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Based on observations, staff interviews, and documents reviewed, it was determined the facility staff failed to implement a system to ensure staff practiced infection reducing behaviors and to ensure patients were protected from potential ESBL Klebsiella exposure resulting in the identification of Immediate Jeopardy(IJ), which is cited at the Condition of Participation level after the facility provided an acceptable Plan of Removal.

The findings included:

During the complaint survey conducted 04/24/17 through 04/27/17, the survey team identified that the CCU (Cardiac Care Unit) and CVICU (Cardiovascular Intensive Care Unit) specialty intensive care units of the facility were involved in an outbreak of ESBL Klebsiella. During observations on 04/24/17 and 04/25/17 in the CCU and CVICU, multiple concerns were identified regarding the staff practicing proper infection control procedures to ensure patients were protected from potential ESBL Klebsiella exposure. The facility showed evidence an "ESBL Action Plan" was put into place to enhance infection prevention precautions starting 04/07/17; however there was no evidence staff received training for the development and implementation of corrective interventions under the "ESBL Action Plan" and of ongoing evaluations of developed and implemented corrective interventions to ensure success, sustainability and reduction of risk to patients in affected problems areas of Infection Control.

This resulted in the determination of a finding of Immediate Jeopardy for the facility.

During observations on 04/24/17 starting at 11:45 p.m. and 04/25/17 starting at 2:20 p.m. in the CCU and CVICU, the survey team made the following observations:

1. No clear delineation of clean and dirty areas on the CVICU;

2. Staff failure to clean equipment after caring for a patient on contact isolation and before new patient contact per policy and procedure on the CCU and CVICU;

3. Failure to ensure equipment used during patient care was in good repair, maintained and environment protected to prevent the spread of infections between patients and to cause harm on the CCU;

4. Staff failure to handle soiled linens in a manner to prevent the spread of infectious agents on the CVICU;

5. Improper hand hygiene after care of a patient on contact isolation and before new patient contact on the CCU;

6. Improper use of PPE (Personal Protective Equipment) when caring for patients on isolation precautions on the CCU;

7. Lack of consistent knowledge about disinfecting cleaners for various surfaces and appropriate cleaning of equipment to prevent the spread of infection between patients on the CCU and CVICU;

8. Implementation of the Infection Control Program. The facility failed to respond in a timely manner and manage a communicable disease outbreak; identifying persons who may be infected and exposed; and sustaining the performance required by the designated individual as its Infection Control Officer;

9. The Infection Control Program, showed evidence the Hospital Leadership team being notified; developing and implementing corrective interventions within the active program for the prevention, control, and investigation of infections and communicable diseases; however failed to show an ongoing evaluation of implemented interventions to ensure success, sustainability and reduction of risk to patients in affected Infection Control problem areas;

On 04/25/17 at 3:48 p.m., the surveyors consulted the SA (State Agency) Supervisor regarding concerns for Immediate Jeopardy. The findings were discussed with additional SA management staff and the finding of Immediate Jeopardy was confirmed at 3:55 p.m.

The survey team then met at 4:02 p.m. with Staff Member #2 (Chief Nursing Officer acting on the behalf of the Chief Executive Officer), Staff Member #3 (Director of Quality), Staff Member #4 (Clinical Management), and Staff Member #5 (Regulatory Staff) and informed them of the Immediate Jeopardy situation. A Plan of Removal was requested for the IJ.

The Plan of Removal was presented to the survey team on 04/25/17 at 5:20 p.m. and evidenced the following:
An emergency meeting was held and the "SMH ESBL Action Plan" dated 04/22/17 was reviewed regarding the implementations that were in place for an enhanced Infection Prevention precautions. The "SMH ESBL Action Plan" read in part the following: "Infection Prevention Discussion: 1. Infection Prevention (IP) enhanced action guidelines initial 4/17 disseminated at meeting with IP, Nursing, CVICU, CCU, Radiology, OR (Operating Room), Pharmacy, CEO, CNO, AOC, EVS (Environmental Services), Respiratory, PT/OT (Physical Therapy/Occupational Therapy), Materials Management, (Name of Lab Medical Director), Nutrition Services, (Name of Medical Director for Infection Control), (Name of Cardiac Surgeon #1), (Name of Cardiac Surgeon #2). 2. 4/12/17: TruD implemented cleaning in CVICU, CCU and OR heart rooms. 3. 4/16/17: CVICU patients moved to CCU to allow for ease of cleaning unit. 4. 4/18/17: VDH (Virginia Department of Health Epidemiologist) toured CVICU, CCU and OR heart rooms. Staff & Provider Education: 1. PPE (Personal Protective Equipment) education and utilization of wipes provided to radiology staff, CVICU, EVS, Aramark beginning 4/6/17. 2. Education on Enhanced IP precautions with staff and providers including hospitalist beginning 4/17/17.

The following components of the Plan of Removal addressed new actions put in place to address the Immediate Jeopardy:
3. Staff check off on revised Enhanced IP precautions days, evening & night shift 4/25/17: Nursing EVS, RT, Radiology, PT/OT, Hospitalists, Materials Mgmt, (Name of Cardiac Surgeon #1), (Name of Cardiac Surgeon #2), Nutrition, Care Management, OR, Aramark, Pharmacy, Pastoral Care. 4. Revision of Enhanced IP precautions includes: a. Describes process for any patient transferred with pending test result. b. Describes process for hand hygiene in patients with ESBL surveillance and positive CDiff. c. Clarified PDI bleach wipes-with top color for ease of identification. d. Clarified process of cleaning shared equipment including using the Purple top wipe on the screens to remove the smearing after the Orange Top wipes have been used. e. Clarified Contact isolation signage process with EVS-removal & wiping of sign. Use of room clean tent cards. f. Place visitor belongs in patient belonging bag and leave outside of room, patient belonging bag disposed of when visitor leaves. 5. Staff checklist and names of education obtained starting 4/26/17. Radiology: 1. Education of Staff regarding 2 pumps of gel and rub for 20 seconds. 2. Bare arms below elbows. 3. Check with RN. 4. Clean equipment with Orange top bleach wipes. 5. IP enhanced guidelines distributed. 6. Staff: (List of four Radiology staff members)."

