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Based on observation, document review, staff interview and review of nationally recognized guidelines, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibility of the operation and management of the facility. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Condition of Participation:
482.42 Infection Control

Based on observation, document review, staff interview and review of nationally recognized guidelines, it was determined that the facility failed to ensure a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings include:

1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases, and failed to implement nationally recognized infection control guidelines. (Cross Refer to Tag A-0749).

2. The chief executive officer, the medical staff, and the director of nursing failed to ensure that the quality assessment and performance improvement (QAPI) program and training programs address problems identified by the infection control officer or officers; and be responsible for the implementation of successful corrective action plans in affected problem areas. (Cross Refer to Tag A-0756).

A. Based on observation, facility document review and staff interview, it was determined that the facility failed to ensure that its Hand Hygiene policy is implemented.

Findings include:

Reference #1: Facility policy, titled, "... 10.103 - Hand Hygiene," states, "III. Policy: A. Personnel shall decontaminate their hands: 1. Upon ENTERING and before LEAVING any patient room. 2. Before contact with patient or patient's environment 3. Before An Aseptic Task a. Examples include, but not limited to: Before inserting ... peripheral vascular catheters, ... 6. ... After removing gloves ... Routine handwashing shall involve vigorous rubbing of all surfaces on lathered hands for at least 15-20 seconds, followed by a thorough rinse under a stream of water ..."

Reference #2: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "Recommendations: 1. Indications for Handwashing and Hand antisepsis ... C. Decontaminate hands before having direct contact with patients. ... E. Decontaminate hands before inserting ... peripheral vascular catheters, or other invasive devices ... F. Decontaminate hands after contact with a patient's intact skin ... G. Decontaminate hands after contact with ... a patient's nonintact skin ... I. Decontaminate hands after contact with inanimate objects ... in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves."

Reference #3: Facility instruction document for visitors and staff, "Are you washing your hands correctly??" that is included in the NICU Mentor/Greeter Packet, states, "Rub hands for hand hygiene! Wash hands when visibly soiled"

1. During a tour of the NICU (Neonatal Intensive Care Unit) on 4/18/17, observations were conducted and the following was revealed:

a. Upon entrance to the NICU, there is a scrub sink for staff and visitors use with instructional signage and designated personnel to monitor removal of jewelry, correct hand washing, bagging personal belongings and cleaning of cell phones before entering the patient care areas.

(i) At 9:30 AM, Staff #11, the Medical Director, upon entrance of the unit, scrubbed his/her hands to the elbows and then cleaned his/her cell phone.

(ii) Staff #11 did not follow recognized guidelines and decontaminate hands after contact with inanimate objects

b. At 1:15 PM, at the entrance scrub sink, Infant #6's Father was observed performing hand hygiene. Infant #6's Father did not wet his hands prior to applying liquid soap. Therefore, he was unable to lather his hands.

c. In the "Bumble Bee" room at 10:40 AM, Staff #13, RN (Registered Nurse), was observed washing his/her hands for less than seven seconds.

(i) At 10:42 AM, Staff #18, RN, was observed washing his/her hands for less than 5 seconds.

(ii) At 10:44 AM, Staff #14, RN, was observed doffing his/her gloves. Staff #14 did not sanitize his/her hands after glove removal.

(iii) At 10:45 AM, Staff #14, RN, was observed donning his/her gloves. Staff #14 did not sanitize his/her hands prior to donning gloves.

d. In the "Respiratory Treatment Workroom" at 10:50 AM, Staff #15, Respiratory Therapist, was observed entering the Respiratory Treatment Room wearing gloves and began typing on the computer keyboard without removing his/her gloves.

2. In the "Firefly" room at 11:00 AM, Staff #19, an X-ray technician, was observed changing gloves, but did not sanitize his/her hands in between glove changes.

a. At 11:05 AM, Staff #20, RN, was observed washing his/her hands for eleven seconds.

3. In the "Dove" room at 11:20 AM, Staff #21, RN, was observed washing his/her hands for twelve seconds.

a. At 11:42 AM, Staff #17, attending NICU physician, was observed washing his/her hands for less than six seconds after direct patient care.

4. In the "Cardinal" room, at 1:20 PM, Staff #24, #25 and #26 gathered supplies to place a peripheral catheter in Infant #17.

a. Staff #24 and Staff #25 sanitized their hands less than seven (7) seconds before donning Personal Protective Equipment (PPE) and gloves.

(i) Staff #26, did not sanitizer his/her hands before donning PPE and gloves.

5. In the "Dragonfly" room at 11:45 AM, Staff #17, a neonatologist, sanitized his/her hands less than 7 seconds and did not cover all areas of his/her hands before going to the patient in Bassinet #17.

6. The above findings were confirmed with Staff #7.

7. Review of document titled, "Are you washing your hands correctly??" from the NICU Mentor/Greeter Packet revealed the following:

a. The document states, "Rub hands for hand hygiene! Wash hands when visibly soiled"

(i) The document is two sided. Both sides of the document are identical.

(ii) The document provides illustrated and written instructions of how to rub hands for hand hygiene.

(iii) The document does not provide illustrated and written instructions for washing hands when visibly soiled.

8. These findings were confirmed with Staff #1, #2, #22, and #23.

B. Based on observation and staff interview conducted on 4/18/17, it was determined that the facility failed to ensure a clean and sanitary environment for the provision of neonatal intensive care services.

Findings include:

Reference #1: Sani-Cloth Plus Germicidal Disposable Cloth Instructions for Use (IFU): "... General Guidelines for Use ... 2. ... When not in use, keep lid closed to prevent moisture loss. ..."

