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Based on observation, interview, and record review, the hospital failed to:

1. Ensure gowns with metal snaps were not stored in the warming unit.

2. Ensure the warming unit was maintained at the correct temperature.

These failures had the potential for patients to receive a burn from the heated metal snaps and change the product being warmed.

Findings:

1. During a concurrent observation and interview with Registered Nurse (RN) 2, on 6/1/16, at 11:20 AM, in the Center Core of Surgical Services, the warming cabinet near Operating Rooms 3 and 4, had a temperature reading on the lower cabinet of 110° (degrees) Fahrenheit (F). Inside the warming cabinet were five patient gowns with metal snaps. RN 2 verified the temperature and findings and had no comment.

2. During an observation on 6/1/16, at 11:22 AM, in the Center Core of Surgical Services, the warming cabinet near Operating Room 8, top chamber temperature read 112° F. Inside the warming cabinet were multiple bags of IV solution. The lower chamber temperature read 130° F. Inside the lower chamber were 10 patient gowns with metal snaps. RN 2 verified the findings and made no further comment.

The hospital policy and procedure titled: "Temperature Control - Solutions/ Gel and Linens" dated 9/2014, indicated "A. 3. a. prolonged storage at higher temperatures may accelerate changes in the final product. B. Warming Linens: Maximum temperature will be at 120°. C. Temperature recommendations for solutions/gel: 1. ...Large volume parenterals 150 ml (milliliter) or greater in the plastic over-pouches: a. Not exceeding 40° (104° F)..."

Based on interview and record review, the hospital's Quality Assurance and Performance Improvement (QAPI) program failed to:

1. Ensure data collection in hand hygiene was consistent when unit staff were involved. This had the potential to skew the accuracy of data collected.

2. Ensure the data collected for "Isolation Compliance" was analyzed to seek opportunities for improvement. This failure had caused the hospital to continue not meeting the goal of 90 percent compliance for four years (2012 to 2015).

Findings:

1. The hospital's "2016 Infection Control Annual Report" was reviewed on 6/1/16. This report included the comparison of compliance from 2012 to 2015, in one of the quality reports for "Hand Hygiene". The report indicated the hospital had a success rate of compliance consistently above 90 percent in the past four years. The data was collected through observing 15 hand hygiene performed by staff (direct care staff, physicians, and ancillary staff) in several patient care units per month.

During an interview with the Infection Control Coordinator (ICC), on 6/2/16, at 2:58 PM, the ICC stated the responsibility of data collection was given to the managers of the patient care units. The managers could then assign this task to other staff to complete. The ICC stated, in comparison to the data collected by the quality staff, the compliance was higher when the data was collected by a staff nurse. She further stated, "The quality staff will start the data collection now." The ICC explained the hand hygiene auditing tool had not been approved by the Infection Control Committee yet and nursing staff on the unit were not trained in how the hand hygiene data should be collected.

2. The hospital's "2016 Infection Control Annual Report" was reviewed on 6/1/16. This report included the comparison of compliance from 2012 to 2015, a quality report, titled "Isolation Compliance" indicated the hospital had not been able to meet the goal of 90 percent in the past four years in the following four areas: Cohort Correct (room patients with the same germs together), Isolation Order (nursing or physician orders for the isolation), Clinical Warning (identified patients may require isolation), and Education (education provided to families and visitors). In the last four years, Cohort Correct was 47 to 55 percent compliance, Isolation Order was 48 to 72 percent, Clinical Warning was 60 to 70 percent, and Education was 29 to 43 percent.

During an interview, on 5/31/16, at 3:35 PM, the ICC reviewed the above information and could not provide any details to show she had done further analysis to identify the causes of the low compliance rates in these four areas.

Based on interview and record review, the hospital failed to ensure:

1. The Anesthesia Technician (AT) was trained in his position.
2. Training records for three of four Patient Service Associates (PSA 2, PSA 3, PSA 4) were complete.

These failures resulted in the AT not keeping accurate logs for reprocessing equipment, and inaccurate training records for PSA's (housekeeping staff).

Findings:

1. During an interview with the Clinical Supervisor Surgery (CSS), on 5/31/16, at 4 PM, she stated a few LMA's (laryngeal mask- is a medical device that keeps a patient's airway open during anesthesia or unconsciousness) are used in the department, and the AT takes care of them.

During an interview with the CSS, on 6/1/16, at 3:25 PM, she was asked about a reprocessing log for the LMA's. The CSS stated "The AT has gone home. There was a log, but he doesn't keep a log anymore." When asked about tracking of use, she said we can ask the AT when he comes in.