The Plan of Removal was reviewed by the survey team on 04/25/17 and accepted at 5:20 p.m. The Immediate Jeopardy was abated during the survey, and findings now cited at the Condition of Participation level.

Please see citations 0748, 0749 and 0756 for further detailed information regarding the observations and concerns identified relating to infection control.

Based on observations, interviews and documents reviewed, it was determined the facility staff failed to ensure an effective Infection Control program was in place, as identified by the facility failing to respond in a timely manner and manage a communicable disease outbreak preventing transmission among patients, healthcare personnel and visitors; identifying persons who may be infected and exposed; and sustaining the performance required by the designated individual as its Infection Control Officer.

The findings included:

During the survey conducted 04/24/17 through 04/27/17, the survey team identified areas of concern in infection control during observations in the CCU (Cardiac Care Unit) and CVICU (Cardiovascular Intensive Care Unit) speciality intensive care units located in the facility.

During a tour and observations made by the survey team in the CCU on 04/24/17 at 11:45 a.m. and 04/25/17 at 2:20 p.m., the following concerns were identified regarding the staff following proper infection control procedures.

Concerns identified were as follows: staff were not able to consistently identify whether equipment used for patient care had been cleaned and disinfected; staff failed to practice proper hand hygiene; improper use of PPE (Personal Protective Equipment) when caring for patients on isolation precautions; failure to clean equipment after patient on contact isolation and before new patient contact per policy and procedure; appropriate knowledge about manufacturers disinfecting cleaners for various surfaces and appropriate cleaning of equipment to prevent the spread of infection between patients. (Please see Citation 0749 for further detailed information regarding the observations and concerns identified relating to infection control).

During observations made by the survey team in the CVIVU on 04/24/17 at 12:15 and 04/25/17 at 2:40 p.m., the survey team observed the following infection control concerns: failure to clean equipment after patient on contact isolation and before new patient contact per policy and procedure; failure to handle soiled linens in a manner to prevent the spread of infectious agents; facility equipment used during patient care was maintained and environment protected to prevent the spread of infections between patients; and no clear delineation of clean and dirty areas. (Please see Citation 0749 for further detailed information regarding the observations and concerns identified relating to infection control).

The surveyors discussed the concerns regarding the staff failure to follow proper infection control and cleaning procedures with Staff Members #3 (Director of Quality), #4 (Clinical Management) and #5 (Regulatory Staff) at the time of the observations. The concerns were again discussed on 04/25/17 at 4:00 p.m. with the identification of Immediate Jeopardy, and again on 04/26/17 at 8:40 a.m.

An interview was conducted with designated individuals as Infection Control Officers, Staff Member #20 and #21 on 04/26/17 starting at 1:14 p.m. in the conference room. Staff Member #3 was present during the interview. Staff Member #20 acknowledged he/she was one (1) of three (3) Infection Control designees for the facility and was considered a full-time employee and responsible for the infection control program. Staff Member #20 reported each of the designated Infection Control officers were assigned particular areas of responsibility; for example: Staff Member #20 was responsible for areas surrounding Clostridium difficile (C. diff), and employee hand hygiene; Staff Member #21 was responsible for areas in the operating room and surgical site infections; Staff Member #26 was responsible for areas involving CAUTI (Catheter-Associated Urinary Tract Infections), CLABSI (Central Line-Associated Bloodstream Infections) and dietary concerns. The surveyor inquired who the Infection Control Designee was for the recent concern of an outbreak of Extended-Spectrum-Lactamase (ESBL)-producing pathogens, particularly Klebsiella pneumoniae involving six (6) patients. Staff Member #20 stated "Mainly I (Staff Member #20) was, but (Name of Staff #21) also assisted me."

During an interview with Staff Member #20 on 04/26/17 at 3:12 p.m., the surveyor inquired when he/she was made aware of the organism, particularly ESBL Klebsiella pneumoniae being a concern. Staff Member #20 stated, "During the first part of March, a CVICU charge nurse informed me (Staff Member #20) while on the unit reviewing a concern over signage placement on the curtains that the unit had two (2) cases of ESBL and may have had a third patient that was transferred out of the unit." Staff Member #20 reported after being notified by the CVICU charge nurse, he/she reviewed current inpatient lab cultures and patient labs for the last thirty (30) days going back to February. Staff Member #20 stated, "During the review, I did find the three (3) test for the patients in question."

The surveyor inquired if the CVICU charge nurse had not informed Staff Member #20 of his/her concern regarding three (3) possible patients having a positive ESBL lab result, when would the infection control department been made aware of the increase in cases. Staff Member #20 validated the infection control department receives daily patient lab results and are divided between the three (3) infection prevention designees. Patients that are suspected, diagnosed or being ruled out for a communicable disease are flagged in the computer system to be placed on the appropriate isolation precautions. If a cluster is seen then the appropriate people are notified and an investigation is started. Staff Member #20 stated, "The lab information would have been captured in the middle of March because of the separation of weeks between the patients with a positive ESBL lab." The surveyor asked Staff Member #20 if and when did the Medical Director become informed about the "Cluster." Staff Member #20 stated, "After starting an investigation, (Name of the Medical Director for Infection Prevention), (Name of Director of Quality), (Name of Chief Nursing Officer) who was filling in for the Chief Executive Officer, (Name of the two (2) additional Infection Control Officers) were notified around April 6 or April 7, 2017."

