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Based on observation, interview and record review, the facility failed to ensure the quality improvement projects conducted met the scope and complexity of the services provided. This resulted in the high level disinfection process, to include quality control monitoring, occurring incorrectly per facility policy and procedure in three out of three departments observed.

Findings:

The following observations, interviews and record reviews were done in the Gastrointestinal Laboratory (GI Lab), Radiology Department, and Perinatal Unit:

a. On January 7, 2015, at 8:50 a.m., a tour of the Gastrointestinal Laboratory (GI Lab) was conducted.

During a concurrent interview with Medical Assistant (MA) 1, she stated the GI Lab had eight (8) bins/machines that were used to perform the high level disinfection process of the flexible endoscopes with the "MetriCide OPA" solution. MA 1 stated the eight bins/machines were tested each morning with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level. MA 1 stated if the level/volume of solution in the machine was low, more solution was added. She stated the Medical Assistants worked Monday through Friday, and the Licensed Vocational Nurses (LVN)/GI Technicians (GI Tech) worked holidays and weekends. MA 1 stated the LVN/GI Tech should perform the quality control on the disinfecting solution for each bin/machine they used on a holiday or weekend.

On January 7, 2015, the "Non-Biological Monitoring of MetriCide Solution" documents/logs dated December 26, 2014, through January 7, 2015, for bins/machines one through eight, were reviewed.

The "Non-Biological Monitoring of MetriCide Solution" logs indicated bins/machines one through eight were "not used" and not tested with a non-biological monitor strip, which ensured the concentration of the disinfecting solution was at a satisfactory level, on January 1, 2, 3, and 4, 2015.

The GI Lab procedure/case review indicated five procedures were performed on January 2, 2015, three procedures were performed on January 3, 2015, and two procedures were performed on January 4, 2015.

During an interview with LVN/GI Tech 1, on January 7, 2015, at 9:40 a.m., she stated she worked on January 2, 3, and 4, 2015, and GI procedures were performed, flexible endoscopes were cleaned and high level disinfection was done. LVN/GI Tech 1 stated the bins/machines used to disinfect the scopes should be tested daily with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level. She stated she did not test the bins/machines she used to disinfect the flexible endoscopes on January 2 and 4, 2015. LVN/GI Tech 1 stated she tested the bins/machines used on January 3, 2015, but did not document the results and did not remember which bins/machines she had used. LVN/GI Tech 1 stated the bins/machines should be tested daily, when used, to ensure the concentration of the disinfecting solution was at a satisfactory level.

During an interview with LVN/GI Tech 2, on January 7, 2015, at 10:15 a.m., she stated she worked on January 1, 2015, and the GI Lab performed four cases. LVN/GI Tech 2 stated the high level disinfecting solution in the bins/machines should be tested daily with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level and the results should be documented on the logs.

There was no documented indication the bins/machines used to perform the high level disinfection of the flexible endoscopes were tested with a non-biological monitor strip, to ensure the concentration of the disinfecting solution was at a satisfactory level, on January 1 through 4, 2015, when the bins/machines were used to disinfect flexible endoscopes.

The facility policy and procedure titled "Program-wide Scope Reprocessing Competency Package" revised December 2014, revealed "... Record high level disinfectant concentration monitoring results before each use in logbook. ... Test the high-level disinfectant solution before each use to be sure it is above the minimum effective concentration level. Log results ..."

During an interview with the Director Perinatal Services (DPS) and Director GI Laboratory (DGIL), on January 7, 2015, at 9:30 a.m., they reviewed the "Non-Biological Monitoring of MetriCide Solution" logs and were unable to find documentation of the bins/machines being tested "with each use" with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level. They stated monitoring, to ensure the concentration of the disinfecting solution was at a satisfactory level, was not being done per facility policy and procedure.

b. During an observation of the Radiology Department, on January 8, 2015, at 8:45 a.m., a wall mounted soak station was observed. The soak station was enclosed to provide protection from fumes. Three containers, were fully enclosed in the soak station. Taped to the outside of the soak station was the date the solution was placed in the container, and the date the solution expired.

