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Based on observation, documents review and interview with staff, the facility:

1. Failed to provide a safe environment to protect patients and staff from exposure to chemical Gluterraldehyde. (Refer to A0723).

2. Failed to maintain supplies by making expired supplies available for patient use and follow the manufacturer's recommendation for the Olympus Scope Processer. (Refer to A0724).

3. Failed to provide the required ventilation for the chemical product, Gluteraldehyde. (Refer to A0726).

Based on observation, documents review and interviews, the facility failed to provide a safe environment that protected patients and staff from the exposure to the disinfectant and sterilant, Gluteraldehyde.

On observation, during the tour of the Endoscopy Suite on 12/13/2012 at approximately 2:00PM with staff #9, the Scope Processing Room was located just to the left once you enter the Endoscopy Suite. (The Scope Processing Room is for the purpose of cleaning and disinfecting the instruments that had been used for either viewing the stomach by way of the mouth or viewing the colon by way of the rectum.) The door of the Scope Processing Room was propped open with a rubber wedge. Upon entering the Endoscopy suite there was an immediate smell of chemicals and an instant tingling was felt in the throat of the surveyor.

Staff #9 traced the route of the patients receiving procedures in the Endoscopy Suite. Patients enter the Suite on a stretcher, through the entry past the Scope Processing Room and into the room approximately 20 feet where the procedure would be performed. Staff #9 traced the same route for the patient exiting the suite once the procedure was completed.

While in the Endoscopy Suite, staff #10 was observed to have a rash on the face and hands. When Staff #10 was asked about the rash, the staff member raised the sleeves of the shirt and exposed the arms. 80% of the staff member's arms were covered with a rash. There were areas around the elbows and hands that were dry and flaking skin. The skin on the other parts of the arms was red in color and had the appearance of an orange pealing. There were bright red streaks approximately 3 to 4 inches long located at different areas on both arms. The staff member revealed the bright red streaks were a result of scratching.

A review of the Material Safety Data Sheet for glutaraldehyde revealed, (Danger! Causes eye and skin burns. Causes digestive and respiratory tract burns. May cause allergic respiratory and skin reaction. Harmful if swallowed, inhaled, or absorbed through the skin. Aspiration hazard if swallowed. Can enter lungs and cause damage. Dangerous for the environment.
Target Organs: Central nervous system, lungs, respiratory system, eyes, skin. Potential Health Effects
Eye: Causes eye irritation and burns. May cause permanent visual impairment. May cause chemical conjunctivitis and corneal damage.
Skin: May cause skin sensitization, an allergic reaction, which becomes evident upon re-exposure to this material. May cause hives. Causes skin irritation and burns. May cause staining of the hands (brownish or tan).
Ingestion: Harmful if swallowed. Causes gastrointestinal tract burns. May cause central nervous system depression, characterized by excitement, followed by headache, dizziness, drowsiness, and nausea. Advanced stages may cause collapse, unconsciousness, coma and possible death due to respiratory failure. Possible aspiration hazard. May cause lung damage.
Inhalation: Harmful if inhaled. Causes chemical burns to the respiratory tract. May cause asthma and shortness of breath. May cause nausea, dizziness, and headache.
Chronic: Effects may be delayed. Repeated or prolonged exposure may cause allergic reactions in sensitive individuals.


A review was done of a document provided by the Biomedical Department of the hospital. This document was presented for review as being the recommendations of the company that manufactures the scope processor. The document revealed, "Appropriate use of glutaraldehyde-based disinfectants requires attention to environmental health and safety issues. If the facility has not performed an air-handling audit, it is recommended to do so before starting to use any glutaraldehyde-bsed disinfectant. In areas where glutaraldehyde-based disinfectant are used, 10-12 air changes per hour are recommended, with facility ventilation placed as close as possible to the unit. It is important to note that the threshold limit value for glutataldehyde is very close to the vapor levels at which the oder can be detected."

During the tour of the Endoscopy Room, staff #9 confirmed that the Scope Processing Room door was propped open due to the smell being so concentrated with the door closed the staff were unable to stay in the room.

