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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance.

C-1206 - The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, interviews and document review, the facility failed to ensure a vaginal ultrasound probe was reprocessed according to the manufacturer's instructions for use (IFUs) and the Cidex (high-level disinfectant solution) IFUs. Specifically, the facility failed to use the Cidex test strips as recommended by the Cidex IFUs and failed to rinse the vaginal probe after cleaning according to the vaginal probe IFUs. Additionally, the facility failed to properly clean and dispose of ultrasound (US) gel bottles in accordance with the Ultrasound gel's IFU.

Based on interviews and document review, the facility failed to ensure a vaginal ultrasound probe was reprocessed according to the manufacturer's instructions for use (IFUs) and the Cidex (high-level disinfectant solution) IFUs. Specifically, the facility failed to use the Cidex test strips as recommended by the Cidex IFUs and failed to rinse the vaginal probe after cleaning according to the vaginal probe IFUs. Additionally, the facility failed to properly clean and dispose of ultrasound (US) gel bottles in accordance with the ultrasound gel's IFU.

Findings include:

Facility policies:

The Cidex OPA policy read, for manual scope (or instrument) disinfection pour at least three gallons of Cidex OPA into Cidex multi-purpose tray kept on metal shelving in Central Supply. (Take tray into Scope Lab first) This Cidex is good for two weeks (14 days) after the bottle is opened. If this solution is used multiple times, it is necessary to test the strength of the solution using Cidex OPA test strips. If the test strip shows a failure, the solution must be replaced with a new solution.

The Ultrasound (US) Gel policy and procedure read, US gel is stored in climate and temperature-controlled space within the US department. US gel is then filled into clean gel bottles that are labeled with an expiration date. US gel bottles are wiped at the dispensing end with cavi wipes letting them set the approximate time to disinfect which is three minutes in between patient use. The US gel that remains in bottles is stored in a temperature-controlled gel warmer. The US gel process is repeated as needed. It is the responsibility of the sonographer to ensure that the US gel is in good standing conditions with expiration date and temperature. It is also the sonographer's job to ensure that each bottle is wiped with appropriate time in between patients.

References:

CIDEX OPA instructions for use read, CIDEX OPA Solution has demonstrated disinfection efficacy in the presence of 5% organic soil contamination and microbiological burden during reuse. CIDEX OPA Solution may be reused for up to a maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Directions for Use. DO NOT rely solely on days in use. Concentration of this product during its reuse life must be verified by the CIDEX OPA Solution Test Strip prior to each use to determine that the concentration of ortho-phthalaldehyde is above the Minimum Effective Concentration (MEC) of 0.3%. The product must be discarded after 14 days, even if the CIDEX OPA Solution Test Strip indicates a concentration above the MEC.

The Cidex Rinsing Procedure section of the IFUs read, following removal from the Cidex OPA solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume of water. Keep the device totally immersed for a minimum of one minute in duration. Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Repeat the procedure two additional times for a total of three rinses to ensure removal of CIDEX OPA solution residues. Residues may cause serious side effects. Three separate large volume water immersion rinses are required.

The vaginal probe instructions for cleaning read, handle the cleaning solution or wipes as described in the documentation provided by the relevant manufacturer. To maintain the effectiveness of the cleaning solution or wipes, ensure that the concentration, temperature, and other conditions specified in the documentation provided by the manufacturer are met. To confirm the effectiveness of the cleaning solution or wipes, use the criteria (such as effective period, number of times of use, discoloration, and results of using the effectiveness test kit) described in the documentation provided by the manufacturer.

The vaginal probe instructions for disinfection read, to maintain the effectiveness of the disinfectant, ensure that the concentration, temperature, and other conditions specified in the documentation provided by the manufacturer are met. To confirm the effectiveness of the disinfectant, use the criteria (such as effective period, number of times of use, discoloration, and results of using the effectiveness kit) described in the documentation provided by the manufacturer.

The Aquasonic 100 Ultrasound Transmission Gel refilling dispenser bottles instructions for use read, consult your facility policy before refilling from a bulk container. For refilling dispenser bottles, wipe the bottleneck and dispenser tip with isopropyl alcohol or a hospital-grade disinfectant, such as Protex disinfectant wipes, just prior to filling. Reusable containers should be washed in hot soapy water, rinsed, and thoroughly dried before being refilled. Isopropyl alcohol or a hospital-grade disinfectant, such as Protex disinfectant wipes can be used to clean dispenser bottles. Only refill product into corresponding labeled dispenser, and mark it with lot number. Reusable bottles should be marked with the date filled and then discarded after one month. Cracked or damaged bottles should be discarded immediately. Reusable bottles should not be topped off. Contents should be consumed, or remaining gel should be disposed of prior to refilling.

1. The facility failed to ensure a vaginal probe was reprocessed according to the manufacturer's IFU.

a. On 9/26/23 at 12:35 p.m. an interview was conducted with radiology technician (Tech) #1. Tech #1 reviewed the cleaning process of the vaginal probe. The instructions were as follows:

Once the probe had been used on a patient, the patient probe cover was removed. The probe was then wiped with a Cavi-wipe (a medical-grade disinfectant wipe). The container containing Cidex, the container for rinse water, and the vaginal probe would then be carried to the CT room sink for the decontamination process.