During an interview with the Lead Sonographer (Lead) on January 8, 2015, at 8:50 a.m., the Lead stated that following the use of an endovaginal (enters the vagina) ultrasound probe, it was rinsed with water, placed (immersed) in one of the containers of Cidex OPA (a high level disinfectant) for 12 minutes, rinsed and dried. The Lead stated each of the two containers of Cidex OPA were tested daily for appropriate concentration of the solution.

The "Cidex OPA Non-Biological Monitoring Log," was reviewed with the Director of Radiology and the Lead Sonographer, on January 8, 2015. The form contained spaces to document the date, time, probe or scope serial number, test strip lot number and expiration date, test results and initials of the person performing the test. In addition, in bold type the following instruction was written: "TEST SOLUTION PRIOR TO EACH IMMERSION." There was no documentation for January 1 and 5, 2015.

During a concurrent interview with the Lead Sonographer, the Lead Sonographer stated testing was done daily, including holidays. The Lead stated the facility was open and performing ultrasounds on January 1 and 5, 2015. The Lead stated there was no documentation of testing on January 1 and 5, 2015, and she did not know why it was not done. The Lead stated the documentation in these logs was reviewed monthly and reported to the Infection Control Manager. If there were no results documented for a day, the day was reported as a "fail." Further review of the December "Cidex OPA Non-Biological Monitoring Log," indicated test results for December 1, 3, and 14, 2014, were not documented.

A document titled "High-Level Disinfection (Cidex OPA)," was reviewed with the Director of Radiology and the Lead Sonographer. According to the document "3. Check Cidex OPA solution before each use with a Cidex OPA Test Strip dipped into the solution for 1 second." During a concurrent interview, the Lead stated, "Before each use meant, to test the solution daily before the use for the day."

Further review of the "Cidex OPA Non-Biological Monitoring Log," revealed there was no documentation the concentration of the solution was tested prior to immersion of the probe.

The facility policy and procedure titled "Ultrasonic (Vaginal Probe) Disinfection," with a last revised date of March 2012, was reviewed. The policy indicated: "...Vaginal probes are used in sonographic scanning...because condoms/probe covers can fail, the probe also should be high level-disinfected...Disinfection solution concentration should be tested prior to each immersion..."

A review of the Lead Sonographer's "Ultrasound Transducer (Vaginal Probe) Pre-Cleaning and High-Level Disinfection Use, Handling and Disposal of Cidex OPA," staff competency check list was conducted. According to the document: "Test Cidex OPA solution for minimum effective concentration (this should be done before each immersion of probe)."

c. On January 6, 2015, at 9:40 a.m., an observation in the Perinatal Unit dirty utility rooms was conducted with Registered Nurse (RN) 6 and Scrub Technician (Scrub Tech) 2.

An ultrasonic vaginal probe disinfection station was established in each of the two dirty utility rooms. The station consisted of three cylinders of solution enclosed in a cabinet mounted on the wall of the dirty utility room.

During a concurrent interview with Scrub Tech 2, she stated the high level disinfectant "Cidex OPA" was in the first cylinder, the concentration of the solution was checked daily with a test strip, and the vaginal probe was placed in the high level disinfectant for 12 minutes. Scrub Tech 2 stated the remaining two cylinders contained tap water. The tap water was used as a water rinse for the vaginal probes and the water was changed daily. She stated the vaginal probes were then rinsed in the dirty utility room sink, wiped off with a sani-cloth, dried, and placed in a clear plastic patient care belongings bag with the date cleaned. Scrub Tech 2 stated no log was maintained as to which vaginal probe had been cleaned when and which vaginal probe had been used on the specific patient. She stated the Perinatal Unit had at least four probes and several vaginal probes could be disinfected each day depending on the use.

In addition, Scrub Tech 2 and RN 6 stated there was no clock/timer in the dirty utility room and they used there own watches to determine the 12 minutes for the soaking of the vaginal probe in the high level disinfectant solution.

The Perinatal Unit "Cidex OPA Non-Biological Monitoring Log(s)" were reviewed on January 6 and 7, 2015.

There was no indication the two cylinders of rinse water were replaced after each use/high level disinfection process.

There was no indication the high level disinfection solution concentration was tested prior to each immersion of a vaginal probe.