During an interview with Registered Nurse (RN) 3, on 6/1/16, at 3:50 PM the Autoclave (machine for steam sterilization) logs from January-May 2016 were reviewed. RN 3 stated "LMA's are autoclaved about once or twice a week."

During an interview with the AT on 6/2/16, at 2:25 PM, he was asked about logging the use of LMA's. The AT stated "...there was a PM (night) person who reprocessed (LMA's). I was never told about 40 times. No one ever said it. I remember logs, but as for me I haven't used the log. We haven't kept track of use." The AT stated "I received most training at another facility, but didn't receive any training here (current facility)."

The manufacturer's insert titled "Instructions for Use- LMA Flexible" dated 2015, indicated "[Manufacturer] recommends the LMA Flexible be used a maximum of 40 times before being discarded. Continued use beyond the maximum times is not recommended as degradation of the components may result in impaired performance or abrupt failure of the device. The LMA Flexible is reusable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from date of purchase (whichever is earlier)..."

2. During a review of the OR (operating room) personnel record for PSA 4, the "Individual Training Record", with PSA 4's name at the top was incomplete. The areas for Position, Date of Hire, and Certificate Date were blank, and did not have Trainer or Trainee signatures at the bottom of the form. The section titled Instructor Initials in the four training areas had initials written in the sections.

During an interview with the CSS, on 6/2/16, at 4:05 PM, she was asked about the blank training record, and stated "They were given to me by the Director of Environmental Services (DEVS)." No further information was given.

During a review of the OR personnel record for PSA 2, the "Individual Training Record", with PSA 2's name at the top was incomplete. The areas for Position, Date of Hire, and Certificate Date were blank, and did not have Trainer or Trainee signatures at the bottom of the form. The section titled Instructor Initials in the four training areas had initials written in the sections.

During an interview with the DEVS, on 6/2/16, at 4:30 PM, he was asked who initialed the blank form, and stated "Oh, those are mine." The DEVS stated "Well, the form is for training and probably forgot it was there." The DEVS was asked when the training was completed, and stated "I don't remember". The DEVS said he did not know why the form was blank.

During an interview with the Personnel Specialist (PS), on 6/2/16, at 4:37 PM, she said she had not seen the form before.

During a review of the OR personnel record for PSA 3, the "Individual Training Record", with PSA 3's name at the top was incomplete. The areas for Position, Date of Hire, and Certificate Date were blank, and did not have Trainer or Trainee signatures at the bottom of the form. The section titled Instructor Initials in the four training areas had initials written in the sections.

The hospital form titled "Individual Training Record" instructions at the top indicated "Please initial and date the gray shaded areas, indicating you have been trained on the topics within that section. The bottom signature areas indicated "Trainer/Facilitator Signature:.. I have been trained in all of the above topics. Trainee Signature.:.."

Based on observation, interview and record review, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to:

1. Ensure the staff in the operating room (OR) follow the hospital's policy and procedure to check the air balance in all operating suites. (Refer to A 0749)

2. Ensure housekeeping staff cleaned a patient room under isolation for Clostridium difficile (often called C. difficile or C. diff, is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon) would be in compliance with its policy and procedure. (Refer to A 0749)

3. Ensure housekeeping staff followed manufacturers' guidelines for cleaning and disinfecting surfaces and dwell time (amount of time required for contact of a chemical agent with a surface). (Refer to A 0749)

4. Ensure housekeeping staff followed Policy and Procedure for mopping of OR floor. (Refer to A 0749)

5. Ensure hands were cleaned, either by washing with soap and water or using an alcohol based hand gel, after contamination. (Refer to A 0749)

6. Ensure all endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body) were stored in a sanitary manner. (Refer to A 0749)

7. Ensure hospital approved cleaner was used. (Refer to A 0749)

8. Ensure LMA's (laryngeal mask airway-a medical device that keeps a patient's airway open during anesthesia or unconsciousness) were stored appropriately. (Refer to A 0749)

9. Ensure signs were posted in Central Processing per hospital practice. (Refer to A 0749)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment which had placed its patients, staff, and visitors at risk of being exposed to infectious and communicable diseases.

Based on observation, interview, and review of the hospital's policy and procedure and the manufacture's manual, the hospital failed to:

1. Ensure the staff in the operating room (OR) follow the hospital's policy and procedure to check the air balance in all operating suites.

2. Ensure housekeeping staff cleaned a patient room under isolation for Clostridium difficile (often called C. difficile or C. diff, is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon) would be in compliance with its policy and procedure.

