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Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 - Standard: The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to maintain appropriate infection control processes in the areas of cleaning/disinfection of vaginal ultrasound probes, surgical instruments and procedure rooms. Additionally, the facility failed to ensure staff disinfected the rubber diaphragm of intravenous (IV) medication vials prior to inserting a device into the vial. These failures created the potential for patients to be at risk for health care acquired infections.

Based on observations, interviews and document review the facility failed to maintain appropriate infection control processes in the areas of cleaning/disinfection of vaginal ultrasound probes, surgical instruments and procedure rooms. Additionally, the facility failed to ensure staff disinfected the rubber diaphragm of intravenous (IV) medication vials prior to inserting a device into the vial in 1 of 1 patient case tracers conducted (Patient #7).

These failures created the potential for patients to be at risk for health care acquired infections.

FINDINGS:

REFERENCE

According to PCI Medical, GUS Model G 14KA Wall-Mounted Vapor Control System for Transvaginal and Transrectal Ultrasound Probes Instruction Manual, the cleaning process consist of:
-removing sheath or condom from probe, wipe off gel and wash probe with enzymatic cleaner prior to disinfection
-soak probes in CIDEX OPA for 12 minutes
-rinse disinfection off probe in the rinse container and wipe dry with paper towel
-final rinse occurs at a sink under running water
-remove rinse water from container, wash both the container and cap using mild detergent solution or cloth
-once dry, replace rinse water in container

According to Cidex OPA manufacturer's instructions, before soaking the vaginal ultrasound probe with the high level disinfectant (HLD), the probe should be wiped with a sani-wipe/alternative to remove proteins. The probe is then dried and inserted into the solution for 12 minutes to disinfect. The solution temperature must be at least 68 degrees Fahrenheit to be effective and changed every 14 days. After soaking in the Cidex OPA, remove probe from solution, place in fresh water, wait one minute, remove probe, replace water, and repeat rinsing two additional times.

According to Stryker ProClean Instrument Detergent, dilute the detergent at a ratio of 0.25 to 2 ounces (oz) per gallon of water.

According to Lippincott Procedures, Drawing up Medication for Injection, wipe the stopper of the medication vial with an alcohol pad and then draw up the prescribed amount of medication.

According to Center for Disease Control (CDC) Morbidity and Mortality Weekly Report Guideline for Hand Hygiene in Health-Care Settings (2002), decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.

1. The facility failed to have a standardized process in place for disinfection of transvaginal probes (probe). Three of 3 staff members failed to follow manufacturer's instructions for both GUS Vapor Control Systems (GUS) and Cidex OPA for High Level Disinfection (HLD) of the probe.

a) Review of the Radiology's departmental policy, High Level Disinfection Process, revealed the policy lacked instructions for pre-cleaning the probes with an enzymatic cleaner in accordance to both the GUS system and the Cidex OPA disinfectant manufacture's instructions. Furthermore, the policy's rinsing instructions were for a device which required it to be immersed in 2 gallons of water and a manual flush of all lumens. The probes used by the Radiology department did not have lumens.

b) On 04/05/16 at 12:50 p.m., Ultrasound Technician (UT #7) was observed demonstrating HLD process of a probe. UT #7 wiped the probe off with a germicidal wipe then immersed the probe into Cidex OPA solution (container #1). After 12 minutes, UT# 7 inserted the probe into container #2 (water) for a rinse and a final rinse at the sink under running water. During the demonstration, at no time was the probe pre-cleaned with an enzymatic cleaner or rinsed according to manufacturer's instructions.

c) On 04/06/16 at 8:24 a.m., an off campus observation of UT #11 demonstrated HLD of a probe. UT #11 removed the sheath, wiped the probe with a germicidal wipe, placed the probe into Cidex OPA for 12 minutes then immersed into a rinse container for 1 minute. UT #11 repeated the rinsed process an additional 2 more times. Although UT #11 did rinse the probe according to Cidex OPA manufacturer's instructions, s/he did not use an enzymatic cleaner during the pre-cleaning process. Furthermore, UT #11's rinse process differed from the two other staff members observed.

UT #11 stated s/he began working at the off campus location in January 2016 and received 1 on 1 training, which included the disinfection process of the probes. UT #11 stated if the probes was not properly disinfected, patients would be at risk for infection.

d) On 04/06/16 at 3:15 p.m., UT #13 demonstrated HLD of the transvaginal probe. After the protective sheath was removed from the probe s/he wiped the probe with a towel to remove any residual gel. Once the probe had soaked in the HLD for 12 minutes, it was then rinsed under running water for 2 minutes. UT #13 stated the process had been done this way since s/he began working at the facility 4 years ago. During the demonstration, at no time was the probe pre-cleaned with an enzymatic cleaner or rinsed according to manufacturer's instructions.

UT #13 stated s/he performed the vaginal ultrasounds at both the main facility location and another off campus location.

e) On 04/05/16 at 4:51 p.m., an interview was conducted with UT #7 who stated, it was unnecessary to pre-clean probes as they were covered with a disposable sheath and wiped off with a towel. This was in contrast to the manufacturer's instructions. UT #7 further stated patients were at risk for infection if probe is not cleaned correctly.

f) On 04/07/16 at 9:45 a.m., an interview with Radiology Manager (RM #6) was conducted. After review of manufacturer's instructions for Cidex OPA high level disinfectant, GUS system cleaning process and departmental policy, RM #6 stated s/he had been unfamiliar with the content of the manufacturer's instructions and confirmed the lack of a clear process for HLD of the probe in the facility. Although 3 of 3 UTs cleaned and rinsed the probes, all 3 of them demonstrated different processes which did not follow manufacturer's instructions. RM #6 further stated the expectation for staff was to follow manufacturer's instructions

g) On 04/07/16 at 12:58 p.m., an interview was conducted with the Infection Preventionist (IP #1). S/he stated germicidal wipes were not considered to be an enzymatic cleaner. An enzymatic cleaner helps digest bio-burden which should be removed to effectively HLD the probe. When compared, IP #1 validated the departmental policy failed to be consistent with manufacturer's instructions. IP #1 further stated it was the expectation for staff to follow manufacturer's instructions.

2. The facility failed to ensure solution used for vaginal probe disinfection reached the manufacturer's required temperature for effectiveness. Additionally, the documentation lacked evidence the disinfectant was changed every 14 days.

a) Review of the main campus Cidex OPA Solution log sheets dated from 10/2015 through 04/07/16, revealed on 10/10/15, 01/01/16 and 02/14/16, the solution temperatures recorded were below the required 68 degrees Fahrenheit. There was no evidence on the log sheets actions were taken to ensure effective disinfection of the probes.

b) Review of the off campus location's Cidex OPA Solution log sheets revealed staff documented in the comment section the disinfectant solution filled canister was changed on 02/12/16. The next documented change occurred on 03/11/16, 28 days later.

Review of the main campus Emergency Department log sheets revealed staff documented in the comment section the solution filled canister was changed on 01/15/16. There was no further documentation noted regarding the change of solution filled canisters in the comments section provided from 01/16/16 through 04/05/16.

According to an email dated 10/07/15 addressed to ultrasound staff, the change of the Cidex solution canisters were to be recorded in the "comments" column.

3. Sterile Processing staff responsible for the disinfection of surgical instruments failed to follow the manufacturer's instructions for use of detergent in the pre-cleaning of surgical instruments.

a) On 04/06/16 at 12:20 p.m., a tour of the Sterile Processing Department was conducted with the Sterile Processing Supervisor (Supervisor #3) and Sterile Processing Technician (SPT #14). SPT #14 was observed pre-cleaning surgical instruments. The sink was filled with water approximately 1 inch above the marked line in the sink. SPT#14 stated s/he did not measure the amount of detergent and further stated it was not important to measure the amount used. SPT #14 stated SPT staff members looked for a specific color consistency to indicate sufficient ratio of detergent to water, which was in contrast to the ProClean manufacturer's instructions.

Supervisor #3 stated measuring the water was unnecessary.

b) On 04/07/16 at 12:58 p.m., an interview was conducted with IP #1 who stated the facility followed CDC infection control guidelines. IP #1 stated staff were expected to follow manufacturer's instruction for the instrument detergent used for pre-cleaning of surgical instruments.

4. Facility staff did not disinfect the rubber septum on intravenous medication vials prior to piercing.

a) On 04/06/16 at 11:15 a.m., in a Gastrointestinal (GI) Procedure room, the Anesthesiologist (Physician #2) was observed throughout Patient #7's GI procedure. Physician #2 removed the plastic cap from an IV medication vial and then pierced the rubber top with a syringe and needle. Physician #2 did not disinfect the top of the vial with a alcohol pad, per the Lippincott Manual.

b) On 04/07/16 at 12:09 p.m. an interview was conducted with Physician #2 who stated s/he would not disinfect the rubber top on a new IV medication vial once the plastic top was removed. Physician #2 stated s/he considered the vial sterile.

c) On 04/07/16 at 12:58 p.m. an interview was conducted with the IP #1 who stated s/he expected staff to follow the Lippincott Manual for medication preparation and administration. IP #1 further stated medication vial diaphragms should be disinfected with an alcohol wipe prior to accessing the vial.

5. The facility failed to ensure adequate procedure room disinfection in between patients.

a) On 04/06/16 at 11:25 a.m. the cleaning of a GI procedure room was observed. At the completion of the procedure, GI Assistant (GI # 10) removed the dirty endoscope from the patient area while wearing gloves and placed in a bin for cleaning. GI #10 continued to clean the bedside table, suction tubing, canister, patient cardiac monitor cables, cardiac monitor, and endoscope monitor and specimen cup holder to prepare for the next patient. This was in contrast to the CDC guidelines.

b) On 04/07/16 at 12:04 p.m. an interview was conducted with GI #9. GI #9 stated once the dirty scope was removed from the procedure the expectation would be to change gloves prior to having the room prepared for the next patient. GI #9 stated gloves were to be changed to ensure the next patient was not cross contaminated from previous patients. S/he was uncertain if the facility had a policy regarding cleaning procedure rooms in between patients.

c) On 04/07/16 at 12:58 p.m. an interview was conducted with the IP #1. IP #1 stated the facility followed CDC infection control guidelines. IP#1 stated gloves should be changed after handling instruments used in a patient's body cavity and prior to cleaning to cleaning the procedure room.