There was no indication as to the identification of which of the vaginal probes was being disinfected by the recording of the serial number/assigned number to a specific probe.

During an interview with the Director Perinatal Services (DPS), on January 7, 2015, at 9:30 a.m., she stated the facility policy and procedure for the high level disinfection of vaginal probes should be followed to include the monitoring of the disinfection solution concentration with each immersion, the changing of the rinse water after each disinfection process, and the recording of the serial number/assigned number of each probe being disinfected on the "Cidex OPA Non-Biological Monitoring Log."

The facility policy and procedure titled "Ultrasonic (Vaginal) Probe Disinfection" revised March 2012, revealed "... Initial rinse: Remove probe from disinfecting cylinder and move to "rinse" cylinder. Leave in rinse cylinder for 30 sec(onds). Rinse water must be replaced after each use. ... Disinfection solution concentration should be tested prior to each immersion. ..."

The "Cidex OPA Non-Biological Monitoring Log" revised February 2012, revealed "Test Solution Prior to Each Immersion" and the "Probe or Scope Serial number" was to be recorded.

On January 7, 2015, at 2:20 p.m., an interview was conducted with the Infection Control Manager (ICM). When asked what quality improvement projects the GI Lab was conducting, the ICM stated she received data on the high level disinfection process using a Cidex OPA solution in an automated system but was not sure what data was collected. The ICM stated the Education Department provided the staff education on the use of the Cidex solution.

On January 8, 2015, the "Disinfection Sterilization Report 2014" submitted by Infection Control listed the departments who used a high level disinfection solution each month. The GI Laboratory, Radiology Department, and Perinatal Unit were listed as departments who used a high level disinfecting solution.

There was no indication a quality improvement project was being conducted by the facility in regards to the use of high level disinfectants.

On January 8, 2015, at 10:50 a.m., an interview was conducted with the Director Quality/Risk Management (DQRM). When asked what quality improvement projects the GI Lab was conducting, the DQRM stated the only data presented by the GI Lab was for "Procedural Sedation Fall-Out Report" which was a facility wide performance improvement project.

Based on observation, interview, and record review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures; nationally recognized infection control practices and guidelines; and applicable regulations, when:

1. The quality control testing of the high level disinfectant solution for the flexible endoscopes was not completed according to the facility policy and procedure;

2. High level disinfection of sonographic probes was not completed according to the facility policy and procedure;

3. Prior to the first surgical procedure of the day, the Operating Rooms (ORs) horizontal surfaces were not damp dusted with a lint-free cloth and approved disinfectant;

4. The Sterile Processing Department (SPD) decontamination temperature was not maintained at an acceptable level per facility policy and procedure for 25 consecutive days;

5. For one employee (Scrub Technician 2), the annual "Alternative Respirator Medical Evaluation Questionnaire" and "N95 Respirator Training and Fit Test Record" were not completed in 2013 and 2014;

6. Laboratory Technician (Lab Tech ) 1 failed to perform Hand Hygiene after removing her gloves;

7. Visitors were observed in isolation rooms without the required personal protective equipment (PPE); and

8. The daily smoke test visualization of a negative pressure room was not conducted on January 4, 2015.

Findings:

1. On January 7, 2015, at 8:50 a.m., a tour of the Gastrointestinal Laboratory (GI Lab) was conducted.

During a concurrent interview with Medical Assistant (MA) 1, she stated the GI Lab had eight (8) bins/machines that were used to perform the high level disinfection process of the flexible endoscopes with the "MetriCide OPA" solution. MA 1 stated the eight bins/machines were tested each morning with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level. MA 1 stated if the level/volume of solution in the machine was low, more solution was added. She stated the Medical Assistants worked Monday through Friday, and the Licensed Vocational Nurses (LVN)/GI Technicians (GI Tech) worked holidays and weekends. MA 1 stated the LVN/GI Tech should perform the quality control on the disinfecting solution for each bin/machine they used on a holiday or weekend.

On January 7, 2015, the "Non-Biological Monitoring of MetriCide Solution" documents/logs dated December 26, 2014, through January 7, 2015, for bins/machines one through eight, were reviewed.