Tech #1 stated she poured a new patch of Cidex solution every 15 days and a thermometer was utilized to ensure the temperature was between 70 degrees and 75 degrees Fahrenheit before each use. The vaginal probe was soaked in the Cidex solution for 12 minutes. Once the soak was completed, the vaginal probe was then placed in the water to rinse. After rinsed, the probe was dried with paper towels and then a new cover was placed over the probe for storage.

Tech #1 stated she learned how to reprocess the vaginal probe at a prior job. She stated it was important for the vaginal probe to be cleaned according to the manufacturer's IFUs in order to ensure it was clean and to prevent the spread of infection between patients.

i. On 9/27/23 at 8:48 a.m., an additional interview with Tech #1 revealed test strips were not used to test the Cidex solution. Tech #1 explained the Cidex solution was not used on more than one vaginal probe cleaning and was changed after each patient use.

The interviews with Tech #1 were in contrast with the Cidex IFU and the Cidex OPA IFU, which instructed to verify the concentration of the product by using the CIDEX OPA Solution Test Strips prior to each use.

Additionally, the Cidex IFUs read, following removal from the Cidex OPA solution, thoroughly rinse the semi-critical medical device by immersing it completely in a large volume of water. Keep the device totally immersed for a minimum of one minute in duration. Remove the device and discard the rinse water. Always use fresh volumes of water for each rinse. Repeat the procedure two additional times for a total of three rinses to ensure the removal of CIDEX OPA solution residues. Residues may cause serious side effects. Three separate large volume water immersion rinses were required.

b. Review of the Cidex log sheet revealed instances where one batch of Cidex was used for more than one vaginal probe. Examples included:

i. In February, Cidex was poured on 2/28/23. A vaginal probe was cleaned in this Cidex on 2/28/23 and again twenty days later on 3/20/23. This was in contrast to the CIDEX OPA instructions for use which instructed to discard the product after 14 days. In addition, there was no evidence to show that the solution was tested with the CIDEX OPA Solution Test Strips prior to each use.

ii. In May, Cidex was poured on 5/29/23. A vaginal probe was cleaned in this batch of Cidex on 5/31/23, 6/1/23, 6/6/23 and 6/7/23. There was no evidence to show that the solution was tested with the CIDEX OPA Solution Test Strips prior to each use.

iii. In July, Cidex was poured on 7/1/23. A vaginal probe was cleaned in this batch of Cidex on 7/13/23, 7/17/23, and 7/19/23. This was in contrast to the CIDEX OPA instructions for use which instructed to discard the product after 14 days. In addition, there was no evidence to show that the solution was tested with the CIDEX OPA Solution Test Strips prior to each use.

c. On 9/26/23 at 2:35 p.m., an interview was conducted with the infection control manager (Manager) #3. Manager #3 stated the staff was expected to follow the manufacturer's recommendations to ensure the equipment was cleaned well and to prevent cross-contamination between patients.


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2. The facility failed to clean the inside of the US gel bottles with warm soapy water and allow them to fully dry before refilling and mark the bottles with the lot number after refilling. In addition, the facility failed to dispose of bottles after one month of use.

A. Observation

i. On 9/25/23 at 12:06 p.m., an observation of the ultrasound room was conducted with radiology technician (RT) #1. RT #1 demonstrated how ultrasound gel was used when ultrasounds were performed. RT#1 demonstrated how she used the opened US gel bag in the storage cabinet to refill the US gel bottles for procedures. RT #1 stated she labeled the bottle with the year it was first opened and explained how she cleaned the bottles with cavi wipes (a medical grade disinfectant wipe) after refilling them and allowed the bottles to dry thoroughly before use on patients.

This was in contrast to the Aquasonic 100 Ultrasound Transmission Gel instructions for use which read, reusable containers should be washed in hot soapy water, rinsed, and thoroughly dried before being refilled. The US gel product should be refilled into the corresponding labeled dispenser and marked with the lot number. Reusable bottles should be marked with the date filled and then discarded after one month.

B. Interviews

i. On 9/27/23 at 8:48 a.m., an interview with RT #1 was conducted. RT #1 stated the US gel came in a bulk shipment and was stored in the US room. RT #1 stated each bag of US gel came with three bottles which she labeled with the year the container of gel was opened. RT #1 stated she rotated the use of three US gel bottles which were sent with each bag of US gel. RT #1 stated she threw out the oldest of the three US gel bottles when a new bag of gel was opened. RT #1 stated infection and decreased efficacy were the risks to patients when the US gel's IFU was not followed. RT #1 stated she referenced the policy she and Manager #1 wrote on US gel and the gel pamphlet that came with every bag of gel when needed.

The interview was in contrast to the Aquasonic 100 Ultrasound Transmission Gel instructions for use which read, reusable containers should be washed in hot soapy water, rinsed, and thoroughly dried before being refilled. US gel product should only be refilled into the corresponding labeled dispenser and marked with the lot number. Reusable bottles should be marked with the date filled and then discarded after one month.

ii. On 9/27/23 at 8:30 a.m., an interview with radiology manager (Manager) #2 was conducted. Manager #2 stated it was important to keep a standard of practice and follow the policies and procedures to reduce the risk of infection and risks to patients. Manager #2 stated risks to patients included minor to major or permanent damage. Manager #2 stated she was unfamiliar with the US department processes, and trusted her US technician to do her job correctly. Manager #2 stated oversight of staff in the US department was important and ensured safety and infection risks to patients were reduced.