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Based on observation, interview and record review, the hospital failed to have a governing body that took legal responsibility for for the conduct of the hospital when:

1. No monitoring system was in place to prevent legionella (a bacteria that can by spread from contaminated water system supply of the hospital) infection. The hospital was aware of a definite hospital acquired legionnaires disease (HA-LD) case as of 10/23/18 and did not implement an effective plan to ensure placement of Point of Use filters and to effectively educate patients and visitors on the restricted water use of faucets and showers. The hospital inappropriately transferred high risk patients (oncology patients) from a patient care area equipped to limit the exposure of legionella (POU filters in the Oncology Unit) to an area not equipped with POU filters (Pediatric Unit). (Refer to A 749, finding 1)

2. Multiple instances of staff not following standards of practice for the prevention of infections were observed while staff were performing patient care duties. (refer to A749, Findings 2 through 9)

The cumulative effects of these systemic problems resulted in the facility's inability to provide quality of care in a safe and effective manner.

Based on interview and record review, the hospital failed to develop current nursing care plans for each patient when:

1. Three of nine oncology patients (Patients-14, 16, and 17) did not have a nursing care plan for neutropenia (the presence of abnormally few white blood cells in the blood, leading to increased susceptibility to infection); and

2. One of 30 sampled patients (Patient 6) did not have a care plan to reflect their diagnosis of Chronic Obstructive Pulmonary Disease (COPD- a lung disease that is characterized by difficulty breathing).

These failures had the potential to place patients at risk of not having nursing care needs addressed and cause possible delays in treatment goals which could result in patient harm and/or prolonged hospitalization.

Findings:

1. On 12/12/18 at 3:45 p.m., during a concurrent interview and record review, the clinical record indicated Patient 14 was admitted to the hospital with diagnoses of chest pain, stage 4 lung cancer (Stage 4 cancer refers to the spreading of cancer to various sites in the body), and pancytopenia (abnormally low levels of all cells in the blood including red blood cells, white blood cells and platelets in the blood). A nursing care plan for neutropenia (abnormally low levels of white blood cells that fight infection) was not in the medical record. The Assistant Manager Oncololgy (AMO) stated Patient 14 was neutropenic upon admission and the doctor wrote orders for neutropenia precautions isolation (neutropenic precautions are infection control nursing procedures that are applied when patient has a high risk of bacterial infections due to low white blood count). The AMO stated "...There should be a neutropenic care plan. There is not a neutropenic care plan..." Manager of Oncology (MO) stated the purpose of a care plan is to personalize a patient's plan of care and it should be developed upon admission to the specific diagnosis and/or condition.

On 12/12/18 at 4 p.m., during a concurrent interview and record review, the clinical record indicated Patient 16 was admitted to the hospital with diagnoses of abdominal pain, shortness of breath, lymphoma (cancer of the lymph nodes), liver mass, and status post chemotherapy (a type of cancer treatment that uses one or more anti-cancer drugs). A nursing care plan for neutropenia was not in the medical record. When the AMO was asked what kind of care plans should be initiated for Patient 16, the AMO stated an oncology and a neutropenia care plan should be initiated. The AMO verified no oncology care plan or neutropenia care plan was initiated. MO stated the purpose of a care plan is to personalize a patient's plan of care and it should be developed upon admission to the specific diagnosis and/or condition.

On 12/12/18 at 4:10 p.m., during a concurrent interview and record review, the clinical record indicated Patient 17 was admitted to the hospital with diagnoses of acute myeloid leukemia (a type of blood cancer), status post chemotherapy and pancytopenia. A nursing care plan for neutropenia was not in the medical record. When the AMO was asked what kind of care plans should be initiated for Patient 17, the AMO stated "...They should have a neutropenia care plan in place...it should be there..." The AMO verified there was no neutropenia care plan initiated.

The hospital policy and procedure titled, "Care Plan, Patient (interdisciplinary) (IPPC)" dated 3/16, indicated "Policy:...B. Each patient will have a plan of care that is appropriate to his his/her specific assessed needs...C. The plan is individualize/revised based on ongoing assessment findings..."

The hospital policy and procedure titled "Neutropenic Precautions (IPPC)" dated 5/18, indicated "Purpose: To provide guidelines for the care and management of the neutropenic patient with the goal of minimizing or preventing potential physiological problems, including the increased risk of infection...Procedure...S. Documentation...2. The patient's plan of care will include the CPG for Neutropenia..."

