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Based on document review, observation and interview, it was determined that the Hospital failed to ensure its Infection Control Program effectively monitored, tracked, and acted upon high rates of nosocomial infections to reduce and/or prevent the cross contamination of infectious organisms. As a result, the Condition of Participation 42 CFR 482.42 Infection Control was not met.

Findings include:

1. The Hospital failed to ensure staff adherence to surgical attire policy. (A-748)

2. The Hospital failed to investigate and act upon the high rates of the nosocomial infection to reduce and/or prevent the risk and cross contamination of infectious organisms. (A-749A)

3. The Hospital failed to ensure staff fingernails were maintained as required. (A-749B)

4. The Hospital failed to ensure specimens were contained in a manner to minimize the risk of cross contamination as required. (A-749C)

5. The Hospital failed to ensure the linen was stored as required. (A-749D)

6. The Hospital failed to ensure direct patient care staff were fit tested as required. (A-749E)

Based on document review, observation and interview, it was determined that for 5 of 5 staff (E #2, #3, #4, #10 and MD #1) observed for surgical attire, the Hospital failed to ensure staff adherence to surgical attire as required.

Findings include:

1. Policy entitled "Operating Room Attire" (revised 10/15) indicated " Personal Protective Equipment...9. All possible head and facial hair including sideburns, beard...should be covered when in a semirestricted and restricted area of the surgical suite."

2. On 3/22/17, during an observational tour from 9:30 AM to 10:30 AM of the Surgical Department, the following was observed in Operating Room (OR) 10:
-Two Registered Nurses (E #2 and #3) had approximately 1 inch of exposed hair from thieir surgical caps, in the neck area.
- The Certified Nurse Anesthetist (E #4) had a mask; however, his sideburns were exposed.
-The Physician (MD #1) had a maskl; however, the beard was exposed.
- The Quality Coordinator (E #10) entered the sterile corridor and remained outside of OR 10 with a mask that covered the nose and mouth; however, facial hair was exposed.

3. On 3/22/17 at approximately 10:30 AM the findings were discussed with the Manager of the Surgical Department (E #5). E #5 stated that it is the responsability of the staff to ensure the hair is contained underneath the surgical cap. E #5 stated that staff forget to readjust their surgical caps throughout the day. E #5 stated that the Hospital did not have the supply for the staff to contain facial hair, and as long as the mouth and nose are covered, it is acceptable.

A. Based on document review and interview, it was determined that the Hospital failed to investigate and acted upon the high rates of the nosocomial infection rates to reduce and/or prevent the risk and cross contamination of infectious organisms.

Findings include:

1. On 3/22/17 at approximately 2:00 PM, the Infection Control Minutes from 1/2015 to 12/2016 were reviewed for the nosocomial rates. The Hospital's goal for the CLABSI (Central Line-associated Blood Stream Infection) and CAUTI (Catheter-Associated Urinary Tract Infection) is 0 episodes. The quarterly reports for the months of 3/2016, 6/2016, 9/2016 and 12/2016 indicated that the Hospital had met their goal; however, in the analysis of the data per month, there were occasions that a CLABSI and CAUTI were identified. 10 total number of CLABSI and 46 CAUTI cases was documented from 1/2015 to 7/2016. Therefore, the Hospital's quarterly reports conflict with their monthly analysis of data. The Hospital's target/goal rate for the C. diff (Clostridium difficile) (Infection in the stool) data is a standardized Infection Ratio (SIR) goal of 0.41. The SIR for C. Diff was 1.065 for 3/2016, 0.616 for 6/2016, and 0.848 for 9/2016; therefore, the Hospital did not meet their target goal/rate for C. Diff. The total documented cases of Hospital acquired C. Diff for the 2016 year was 38 cases.

2. The Hospital is not able to provide an investigation report for the high nosocomial infection rate. The infection rate remains above the acceptable Hospital goals, and the Hospital is not able to provide evidence of interventions they implemented in an attempt to decrease their nosocomial infection rates (i.e. staff audits, in-services/training, or additional cultures of the environment to verify proper sanitation and disinfection).

3.On 3/23/17 at approximately 9:30 AM, the Infectious Disease Officer (E #1) stated that the Hospital nosocomial infection rate is high. E #1 stated she is the only ICO at the Hospital and that it is difficult to investigate and audit staff to determine the causes of cross contamination, resulting in high nosocomial infection rates. E #1 that stated her surveillance is mainly data driven from the laboratory results and the report that is submitted from the NHSN. (National Healthcare Safety Network.

B. Based on document review, observation, and interview, it was determined that for 1 of 1 Gastrointestinal (GI) Technician observed for infection control practices, the Hospital failed to ensure fingernails were maintained as required.