An interview was conducted by phone with both staff #5 and staff #6 in the Administration Conference Room on 12/14/2012. Staff #1 and staff # 2 were present in the Administration Conference Room during the phone interview with staff #5 and staff #6. The interview with staff #5 and staff #6 revealed there had not been an air audit done of the Scope Processing Room. Staff #5 and staff #6 were unable to quantify there were 10-12 air changes per hour in the Scope Processing Room.

Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.

Based on observations, documents review and interviews the facility failed to:

A. Provide the manufactures recommended 10-12 air changes for the Olympus Scope Processer.

A review was done of a document provided by the Biomedical Department of the hospital. This document was presented for reviews as being the recommendations of the company that manufactures the scope processor. The document revealed, Appropriate use of glutaraldehyde-based disinfectants requires attention to environmental health and safety issues. If the facility has not performed an air-handling audit, it is recommended to do so before starting to use any glutaraldehyde-bsed disinfectant. In areas where glutataldehyde-bsed disinfectant are used, 10-12 air changes per hour are recommended, with facility ventilation placed as close as possible to the unit. It is important to note that the threshold limit value for glutataldehyde is very close to the vapor levels at which the oder can be detected.

An interview was conducted by phone with both staff #5 and staff #6 in the Administration Conference Room on 12/14/2012. Staff #1 and staff # 2 were present in the Administration Conference Room during the interview with staff #5 and staff #6. The interview with staff #5 and staff #6 revealed there had not been an air audit done of the Scope Processing Room. Staff #5 and staff #6 were unable to quantify there were 10-12 air changes per hour in the Scope Processing Room.

B. Maintain the quality of supplies. Expired supplies were available for patient use.

While touring the Surgical Department on 12/13/2012 at approximately 2:00PM with staff # 9, expired supplies were gathered from each surgical area toured. With the help of staff #9 the expired supplies too numerous to count were gathered and placed on a cart measuring two feet by three feet. Both shelves on the cart were filled to over flowing. Staff #9 confirmed each and every expired item placed on the cart. These expired supplies were found in patient care areas or accessible by staff for patient care.

On 12/14/2012 at approximately 10:00AM a tour of the Surgical Department with staff #3 revealed expired supplies on the:

a. Pediatric Crash Cart,
Umbilical vessel catheter x1 expired 2010-10
Uncuffed endotracheal tubes x4 expired 2011-05
Toomey syringe x1 expired 2011-08
Nasal trumpet 12 F x2 expired 2008-08

b. Emergency Airway Cart
Endotracheal tubes x 4 expired 2010-02
Laryngoscope blade extender x4 expired 2011-10
Endotracheal stylet x13 expired 2011-11

c. Bronchoscopy Cart
Biopsy forceps expired 2010-06
Nasal trumpet 24 F x1 expired 2006-06
Endotracheal tubes x1 expired 2011-07

Staff #1 was called to the Surgical Department by staff #3 to confirm the expired items. Both staff #1 and staff #3 confirmed the expiration date of the found items.

Based on document review and interview the facility failed to provide the required ventilation for the chemical product, Gluteraldehyde.

A review of the Material Safety Data Sheet for Gluteraldehyde revealed, "Danger! Causes eye and skin burns. Causes digestive and respiratory tract burns. May cause allergic respiratory and skin reaction. Harmful if swallowed, inhaled, or absorbed through the skin. Aspiration hazard if swallowed. Can enter lungs and cause damage. Dangerous for the environment.
Target Organs: Central nervous system, lungs, respiratory system, eyes, skin. Potential Health Effects
Eye: Causes eye irritation and burns. May cause permanent visual impairment. May cause chemical conjunctivitis and corneal damage.
Skin: May cause skin sensitization, an allergic reaction, which becomes evident upon re-exposure to this material. May cause hives. Causes skin irritation and burns. May cause staining of the hands (brownish or tan).
Ingestion: Harmful if swallowed. Causes gastrointestinal tract burns. May cause central nervous system depression, characterized by excitement, followed by headache, dizziness, drowsiness, and nausea. Advanced stages may cause collapse, unconsciousness, coma and possible death due to respiratory failure. Possible aspiration hazard. May cause lung damage.
Inhalation: Harmful if inhaled. Causes chemical burns to the respiratory tract. May cause asthma and shortness of breath. May cause nausea, dizziness, and headache.
Chronic: Effects may be delayed. Repeated or prolonged exposure may cause allergic reactions in sensitive individuals.