3. Ensure housekeeping staff followed manufacturers' guidelines for cleaning and disinfecting surfaces and dwell time (amount of time required for contact of a chemical agent with a surface).

4. Ensure housekeeping staff followed Policy and Procedure for mopping of OR floors.

5. Ensure hands were cleaned by washing with soap and water or using an alcohol based hand gel after contamination.

6. Ensure all endoscopes (an instrument used to examine the interior of a hollow organ or cavity of the body) were stored in a sanitary manner.

7. Ensure hospital approved cleaner was used.

8. Ensure LMA's (laryngeal mask airway-a medical device that keeps a patient's airway open during anesthesia or unconsciousness) were stored appropriately.

9. Ensure signs were posted in Central processing per hospital practice.

These failures had the potential to spread infectious diseases to other patients, staff, and visitors.

Findings:

1. On 6/1/16, the "TEMPERATURE, HUMIDITY AND AIR BALANCE LOG" for all operating rooms for the months of March, April, and May were reviewed. The hospital has one log per month for each of the eight operating rooms, Sterile Processing Area, and the surgical core (an area surrounded by operating rooms and used to store sterile supplies). It was noted, in March and May, there was no documentation of the air balance at all. In the month of April, there was only one day, 4/28/16, the air balance was checked for all eight operating rooms. The Sterile Processing Area and the core were left blank.

On 6/1/16, at 4:15 PM, during an interview, the Clinical Supervisor Surgery (CSS) stated the air balance for all operating rooms, Sterile Processing Area, and the core should be checked and documented on the log weekly. At the end of each month, the log was placed in a binder. The charge nurse was to complete the information on all rooms and the supervisor should ensure the temperatures, humidity, and air balance were within normal range. The CSS stated these logs were not reviewed before being placed in a binder.

2. On 6/1/16, at 9:48 AM, during a tour of a Medical-Surgical unit (3D), accompanied by the Quality Staff Nurse (QRN), outside Room 3402, Patient Services Associate (PSA) 1 was just finishing cleaning the room. A sign on the door read "CONTACT ISOLATION." During a concurrent interview, PSA 1 explained the patient in the room is on C-diff isolation and she had to use bleach wipes to clean all surfaces. Upon request, PSA 1 demonstrated how she cleaned the floor. PSA 1 took two wipes from a 75-count canister and applied directly to the mop head without using a mop pad first. She stated the Velcro on the mop head would keep the wipes in place.



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7. During an observation on 5/31/16, at 9:58 AM, in the Surgery Department hallway outside of OR 4, the housekeeping cart had a spray bottle labeled "Clean by Peroxy".

During an interview with PSA 2, on 5/31/16, at 10 AM, she said Clean by Peroxy was for blood. PSA 2 stated "We spray and remop."

During an interview with the ICC, on 6/1/16, at 4:10 PM, she said she was not aware of the product (Clean by Peroxy) being used by housekeeping. The ICC stated "It was not brought to committee... I was not aware they were using it."

The Clean on the Go Clean by Peroxy [15] "Safety Data Sheet" dated 8/20/14 indicated the chemical name "hydrogen peroxide".

The manufacture's "Letter of Continuing Guaranty: Clean on the Go Clean by Peroxy [15]" dated 1/2/13, indicated "...this product is safe and effective for use in food processing plants, including USDA (United States Department of Agriculture) inspected facilities..." The letter also indicated "Clean on the Go Clean by Peroxy [15] is a hydrogen peroxide based all purpose cleaner. ...quickly removes everyday soils and greasy residue from floors, walls, and many other surfaces."

The hospital policy and procedure (from the housekeeping company) titled "Surgical Areas Cleaning" dated 10/1/15, indicated "Equipment: Approved Hospital Disinfectant (s). Preparation: Cleaning methods that produce mist, aerosols or dust (eg; spray bottles containing disinfectant) should not be used. Daily Routine Cleaning: Wet mop floor...with germicidal solution."

8. During an observation and interview with the CSS, on 5/31/16, at 9:55 AM, in Storage Room 2522 of the Surgery Department, there was a storage rack with bags of LMA's. The lower shelf of the rack was approximately 1 inch from the floor, and had two bags with LMA's inside. There was one LMA out of the bag, laying on the floor. The CSS verified the findings, and stated "Anesthesia stores things in here." The CSS then said those items should not be used if on the floor..."

The hospital policy and procedure titled "Event Related Sterilization" dated 7/2014, indicated "G. 1. The supplies will be stored on carts or cupboards that are at least 8 inches from the floor..."

