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Based on observation, policy and procedure review, document review, staff interview, and review of the hospital's Infection Control Plan, the hospital and the hospital's designated Infection Control Officer failed to follow the hospital's Infection Control Plan to develop policies and procedures that followed manufacturer guidelines, and failed to monitor the Cardio-Pulmonary department's cleaning of the bronchoscopes (an instrument that can be used to obtain tissue for biopsy or to remove a foreign body from the lung) in order to maintain a safe, sanitary environment for patients. In addition, the hospital's infection control officer failed to ensure hospital personnel followed basic infection control practices when storing fluid's in two warming cabinets, and storage of the yankauer suction tips (a rigid hollow tube made of metal or disposable plastic with a curve at the distal end to facilitate the removal of thick secretions during oral pharyngeal suctioning).

See deficiencies at A-0748 and A-0749.

The cumulative effect of the systemic problems in infection control resulted in the hospital's inability to ensure effective implementation of infection control practices throughout the hospital which placed patients at risk.

Based on observation, policy and procedure review, review of the infection control plan and staff interview, the hospital's designated infection control officer:

- Failed to ensure the policies and procedures for cleaning the bronchoscopes in the Cardio-Pulmonary Department were followed according to manufacturer guidelines; and
- Failed to monitor all areas of the hospital and educated healthcare workers for compliance related to basic infection control practices.

These failures resulted in lack of a system to maintain safe, sanitary practices for patients in the Cardio-Pulmonary Department, ED (Emergency Department), Labor/Delivery Department, Imaging Department, and PACU (Post Anesthesia Care Unit).

Findings include:

1. The hospital's "Infection Control Plan" reviewed on 5/25/11 at 10:00am, dated "8/20/10", revealed the plan delegates the responsibility for implementation and management of the infection control plan to the Infection Control Officer. The plan directs the Infection Control Officer to govern the policies and identify educational opportunities for Associates (Employees).

2. Observations between 5/23/11 to 5/26/11 revealed the Cardio-Pulmonary Department staff failed to clean the bronchoscope according to manufacturer guidelines and failed to ensure the hospital policy and procedure followed manufacturer's guidelines. Observations in the ED and Labor/Delivery Department revealed two warming cabinets with a total of 21 bags/bottles of fluid that lacked a date when placed in the warming cabinet and/or staff failed to remove the item from the warming cabinet when expired. Observation in the ED, PACU, and Imaging Department revealed a total of 19 Yankauer suction tip packages were open and ready for use.

3. Staff L, Infection Control Officer, interviewed on 5/25/11 at 1:30pm acknowledged the hospital failed to monitor the Cardio-Pulmonary staff to ensure they were following manufacturer guidelines and failed to provide staff educational opportunities for cleaning the bronchoscope (an instrument that can be used to obtain tissue for biopsy or to remove a foreign body from the lung). Staff L, Infection Control Officer, confirmed the hospital failed to ensure the policies followed the manufactures guidelines for the bronchoscopes and fluids in the warming cabinet.

See the findings at A-0749.

1. Based on observation, policy and procedure review, document review, and staff interview, the hospital's infection control officer failed to develop a system that ensured that all medical equipment was disinfected following manufacturer's guidelines when from March through May 2011 31 patients had the potential to be affected by the hospital's Cardio-Pulmonary department's failure to disinfect the bronchoscopes according to manufacturer's guidelines.

Findings include:

a. AMetriCide OPA Plus Solution is a convenient, ready-to-use, high-level disinfectant that kills a broad spectrum of bacteria that includes Tuberculosis, Hepatitis A, Hepatitis B, HIV-1 and Polio Virus Type 1. It can disinfect a wide range of endoscopes and other heat-sensitive medical devices.

A bronchoscope is an instrument that can be inserted into the bronchi (located in the upper chest that extend roughly from the back of the mouth/throat into each lung) and used to obtain tissue for biopsy or to remove a foreign body from the lung.