The "Non-Biological Monitoring of MetriCide Solution" logs indicated bins/machines one through eight were "not used" and not tested with a non-biological monitor strip, which ensured the concentration of the disinfecting solution was at a satisfactory level, on January 1, 2, 3, and 4, 2015.

The GI Lab procedure/case review indicated five procedures were performed on January 2, 2015, three procedures were performed on January 3, 2015, and two procedures were performed on January 4, 2015.

During an interview with LVN/GI Tech 1, on January 7, 2015, at 9:40 a.m., she stated she worked on January 2, 3, and 4, 2015, and GI procedures were performed, flexible endoscopes were cleaned and high level disinfection was done. LVN/GI Tech 1 stated the bins/machines used to disinfect the scopes should be tested daily with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level. She stated she did not test the bins/machines she used to disinfect the flexible endoscopes on January 2 and 4, 2015. LVN/GI Tech 1 stated she tested the bins/machines used on January 3, 2015, but did not document the results and did not remember which bins/machines she had used. LVN/GI Tech 1 stated the bins/machines should be tested daily, when used, to ensure the concentration of the disinfecting solution was at a satisfactory level.

During an interview with LVN/GI Tech 2, on January 7, 2015, at 10:15 a.m., she stated she worked on January 1, 2015, and the GI Lab performed four cases. LVN/GI Tech 2 stated the high level disinfecting solution in the bins/machines should be tested daily with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level and the results should be documented on the logs.

There was no documented indication the bins/machines used to perform the high level disinfection of the flexible endoscopes were tested with a non-biological monitor strip, to ensure the concentration of the disinfecting solution was at a satisfactory level, on January 1 through 4, 2015, when the bins/machines were used to disinfect flexible endoscopes.

The facility policy and procedure titled "Program-wide Scope Reprocessing Competency Package" revised December 2014, revealed "... Record high level disinfectant concentration monitoring results before each use in logbook. ... Test the high-level disinfectant solution before each use to be sure it is above the minimum effective concentration level. Log results ..."

During an interview with the Director Perinatal Services (DPS) and Director GI Laboratory (DGIL), on January 7, 2015, at 9:30 a.m., they reviewed the "Non-Biological Monitoring of MetriCide Solution" logs and were unable to find documentation of the bins/machines being tested "with each use" with a non-biological monitor strip to ensure the concentration of the disinfecting solution was at a satisfactory level. They stated monitoring, to ensure the concentration of the disinfecting solution was at a satisfactory level, was not being done per facility policy and procedure.

2a. During an observation of the Radiology Department, on January 8, 2015, at 8:45 a.m., a wall mounted soak station was observed. The soak station was enclosed to provide protection from fumes. Three containers, were fully enclosed in the soak station. Taped to the outside of the soak station was the date the solution was placed in the container, and the date the solution expired.

During an interview with the Lead Sonographer (Lead) on January 8, 2015, at 8:50 a.m., the Lead stated that following the use of an endovaginal (enters the vagina) ultrasound probe, it was rinsed with water, placed (immersed) in one of the containers of Cidex OPA (a high level disinfectant) for 12 minutes, rinsed and dried. The Lead stated each of the two containers of Cidex OPA were tested daily for appropriate concentration of the solution.

The "Cidex OPA Non-Biological Monitoring Log," was reviewed with the Director of Radiology and the Lead Sonographer, on January 8, 2015. The form contained spaces to document the date, time, probe or scope serial number, test strip lot number and expiration date, test results and initials of the person performing the test. In addition, in bold type the following instruction was written: "TEST SOLUTION PRIOR TO EACH IMMERSION." There was no documentation for January 1 and 5, 2015.

During a concurrent interview with the Lead Sonographer, the Lead Sonographer stated testing was done daily, including holidays. The Lead stated the facility was open and performing ultrasounds on January 1 and 5, 2015. The Lead stated there was no documentation of testing on January 1 and 5, 2015, and she did not know why it was not done. The Lead stated the documentation in these logs was reviewed monthly and reported to the Infection Control Manager. If there were no results documented for a day, the day was reported as a "fail." Further review of the December "Cidex OPA Non-Biological Monitoring Log," indicated test results for December 1, 3, and 14, 2014, were not documented.