The surveyor asked Staff Member #20 if he/she could reaffirm the reason the Medical Director was not notified of a possible outbreak of ESBL for approximately one (1) month after being notified by a charge nurse on CVICU of his/her concern. Staff Member #20 stated, "The patient's lab results were not close together or even in the same week. Some had more than a week between cases. Once I (Staff Member #20) compared the patient's information from a previous chart list created by (Name of Medical Director) from the implementation of a 2014 ESBL action plan, I saw we had a possible cluster." The surveyor asked Staff Member #20 to clarify a chart list. Staff Member #20 reported a chart list was information collected from each patient involved in the investigation that include: admission date, date to unit, bed assigned in the unit, culture result, when tested and from what source, procedures done while in the hospital, and if on a ventilator.

A review of the policy titled "Outbreak Investigation" read in part the following: "Healthcare Associated Infections (HAI's) are a significant problem in the healthcare environment; however, when the occurrence of HAI's exceeds the expected benchmark, or when an unusual pathogen is isolated, an outbreak investigation will be conducted to identify the contributing factors and to prevent or minimize the spread of the disease. PROCEDURES 1. Prepare for the Investigation: The Director of Infection Control (DIC) or designee will notify the Medical Director for Infection Control, administration, affected patient care services, the laboratory (microbiology) and provide a specific summary of the problem and the resources needed including additional personnel and/or supplies. Microbiology staff will save all existing and future specimens and isolates of the implicated pathogen for potential further testing, as feasible. Confirm the Existence of the Outbreak: A. A case definition will be developed by Infection Control, when criteria are met requiring an investigation, consulting with the laboratory director, medical director of infection control and health department. In order to establish the scope and nature of the problem......B. The laboratory may be asked to provide the names of all patients positive for the same organism for the three (3) month period prior to the identification of the first case(s) to determine if the problem is old or new and to evaluate the intensity of the problem. C. A specific data collection/abstraction form will be used by infection control to document the cases. Data will then be further abstracted onto a line listing to identify commonalities among the cases/risk factors.......Identify Additional Cases: Physicians, nursing, laboratory and radiology staff will be notified to immediately report to the Infection Control Department any new patients and/or staff meeting the case definition.....Implement and Evaluate Control Measures: A. Educate staff on the occurrence of the problem and the importance of Standard Precautions and Hand Hygiene as essential control measures. Transmission Based Precautions will be used when indicated. Patient care products, equipment or supplies implicated in the outbreak will be removed from patient care areas and their use suspended until the investigation points to a specific source. Patient care procedures will be modified if indicated. Appropriate treatment and/or prophylaxis will be provided to affected patients and staff......."

[According to http://emedicine.medscape.com: "Klebsiella organisms are resistant to multiple antibiotics. Length of hospital stay and performance of invasive procedures are risk factors for acquisition of these strains. Treatment depends on the organ system involved. The genus Klebsiella is a member of the Enterobacteriaceae family. Klebsiella spp (several species) are ubiquitous in nature and can be found in the natural environment (e.g., water and soil) and on mucosal surfaces of mammals. Common sites of colonization in healthy humans are the gastrointestinal tract, eyes, respiratory tract, and genitourinary tract."

"Certain strains of bacteria are resistant to treatments with commonly used antibiotics such as penicillin and cephalosporins. These bacteria produce enzymes known as Extended Spectrum Beta-Lactamases or ESBLs for short. Extended-spectrum ß-lactamases (ESBLs) are plasmid-mediated enzymes that confer resistance to all penicillins and cephalosporins."

"The majority of ESBL producing strains are either klebsiella pneumoniae (K. pneumoniae), klebsiella oxytoca (K. oxytoca) and Escherichia coli (E. coli)." "According to some sources, the incubation period for K. granulomatis is usually 1 to 6 weeks."

"ESBLs cause illness and infection when they get into an area of the body where they are not usually found or in an individual that is elderly or immunocompromised."]

The surveyor discussed the concerns regarding the staff failure to follow proper infection control and cleaning procedures with Staff Members #3, #4 and #5 at the time of the observations on 04/24/17. The concerns were again discussed on 04/25/17 at 4:00 p.m. with the identification of Immediate Jeopardy. Concerns were again discussed as well as concerns that the designated staff failed to respond in a timely manner and manage a communicable disease outbreak on 04/26/17 at 8:40 a.m. On 04/27/17 at approximately 2:50 p.m. during the exit conference, the survey team discussed the multiple concerns regarding the survey findings with the Administrative Team.

Based on observations, staff interviews and facility document reviews, the facility staff failed to ensure infection control procedures and policies were implemented on 2 (two) of 2 (two) observed units of the facility resulting in the finding of Immediate Jeopardy (IJ) as evidenced by the following:

A. No clear delineation of clean and dirty areas on the CVICU;
B. Failure to clean equipment after patient on contact isolation and before new patient contact per policy and procedure;
C. Failure to ensure facility equipment used during patient care was in good repair, maintained and the environment protected to prevent the spread of infections between patients;
D. Failure to handle soiled linens in a manner to prevent the spread of infectious agents;
E. Improper hand hygiene;
F. Improper use of personal protective equipment (PPE) when caring for patients on isolation precautions;
G. Inconsistent knowledge about cleaners for various surfaces and appropriate cleaning of equipment to prevent the spread of infection between patients.

The facility provided a Plan of Removal for the Immediate Jeopardy, the IJ was abated during the survey, and the findings are cited at the Condition of Participation level.

The findings included:

1.A. During a tour and observations on 04/24/17 at 12:15 p.m. on the CVICU (Cardiovascular Intensive Care Unit) with Staff Member #3 (Director of Quality) and #4 (Clinical Management), the survey team observed upon entrance to the unit, Rooms #36, #37 and #38 with opened curtains, beds that were prepared for new patients, but no patients assigned to the rooms. Observation revealed a "Contact Isolation" sign attached to the room curtains making it unclear if the the rooms were previously on contact isolation or the patient being assigned to the rooms were going on contact isolation.