2. A review of Patient 6's clinical record titled, "Hospital History and Physical Note" dated 12/10/18 indicated " ...History of present Illness ...significant for COPD on two liter oxygen, and Valley Fever (A fungal infection in the lungs) ... Assessment/Plan: Active Problems: Respiratory Failure, Acute Chronic Respiratory with Hypoxia ( condition in which the body or a region of the body is deprived of adequate oxygen supply at the tissue level), COPD Exacerbation ..."

On 12/11/18 at 1:54 p.m., during a concurrent interview and record review of Patient 6's clinical record, the Clinical Informatics Specialist (CIS) validated Pt 6 did not have a documented care plan for COPD completed and should have.

On 12/12/18 at 1:40 p.m., during an interview the Director of Patient Safety (DPS) stated the purpose of a care plan is to personalize a patient's plan of care and it should be developed upon admission to the specific diagnosis and/or condition.

The hospital policy and procedure titled, "Care Plan, Patient (Interdisciplinary) (IPPC)" dated 3/16 indicated, "Purpose: To establish the process for the ongoing development, maintenance, and documentation of the individualized Patient Plan of Care within the acute care ...setting ... B. Each patient will have a plan of care that is appropriate to his /her specific assessment needs. Care planning begins on admission ..."

Based on interview and record review, the hospital failed to follow the physician's order related to medication administration when the Registered Nurse (RN) failed to assess one of 30 Patient's (Patient 8) blood pressure (BP-related to the force and rate of the heartbeat) prior to administering a medication to reduce the blood pressure.

This failure had the potential to place Patient 8 at risk of receiving a BP medication when contraindicated.

Findings:

On 12/11/18 at 2:35 p.m., during a concurrent interview and record review of Patient 8's clinical record, the Clinical Informatics Specialist (CIS) validated Patient 8 did not have a documented blood pressure on 12/11/18 prior to the administration of a BP reducing medication.

On 12/12/18 at 1:40 p.m., during an interview, the Director of Patient Safety (DPS) stated the purpose of medications with hold instructions is to provide RNs with direction to establish if the BP does not meet the requirement, it needs to be held. The DPS stated it is his expectation that the nurse completes an assessment of the BP at the time of administration, not hours prior. The DPS stated assessment of the BP prior to administration is important to not cause risk and/or complications of a patient's health.

A review of Patient 8's clinical record titled, "MD order 982051449" dated 12/10/18 indicated, "(name of medication) Tab 6.25 mg oral BID (two times daily), administration instructions: Hold for systolic blood pressure less than 90 or heart rate less than 60..."

A review of Patient 8's clinical record titled, "MAR" (medication administration record) dated 12/11/18 indicated (name of medication) Tab was given at 8:37 a.m., with no assessment of the BP prior to administration.

A review of Patient 8's clinical record titled, "Flowsheets" dated 12/11/18 indicated there was no documented blood pressure assessment prior to the medication administration at 8:37 a.m. The flowsheet indicated a BP assessment was documented at 4:07 a.m., four hours and thirty minutes prior to the medication administration at 8:37 a.m.

The hospital policy and procedure titled, "Medication: Administration of (IPPC)" dated 1/17, indicated "Purpose: A. To define the role of the health care professional in the administration of medication to the patient. B. To identify some general safety precautions that the health care professional observes in the preparation and administration of medication. C. To insure a uniform approach in the administering of medication to all patient...Policy...C. The health care professional's responsibility will include knowledge of the drugs actions...upward effects, and contraindications...Procedure ...A. All medication orders will include indication for use of each medication ordered... I. Before administering a medication, the health care professional does the following: 1. Verifies...the medication selected for administration is correct based on the medication order...3. Verifies that there is no contraindication for administering the medication..."