A document titled "High-Level Disinfection (Cidex OPA)," was reviewed with the Director of Radiology and the Lead Sonographer. According to the document "3. Check Cidex OPA solution before each use with a Cidex OPA Test Strip dipped into the solution for 1 second." During a concurrent interview, the Lead stated, "Before each use meant, to test the solution daily before the use for the day."

Further review of the "Cidex OPA Non-Biological Monitoring Log," revealed there was no documentation the concentration of the solution was tested prior to immersion of the probe.

The facility policy and procedure titled "Ultrasonic (Vaginal Probe) Disinfection," with a last revised date of March 2012, was reviewed. The policy indicated: "...Vaginal probes are used in sonographic scanning...because condoms/probe covers can fail, the probe also should be high level-disinfected...Disinfection solution concentration should be tested prior to each immersion..."

A review of the Lead Sonographer's "Ultrasound Transducer (Vaginal Probe) Pre-Cleaning and High-Level Disinfection Use, Handling and Disposal of Cidex OPA," staff competency check list was conducted. According to the document: "Test Cidex OPA solution for minimum effective concentration (this should be done before each immersion of probe)."


b. On January 6, 2015, at 9:40 a.m., an observation in the Perinatal Unit dirty utility rooms was conducted with Registered Nurse (RN) 6 and Scrub Technician (Scrub Tech) 2.

An ultrasonic vaginal probe disinfection station was established in each of the two dirty utility rooms. The station consisted of three cylinders of solution enclosed in a cabinet mounted on the wall of the dirty utility room.

During a concurrent interview with Scrub Tech 2, she stated the high level disinfectant "Cidex OPA" was in the first cylinder, the concentration of the solution was checked daily with a test strip, and the vaginal probe was placed in the high level disinfectant for 12 minutes. Scrub Tech 2 stated the remaining two cylinders contained tap water. The tap water was used as a water rinse for the vaginal probes and the water was changed daily. She stated the vaginal probes were then rinsed in the dirty utility room sink, wiped off with a sani-cloth, dried, and placed in a clear plastic patient care belongings bag with the date cleaned. Scrub Tech 2 stated no log was maintained as to which vaginal probe had been cleaned when and which vaginal probe had been used on the specific patient. She stated the Perinatal Unit had at least four probes and several vaginal probes could be disinfected each day depending on the use.

In addition, Scrub Tech 2 and RN 6 stated there was no clock/timer in the dirty utility room and they used there own watches to determine the 12 minutes for the soaking of the vaginal probe in the high level disinfectant solution.

The Perinatal Unit "Cidex OPA Non-Biological Monitoring Log(s)" were reviewed on January 6 and 7, 2015.

There was no indication the two cylinders of rinse water were replaced after each use/high level disinfection process.

There was no indication the high level disinfection solution concentration was tested prior to each immersion of a vaginal probe.

There was no indication as to the identification of which of the vaginal probes was being disinfected by the recording of the serial number/assigned number to a specific probe.

During an interview with the Director Perinatal Services (DPS), on January 7, 2015, at 9:30 a.m., she stated the facility policy and procedure for the high level disinfection of vaginal probes should be followed to include the monitoring of the disinfection solution concentration with each immersion, the changing of the rinse water after each disinfection process, and the recording of the serial number/assigned number of each probe being disinfected on the "Cidex OPA Non-Biological Monitoring Log."

The facility policy and procedure titled "Ultrasonic (Vaginal) Probe Disinfection" revised March 2012, revealed "... Initial rinse: Remove probe from disinfecting cylinder and move to "rinse" cylinder. Leave in rinse cylinder for 30 sec(onds). Rinse water must be replaced after each use. ... Disinfection solution concentration should be tested prior to each immersion. ..."

The "Cidex OPA Non-Biological Monitoring Log" revised February 2012, revealed "Test Solution Prior to Each Immersion" and the "Probe or Scope Serial number" was to be recorded.

3. On January 7, 2015, at 12:15 p.m., Environmental Services Staff 1 was observed cleaning the Operating Room (OR) following a scheduled cesarean section (abdominal birth of an infant).