Handling: Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Do not get in eyes, on skin, or on clothing. Use only with adequate ventilation. Avoid breathing vapor. "

A review was done of a document provided by the Biomedical Department of the hospital. This document was presented for reviews as being the recommendations of the company that manufactures the scope processor. The document revealed, Appropriate use of glutaraldehyde-based disinfectants requires attention to environmental health and safety issues. If the facility has not performed an air-handling audit, it is recommended to do so before starting to use any glutaraldehyde-bsed disinfectant. In areas where glutataldehyde-bsed disinfectant are used, 10-12 air changes per hour are recommended, with facility ventilation placed as close as possible to the unit. It is important to note that the threshold limit value for glutataldehyde is very close to the vapor levels at which the order can be detected.

While touring the Clean Equipment Processing Room, used for preparation and packaging surgical instruments, on 12/14/2012 with staff #3, the door to the processing room was propped open with a rubber stop. Staff #8 was asked about the rubber stop holding the door open. Staff #8 revealed when the washer is opened the room gets too hot to stay in. Staff # 3 confirmed the door was propped open.

A review of the perioperative standards and recommended practices of AORN (Association of perioperative Registered Nurses) revealed, Recommendation 1,1.b. Room temperature, humidity, and ventilation should be controlled in accordance with local and state, and federal policy and regulation. Table 2 provides parameters for the controlled environment. A review of Table 2 titled, Parameters for Controlled Environments During Sterilization revealed, the functional area for preparation and packaging of surgical instruments should have a positive airflow with a minimum number of air exchanges per hour of 10 (downdraft type). The room ' s temperature should be maintained at 68 degrees to 73 degrees Fahrenheit with a relative humidity of 30 to 60 percent.

An interview was conducted by phone with both staff #5 and staff #6 in the Administration Conference Room on 12/14/2012. Staff #1 and staff # were present in the Administration Conference Room during the interview with staff #5 and staff #6. The interview with staff #5 and staff #6 revealed there had not been an air audit done of the Scope Processing Room. Staff #5 and staff #6 were unable to quantify there were 10-12 air changes per hour in the Scope Processing Room. When staff #5 and staff #6 were asked about the positive airflow and the number air exchanges in the Clean Equipment Processing Room, the reply was that room was not checked by bio-med. No records were presented or made available the room was being monitored for air-flow, air exchanges, temperature or humidity.

An interview was conducted by phone with both staff #5 and staff #6 in the Administration Conference Room on 12/14/2012. Staff #1 and staff # were present in the Administration Conference Room during the interview with staff #5 and staff #6. The interview with staff #5 and staff #6 revealed there had not been an air audit done of the Scope Processing Room. Staff #5 and staff #6 were unable to quantify there were 10-12 air changes per hour in the Scope Processing Room.

Based on observation, document review and interview the facility failed to provide up to date policies for the sterilization of surgical supplies. Policies identified specific products by name the facility was no longer using.

A review of the perioperative standards and recommended practices of AORN (Association of perioperative Registered Nurses) revealed, Recommendation XIX, Competency, Personnel should receive initial education and competency validation on procedures, chemicals used, and personal protection and should receive additional training when new equipment, instruments, supplies, or procedures are introduced. No evidence was provided that staff #8, staff #9 or staff #10 received training on the new products, biological packs, Bowie Dick Test packs or chemical indicators being used by the facility.

On 12/14/2012 while touring with staff #3 a bacteriological incubator was observed in the Clean Equipment Processing Room with biological being incubated.

A review of the policy titled: Bacteiological, (a test to determine if live bacteria are killed during the sterilization process) revision date: August 2009, revealed the process, 3. When the sterilization cycle is complete and disposable test pack has cooled for at least 10 minutes, remove the indicator, write the appropriate data on the indicator (date, load number, sterilizer, and if indicated, implantable item) and take to the lab, with a control dedicator. # 4. A written report is received from the lab after 48 hours.