The manufacturer's guidelines for the use of the "High-Level Disinfection-Metricide OPA (Ortho-Phthalaldehyde) Plus solution", reviewed on 5/25/11 at 3:53pm, direct the user:

- To preclean used medical devices in a dual-enzymatic detergent solution, rinse the instruments with fresh water, place instruments in the OPA solution, and soak for 12 minutes.
- Then thoroughly rinse with clean water three times, and flush all channels with 70% alcohol.
- The OPA solution placed in a basin "must be discarded after 14 days," and, "The concentration of the OPA solution must be verified by a test strip prior to each use to guard against dilution of the OPA solution and log each test result in a log book."

The hospital's Cardio-Pulmonary Policy and Procedure titled "Infection Control", reviewed on 5/25/11 at 10:45am, revealed the following directions for sterilization/disinfecting of the bronchoscopes, "Rinse in soapy water, soak in Cidex/OPA [Cidex is not used anymore and the OPA is the same as the AMetriCide OPA Plus Solution] for a minimum of 30 minutes, rinse with water, draw isopropyl alcohol into the interior of the scope three times, drain and let air dry."

Therefore, the Cardio-Pulmonary policy and procedure failed to follow the manufacturer's guidelines for cleaning the bronchoscopes.

Furthermore, the a letter from the manufacturer (Olympus) of the bronchoscopes, dated 5/26/11 at 9:32am and reviewed on 5/26/11 at 12:45pm, found it stated, "When Olympus says that you immerse the scope in 'detergent solution', we are referring to any form of enzymatic cleaner." (Enzymatic cleaners have the ability to break down soils, stains and other debris with the use of natural enzymes.) An enzymatic cleaner is not soapy water as described in the facility's policy and procedure.

b. Observation on 5/25/11 at 10:20am of the Cardio-Pulmonary services equipment room revealed a two-compartment sink with an unlabeled covered green plastic tub placed between the two sinks.

When interviewed at this time, Staff C revealed the green tub contained OPA solution for cleaning the bronchoscope. Documentation reviewed at this same time revealed the staff changed the OPA solution on 6/28/10, 11/9/10, 12/27/10, 2/18/11, and 3/21/11. However, according to the manufacturer's guidelines of the OPA disinfectant, the solution dated 2/18/11 would have needed to be discarded 3/4/11 (14 days after the disinfectant solution is placed in the basin for cleaning the bronchoscopes) rather than 3/21/11.

Review of a list of bronchoscopes performed on patients in the medical/surgical Intensive Care Unit (MSICU) or Cardiac Intensive Care Unit (CICU) with the assist of Cardio-Pulmonary services for the last three months (reviewed on 5/26/11 at 12:45pm) revealed that 12 bronchoscope procedures were performed and the bronchoscope cleaned by the Cardio-Pulmonary services staff in the disinfectant solution between 3/4/11 (when the solution needed to be discarded) and 3/21/11 (when the solution was discarded).

The disinfectant solution dated 3/21/11 needed to be discarded on 4/4/11. Review of the list of bronchoscope procedures preformed in MSICU or CICU revealed 19 bronchoscopes performed with the assist of Cardio-Pulmonary services and cleaned by Cardio-Pulmonary services in the disinfectant solution after 4/4/11 when the disinfectant solution needed to be discarded.

Staff C, Director of Cardio-Pulmonary Services, interviewed on 5/25/11 at 10:20am acknowledged the hospital failed to follow manufacturer's guidelines for the cleaning of the bronchoscopes.

c. Observation in the Cardio-Pulmonary equipment room on 5/25/11 at 10:20am revealed a partial empty bottle of "Dawn Pure Essentials" dish washing soap (Dawn dish washing soap is not an enzymatic cleaner) in the cabinet above the sink. When interviewed at this time, Staff D, Respiratory Therapist, confirmed the staff used the dishwashing soap to initially clean the bronchoscope before placing the bronchoscope the the disinfectant solution and acknowledged the Cardio-Pulmonary services lacked the test strips to monitor the disinfectant solution before each use of the disinfectant solution.

d. Staff C, Director of Cardio-Pulmonary Services, interviewed on 5/26/11 at 1:15pm revealed all the respiratory staff (RT) use the "Bronch Quiz" to monitor competency in the cleaning of the bronchoscopes. The "Bronch Quiz" identifies whether RT staff are able to follow the required steps for cleaning the bronchoscopes.

Review on 5/26/11 of the "Bronch Quiz", used for competency monitoring of all RT staff on a yearly basis, revealed the steps for cleaning the bronchoscopes did not include evidence they followed the manufacturer's guidelines.