Finding include:

1. Policy entitled "Hand Hygiene/Handwashing Guidelines/ Artificial Nails" (revised 9/2015) indicated "B. Fingernails 1. Fingernails are be kept clean, well cared for and no longer than ¼ inch in length from finger tip ...4. Artificial nails are not permitted to be worn by those employees involved in direct patient care activities. Direct patient care providers include ...clean the patient environment. 5. Artificial nails include anything applied to the nail that is naturally occurring components of the nail. This includes but not limited to; ...overlays ..."

2. On 3/22/17 at approximately 11:00 AM to 11:20 AM an observation tour was conducted to the GI Lab and area designated for the cleaning of their scopes. The GI Technican (E #6) had artificial nails and nails that were more than ¼ inch from the fingertip.

3.On 3/22/17 at approimately 11:30 AM the aforementiond finding was discussed with the Manager of Surgical Serives (E #5). E #5 stated the use of artificial nails is prohibited.


C. Based on document review, observation and interview it was determined that 1 of 2 specimen collected, the Hospital failed to ensure the specimen was contained as required.

Findings include:

1. Policy entitled "Specimen Collection General Guidelines" dated 9/1/15 indicated "7. Transporting Specimens: All specimens submitted to the lab (laboratory) must be placed in biohazard bags with one patient per bag. (The Hospital) specimens should be sent to the lab via the pneumatic tube system or hand delivered to the specimen recieving area. Specimens should not be held but sent to the lab as soon as possible after collection...Specimens referred from outside the hospital must be placed in individual biohazard bags..."

2. On 3/22/17 at approximately 10:30 AM,an observational tour in the Surgical Department was conducted. A basin which held a white container (approximately 1 pint in size) was on to p of a grey care, in fron t of the surgical schedule board. The specimen was not in a biohazard bag.

3. On 3/22/17 at approximately 10:34 AM, the Manager of Surgical Serives (E #5) was interviewed. E #5 stated that the container in the basin contained a specimen that would to be sent to the pathology department. E #5 stated "that is usually how the specimens are kept (not in a bag), and the pathology department will be notified so they can come and pick it up. They (Pathology Department) will usually pick up the specimen shortly after they are notified. If not, then we take it the the laboratory."

D. Based on observation and interview it was determined the Hospital failed to ensure the linen was stored as required.

Findings include:

1. On 3/21/17 at approximately 2:00 PM, an observational tour was conducted to the designated area were the linen is stored. The following was observed in the clean storage area:

- Two carts that contained clean linen were covered, pending transport to patient units. However, there were blankets on top of the protective barrier of the carts.
-One container had fitted sheets without a protective barrier.
-Five uncovered linen carts contained gowns, blankets, bed sheets, and towels.
- One cart with scrubs was not covered.

2. On 3/21/17 at approximately 2:10 PM, the Enviromental Technician (E #7) was interviewed. E #7 stated that the linen in the containers are delivered in bags and there are times when the staff may break the bags, leaving the linen exposed inside of the container. E #7 stated that the carts in the clean linen room are ready to be delivered to the unit, including the carts that have blankets on top of the protective barrier.

3. On 3/21/17 at approximately 2:20 PM, the Director of Enviromental Services (E #8) was interviewed. E #8 stated that all clean linen must remain covered while in storage and during transport.

E. Based on interview and document review, it was determined for 7 of 7 inpatient units (Intensive Care Unit; Telemtery (11th floor); Medical/Surgical (9th floor); 7th floor; Mother/Baby Unit (3M/B); Special Care Unit (SCU); and Labor and Delivery) and 3 of 3 outpatient units (Emergency Department; GI Laboratory (GI Lab); Surgical Department; and Recovery Room) with negative pressure isolation rooms, that the Hospital failed to ensure all direct patient care staff wase fit tested as required, increasing the risk of respiratory cross contamination from staff to patients.

Findings include:

1. On 3/21/17 at approximately 11:00 AM, the Director of Quality and Patient Safety (E #9), stated that the Hospital does not have a policy on fit testing (respiratory mask) scheduled for the staff. E #9 stated it has been the Hospital practice to only perform a fit test upon hire, with the exception of the staff in the respiratory department, which is done annually.

2. On 3/23/17 at approximately 11:00 AM, the Infection Control Officer (E #1) presented a list of the negative pressure rooms available in the Hospital. There is a total of 21 negative pressure rooms in the multiple patient care units: 4-Emergency Department; 2-Intensive Care Unit; 4-Cardiac Care Unit; 2-Telemtery (11th floor); 2-Medical/Surgical (9th floor); 2-7th floor; 1-Mother/Baby Unit (3M/B); 1-Special Care Unit (SCU); 1-Labor and Delivery (L/D); 1-GI Laboratory (GI Lab); 1-Surgical Department (OR #10); and 1-Recovery Room.

A patient that requires placement on airborne precaution (negative pressure room) would be assigned to any of these rooms, putting staff at risk for respiratory cross contamination, due to the failure to perform fit-testing, as required.