9. During an observation with the CSS, on 5/31/16, at 9:40 AM, in Central Processing, there were three instrument carts with instrument trays on them. Two carts had been processed (autoclaved machine for steam sterilization) and one cart was not processed. One cart had a sign that read "Go Instruments have been processed", and the other two carts did not have signs.

During an interview with the CSS, on 5/31/16, at 9:47 AM, she verified the findings and stated "They should all have signs on them."

During an interview with Central Supply Associate (CSA) 2, on 5/31/16, at 9:50 AM, she was asked about the carts, and stated (while pointing to the processed and unprocessed carts) "That one should've had a sign on it, and that one."

The hospital Plan of Correction with completion date of 1/20/16, indicated "The following has been implemented and OR staff educated on 10/22/15 1. All sterile processing carts in the sterile processing room will have a sign on them that states either "Instruments are not processed" of [sic] "Instruments are processed and ready for use."

The hospital Education Report Form with course titled "Corrective Action for Sterile Tray Security" dated 10/22/15 had instructions to "Place...and signature in the appropriate boxes indicating your attendance or receipt of education." There was a signature from CSA 2 on the form.



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During an interview with the Director Environmental Services (DEVS), on 6/2/16, at 3:20 PM, he stated when cleaning the room of a patient infected with C-diff , the larger 8 x 11 inches bleach wipes should be used with the mop. The bleach wipes need to be replaced (on the mop head) several times when mopping a room as the floor needs to remain visibly wet for four minutes. He stated the procedure to prepare the mop for cleaning the room was to attach a blue microfiber pad to the mop and then four or five of the floor wipes would be wrapped around the mop head and the room was to be mopped in an "S" pattern. The DEVS brought in a 160-count pail of 7.5 inches by 15 inches of the bleach floor wipes and a mop to demonstrate. He unrolled three wipes and wrapped them around the mop head with the blue microfiber pad. The wipes were not secured to the mop or pad in any way. The three wipes left some areas of the microfiber pad exposed. The DEVS was unable to demonstrate the actual mopping technique.

The hospital training document "Eliminating C.Diff - Chemicals" used in a training session for housekeeping staff during 9/2015, indicated "Assemble mop or microfiber system and saturate with cleaning solution. Wring out until mop is just damp, not dripping."

The manufacturer's website for the bleach wipes in-service video (http://pdihc.com/all-resources), titled "Sani-Cloth Bleach Wipes Training For new hire training or yearly refresher education" dated 2016, indicated "The presaturated wipes have the correct amount of germicidal solution... The treated surface must remain wet for the full four minutes... Use additional wipes as needed to ensure continuous four minute wet contact time... Do not reuse the wipe."

3. During an observation on 5/31/16, at 10:05 AM, in OR 4, PSA 2, PSA 3 and PSA 4 were observed cleaning. The PSA's removed multiple cleaning wipes from the container without the canister dispensing top in place. The PSA's were not wearing eye protection and allowed their contaminated gloves to come in contact with the remaining clean wipes in the container. PSA's 2, 3 and 4 were observed to clean multiple surfaces without changing the wipes. One PSA cleaned the OR 4 overhead procedure lights, the operating table mattress and the operating table utilizing the same same bundle of cleaning wipes and did not re-moisten any surfaces.

During an interview with the Infection Control Coordinator (ICC), on 5/31/16, at 10:19 AM, when asked about cleaning multiple items with the same cleaning wipe, she stated "doubt they could maintain the wet time." She then said the cleaning wipes have a dwell time of two minutes.

The hospital document titled "Cleaning Basics Module 1" undated, indicated "Team members must wear masks, eye protection, and face shields when you might come in contact with splashes, ..."

The manufacturers website for the sanitizing wipes in-service video (http://pdihc.com/all-resources), titled "Super Sani-Cloth Wipes For new hire training or yearly refresher education" dated 2016, indicated "The presaturated wipes have the correct amount of germicidal solution... Always dispense wipes through the canister lid... Cup one hand over the opening halfway, with the other hand remove a wipe with a uniform pull, out and away from your face and eyes... The treated surface must remain wet for the full two minutes... Use additional wipes as needed to ensure continuous two minute wet contact time... Do not reuse the wipe."

The Centers for Disease Control and Prevention (CDC) document, "Guideline for Disinfection and Sterilization in Healthcare Facilities" dated 11/2008, indicated "The effective use of disinfectants is part of a multibarrier strategy to prevent health-care-associated infections... Studies also have shown that, in situations where the cleaning procedure failed to eliminate contamination from the surface and the cloth is used to wipe another surface, the contamination is transferred to that surface and the hands of the person holding the cloth."

