealed (4) bottles of Wavicide-01 with an expiration date of 4/30/18. The facility provided patient list, dated from 5/1/18 to 8/20/18, revealed the facility performed (52) transvaginal procedures after the Wavicide-01 had expired.

Review of the facility provided WAVACIDE [sic] LOG reflected the Wavicide-01 had been changed out on 5/3/18 and 6/6/18, based on the manufacturer's instructions the Wavicide needed to be replaced on 6/3/18. The Wavicide had been changed out on 7/13/18, based on the manufacturer's instructions the Wavicide needed to be replaced on 7/6/18.

During a telephone interview on the afternoon of 8/20/18, Staff #8, Ultrasound Technician stated, "...I change the Wavicide every 30 days.... I soak the probe for at least 30 minutes."

During an interview on the afternoon of 8/20/18, in the Radiology department, Staff #6, Radiology Director stated, "...We use high level disinfecting.... We don't have a written procedure." Staff #6 confirmed the findings.