Reference #2: Facility policy titled, "... Section: Infection Prevention, Subject: 10.111 - Isolation Precautions ... B. Contact Precautions ... 4. PPE Requirements: a. Healthcare Personnel: i. Gowns and gloves are required for healthcare staff upon entering the patient care environment in addition to any other PPE that would be required when following Standard Precautions. ..."

1. During a tour of the NICU on 4/18/17, observations were conducted and the following was revealed:

a. At 9:35 AM, Staff #8 and Staff #29, the monitoring personnel and Staff #7, one of the unit leaders, who conduct the entrance monitoring training, did not know when to instruct staff and/or visitors when to clean their cell phones; before or after performing the hand hygiene scrub.

(i) Staff #8 presented the product/container designated to clean cell phones as "Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant."

(ii) Staff #15, a respiratory therapist, confirmed he/she did not know the correct wet time per the IFU [instructions for use] of the product designated to clean her/his cell phone.

b. In the Transitional Care Unit area at 1:45 PM, an Isolation Cart was found touching a Soiled Linen Cart.

c. In the "Cardinal" room, at 11:15 AM to 1:30 PM, a soiled linen cart was found touching an isolation cart that contained PPE supplies, and the drawer containing the PPE gowns was left open. A Sani-Cloth Plus germicidal disposable clothes container that was on top of the PPE cart, did not have the top of the container closed and a wipe was found protruding out open to the environment.

(i) At 1:20 PM, Staff #24, #25 and #26 were preparing supplies to place a peripheral catheter in infant #17. Staff #25, a provider, took a clean bag of medical supplies to the bassinet of Infant #17, then after direct patient care, brought the plastic bag containing the medical supplies and placed the bag on top of a clean supply cart used for all infants cohorted in the room.

(ii) At 11:15 AM, Staff #11 placed a dirty line cart approximately one (1) inch away from a clean IV supply cart.

d. In the "Dragonfly" room at 11:45 AM, Staff #17, a neonatologist, walked into bassinet #17's designated space without donning the required PPE.

e. In the "Bumble Bee" room at 10:45 AM, Staff #14 prepared a clean field with peripheral IV supplies and fluids on a blue towel. Staff #13, an RN, picked up an IV line in its' packaging that fell on the floor and placed it on top of a clean cart with the other IV supplies. Staff #14, was opening the IV supplies onto the clean aseptic field. The package that fell on the floor touched the opened exposed IV supplies that were opened and out of their packages.

(i) At 2:00 PM, Staff #16 and #29 used the Sani-Cloth Plus germicidal disposable clothes to clean/disinfect the designated patient space after the patient was transferred to another facility.

(ii) Upon interview, both staff did not know the contact/wet time per the IFU to use the product correctly.

f. Review of two (2) medical records (#3 and #4) out of five (5) medical records, of infants that had confirmed Methicillin Resistant Staphylococcus aureus (MRSA) culture results revealed the following:

(i) Medical Record #3 had MRSA results called to the unit on 4/29/16 at 9:10 AM and there was no documented evidence of any clinical personnel implementing contact precautions.

(ii) Medical Record #4 had MRSA results called to the unit on 7/21/16 at 10:51 AM and on 9/7/16 at 4:30 PM contact precautions were documented as being implemented.

(iii) Precaution requirements were not implemented at the time the know MRSA results were obtained.

2. The above finding was confirmed with Staff #4, #5 and #7.

Based on staff interview and document review it was determined that the facility failed to ensure that the hospital-wide quality assessment and performance improvement (QAPI) program addresses problems identified by the infection control officer, and failed to ensure implementation of a corrective action plan in an affected problem area.

Findings include:

Reference: Facility policy titled, "... 10.103 - Hand Hygiene ... IV. Compliance & Education: A. Hand hygiene compliance rates are monitored through observation and reported back to each unit/area. B. All staff are provided education at orientation and individually as needed. ..."

1. Review of the Infection Control data on April 17, 18, 19 and 20, 2017 in the presence of Administrative Staff #1, #2, #4, #5, #6, #23 and Medical Staff, #3, #7, #11, #17, did not identify problems and implement corrective actions to ensure the QAPI program and training programs address problems identified.

2. On 4/18/17 at 3:05 PM, Staff #4 and Staff #5, both Infection Preventionist's confirmed they do go to the NICU [neonatal intensive care unit] to conduct observations and monitor hand hygiene, proper use of PPE [personal protective equipment] and cleaning of the patient care areas. They also taught unit leadership hand hygiene monitoring, however, they never watched a session on the unit leadership conducting actual teaching and/or monitoring.

3. The "Hand Hygiene Monitoring Tool" used for observation of hand hygiene compliance on the NICU in January, February and March 2017 was reviewed with Staff #4 and Staff #5, Infection Preventionist's, and the following was revealed:

a. On March 15, 21, and 30, 2017, four (4) physicians and six (6) nurses were monitored for proper hand hygiene practices either at entry or exit of direct patient care.

(i) Four (4) out of the ten (10) healthcare personnel monitored were observed not practicing hand hygiene before entering the infants' direct care area and one (1) was observed not practicing hand hygiene after leaving the infants' direct care area.

(ii) 50% of the healthcare physicians and nursing personnel, observed did not practice proper hand hygiene before and/or after direct patient contact by the infection preventionist's.

b. There was no documented evidence that the monitors, Staff #4 and Staff #5 (Infection Preventionist's) that conducted the observations of the healthcare personnel, provided feedback and/or documented comments to correctly instruct them about the lack of hand hygiene practice before and/or after direct patient contact.

c. Staff #4 and Staff #5 confirmed during monitoring observations that the observed staff are not always made aware at the time of the findings. General in-services were scheduled for staff to address findings and provide instructions at a later date.

4. The above was confirmed by Staff #1, #2, #4, #5, #6 and #7.