Based on observation, interview, and record review, the facility failed ensure a sanitary environment and an effective infection control program when:

1. The hospital was notified by the California Department of Public Health and Stanislaus County Health Department in a letter dated 10/23/18 of a definite Hospital Acquired Legionnaires Disease (HA LD) (a disease caused by a bacteria that is found naturally in fresh water. It can contaminate hot water tanks, hot tubs, and cooling towers of large air conditioners. It is usually spread by breathing in mist that contains the bacteria). An effective system was not put into place to monitor whether or not point of use filters were properly installed in patient care areas. Education of staff, patients and staff as well as signs to reduce the risk of LD was not implemented for the Emergenecy Department, which the hospital determined was greater than average risk and the Hemodialysis (Hemodialysis (the process of removing excess water and toxins from the blood in people whose kidneys can no longer perform these functions naturally) unit which the hospital determined was high risk. The Infection Control Officer did not intervene in a timely manner to prevent the room change of XX of XX oncology patients who were transferred to a patient care area that did not have point of use filters. The oncology patients showered and used faucets for tooth brushing against the hospital procedure to restrict water use in these patients. The oncology patients were not educated to not shower and use faucets because of the risk of LD;

2. A Registered Nurse (RN) did not wear a gown or gloves in a "Contact Isolation" (designed to reduce the risk of transmission of infectious agents, which can be spread directly or indirectly by contact with the patient or the patient's environment) room;

3. A visitor did not wear gloves when in an "Enhanced Contact Isolation" (isolation designed to reduce the risk of transmission of infectious agents, primary found in diarrhea) room;

4. A visitor did not wear gloves when in a "Contact Isolation" room;

5. Tape and tape residue was on the floor of the operating room;

6. Temperature and humidity were not monitored daily in the Cardiac Catheterization procedure rooms and storage area;

7. Staff responsible for the turnover cleaning of operating rooms did not know the correct contact time for disinfectant products;

8. Terminal cleaning was not performed in the endoscopy processing room and procedure rooms;

9. The manufacturer's guideline for use of sterile (free from germs) water for irrigation (process of washing with a continuous flow of water or medicine) was not followed; and

10. An isolation "basket" was placed on a chair outside of a patient's room. (Refer to A0749).



The cumulative effects of these systemic problems resulted in the facility's inability to provide quality of care in a safe and effective manner.

Based on observation, interview and document review, the hospital 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 regulations when:

1. The hospital was notified by letter dated 10/23/18 from the California Department of Public Health (CDPH) and Stanislaus County Health Department of a definite Hospital Acquired Legionnaires Disease (HA-LD) (a disease caused by a bacteria which can contaminate health care facility water systems. It is usually spread by breathing in water mist that contains the bacteria). An effective system was not put into place to monitor whether or not point of use filters were properly installed in patient care areas to control the source of Legionella. Education of staff and patients as well as signs posted at sinks to restrict water use were not implemented for areas of the hospital at greater risk of Legionella, such as the Emergency Department and the Hemodialysis (Hemodialysis is the mechanical process of removing excess water and toxins from the blood in people whose kidneys can no longer perform these functions naturally) unit. The Infection Control Officer did not intervene in a timely manner to prevent the room change of 22 of 22 oncology patients (Patients 4, 5, 14, 15, 16, 17, 21, 23, 31, 32, 33, 34, 36, 37, 38, 39, 40, 41, 42, 43, 44) who were transferred to a patient care area that did not have point of use filters. The oncology patients showered and used faucets for tooth brushing against the hospital procedure to restrict water use for these identified high-risk patients. The oncology patients were not educated and cautioned against the use of showers and use of faucets.

2. A Registered Nurse (RN) did not wear a gown or gloves in a "Contact Isolation" (designed to reduce the risk of transmission of infectious agents, which can be spread directly or indirectly by contact with the patient or the patient's environment) room;

3. A visitor did not wear gloves when in an "Enhanced Contact Isolation" (isolation designed to reduce the risk of transmission of infectious agents, primary found in diarrhea) room;

4. A visitor did not wear gloves when in a "Contact Isolation" room;

5. Tape and tape residue was on the floor of the operating room;

6. Temperature and humidity were not monitored daily in the Cardiac Catheterization procedure rooms and storage area;

7. Staff responsible for the turnover cleaning of operating rooms did not know the correct contact time for disinfectant products;

8. Terminal cleaning was not performed in the endoscopy processing room and procedure rooms;

9. The manufacturer's guideline for use of sterile (free from germs) water for irrigation (process of washing with a continuous flow of water or medicine) was not followed; and

10. An isolation "basket" was placed on a chair outside of a patient's room.

These failures had the potential to expose patients, staff, and visitors to disease causing organisms that could lead to illness.

