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1201 WEST FRANK STREET

LUFKIN, TX 75901

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on observation, interview and record review the facility failed to ensure staff maintained a sanitary environment in 1 of 1 laboratory areas to prevent the risk of infections.

They failed to ensure floors were clean and equipment used for laboratory testing was properly cleansed.

They failed to ensure sterile water used for testing was discarded timely.

They failed to ensure laboratory supplies and specimens were stored in a sanitary environment.

This deficient practice had the likelihood to cause harm in all patients.

Findings include:

Review of a facility "Surveillance Plan 2014" revealed the following:

"06/22, Informed by lab that one of the techs has been using non sterile saline to set up cultures. Bottle being used has been cultured ....

06/23, Administration notified of above. Cultures done on the bottle are showing pseudomonas. All cultures set up by this employee are being reviewed.

06/24/2014, Meeting held with all physicians to notify them of our findings. Recommendations from the meeting to be done include: All patients with pseudomonas will be reviewed to see if they were true positives or not by reviewing the clinical presentations. Will resume bronchs 06/25/2014. All bronchs will continue to be monitored. Lab will review procedure policies and make sure staff competencies are complete."

There was no documentation in the plan addressing sanitary environmental conditions in the laboratory.

During an interview on 06/25/2014, after 1:50 p.m., Staff #16 confirmed the problems found in lab that were documented on the report.

During an observation on 06/26/2014, after 10:40 a.m., the following was observed in the Microbiology section of the lab:

*The laminar bio flow chamber (vent-a- hood) was observed with the front acrylic shield soiled and coated with a film. You could not see clearly through the shield. The front lower metal portion of the equipment was soiled with dried white spills. The floor and sides of the equipment were soiled with a build-up of dirt and dust. Inside the laminar vent-a- hood was two racks used for holding test tubes. One rack was metal and was covered with rust and the other one had peeling paint and was covered with rust. There was a container made out of cardboard used to store pencils, tweezers, inoculation loops and gauges for urine loops. The cardboard container stored in the bio flow chamber was not santizable. The base of a burner identified as the place where inoculation loops were sterilized was soiled with a build-up of black substance. There were two open boxes of (microscope) slides used for testing. The boxes that were holding the slides were soiled with dry stains and spills. There was a vented area near the front opening of the chamber which had a buildup of spills.

During an interview on 06/26/2014, after 10:40 a.m., Staff #20, 21 and 22 confirmed the findings. Staff #20 reported that the laminar bio flow chamber was cleaned about a month ago when it was serviced and the lab staff had no cleaning schedule for the equipment.

Review of the manufacturer's manual for the bio flow chamber revealed the following:

"The Bio flow Chamber is a minimal turbulence, unidirectional, vertical down flow, recirculating laminar flow unit which provides a safe work area for handling pathogenic microorganisms, plate streaking, special tuberculosis and mycology techniques, etc. In addition, tissue culture procedures including work with potentially oncogenic material may be performed in the Bio flow Chamber while affording protection to the laboratory worker. This chamber eliminates cross-contamination and accidental release of pathogenic micro-organisms to the outside atmosphere. The unit can be used wherever sterile air is required, e.g. pouring plates, sealing vials, sterile packaging, etc.

For initial cleaning and daily maintenance, the interior of the chamber should be completely wiped with 70 percent alcohol, using a soft cloth. The outside of the all stainless steel units may be similarly maintained.

Clean all of the stainless steel surfaces in the work area thoroughly, using a soft, lint-free cloth and 70 % alcohol. Using your checklist, collect all items of equipment, etc., which are to be placed in the chamber. Clean all of these items thoroughly before introducing them into the chamber. Open the viewing panel only for introduction of large items of equipment. Do not overload the work area ...."

*The floor in the microbiology area of the laboratory had an original color which was mingled with light blue and white. The middle of the floor had turned black and the base boards had a build-up of dust and dirt. The baseboards behind equipment in the area had a buildup of dirt, dust, and paper.

Staff #20 confirmed someone tried to clean the floor about 2-3 weeks ago and they were told it could not be cleaned.

*An uncovered shelf next to the Bio flow chamber was found with 3 containers of clear solution dated 07/20/2014. The shelf contained other clean lab supplies and was next to the Bio flow chamber sitting almost directly underneath the area. The bottom shelf had supplies stored on it and was approximately an inch from the floor. The floor around the bottom shelf was soiled with a build-up of dirt and dust. The supplies on the shelf were not protected from spills and dust.

Bottles of sterile water used for irrigation was found on another shelf in the room in front of a glass window (exposed to sunlight). The instructions on the label revealed they were to discard unused portion. Recommendations for storage included to avoid excessive heat.

Staff #20 identified the 3 containers on the shelf as being a sterile water solution and Mycolyse (a sputum liquefying agent used to digest and thin out the sputum, thus enhancing the isolation of organisms responsible for chronic lung disease). Staff #20 reported they were prepared on 06/20/2014 (6 days ago) and placed on the shelf. She reported she makes up 4 containers of the solution at a time for convenience. Staff #20 reported they use approximately 500 cc of the sterile water out of a 1000 cc bottle to mix up the Mucolyse (about 4 cups). The rest of the sterile water is used up to 1 month - 6 weeks later and then discarded.

Review of facility provided information sheet on "Sterile Water for Irrigation, USP" dated 06/26/2014 revealed "Sterile Water for Irrigation, USP (United States Pharmacopeia) contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded."

During an interview on 06/26/2014 after 12:00 p.m., Staff #3 confirmed the staff was supposed to discard the unused portion of sterile water.

*Ten plus test tubes were on a table in the lab. Some were placed directly on top of others. There was no protective barrier on the table underneath the tubes. The rack that was used to place the test tubes in was soiled and rusted.

Staff #20 reported they were urine samples that needed to be tested and they were being sorted. Staff #20 and 21 confirmed the observations.

*A piece of laboratory equipment was stored on a shelf with manuals and was covered with a layer of dust. Staff #20 identified the equipment was still being used for Meningitis testing. Staff #20 took a wet wipe and cleaned the top of the equipment and the wipe was soiled with dust. Staff #20 and 21 confirmed the observations.

Review of a lab rounding list of environmental issues/deficient areas found by facility staff on 05/30/2014, revealed some of the following items: disorderly work area, supplies stored on the floor, condition of floors, hematology desk area, unapproved chemicals, condition of chairs in the room, biomed checking fans, stained ceiling tiles, and needing temperature logs. There was not a resolution written for all of the areas and the laminar hood was not listed on the forms to be checked.

During an interview on 06/26/2015, after 1:00 p.m., Staff #s' 1, 16, and 26 confirmed when the environmental rounds were made by safety, security, hazardous materials, emergency preparedness, fire prevention, medical equipment, and infection control management the deficient findings were documented; but the resolution to the deficiencies were not always documented. Staff #1 stated, "I guess we are not always closing the loop" (meaning they were not always following up on identified issues).