During an interview with Environmental Services Staff 1, on January 7, 2015, at 12:30 p.m., she stated Environmental Services was not responsible for the damp dusting of all horizontal surfaces in the OR before the first procedure of the day.

On January 8, 2015, at 8:35 a.m., a tour of Surgical Services was conducted.

During an interview with OR Technician (OR Tech) 1, on January 8, 2015, at 9 a.m., she stated Surgical Services had seven ORs and a minor procedure room. OR Tech 1 stated Environmental Services terminally cleaned ORs 2 through 5 on the P.M. shift and ORs 1, 6, 7 and the minor procedure room on the night shift. She stated she worked the night shift with a Registered Nurse, and her job duties included performing surgical cases, checking for outdates, pulling case preferences and getting cases ready for the day shift. OR Tech 1 stated it was not part of her job duties to damp dust all horizontal surfaces in the OR before the first procedure of the day.

During an interview with the Assistant Clinical Manager Perioperative Services (ACMPOS), on January 8, 2015, at 9:10 a.m., she stated the horizontal surfaces in the ORs were not damp dusted before the first procedure of the day using a clean, lint-free cloth and EPA-registered hospital detergent/disinfectant. The ACMPOS stated they did not follow the facility policy and procedure for cleaning the ORs which included damp dusting before the first scheduled procedure of the day.

The facility policy and procedure titled "Cleaning the Operating Room" reviewed March 2014, revealed "... Prior to the first scheduled procedure of the day, all horizontal surfaces, including overhead lights will be damp dusted. ..."

4. On January 6, 2015, at 1:30 p.m., a tour of the Sterile Processing Department (SPD) decontamination area was conducted with Sterile Processing Technician (SPT) 1.

The temperature gauge on the wall of the SPD decontamination room indicated the current room temperature was 70?F (degrees Fahrenheit).

During a concurrent interview with SPT 1, she stated the temperature and humidity, of the SPD decontamination room, were read and recorded at the start of the day by the day shift SPT. SPT 1 stated the temperature in the room was high and had been reported to the Engineering Department on multiple occasions through the facility's electronic work order system.

The "SPD Cleaning Schedule - Decon" indicated the temperature of the decontamination room was 70?F from December 13, 2014, through January 6, 2015 (25 consecutive days).

The "Detailed Requested Work Order Report" for December 1 through 31, 2014, indicated a request for service of the out of range temperature in the SPD decontamination room had been initiated for 21 out of 31 days in the month of December 2014.

During an interview with the Director Technical Services (DTS), on January 7, 2015, at 3:50 p.m., he reviewed the temperature log from the SPD decontamination room and verified the documentation indicated the SPD decontamination room had been out of temperature compliance since December 13, 2014. The DTS stated the Engineering Department had received work orders for the out of range temperature.

During a subsequent interview with the DTS, on January 8, 2015, at 11 a.m., he stated the Sterile Processing Department was "on the radar for a new design and upgrade" to the temperature and humidity system in the SPD area and this was a future project.

The facility policy and procedure titled "Temperature and Humidity, Monitoring of" reviewed October 2014, revealed " ... Decontamination temperature is 60?F to 65?F. ... Plant Facilities Department in collaboration with the Director of Perioperative Services or designee is responsible to ensure that the temperature and humidity levels are maintained within the appropriate range. ..."

5. On January 8, 2015, the employee file for Scrub Technician (Scrub Tech) 2 was reviewed with the Employee Health Manager (EHM).

Scrub Tech 2 was hired on January 2, 2006. Scrub Tech 2's Annual Health Screening was completed on September 22, 2014.

The annual "N95 Respirator Training and Fit Test Record" and "Alternative Respirator Medical Evaluation Questionnaire" was last completed on July 3, 2012.

There was no indication the annual "N95 Respirator Training and Fit Test Record" and "Alternative Respirator Medical Evaluation Questionnaire" had been completed for 2013 and 2014.

During an interview with the EHM, on January 8, 2015, at 12:30 p.m., she reviewed the employee file for Scrub Tech 2 and was unable to find documentation of the annual "N95 Respirator Training and Fit Test Record" and "Alternative Respirator Medical Evaluation Questionnaire" since July 3, 2012. The EHM stated Scrub Tech 2 should have completed the annual questionnaire and been Fit tested in 2013 and 2014.