The surveyor also observed Rooms #31, #32, #33 and #34 with a sign on the room which indicated the patient was on contact isolation and staff were in the room providing care to the patients. The surveyor then observed at Room #37, which was also designated as "Contact Isolation" a piece of equipment located on the patient table with three (3) packs of "adhesive tape." One (1) pack was opened, two (2) were unopened and a used white cloth lying on top of the equipment. At that time, the surveyor pointed out the observation to Staff Member #3 and Staff Member #4. Staff Member #4 stated, "This is a used sanicloth (PDI Sani Cloth Wipes) for disinfecting and should be thrown away." Staff Member #4 immediately disposed of the used cloth and the one (1) opened package. Staff Member #4 clarified the device was a pacemaker and stated, "I am unsure if it has been cleaned or in the process of being cleaned." Staff Member #3 stated, "If the signs are up I think the rooms are dirty because EVS are the only staff that should be taking them down once the room is clean. I'm not sure if these empty rooms are clean and ready for patients, since the sign is still up, but I will check on this."

Staff Member #3 was interviewed at approximately 12:30 p.m. to clarify if the rooms were clean or dirty due to the "Contact Isolation" signage on the curtains. Staff Member #3 acknowledged he/she clarified with the CVICU and EVS (Environmental Services) staff and stated, "Sorry for the confusion, but the rooms are clean. EVS removes and wipes the isolation signs during the process of cleaning the rooms and is validated by the use of room clean tent cards." Regarding the pacemaker located on the patient room table, Staff Member #4 reported the Registered Nurse (RN) was a little unclear regarding the new implementations in place due to the cluster of ESBL Klebsiella patients. Staff Member #4 stated, "The RN had cleaned the pacemaker and left it on the table for the disinfectant's four (4) minute contact time and got called away for patient care. The RN should have disposed of the cleaning supplies."

1.B. During observations on CVICU at 12:31 p.m. with Staff Member #3 and #4, the surveyor observed an uncovered piece of equipment on wheels located next to two (2) pieces of equipment covered in plastic in an area adjacent to the nurses station of the unit. The area was designated for "storage of clean equipment" which would be used for patients if necessary, according to Staff Member #3. Upon further inquiry as to how staff would be able to identify whether equipment in this area had been cleaned and disinfected, Staff Member #3 stated that the patient in Room #33 had a balloon pump earlier, but it had been placed out by the nurses station before it was cleaned, because a plastic bag would have been placed over any equipment that was cleaned. He/she verified the pump didn't have a plastic bag indicating it was clean." Staff Member #4 stated, "Once the balloon pump is cleaned, a plastic bag is placed over it, and it is stored across the hall adjacent to the CVICU entrance in a room designated for clean equipment."

1.E. On 04/25/17 at 2:20 p.m. on the CCU (Cardiac Care Unit) with Staff Member #3, the surveyor observed Room # 25 to have a large yellow cart beside the door containing various items: gloves, masks, yellow fluid impervious gowns, and other patient care items. There was a "Contact Isolation Precautions #2" signage on the door to indicate the patient was on isolation.

The surveyor inquired as to the status of Room #25 because the signage showed "Contact Isolation Precautions #2 and the surveyor had only observed "Contact Isolation" signage during observations on the CCU and CVICU. At 2:31 p.m. Staff Member #3 informed the surveyor that the patient was on contact precautions for clostridium difficile (C-diff). The sign for "Contact Isolation Precautions #2," stated staff should wear gowns and gloves when entering the room and wash hands immediately with an antimicrobial soap after glove removal and before leaving the patients room.

From approximately 2:20 p.m. to 3:10 p.m., seven (7) observations were conducted of staff caring for Patient #12 on isolation precautions in Room #25. Six (6) of seven (7) observations revealed staff and family members washing their hands at the sink provided in Room #25 located at the door to enter/exit Room #25. At 2:40 p.m., Staff Member #11 (Clinical Nurse Leader of CCU) removed gown and gloves at the designated area and performed hand hygiene with hand gel. No hand hygiene in the sink provided was observed prior to Staff Member #11 exiting Room #25. The surveyor inquired if Staff Member #11 was planning to perform hand washing. Staff Member #11 stated, "Yes, in the communal sink." The surveyor observed Staff Member #11 leave Room #25 and cross the entire CCU, but stopping at the nurse's station to talk with another staff RN before preceding to the communal sink located at the entrance to the CCU. Staff Member #11 did not ensure proper hand hygiene prior to exiting a patient's room on C-diff isolation precautions and prior to stopping at the nurse's station.

Staff Member #3 was present during the observation and was interviewed by the surveyor to verify if this observation of hand washing for a C-diff patient was consistent with hospital infection control policies and procedures. Staff Member #3 reported staff have a choice to use the sink in the room or the communal sink, whichever is the closest and most accessible. The surveyor requested a copy of the policy.

Review of the policy and procedure titled "Management of Clostridium Difficile Infection (CDI) and Environmental Disinfecting Guidelines" read in part the following: "Purpose: The purpose of this policy is to promote early identification and isolation of patients infected with Clostridium difficile to decrease the risk of transmission. c. Specifications for C difficile Contact Precautions: i. Patients who are suspected of or known to have C. difficile: 3. Use full barrier precautions (gowns and gloves) for contact with patients, their body substances and the patient's environment. 4. Follow Centers for Disease Control and Prevention (CDC) hand hygiene guidelines before and after entering the room. Perform hand hygiene with soap and water. Alcohol bases products can be used only if a sink is not readily accessible. If alcohol based products are used, a sink will immediately be located for soap and water hand hygiene."

1. F. During observations of staff caring for patients on isolation precautions in the CCU from approximately 2:20 p.m. to 3:10 p.m., four (4) out of eleven (11) observations revealed improper use of PPE by staff and isolation precautions when caring for patients on isolation as evidenced by the following:

At 2:25 p.m. observations revealed a family member visiting Patient #13 located in Room #23 and on "Contact Isolation." Patient #13's family member donned a gown and gloves as directed by Staff Member #15 (Registered Nurse). Staff Member #15 directed the family member that he/she could not take personal belongings into the room and could leave them on the floor outside of Room #23.

Staff Member #3 was present during the observations and was interviewed by the surveyor to verify if this observation of contact isolation precautions is consistent with hospital infection control policies and procedures. Staff Member #3 reported that storing items on the floor is not ideal, but in this case the only place the unit has for personal belongings is on the floor. Staff Member #3 continued to acknowledge supplies are kept on the isolation carts and no additional items can be placed there. The "Defibrillator Cart" located next to the isolation cart has a place for things to be stored on the bottom of the cart, but that has to be available for all patients at any time, so no items can be placed on that cart.

At 2:44 p.m. Staff Member #16 entered into "Contact Isolation" Room #23 to assist with Patient #13, but failed to tie the gown which was visibly hanging off of Staff Member #16's shoulders .

At 2:45 p.m. Staff Member #18 entered into "Contact Isolation Precautions #2" Room #25 to administer Patient #12's medication, but failed to tie the gown which was visibly hanging off of Staff Member #18's shoulder.

At 2:50 p.m. Staff Member #10 (Respiratory Therapist) entered into "Contact Isolation" Room #23 to assist with Patient #13's respiratory care, but failed to tie the gown which was visibly hanging off of Staff Member #10's shoulders.

Staff Member #3 was present during the findings and was interviewed by the surveyor to verify if this observation of contact isolation precautions is consistent with hospital infection control policies and procedures. Staff Member #3 reports that Staff Member #10, #16 and #18 failed to follow contact isolation procedures because the staff members' gowns should have been tied to prevent potential cross contamination.

A record review on 04/25/17 revealed Patient #13 was placed on contact isolation because he/she was being ruled out for ESBL Klebsiella organism. According to the review of the facility "plan of action" regarding the instruction for staff for surveillance cultures and isolation measures "obtain and send any new admissions to CCU or CVICU and weekly rectal, sputum or throat swab cultures." Staff Member #3 and #7 (CCU Nurse Manager) were present with the surveyor at the time of of the observation and were aware of the isolation procedures that were used.

1. G. On 4/25/17 at 2:31 p.m. the surveyor observed Interventional Radiology staff obtaining a portable ultrasound for Patient #13 in Room #23-CCU, who was identified as being on "Contact Isolation." After completing the procedure, the Staff was observed to clean the portable ultrasound machine with the "purple" (PDI Sani Cloth Wipes) top container of disinfecting wipes. Staff Member #7 (CCU Nurse Manager) asked the staff member if the machine had been cleaned with a "Bleach Wipe" and the staff member stated, "Yes."

A second observation was conducted in Room #23-CCU on 04/25/17 which revealed two (2) Radiology staff members obtaining a portable x-ray for Patient #13, who was identified as being on "Contact Isolation." After completing the procedure, the Staff were observed to clean the portable x-ray machine with the "purple" top container of disinfecting wipes. Staff Member #7 asked the staff members if the machine had been cleaned with a "Bleach Wipe" and the staff members stated, "Yes, we did."

According to the review of the facility "plan of action" regarding the instruction for staff for cleaning of equipment "shared equipment is to be cleaned first with 'orange top-bleach" disinfectant wipes and then the 'purple top" disinfectant wipe is to be used on the screens to remove the smearing after the orange top wipes have been used". Staff Member #3 and #7 were present with the surveyor at the time of of the observation and were aware of the cleaning process that was used.

Review of the Infection Control policy titled "Standard and Transmission Based Precautions" read in part: "POLICY: Precautions will be instituted whenever a communicable disease is suspected or diagnosed. Precautions will be instituted by the nursing staff and/or by the attending physician as soon as there is reasonable evidence that a patient has a communicable disease...RESPONSIBILITY AND AUTHORITY: 1. All healthcare providers contract vendors, volunteers, and visitors are responsible for the prevention or spread of microorganisms in the workplace and will follow required precautions at all times with all patients. 6. The Medical and Nursing leadership, unit and department managers (inpatient and outpatient) are responsible to implement this policy and monitor compliance. Managers are responsible for insuring that required personal protective equipment (PPE) is available and properly utilized on the unit. 8. The Infection Prevention staff is responsible for following, reporting and maintaining a record of all patients with communicable diseases. If there are questions about isolation appropriateness, IP should be consulted for directions on the category and duration of precautions required. Education for healthcare providers and patients/visitors will be provided as needed....9. The Hospital Administration has the ultimate authority and responsibility for insuring compliance with isolation policies. Tier 1--Standard Precautions are used with all patients. Tier 2--Transmission-Based Precautions are used for patients with documented or suspected colonization or infection with certain microorganisms. GOWNS: A. Disposable gowns will be worn (clean, non-sterile) to protect skin and to prevent soiling of clothing during procedures and patient care activities likely to generate splashes or sprays of blood, body fluids, secretions or excretions. Gowns will be discarded after a single use. C. Perform hand hygiene prior to leaving the room to avoid transfer of microorganisms to other patients or environment surfaces. D. Procedure for Gown Removal: 1. After untying the back and neck ties; grasp the gown at the shoulders and pull the gown forward and down over the arms and gloved hands......D. CONTACT PRECAUTIONS: Contact Precautions are designed to reduce the transmission of microorganisms from an infected or colonized patient through direct (touching the patient) or indirect (touching surfaces or objects in the patient's environment) contact....Gloves and Hand hygiene: 4. Perform hand hygiene immediately after glove removal and before leaving the patients room. 5. Ensure hands do not touch potentially contaminated surfaces or items in the patient room after washing hands and while leaving room. Gowns: 1. Disposable Gowns will be worn when entering the room because of the possibility to contact with potentially contaminated surfaces/equipment or infective material (i.e. the patient is incontinent or has diarrhea, a colostomy, ileostomy, copious wound drainage not contained by a dressing). Gowns protect the clothing of healthcare workers and minimize the risk of cross contamination when caring for subsequent patients....E. ENTERIC CONTACT PRECAUTIONS: Enteric Contact Precautions are designed to reduce the transmission of microorganisms from an infected or colonized patient through direct (touching the patient) or indirect (touching surfaces or objects in the patient's environment) contact Examples of illnesses requiring Contact Precautions are: Clostridium difficile, Norovirus, Rotavirus, and in diapered or incontinent patients, Salmonella, E coli 0157:H7 or Hepatitis A. Gloves and Hand hygiene: 4. Wash hands immediately with an antimicrobial soap after glove removal and before leaving the patients room. 5. Ensure hands do not touch potentially contaminated surfaces or items in the patient room after washing hands and while leaving room."

According to http://emedicine.medscape.com "Klebsiella organisms are resistant to multiple antibiotics. Length of hospital stay and performance of invasive procedures are risk factors for acquisition of these strains. Treatment depends on the organ system involved. The genus Klebsiella is a member of the Enterobacteriaceae family. Klebsiella spp are ubiquitous in nature and can be found in the natural environment (e.g., water and soil) and on mucosal surfaces of mammals. Common sites of colonization in healthy humans are the gastrointestinal tract, eyes, respiratory tract, and genitourinary tract.

Certain strains of bacteria are resistant to treatments with commonly used antibiotics such as penicillin and cephalosporins. These bacteria produce enzymes known as Extended Spectrum Beta-Lactamases or ESBLs for short. Extended-spectrum ß-lactamases (ESBLs) are plasmid-mediated enzymes that confer resistance to all penicillins and cephalosporins. The ESBL enzyme breaks down and destroys most antibiotics causing them to be inactive, which is why they are not effective against infections caused by these types of bacteria. ESBLs are most commonly detected in Klebsiella pneumoniae, which is an opportunistic pathogen associated with severe infections in hospitalized patients, including immunocompromised hosts with severe underlying diseases.

According to www.cdc.gov "Clostridium difficile (C-diff) is a bacterium that causes inflammation of the colon, known as colitis. People who have other illnesses or conditions requiring prolonged use of antibiotics, and the elderly, are at greater risk of acquiring this disease. The bacteria are found in the feces. People can become infected if they touch items or surfaces that are contaminated with feces and then touch their mouth or mucous membranes. Healthcare workers can spread the bacteria to patients or contaminate surfaces through hand contact. Clostridium difficile spores are transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item. Clostridium difficile can live for long periods on surfaces."

The surveyor discussed the concerns regarding the staff failure to follow proper infection control and cleaning procedures with Staff Members #3, #4 and #5 (Regulatory Staff) at the time of the observations on 04/24/17. The concerns were again discussed on 04/25/17 at 4:00 p.m. with the identification of Immediate Jeopardy and on 04/26/17 at 8:40 a.m.


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2.C. During a tour and observations made by the survey team on 4/24/17 at 11:45 a.m. on the CCU (Cardiac Care Unit) the following was observed: Two wheelchairs, a high back chair and various equipment were observed in an area adjacent to the nurses station of the unit. The area was designated for "storage of clean equipment " which would be used for patients if necessary, according to Staff Member #7 (Nurse Manager). Upon close observation, the surveyor noted both wheelchairs (one blue and one black) to have torn areas on the armrests and one wheelchair was missing an armrest. The surfaces were not intact and would not have been able to be properly disinfected after use. The high back chair was covered with a vinyl type material of which the seat was cracked and split rendering the surface unable to be properly disinfected. At 12:00 p.m. on 4/24/17, the surveyor pointed out the tears in the wheelchair and chair material and inquired as to how the surfaces would be cleaned and disinfected. Staff Member #4 (Clinical Management) stated, "They would not." Upon further inquiry as to how staff would be able to identify whether equipment in this area had been cleaned and disinfected, Staff Member #7 stated, "There should be a plastic bag placed over equipment that has been cleaned." No bags were on the equipment in this area. Staff Member #7 stated, "I cannot tell if it is clean without a bag on it. Typically there would be a bag placed over the items once it has been cleaned." The surveyor also observed a blue plastic-type cart which contained a "Phillips Headstart transport response to emergency monitor. The cart was dusty and had some white colored material which had been spilled on the bottom shelf and appeared to be dried.

2.D. At 12:15 p.m. on the CVICU (Cardiovascular Intensive Care Unit) the survey team observed, upon entrance to the unit, a cart marked "Intubation" which had an area of a white colored dried material smeared on one of the drawers and along the side of the cart. At Room 34, the curtain was closed, as there were staff in the room providing care to the patient. There was a sign on the room which indicated the patient was on contact isolation. The surveyor observed linens on the floor which were visible from underneath the curtain. At that time, the surveyor pointed out the observation to Staff Member #3 (Director of Quality) and Staff Member #4. Staff Member #3 stated, "There should be no linen on the floor at anytime." The surveyor then observed at Room 32, which was also designated as "Contact isolation" the curtain to be pulled and staff providing care to the patient. The surveyor observed linens on the floor visible underneath the curtain. The observation was shared with Staff Member #4 at that time.

Further observation at 12:20 p.m. evidenced a staff member double bagging linen and trash from another room (Room 33). The staff member (Registered Nurse #12) took the bags of linen and placed them on the floor in front of the nurses station and stated, "I have to put these here until we can take them to the bins." Alongside the bags of linen and trash was a chair and a plastic bin behind the chair containing some foam type material and other articles. RN #12 stated, "All that is to be thrown away."

Review of the facility policy and procedure regarding the cleaning of equipment and handling of linens revealed:
"Standard and Transmission Based Precautions: Patient -Care Equipment a. soiled patient care equipment will be handled in a manner to prevent skin and mucous membrane exposures, contamination of clothing, and the transfer of microorganisms to other patients and environments. B. Reusable equipment will be cleaned and reprocessed appropriately per manufacturer recommendations before used in care of another patient....Environmental Control - A. Procedures are in place for routine are, cleaning and disinfection of environmental surfaces and patient furniture...Linen- a. All soiled linen is treated as if contaminated with blood or body fluids and therefore does not require additional labeling or color-coding. B. Soiled linen will be handled in a manner to prevent skin and mucous membrane exposures, contamination of clothing, and transfer of microorganisms to other patients and environments...CLEAN SWEEP ROUNDING TOOL for Inpatient Units: - DAILY Department Checks: ...10. All carts are CLEAN; includes isolation cart, code, linen, pyxis...17. Linen carts are covered- no flaps up or askew- no linen bags on floor...18...Clean utility has only clean items stored therein-must have plastic bag on it (indicates clean)..."

The surveyor discussed the concerns regarding improper infection control procedures with Staff Members #3, #4 and #5 (Regulatory) at the time of the observations. The concerns were again discussed on 4/25/17 at 4:00 p.m. with the identification of Immediate Jeopardy, and again on 4/26/17 at 8:40 a.m.

2.G. On 4/25/17 at 2:40 p.m. the surveyor observed Radiology staff obtaining a portable x-ray for the patient in Room 32 CVICU, who was identified as being on contact isolation. After completing the procedure, the Staff were observed to clean the portable x-ray machine with the "purple" top container of disinfecting wipes. According to the review of the facility "plan of action" regarding the instruction for staff for cleaning of equipment "shared equipment is to be cleaned first with 'orange top-bleach" disinfectant wipes and then the 'purple top" disinfectant wipe is to be used on the screens to remove the smearing after the orange top wipes have been used". Staff Member #4 and #5 were present with the surveyor at the time of of the observation and were aware of the cleaning process that was used.

Based on the observations revealing improper infection control practices after the facility had developed a plan of action related to the incidence of ESBL Klebsiella, the survey team contacted the State Agency (SA) on 04/25/17 at 3:48 p.m. concerns for Immediate Jeopardy. The findings were discussed with additional SA management staff and the finding of Immediate Jeopardy was confirmed at 3:55 p.m.

The survey team then met at 4:02 p.m. with Staff Member #2 (Chief Nursing Officer acting on the behalf of the Chief Executive Officer), Staff Member #3 (Director of Quality), Staff Member #4 (Clinical Management), and Staff Member #5 (Regulatory Staff) and informed them of the Immediate Jeopardy situation. An immediate plan of removal was requested.

The Plan of Removal was presented to the survey team on 04/25/17 at 5:20 p.m.. and evidenced the following:
An emergency meeting was held and the "SMH ESBL Action Plan" dated 04/22/17 was reviewed regarding the implementations that were in place for an enhanced Infection Prevention precautions. The "SMH ESBL Action Plan" read in part the following: "Infection Prevention Discussion: 1. Infection Prevention (IP) enhanced action guidelines initial 4/17 disseminated at meeting with IP, Nursing, CVICU, CCU, Radiology, OR (Operating Room), Pharmacy, CEO, CNO, AOC, EVS (Environmental Services), Respiratory, PT/OT (Physical Therapy/Occupational Therapy), Materials Management, (Name of Lab Medical Director), Nutrition Services, (Name of Medical Director for Infection Control), (Name of Cardiac Surgeon #1), (Name of Cardiac Surgeon #2). 2. 4/12/17: TruD implemented cleaning in CVICU, CCU and OR heart rooms. 3. 4/16/17: CVICU patients moved to CCU to allow for ease of cleaning unit. 4. 4/18/17: VDH (Virginia Department of Health Epidemiologist) toured CVICU, CCU and OR heart rooms. Staff & Provider Education: 1. PPE (Personal Protective Equipment) education and utilization of wipes provided to radiology staff, CVICU, EVS, Aramark beginning 4/6/17. 2. Education on Enhanced IP precautions with staff and providers including hospitalist beginning 4/17/17.

The following was additional plans to remove the Immediate Jeopardy finding:
3. Staff check off on revised Enhanced IP precautions days, evening & night shift 4/25/17: Nursing EVS, RT, Radiology, PT/OT, Hospitalists, Materials Mgmt, (Name of Cardiac Surgeon #1), (Name of Cardiac Surgeon #2), Nutrition, Care Management, OR, Aramark, Pharmacy, Pastoral Care. 4. Revision of Enhanced IP precautions includes: a. Describes process for any patient transferred with pending test result. b. Describes process for hand hygiene in patients with ESBL surveillance and positive CDiff. c. Clarified PDI bleach wipes-with top color for ease of identification. d. Clarified process of cleaning shared equipment including using the Purple top wipe on the screens to remove the smearing after the Orange Top wipes have been used. e. Clarified Contact isolation signage process with EVS-removal & wiping of sign. Use of room clean tent cards. f. Place visitor belongs in patient belonging bag and leave outside of room, patient belonging bag disposed of when visitor leaves. 5. Staff checklist and names of education obtained starting 4/26/17. Radiology: 1. Education of Staff regarding 2 pumps of gel and rub for 20 seconds. 2. Bare arms below elbows. 3. Check with RN. 4. Clean equipment with Orange top bleach wipes. 5. IP enhanced guidelines distributed. 6. Staff: (List of four Radiology staff members)."

The Plan of Removal was reviewed by the survey team on 04/25/17 and accepted at 5:20 p.m.

Based on observations, interviews and review of documentation, it was determined the facility staff failed to show an ongoing evaluation of developed and implemented corrective interventions to ensure success, sustainability and reduction of risk to patients in affected problems areas of Infection Control.

The findings included:

Though the hospital had developed and enacted a corrective action plan related to the ESBL Klebsiella cases, prior to the start of the survey on 4/24/17, survey observations and interviews indicated improper infection control practices were present.

During the survey conducted 04/24/17 through 04/27/17, the survey team identified multiple areas of concern in infection control during observations in the CCU (Cardiac Care Unit) and CVICU (Cardiovascular Intensive Care Unit) speciality intensive care units located in the facility.