Findings:

1. A letter dated 10/23/18 from CDPH Healthcare Associated Infections (HAI) unit referenced Patient 1 (Calredie - California Reportable Disease Information Exchange #4998886) and indicated " ...This case meets the definition of a definite HA-LD case..." The letter outlined comments and recommendations that included: " ...Complete environmental assessment conducted by a qualified consultant including water testing on the floor where patient resided. In situations such as these, we recommend consultation by an individual who is experienced in investigations of HA-LD. We have reviewed the results of your routine water samples submitted on July 17, 2018 and your water samples submitted August 1, 2018 as part of this investigation. We are pleased to see that there is ongoing routine monitoring of water cultures. Findings of concern: Small numbers of Legionella sp., non-pneumophila, in samples obtained on July 17, 2018 and of L. pneumophila serogroup 1 in Room 2325, pre-flush, on August 1, 2018. When an HA-LD case has occurred in a facility, other patients are potentially exposed and at risk for developing Legionnaire's Disease; therefore even small numbers are of interest ...Note below the CDC Considerations When Working with Legionella Consultants, which we have provided directly to [Hospital Corporate Name] personnel. Avoid potable water use and consider using point-of-use (POU) filters on showers on the unit(s) where the case patient resided. We have reviewed this facility's Water Management Plan, last revised 3/16/2018. We would like to see more specific information in this plan. Centers for Medicare and Medicaid (CMS) memo requires a water management plan in hospitals and nursing homes. (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-30.pdf). Other documents that may be helpful to the facility in refining their Water Management Plan: CDC Water Management Toolkit; The Department of Veterans Affairs has a healthcare-specific document on prevention of healthcare- associated Legionella (https://www.cdc.gov/legionella/resources/guidelines.html). See also the July 27, 2018 follow up.CDC Considerations When Working with Legionella Consultants: https://www.cdc.gov/legionella/wmp/consultant-considerations.html..."

On 12/10/18 at 3:40 p.m., during an interview, the Chief Executive Officer (CEO), Interim Director of Quality and Safety (IDQS) and Regional Plant Operations Director (RPOD) stated they were aware of the letter dated 10/23/18 from CDPH HAI public health officer. The CEO and Quality Director were aware Patient 1 was identified as a definite case of HA-LD. The CEO stated the hospital was aware of the recommendations stipulated on the letter and had embarked on completing a water system assessment and patient risk assessment as well as using POU filters. The CEO stated the hospital had formed a committee to address the HA-LD and the assessment of the water system plan. The name of the committee was the Water System Team and its members were the CEO, IDQS, Infection Control Medical Director (ICMD) (a doctor specializing in infection control) , Infection Preventionist (IP), RPOD. The CEO stated the hospital had evaluated all areas of the hospital water system for risk of Legionella and evaluated patient care areas for risk to contract LD. The CEO stated areas of high risk in the hospital were equipped with filters and faucets without filters had signs indicating for "handwashing only". The CEO indicated the signs were meant to restrict water use at point of use faucets and drinking water at the faucets was not permitted.

A review of the facility record titled, "Risk Assessment-Potable Water" dated 12/12/18, indicated "...This risk assessment is derived from possible/potential risks identified at (name of hospital)...Any items score of more than 4 or higher is considered highest risk and necessitates the use of "point-of-use" filter..." The Hemodialysis Unit had a total risk score of "5".

On 12/10/18 at 2:22 p.m., during a concurrent observation and interview in the hemodialysis unit, RN 1 stated filters were placed on the faucets in the dialysis unit about two to three weeks ago to prevent the spread of the Legionella bacteria. A sink labeled "dirty sink" was observed to have a filter placed to the left side of the sink, it was not attached to the faucet. RN 1 stated the filter had fallen off and the department staff was waiting for the filter to be reattached. RN 1 was unable to provide a date when the faucet was first without a filter. RN 1 stated there was no active program to monitor whether or not the POU filters were placed properly. RN 1 stated there was no active program to educate patients and staff to restrict use of water.

On 12/12/18 at 10 a.m., during an interview, the Manager of Renal/Telemetry/Dialysis (MRTD) stated there was no work order placed to fix the faucet with the detached filter. The MRTD stated his expectation was for the staff to put in a work order when it fell off. The MRTD stated the importance of getting the filter placed on the faucet is to prevent anyone from drinking the water from that faucet and being exposed to Legionella. The MRTD was unable to identify the date or timeframe for how long the sink faucet was without a filter. MRTD stated the POU filters were not monitored for placement and there was no active program to educate patients and visitors regarding the restriction of water use at faucets.

On 12/10/18 at 1:20 p.m., during a concurrent observation and interview in the ED, the Emergency Department Manager (EDM) and Director of Patient Care Services (DPS) validated the restrooms in the lobby did not have POU filters on the sinks; and D Pod (patient care unit within the ED) bathrooms did not have filters on the sinks and no signage to indicate "For hand washing only".

On 12/10/18 at 1:30 p.m., during an interview, the DPS stated the lobby bathrooms' plumbing was different than the rest of the ED and filters were not needed in that area. The EDM and DPS stated the ED department did not have a program to monitor water use from sinks in any area of the ED and no monitoring of placement of the filters. The EDM and DPS stated there was no active program to educate patients and visitors regarding water use restriction.

On 12/10/18 at 1:35 p.m., the EDM stated the bathrooms located in D Pod should have had a filter or signage but they did not. The EDM stated she cannot ensure the ED filters are always in place because there was not a monitoring process to ensure placement of the filters or signs.

On 12/10/18 at 4:03 p.m., during an observation and concurrent interview in the Pediatric Unit (a unit for children up to and including age 13) located on the 4th floor, South Tower, there were no POU filters on three of three sinks (patient room 4303, nursing station, and a nourishment (a room for food) room. The Assistant Manager of Oncology (AMO) indicated that due to low census the adult oncology patients were relocated to the pediatric unit for staffing purposes on 11/26/18. The AMO stated most of the South Tower was affected by the HA-LD plan and the Pediatric Unit was graded as low risk and did not need POU filters. The Assistant Manager of Pediatrics (AMP) stated staff educated pediatric patients not to swallow the water when brushing their teeth. The AMP stated the Pediatric Unit and pediatric patients were identified as low risk for HA-LD, so water filters and signs over sinks indicating "handwashing only" were not required. The AMP stated "...We don't drink out of it [water faucet] ..." The AMP stated the expectation is that water is obtained from the ice machine water dispenser. Neither the AMP or the AMO were able to provide a hospital policy which supported the expectation of the water to come from the ice machine water dispenser. The AMP indicated pediatrics patients were not allowed to take a shower.

On 12/11/18 at 9:10 a.m., during a concurrent observation and interview in the Pediatric Unit, the AMO indicated the Pediatric Unit was not identified as a high risk unit for HA-LD. The AMO indicated oncology patients were considered high risk. The Manager of Pediatrics (MP) stated oncology patients were moved to the Pediatric Unit two weeks ago on 11/26/18 per the hospital's surge (influx of patients) policy. The MP indicated the consolidation of two patient populations (pediatrics and oncology) was due to the hospital's low census. The MP stated there was not an infection control meeting to discuss the move prior to moving oncology patients. The AMO stated that the risk assessment for HA-LD was based on two things-water quality and patient-specific risk factors.

On 12/11/18 at 9:35 a.m., during a concurrent observation and interview in the Pediatric Unit, Patient 23 (an adult oncology patient) stated "...I use the sink water to brush my teeth..." Patient 23 stated she independently showered and bathed on the unit. Patient 23 stated she also received a bed bath. Patient 23 stated she used the sink to brush her teeth. There was no POU filter on the faucet in Patient 23's room. The sink had a sign indicating "for handwashing only; do not drink." Patient 23 stated she was unaware of the restricted use of the water from the faucet or shower. Patient 23 was unaware she should not have showered.

The clinical record for Patient 23 indicated an admission to the hospital and located in the Pediatric Unit. Patient 23 was admitted with diagnoses of atrial fibrillation (irregular rapid heart rate), chronic idiopathic thrombocytopenia (abnormally low blood cells that function to clot blood), and lymphoma (cancer of the system affecting immunity). Patient 23 was discharged to home on 12/11/18.