The facility "Aerosol Transmissible Diseases Includes Tuberculosis Exposure Control Plan" reviewed November 2014, revealed "... After being fit tested at time of hire, employees must complete an annual questionnaire within 12 months of being fit-tested, review and sign provided educational material. ... EHS (Employee Health Services) will be responsible for informing managers when the annual questionnaire is due for their employees. ..."



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6. During an observation on January 6, 2015, at 10:50 a.m., Lab Tech 1 was observed in Patient 14's room. While wearing gloves, Lab Tech 1, obtained a blood specimen using a small needle placed into Patient 14's arm. At the conclusion of the blood draw, while still wearing the gloves she wore for the lab draw, Lab Tech 1 carried several small vials of blood, turned off the room light, exited Patient 14's room, and placed the vials of blood on a portable cart. Still wearing the gloves, Lab Tech 1 picked up a small hand held computer and used the computer to print labels for the vials. Lab Tech 1 held both the small computer and the printer with her gloved hands. Lab Tech 1 concluded what she was doing with Patient 14's specimens then removed her gloves and performed hand hygiene using hand gel located outside Patient 14's room.

During an interview with Lab Tech 1, on January 6, 2015, at 10:55 a.m., Lab Tech 1 stated she would need to wipe off the equipment she touched with her gloved hands.

On January 6, 2015, at 11 a.m., Physician A (who had just exited from Patient 14's room), came to the charge nurse and instructed her that Patient 14 would need to be placed in a private room, in isolation, as the patient was experiencing loose stools.

The facility policy and procedure titled, "Hand Hygiene," with a last reviewed date of December 2014, indicated all personnel who provide "hands-on" patient care were required to be compliant with all hand hygiene requirements. The policy indicated, "..microorganisms proliferate on the hands within the moist environment of gloves. ... The Centers for Disease Control and Prevention states that hand hygiene is the single most important procedure for preventing health-care acquired infections. ... Hand decontamination with alcohol based degermer (gel, rinse or foam) is the preferred method of hand hygiene for all situations as defined below unless hands are visibly soiled or patient has Clostridium difficile (an infection of the bowel that causes loose/watery stools). ... All personnel and providers must perform hand hygiene according to the World Health Organizations Five Moments for Hand Hygiene defined as:

-Before patient contact,
-Before an aseptic task (i.e. Foley catheter insertion)
-After body fluid exposure
-After patient contact
-After contact with patient surroundings..."

Further review of the World Health Organizations Five Moments for Hand Hygiene indicated "Clean your hands immediately after an exposure risk to body fluids (and after glove removal)."

7. The facility's policy and procedure titled, "Expanded Precautions," with a last reviewed date of December 2014, was reviewed. The policy indicated, "Expanded Precautions," were to be used in addition to "Standard Precautions," for patients with a confirmed clinical syndrome or a specific diagnosis. The policy indicated "Attach the Precaution Sign outside the patient's room (on the door frame) so that it is visible before entering the room. ... Instruct visitors and ancillary health care workers regarding appropriate precautions, as necessary. ..."

a. On January 6, 2015, at 9:15 a.m., a tour of 5 West (24 bed telemetry unit) was conducted. A sign posted on the door frame, outside room 5111 indicated "Droplet Precautions," were required. The sign indicated visitors were to report to the nurses station before entering. The sign indicated a mask and gloves were required "(whether or not contact with the patient or environment is anticipated)." Patient 31, was observed in bed, in the room. A visitor was at the patient's bedside, wearing a mask, but no gloves.

The facility policy titled, "Expanded Precautions," with a last reviewed date of December 2014, was reviewed. The policy indicated "Droplet Precautions prevent transmission of microorganisms...are produced when the patient talks, coughs, or sneezes. ... Droplet precautions require...change gloves after having contact with infective material, and remove when leaving the patients' environment. ... Droplet precautions are indicated for...influenza...from an infected or colonized patient through direct (touching the patient) or indirect (touching surfaces or objects in the environment) contact."