During a tour and observations made by the survey team in the CCU on 04/24/17 at 11:45 a.m. and 04/25/17 at 2:20 p.m., the following concerns were identified regarding the staff following proper infection control procedures. Concerns identified were as follows: staff was unable to consistently identify whether equipment used for patient care had been cleaned and disinfected; lack of staff using proper hand hygiene; improper use of PPE (Personal Protective Equipment) when caring for patients on isolation precautions; failure to clean equipment after patient on contact isolation and before new patient contact per policy and procedure; appropriate knowledge about cleaners for various surfaces and appropriate cleaning of equipment to prevent the spread of infection between patients. (Please see Citation 0749 for further detailed information regarding the observations and concerns identified relating to infection control).

During observations made by the survey team in the CVICU on 04/24/17 at 12:15 and 04/25/17 at 2:40 p.m., the following infection control concerns were identified: failure to clean equipment after patient on contact isolation and before new patient contact per policy and procedure; failure to handle soiled linens in a manner to prevent the spread of infectious agents; facility equipment used during patient care was maintained and environment protected to prevent the spread of infections between patients; and no clear delineation of clean and dirty areas. (Please see Citation 0749 for further detailed information regarding the observations and concerns identified relating to infection control).

On 04/26/17 starting at 1:14 p.m., the survey team interviewed the designated individuals as Infection Control Officers, Staff Member #20 and #21, regarding the Infection Control Program. Staff Member #3 (Director of Quality) was present during the interview. Staff Member #20 acknowledged he/she was one (1) of three (3) Infection Control designees for the facility and was considered a full-time employee and responsible for the infection control program. Staff Member #20 stated "We each are responsible for collecting and reporting data to the Infection Control Committee and QAPI (Quality Assurance and Performance Improvement) Committee, where infection control data is reported." The Infection Control report is presented to the Infection Control Committee and QAPI committee on a monthly basis. Staff Member #20 acknowledged that hospital leadership members are active on the Infection Control Committee and QAPI Committee that meet monthly; many meetings overlap, so members sit on other committees where data and information is shared.

During an interview with Staff Member #20 and #21 on 04/26/17 starting at 3:12 p.m., he/she verified the information from the increase ESBL Klebsiella cases in February and March 2017 are a part of the Infection Control Committee and QAPI's monthly reports. No evidence was found in the Infection Control or QAPI minutes that ESBL Klebsiella problems were identified in February or March 2017. The 02/06/17 and 03/06/17 Infection Control and QAPI meeting minutes were reviewed and failed to contain corrective action plans identified from the increase of ESBL Klebsiella cases to identify program data and activities on the high risk and problem areas based on the ESBL Klebsiella increase in February and March 2017. The surveyor inquired why the increase of ESBL Klebsiella cases were not documented as a part of the committee meetings. Staff Member #3 stated, "The data that is reviewed at the committee meetings is behind data and has not shown up yet. For example, information collected in March will be presented at the April meeting. However, QAPI and the hospital leadership were notified on 04/06/17 and a QAPI meeting is scheduled for 04/27/17 and the committee will be updated."

The survey team inquired as to the responsibilities of the Infection Control department in maintaining their own quality program and how they were overseeing and reporting to the hospital leadership committee. An interview was conducted with Staff Member #20 on 04/26/17 starting at 3:12 p.m. to 3:55 p.m., he/she confirmed if a cluster is seen then the appropriate people are notified and an investigation is started. Staff Member #20 stated, "After starting an investigation, (Name of the Medical Director for Infection Prevention), (Name of Director of Quality), (Name of Chief Nursing Officer) who was filling in for the Chief Executive Officer, (Name of the two (2) additional Infection Control Officers) were notified around April 6 or April 7, 2017. On 04/11/17 a discussion related to the action plans were communicated with the Manager of Critical Care Lead, Director of CVICU (Cardiovascular Intensive Care Unit), Respiratory (RT), Radiology, and Environmental Services (EVS)."

Staff Member #3 presented the survey team with a document titled "SMH ESBL Action Plan" on 04/26/17. The document revealed columns listing the following headers: "Topic, Discussion, Action, Responsible Person, Timeframe." Evidence of documentation in the action plan revealed the responsible person for Infection Prevention was (Name of Staff Member #20). Evidence revealed the following documentation under "Discussion: 4/6/17 Admin Director of IP (Infection Prevention) (Name of Staff Member #3) and Medical Director of IP informed of 3 ESBL patients in CVICU and implementation of 2014 ESBL action plan with VDH (Virginia Department of Health). IP working with CVICU, EVS, RT and Radiology. CNO (Chief Nursing Officer) informed of ESBL, CEO (Chief Executive Officer) out of country. 4/10-4/13 continued to review processes, IP rounding on CVICU. CEO returns and information provided. Escalation.....Board notified....4/17 - Scheduled Board meeting - CEO updated board on VDH upcoming visit..... "

A review of the facility "plan of action" for the "Cluster" of ESBL cases revealed instructions for staff for education, communication, reviewing facility processes, implementing cleaning, patient cultures, environmental cultures, patient screening, cohorting staff, and working with the recommendations from the Virginia Department of Health.

During an interview with Staff Member #3 on 04/27/17 starting at 2:12 p.m. regarding evidence of implemented corrective action in affected Infection Control problem areas. Staff Member #3 stated, "We did validate the action plan was in place and the changes that were made along the way; however we did not document the actual implementations. There should be evidence, but it is not documented and I can't prove we did it; other than we have had no new cases with the active surveillance in place."

The surveyor discussed the concerns regarding the staff failure to follow proper infection control and cleaning procedures with Staff Members #3, #4 and #5 at the time of the observations on 04/24/17. The concerns were again discussed on 04/25/17 at 4:00 p.m. with the identification of Immediate Jeopardy. Concerns were again discussed and included the concern that the designated staff failing to respond in a timely manner and manage a communicable disease outbreak on 04/26/17 at 8:40 a.m. Problems identified in the Infection Control Program showed evidence the Hospital leadership was notified and documentation for the development and implementation of corrective interventions, but failed to show an ongoing evaluation of implemented interventions to ensure success, sustainability and reduction of risk to patients in affected Infection Control problem areas.