The hospital policy and procedure titled "Cleaning Schedule for Patient Care Equipment" dated 10/2014, indicated "E. All personnel using disinfectants will wear appropriate personal protective equipment during the disinfectant use." Addendum A indicated "Bed/Mattressess... Use Hospital approved disinfectant solution (Super Sani-Cloth wipes). Contact time is 2 minutes."

4. During an observation on 5/31/16, at 10:05 AM, OR 4, a PSA was mopping the operating room floor. It was observed only the open areas of the floor were mopped. The operating room table was not moved to allow mopping underneath it and the wheels and casters of the furniture were not disinfected. After the mopping was completed, the staff left the operating room. The floor was visibly dry within six minutes.

During an interview with the ICC, on 5/31/16, at 10:19 AM, she said the floor drying in less than ten minutes "is a problem."

During an interview with the ICC, on 6/1/16, at 4:45 PM, she stated she was not aware the operating room table was not being moved to the side of the room during the between case cleaning."

During an interview with the DEVS, on 6/2/16, at 3:20 PM, he stated the process for mopping the floor was to use a microfiber mop in an "S" motion from one side to the other - move the table, clean the wheels and kick bucket. The floor should be wet for ten minutes.

The manufacturer's label for the HDQL floor cleaner indicated "Allow surface to remain wet for ten minutes."

The Association of Perioperative Registered Nurses (AORN) publication, "Guidelines for Perioperative Practice," dated 2016, indicated "Disinfectants should be applied and the reap-plied [sic] as needed, per manufacturers' instructions, for the dwell time required to kill..."

The hospital policy and procedure titled "Environmental Preparation and End of Case Clean-Up for the Operating Room and Procedure Rooms" dated 11/2013, indicated "The wheels and casters of furniture are pushed through detergents used for floor cleaning. Wet mop perimeter of room and move furniture to sides of room, replace furniture after moping. Move operating/procedure room table to side of room. Mop center of room and replace table in center of room under lights. Set and lock wheels. Wipe casters on equipment and table with damp cloth soaked in disinfecting solution."

5. During an observation on 5/31/16, at 10:11 AM, in OR 4, the Anesthesia Technician (AT) was observed cleaning the anesthesia equipment. The AT wiped down the equipment and disposed of the used breathing hoses, he removed his contaminated gloves, and put on clean gloves without cleaning his hands. The AT then opened a new package of breathing hoses, and attached them to the anesthesia machine.

During an interview with the ICC, on 5/31/16, at 10:19 AM, she stated he should have cleaned his hands between changing gloves.

During an interview with the AT, on 6/2/16, at 2:25 PM, he stated "I messed up, it won't happen again."

The AORN publication, "Guidelines for Perioperative Practice," dated 2016, indicated "A hand wash should be performed...before putting gloves on and after removing gloves..."

The hospital document titled "Cleaning Basics Module 1" undated, indicated "Hand hygiene must always be performed when you remove PPE [personal protective equipment e.g. gloves]."

The hospital policy and procedure titled "Hand Hygiene" dated 7/2015, indicated hands should be cleaned after contact with medical equipment in the immediate patient vicinity and after removing personal protective equipment, including gloves.

6. During an observation and concurrent interview with Registered Nurse (RN) 1, on 5/31/16, at 10:33 AM, the ureterorenofiberscope (an instrument used to look inside the urinary system) and the bronchoscope (an instrument used to look inside the lung's airways) in the Sterile Core (a clean storage area for surgery) were observed hanging in the storage cabinet with one end looped up, resembling the letter "J" and without protective devices on the scope tip. RN 1 said the scope was too long to be hung straight. The end would touch the bottom of the cabinet.

The hospital policy and procedure titled "Care and Sterilization of Flexible Endoscopes and Endoscope Accessories" dated 7/2014, indicated clean flexible endoscopes will be stored in a closed cabinet with adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet.

The Olympus training DVD title "Bronchoscope Reprocessing" dated 2016, indicated "Wet equipment promotes the growth of microorganisms, and presents an infection control risk... The distal tip should hang freely with the insertion tube as straight as possible."

The Olympus Instruction Manual for the Ureterorenofiberscope, undated, indicated "Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion tube hangs vertically and as straight as possible."

The CDC document titled "Guidelines for Disinfection and Sterilization in Healthcare facilities" dated 2008, indicated "...endoscopes are to be stored in a way that prevents recontamination and promotes drying (e.g., hung vertically)."

The AORN publication, "Guidelines for Perioperative Practice" dated 2016, indicated "Endoscopes should be stored in a closed cabinet with...adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet...hanging in a vertical position...with scope protectors applied...When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination."