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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 and disinfection of flexible endoscopes and the integrity of patient care supplies and equipment. These failures created the potential for transmission of health care acquired infections (HAIs) to patients receiving care in the facility.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of cleaning and disinfection of flexible endoscopes and the integrity of patient care supplies and equipment.

These failures created the potential for transmission of healthcare acquired infections (HAIs) to patients receiving care in the facility.

FINDINGS

POLICY

According to the policy Endoscope Reprocessing and Storage, manually cleaning the endoscope removes 99% of the bioburden on the endoscope. Failure to adequately clean the endoscope could diminish the effectiveness of high level disinfection. A recommended enzymatic detergent should be used for cleaning the endoscope.

Clinical staff members are required to complete an initial and annual scope cleaning and storage competency which must address all aspects of scope care, cleaning and storage.

According to Temperature Controlled Storage Unit Monitoring, temperatures of items in fluid warmers were not to exceed 40 degrees Celsius (104 degrees Fahrenheit), with rotation every 14 days in accordance with the manufacturer's product recommendation.

REFERENCE

According to the Association of periOperative Nurse's (AORN) Guidelines for Perioperative Practice (2015):

Recommendation II.b.1 (page 530) fluids kept in warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature. Adherence to the manufacturer's instructions for will provide stability of the solutions being stored.

Recommendation I (page 589) flexible endoscopes should be cleaned and stored in accordance to the manufacturer's written instructions. Failure to follow the manufacturer's written instructions could result in ineffective cleaning that interferes with high-level disinfection or sterilization, creating a risk of infection for the patient.

According to the manufacturer Olympus OnTrack Reprocessing In-Service/Competency for OER-Pro Automated Endoscope Reprocessor, the first step in manual cleaning of the endoscope requires filling a basin with fresh detergent solution prepared as recommended by the manufacturer.

According to the manufacturer's instructions, Renuzyme Plus dual-enzyme cleaning solution, for manual cleaning the soak solution must be mixed using 1-2 ounces of cleaner per gallon of water.

According to the manufacturer's instructions for Endochoice Pure Enzymatic Detergent, specially formulated for cleaning flexible endoscopes, the soak solution must be mixed using 1/2 ounce of detergent to 1 gallon of water. Use of an enzymatic cleaner that is compatible with the endoscope is important in breaking down proteins that make up a large portion of common soil.

1. The facility failed to maintain infection control processes in the cleaning of flexible endoscopes at 2 of 2 surgical locations.

a) On 06/28/16 a tour of the facility's off-site outpatient surgical location (Site B) was conducted. During the tour of the Sterile Processing Department at 9:05 a.m., an interview was conducted with the Specialty Instrument Technician (ST #3) responsible for the care, cleaning and storage of flexible endoscopes used in surgical procedures. According to ST #3, after the endoscope was used during a patient surgical procedure it was taken to the decontamination room for manual cleaning. ST #3 stated manual cleaning required the use of an enzymatic cleaning solution to remove surgical debris prior to disinfection of the endoscope. ST #3 explained the process for mixing the enzymatic cleaning solution required the use of 9 gallons of water and 9 ounces of Renuzyme Plus concentrate mixed in a steel sink. ST #3 pointed to a sticker applied to the inside of the steel sink which identified the level of 9 gallons of water. ST #3 then explained the Renuzyme Plus container required pressing the dispensing pump 9 times to achieve 9 ounces of detergent.

ST #3 denied s/he had ever measured the water or detergent to ensure the soak solution was correctly mixed and relied on the instruction given during initial training. ST #3 was requested to measure the amount of detergent in 1 pump from the enzymatic detergent dispenser. No measuring cup was present in the decontamination room. The Site B Charge Nurse (Registered Nurse, RN #2) was also present and retrieved a graduated specimen cup to measure the detergent. ST #3 verified s/he was not the only staff member trained to clean endoscopes and could not verify that all staff members depressed the dispensing pump completely to ensure a full ounce of detergent was used. ST #3 was requested to fill the steel sink to the marked water level line with a graduated measure tool. No measuring container was available in the decontamination room to measure the water. A bucket which held 2 gallons of liquid was retrieved from another area of the Site B location. ST #3 filled the steel sink to the marked water level and calculated the level held 10 gallons of water, not the 9 gallons previously verbalized.

Site B Manager (RN #1) was also present during the interview and stated a bucket should be kept in the decontamination room for accurate measuring of the water used to mix the enzymatic soak solution.

An interview was conducted with the Site B Supply Coordinator and Anesthesia Technician (ST #4) at 11:33 a.m. on 06/27/16. RN #1 and RN #2 were also present during the interview. ST #4 stated s/he performed the cleaning and disinfection of endoscopes when ST #3 was not present. ST #4 explained the process for the manual cleaning of endoscopes after use in a surgical procedure. ST #4 explained the mixture of the enzymatic soak solution required 6 full pumps (6 ounces) of the Renuzyme Plus detergent in 9 gallons of water. ST #4 stated s/he relied on the water level sticker in the steel sink to determine the amount of water used and was trained to depress the dispenser in the enzymatic detergent bottle. ST #4 stated s/he had never measured the detergent or the water used for mixing the enzymatic soak solution. RN #2 informed ST #4 the water level marking in the steel sink was not 9 gallons as previously verbalized.

b) On 06/28/16 at 8:47 a.m., a tour of the gastrointestinal (GI) lab was conducted. During the tour, an observation was conducted of the process of pre-cleaning duodenoscopes (an instrument inserted through the patient's mouth and used to visualize and perform procedures in the gastrointestinal system) with a Reprocessing Technician (Tech #14). Observation revealed a sink filled approximately half full and up to a black marking line in the sink. After placing the scope in the sink, Tech #14 administered 3 pumps of Endochoice enzymatic detergent into the sink. Tech #14 stated the volume of water in the sink equaled 6 gallons; however, s/he was unsure as to how much detergent equaled one pump.

Further observation revealed Tech #14 administering concentrated enzymatic detergent directly onto the distal tip of the scope. Tech #14 stated if the scope appeared dirty, s/he would typically add more detergent to the tip of the scope. This was in contrast to the manufacturer's instructions for use which stated to dilute one half ounce of enzymatic detergent into one gallon of water.

Tech #14 then proceeded to place the scope into a white basin filled with water and administer one pump of enzymatic solution into the white basin. Tech #14 stated s/he was not sure of the volume of water in the white basin but guesstimated the volume at around one gallon.

c) On 06/28/16 at 1:09 p.m. an interview was conducted with the Medical Director of Infection Control and Prevention (Physician #5). Physician #5 stated s/he was not involved with the choice of enzymatic cleaner used for the manual cleaning of endoscopes but expected the manufacturer's recommended brands, processes and amounts be used. Physician #5 stated when the manufacturer's instructions for use of the enzymatic cleaner were not used there was a risk of compromising the integrity of the endoscope.

d) An interview was conducted with the Clinical Nurse Manager of Endoscopy (RN #5) and the Clinical Nurse Coordinator of Endoscopy (RN #6) located at the Main location on 06/29/16 at 10:05 a.m. RN #5 verified the measurement of water in the sink used for cleaning endoscopes in the GI lab was 5 gallons. RN #6 verified the amount of Endochoice Pure Enzymatic detergent should have been 2.5 ounces in 5 gallons of water. RN #5 stated the use of too much enzymatic detergent might damage the endoscope and too little detergent could leave bacteria on the endoscope.

e) On 06/29/16 at 11: 02 a.m. an interview was conducted with Infection Preventionists (IP #8, IP #9, and IP #11) regarding the enzymatic detergent used in the manual cleaning of endoscopes at both surgical processing locations. IP #8 stated the mixture of detergent to water must be correct to ensure complete removal of surgical debris and bacteria from the endoscope and to protect the integrity of the endoscope. IP #8 stated it was expected that the manufacturer's instructions for mixing the enzymatic soak solution would be followed at all times.

IP #11 stated s/he was a member of the committee established to oversee the cleaning and disinfection of endoscopes at both facility locations and agreed the manufacturer instructions for mixing the enzymatic soak solution should be followed at all times by staff responsible for the care, cleaning and storage of endoscopes. IP #11 further stated every step in the process for cleaning and disinfecting endoscopes was important to ensure all the bioburden was removed and a clean instrument was created. Too little enzymatic detergent wouldn't completely kill the bacteria and too much enzymatic detergent could degrade the endoscope.


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2. The facility did not ensure intravenous (IV) fluids stored in warming cabinets were safe for patient use.

a) On 06/27/16 at 1:41 p.m., a tour of the Inpatient Surgical Department was conducted with the Manager of Inpatient Surgery (Manager #13) and the Associate Manager of Inpatient Surgery (Associate Manager #12). Observations during the tour revealed the following IV and irrigation solutions were stored in fluid warming cabinets beyond their discard date:

- In Operating Room (OR) #10, two 1000 milliliters (ml) bottles of 0.9% Sodium Chloride (NaCl) with 15 (ml) of epinephrine were observed in a fluid warming cabinet with a written expiration date of 06/25/16. Both bottles had printed stickers on them containing patient information.

- In OR #23, three 1000 ml bags of Lactated Ringer's irrigation solution were observed in a fluid warming cabinet with a written discard date of 05/08/16 (more than a month before the observation). Further observation in the fluid warming cabinet revealed three 1000 ml IV bags of 0.9% NaCl with no written discard date indicated on the bags.

During the observation of the fluid warming cabinet in OR #23, Associate Manager #12 stated the expectation was for staff to discard IV or irrigation fluids past the discard date or with no discard date indicated on the item. Associate Manager #12 then removed the fluids from the fluid warming cabinet.

b) On 06/29/16 at 11:02 a.m., an interview was conducted with Infection Preventionists (IP #8, IP #9, and IP #11). During the interview, IP #9 stated staff were expected to follow the manufacturer's determined date of use when using IV and irrigation solutions stored in fluid warming cabinets.

c) On 06/29/16 at 1:49 p.m., an interview was conducted with the Manager of Inpatient Surgery (Manager #13), who revealed IV fluids could be stored for 14 days and irrigation solutions could be stored for 60 days in the fluid warming cabinets. Manager #13 stated the expired fluids should have been removed from the warming cabinets to ensure they wouldn't be used.

3. The facility stored clean and soiled patient equipment on the floor.

a) On 06/27/16 at 1:13 p.m., a tour of the Surgical and Trauma Intensive Care Unit (ICU) was conducted. Observation revealed one IV pump on the floor directly outside of Patient Room 575 and a second IV pump on the floor directly outside of Patient Room 578.

During the observation, RN #18 was interviewed, who stated one of the IV pumps was soiled and needed to go to the decontamination room to be cleaned; however, s/he did not have time to take it there so it was placed on the floor until s/he was able to bring it to the decontamination room.

Further observation of the ICU revealed a staff member rolling a cart with an IV pump on it. The staff member placed the pump on the floor outside of Patient Room 576 and then left the area. An RN was then observed picking up the IV pump off of the floor and entering Patient Room 576.

b) On 06/29/16 at 11: 02 a.m. an interview was conducted with Infection Preventionists (IP #8, IP #9, and IP #11). During the interview, IP #8 stated s/he was unaware of the practice of staff placing clean and soiled IV pumps on the floor. IP #8 further stated the expectation was that there should never be anything placed on the floor. IP #8 continued by stating once clean equipment was placed on the floor it could not be considered to be clean for patient use. Further, dirty equipment was expected to be taken directly to the decontamination area for cleaning.