Staff K, Respiratory Therapist, interviewed on 5/26/11 at 1:35pm confirmed the Cardio-Pulmonary staff used the "Bronch Quiz" to test their competency in the cleaning of the bronchoscopes.


2. Based on observation, review of documents, and staff interview, the hospital's infection control officer failed to develop a system that ensured that all medical liquids were warmed before patient use for no more than 14 calendar days. If warmed for a longer period there is the potential not only to change properties and be less, but also to grow potentially harmful bacteria in the solution. The practice has the potential to affect any patient who needed these intravenous solutions.

Findings include:

Review of the document provided by the Hospital from the manufacturer "Hospira, Inc." on 5/25/11 at 1:00pm revealed, "solutions for injection and irrigation may be warmed at a temperature not to exceed 40 degrees Centigrade (C) (104 degrees Fahrenheit (F) ), and for a period no longer than two weeks (14 days)."

Review of the hospital's procedure titled "Fluid & Medication Warming" (reviewed on 5/26/11 at 12:25pm) found, "Intravenous (IV) solutions can be warmed in their plastic pouches to a maximum of 40 degrees C [centigrade] (104 degrees F [Fahrenheit]) for a maximum of 14 days. Irrigating solutions can be warmed to 40 degrees C (104 degrees F) for a maximum of 72 hours and labeled with the date when placed in the warming cabinet."

Observation in the Emergency Department (ED) on 5/23/11 at 9:15am revealed a fluid warming cabinet with Intravenous Solutions (IV) in the warmer. The fluid warmer contained an IV bag, 1000 milliliters (ml) of .9% Sodium Chloride (a salt solution), with a date on it of 4/5/11 (48 days previously). Staff D, Respiratory Therapist, interviewed on 5/23/11 at 3:10pm, acknowledged the dated fluids in the warming cabinet indicated the date when placed in the warming cabinet. Staff D, Respiratory Therapist, confirmed the ED staff failed to remove the expired fluid from the warming cabinet as directed by hospital procedure.

Observation in the labor and delivery area of the Obstetric unit on 5/24/11 at 10:15am revealed a fluid warming cabinet that contained 12 individual 1000 ml containers of .9% Sodium Chloride irrigation solution and eight containers of 1000 ml of Sterile Water irrigation solution. The containers lacked a date when the staff placed the fluids in the warming cabinet. Staff F, Registered Nurse, interviewed on 5/24/11 acknowledged the hospital staff failed to date the fluids when placed in the warming cabinet.


3. Based on observation and staff interview, the hospital's infection control officer failed to develop a system that ensured that all medical equipment, including Yankauer suction tips, were kept with its packaging intact until the time of use. There is a risk of contamination when the package is open and the Yankauer not used promptly. This potentially affects any patient with whom staff used the open-packaged Yankauer suction tip in four areas of the hospital.

Findings include:

Observation of the ED on 5/23/11 at 9:15am revealed an open Yankauer suction tip (a rigid hollow tube made of metal or disposable plastic with a curve at the distal end to facilitate the removal of thick secretions during oral pharyngeal suctioning) in room #'s 3, 4, 8, 11 and 12 with the covering package partially open. Staff E, Director of Emergency Department, interviewed on 5/23/11 at 9:15am acknowledged the open Yankauer suction tip.

Observation of the CT (Computerized Tomography) San 64 room on 5/25/11 at 11:25 revealed an open Yankauer suction tip with the covering package partially open. Staff G, X-ray Technician, interviewed on 5/25/11 at 11:25am acknowledged the open Yankauer suction tip.

Observation of two fluoroscopy/diagnostic x-ray rooms on 5/25/11 at 11:30am revealed an open Yankauer suction tip with the covering package partially open. Staff H, X-ray Technician, interviewed on 5/25/11 at 11:30am acknowledged the open Yankauer suction tip.

Observation of the Post Anesthesia Care Unit (PACU) on 5/25/11 at 4:00pm revealed 11 open Yankauer suction tips with the covering package partially open. Staff I, Registered Nurse, interviewed on 5/25/11 at 4:00pm acknowledged the open Yankauer suction tip.