On 12/11/18 at 9:40 a.m., during a concurrent observation and interview in the Pediatric Unit with AMO in attendance, Patient 5 (adult oncology patient) stated "...I have not been instructed how to brush my teeth...I can use the shower..." No POU filter was on the faucet, the sink or shower. There was no bottled water on bedside table in Patient 5's room. The AMO stated patients were educated regarding the risk of the transmission of LD. The AMO was unable to explain the transmission of LD and thought if the patient did not aspirate (breathe water into lungs) there was no risk for HA-LD.

The clinical record for Patient 5 indicated an admission to the hospital on 12/10/18 to the Pediatric Unit. Patient 5 was admitted with a diagnosis of metastatic (spread of disease from primary site to secondary site) cancer. Patient 5 was transferred from the Pediatric Unit to the Oncology Unit on 12/11/18.

On 12/11/18 at 11:30 a.m., during an interview, the IDQS stated oncology patients were moved to the Pediatric Unit on 11/26/18. IDQS stated the Oncology Unit was equipped with POU filters because the oncology patients were identified as higher risk for HA-LD. IDQS stated when the oncology patients were transferred to the Pediatric Unit, POU filters were not installed onto faucets or showers in that area.

On 12/11/18 at 2:15 p.m., during concurrent observation and interview in the Pediatric Unit, there was no POU filter on the faucet in Patient 16's room and no bottled water on the bedside table. Patient 16 (an adult oncology patient) stated "...I brush my teeth at the sink..." Patient 16 stated he was unaware the sink faucet was for handwashing purposes only.

The clinical record for Patient 16 indicated an admission to the hospital on 11/29/18 to the Pediatric Unit. Patient 16 was admitted with diagnoses of lymphoma (tumor in lymph nodes) of the gastrointestinal tract, anemia (low red blood cells), pleural effusion (excess fluid in the space around the lung), respiratory distress (difficulty breathing), and sepsis (life-threatening body response to infection). Patient 16 was transferred from the Pediatric Unit to the Oncology Unit on 12/11/18.

On 12/11/18 at 2:30 p.m., during concurrent observation and interview in the Pediatric Unit, Patient 15 (an adult oncology patient) stated she did not take showers, but had bed baths. Patient 15 stated she brushed her teeth by using water from the faucet in a container. Patient 15 stated she brushed her teeth in this manner until yesterday (12/10/18) when the staff told her to use bottle water. During an interview, V (patient 15's visitor who stated she visited around the clock-24 hours a day, 7 days a week) stated the first education regarding restricting use of the faucet water occurred 12/10/18. V indicated prior to yesterday (12/10/18), the faucet and sink were used for brushing teeth. There was no POU filter on sink. The sink had a sign indicating, "for handwashing only; do not drink" above the sink in the room.

The clinical record for Patient 15 indicated an admission on 11/2018 to the Oncology Unit. Patient 15 was admitted with diagnoses of metastatic breast cancer, metastasis to spinal column, and pleural effusion. Patient 15 was transferred to the Pediatric Unit on 11/26/18. Patient 15 was transferred back to the Oncology Unit on 12/11/18.

On 12/11/18 at 3:40 p.m., during an group interview conducted in the hospital conference room, the following staff were present: CEO, the ICMD, the IDQS, DPS, DPO, and ICP. The topic of discussion was to clarify the hospital decision to transfer oncology patients to the Pediatric Unit on 11/26/18. The CEO stated he was aware of the transfer of oncology patients from the Oncology Unit to the Pediatric Unit on 11/26/18. The IDQS stated the total number of oncology patients cared for on the Pediatric Unit between 11/26/18 and 12/11/18 was 23. The CEO and others in the group interview stated they were aware the oncology patients were considered high risk for HA-LD. The CEO stated he was aware the Oncology Unit was equipped with POU filters and the Pediatric Unit was not. The CEO stated he was aware the rationale for the transfer was communicated as implementing the hospital's surge plan and high ED census. The CEO stated the hospital was not in high ED census and the triggers for the hospital surge should not have been implemented. The CEO stated the hospital should not have implemented their surge plan and should not have transferred the oncology patients to the Pediatric Unit which was not equipped with POU filters. The CEO indicated to consolidate resources, the oncology patients were moved to the Pediatric Unit. The CEO stated, "...We missed it, the buck stops with me..." The CEO indicated the oncology patients were being physically repatriated (moved back) to the oncology unit during the current interview. The oncology unit had POU filters on the faucets and showers. The CEO stated "...It was a mistake; I am sick to my stomach about it..." The CEO stated the hospital staff did not have a plan to educate patients and visitors regarding restricted water use for Legionella and did not have an effective plan to monitor the placement of POU filters.