An interview was conducted with staff #8, with staff #3 present. Staff #8 explained the process was to run the biological in the auto-clave. Once the sterilizing cycle was complete, the biological was placed in the incubator along with a control indicator. The staff monitored and recorded if the tests were positive or negative. Staff #8 was asked if there was a policy laying out the process for processing biological, staff #8 replied, I don't know. This is how I do it.

Interview on 12/14/2012 at approximately 2:00PMwith staff #1 in the Administration Conference Room confirmed the policy titled, Bacteiological was incorrect. Bacteriological are processed in the Surgical Department.

On observation while touring the Clean Equipment Processing Room on 12/14/2012 with staff #3 and staff #8 the products being used by the facility to test the autoclaves (surgical equipment sterilizers) were products different from what the policy stated the facility was using.

A review of the policy titled, "Disposable Smart Pack" with the last revision date of August 2009 revealed an instruction sheet for a specific manufacturer and a specific product. The product specified in the policy is not being used by the facility to perform the Bowie Dick Type Test.

On observation while touring the Clean Equipment Processing Room with staff #3 and staff #8 confirmed the current products being used by the facility to test the autoclaves (surgical equipment sterilizers). The facility's policy had not been updated.

A review of the policy titled, "Chemical Indicators" with the last revision date of August 2009 revealed an instruction sheet by a specific company. The product reflected in the policy is not the product being used by the facility.

Interview with staff #8, #9 and #10 on 12/13/2012 at approximately 2:00 PM in the room that housed the auto-clave confirmed they had not been educated on current test to do the Bowie Dick Type Test or the current pack containing the biological test. Staff #8, staff #9 or staff #10 was not familiar with the facilities policy.

A review of the policy titled, "Terminal Sterilization of Wrapped Supplies" with the last revision date of February 2003 revealed the policy statement, "It is the policy of this facility Surgical Department to utilize the Eagle Series 3053 Pre-Vacuum Sterilizer for terminal sterilization of wrapped supplies."

Interview with Staff #8, staff #9 and staff #10 on 12/13/2012 at 02:15 PM in the room that houses the Castle Gravity /Flash Sterilizer revealed the Castle Gravity /Flash Sterilizer was the primary sterilizer used for wrapped supplies.

While touring the contaminated utility room on 12/14/2012 with staff #3, the utility room did not have a sonic-cleaner.

A review of the policy titled, "Decontamination and Processing Instruments by O.R. Personnel" revealed the Process: #3. Cannulated instruments and excessively dirty instruments are put through sonic first, then the washer.

A review of the policy titled, "Packing and Storage of Sterile Supplies," revealed the Process: #1 After all instruments have been processed through the washer-disinfector and sonic-cleaner, they are to be inspected for cleanliness and working condition.

Interview with staff #8 revealed there had not been a working sonic washer for the year of the staff's employment.

Staff #8 was observed hand cleaning instruments in the sink. contaminated utility room. Staff #8 was not wearing (PPE) a protective gown, protective eyewear or appropriate protective gloves while washing the surgical instruments.

A review of the perioperative standards and recommended practices of AORN (Association of perioperative Registered Nurses) revealed, Personnel handling contaminated instruments and equipment must wear appropriate personal protective equipment (PPE) and should be vaccinated against the hepatitis B virus. XVIII.a. Personal protective equipment consistent with the anticipated exposure must be worn. Splashes, splatters, and skin contact can be reasonably anticipated when handling contaminated instruments. XVIII.a.1. The appropriate PPE for these types of exposures include, but are not limited to, a fluid-resistant gown, heavy-duty gloves, a mask and face protection.

An interview with staff #8 was done on 12/14/2012 with staff #3 present. Staff #8 was asked if education had been provided for the hand cleaning of instruments or was there a policy for hand cleaning instrument. Staff #8 stated there had not been any education provided nor was there a policy for hand washing instruments. Staff #8 stated the instrument technician had quit and the scrubs were now doing the instruments.