During an interview with the Director of 5 West, on January 6, 2015, at 9:30 a.m., he observed Patient 31's visitor was not wearing gloves and addressed it with the visitor.

b. On January 6, 2015, at 11:30 a.m., a tour of 4 West (24 bed Medical Surgical unit) was conducted. A sign posted on the door frame, outside room Patient 4's room indicated "Contact Precautions" were required. The sign indicated visitors were to report to the nurses station before entering, and gown and gloves were required "(whether or not contact with the patient or environment is anticipated)." Patient 4 was observed in bed, undergoing hemodialysis. The dialysis nurse, at the patient's bedside, was wearing a gown and gloves. Two visitors at the patient's bedside were wearing yellow isolation gowns, but were not wearing gloves.

During an interview with Family Member 1, on January 6, 2015, at 11:40 a.m., the family member stated he had been told about the requirement for gloves, but "we live with him and choose to ignore it."

The facility policy titled, "Expanded Precautions," with a last reviewed date of December 2014, was reviewed. The policy indicated "Contact precautions prevent transmission of epidemiological important organisms from an infected or colonized patient through direct (touching the patient) or indirect (touching surfaces or objects in the environment) contact." According to the policy Contact Precautions required: "Wear gloves when entering the room."

During an interview with the Director of 4 West, on January 6, 2015, at 11:30 a.m., the Director stated Patient 4 was in isolation for an infection, and family members should be wearing gloves when entering the room.

8. On January 6, 2015, at 10:30 a.m., a tour of 5 East (24 bed Medical Surgical unit) was conducted. Two signs were posted on the door frame, outside room 5303. One indicated "Airborne Precautions" and the other indicated "Contact Precautions." The door to room 5303 was closed and a portable cart with PPE was located nearby. A green light was illuminated on a digital monitor located right outside the room.

Registered Nurse (RN) 4 was observed donning PPE, including a N95 mask (a device with a filter efficiency of 95 %, used for protection against airborne particles), in preparation for entering the room. RN 4 stated she had been "fit tested" (assessed for the adequacy of mask to the individual) and wore a small N95 mask when entering Patient 1's room.

During an interview with the Clinical Manager of 5 East, on January 6, 2015, at 10:40 a.m., the Clinical Manager stated room 5303 was one of the facilities negative pressure rooms. (Negative air pressure rooms are those rooms where the air pressure in the room was lower than adjacent areas, which kept air from flowing out of the containment room and into adjacent rooms or areas). The Clinical Manager stated engineering checked the negative pressure of Room 5303 daily when the room was occupied. The Clinical Manager stated that an engineer had just been there and conducted a "powder (smoke) test." The Clinical Manager stated if abnormalities were seen during the test, the engineer would let staff know.

On January 6, 2015, at 10:45 a.m., the Director Technical Services was interviewed. The Director stated the negative pressure rooms were checked daily, when occupied by a patient requiring isolation. The Director stated staff would perform a "smoke" test to verify the digital readings. The log sheets used to document the smoke test were reviewed with the Director. The Director stated there was no documentation for a test conducted on January 1 and 4, 2015. The Director stated a visual check was required "to be sure the negative air pressure existed."

A second interview was conducted with the Director Technical Service on January 7, 2015, at 10:30 a.m. The Director found documentation for the smoke test conducted on January 1, but could not find any documentation for January 4, 2015. The Director stated the room should have undergone a daily visual check for negative air pressure.

A review of Patient 1's record indicated the patient was being treated for active tuberculosis (a contagious disease caused by Mycobacterium tuberculosis). Physician orders included "Airborne and Contact Precautions."

The facility policy and procedure titled, "Aerosol Transmissible Diseases Includes Tuberculosis Exposure Control Plan," with a last reviewed date of November 2014, was reviewed. The policy indicated "Ensure daily checks of airborne infection isolation rooms for negative pressure while room is occupied using a smoke test or other method that allows visual confirmation of negative pressure. Method must be independent of room pressure monitoring system...Negative pressure must be checked daily using smoke trails or an equally effective means of visually confirming negative pressure while the AIIR (airborne infection isolation room) or area is occupied by a suspect or confirmed patient."