The clinical record of the following oncology patients who were cared for in the Pediatric Unit were reviewed: Patients 4, 14, 17, 21, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43 and 44.

The clinical record for Patient 4 (an adult oncology patient) indicated an admission to the hospital on 12/6/18 to the Pediatric Unit. Patient 4 was admitted with diagnoses of metastatic small cell lung cancer with metastases (spreading) to the brain and bone and a pathological fracture of vertebra (a break caused by the disease to the bones around the spine). Patient 4 was transferred to the Oncology Unit on 12/11/18.

The clinical record for Patient 14 (an adult oncology patient) indicated an admission to the hospital on 12/9/18 to the Pediatric Unit. Patient 14 was admitted with diagnoses of atrial fibrillation (rapid irregular heartbeat), malignant neoplasm (cancer) of lower lobe of lung, pancytopenia (low number of blood cells), type 2 diabetes mellitus (metabolic disorder that leads to high blood sugars), chest pain, and chemotherapy induced neutropenia (treatment causing low white blood cells). Patient 14 was transferred to the Oncology Unit on 12/11/18.

The clinical record for Patient 17 (an adult oncology patient) indicated an admission to the hospital on 12/4/18 to the Pediatric Unit. Patient 17 was admitted with diagnoses of acute myeloid leukemia (blood cancer) not having achieved remission, pancytopenia, and right pleural effusion. Patient 17 was discharged to home from the Pediatric Unit on 12/10/18.

The clinical record for Patient 21 (an adult oncology patient) indicated an admission to the hospital on 11/27/18 to the Pediatric Unit. Patient 21 was admitted with diagnoses of ovarian (female reproductive organ) cancer, paranoid schizophrenia (a chronic mental disorder), brain metastases, and palliative care. Patient 21 was discharged to home from the Pediatric Unit on 12/11/18.

The clinical record for Patient 31 (an adult oncology patient) indicated an admission to the hospital on 11/18/18 to the Oncology Unit (a unit specializing in cancer). Patient 31 was admitted with diagnoses of metastatic breast cancer stage 4 with metastases to the bones, liver and lymph nodes and septic shock (a widespread infection). Patient 31 was transferred to the Pediatric Unit on 11/26/18. Patient 31 was discharged from the Pediatric Unit on 11/29/18.

The clinical record for Patient 32 (an adult oncology patient) indicated an admission to the hospital on 11/20/18 to the Oncology Unit. Patient 32 was admitted with diagnoses of metastatic cancer to brain and prostate cancer metastatic to multiple sites. Patient 32 was transferred to the Pediatric Unit on 11/26/18. Patient 32 was discharged to home from the Pediatric Unit on 11/30/18.

The clinical record for Patient 33 (an adult oncology patient) indicated an admission to the hospital on 11/27/18 to the Pediatric Unit. Patient 33 was admitted with diagnoses of diabetes mellitus, adenocarcinoma (a cancerous tumor), sepsis, obstructive pneumonia (infection of the lung), malignant pleural effusion and palliative care (care focused on improving quality of life with serious illness). Patient 33 was discharged to home from the Pediatric Unit on 12/08/18.

The clinical record for Patient 34 (an adult oncology patient) indicated an admission to the hospital on 11/27/18 to the Pediatric Unit. Patient 34 was admitted with diagnoses of chronic obstructive pulmonary disease exacerbation (lung disease causing shortness of breath), home oxygen therapy, squamous cell carcinoma of left lung, congestive heart failure, bronchitis (swelling of the tubes letting air in and out of the lungs), and palliative care. Patient 34 was discharged to home from the Pediatric Unit on 12/09/18.

The clinical record for Patient 35 (an adult oncology patient) indicated an admission to the hospital on 11/27/18 to the Pediatric Unit. Patient 35 was admitted with a diagnosis of metastatic cancer. Patient 35 was discharged to home from the Pediatric Unit on 11/28/18.

The clinical record for Patient 36 (an adult oncology patient) indicated an admission to the hospital on 11/28/18 to the Pediatric Unit. Patient 36 was admitted with a diagnosis of malignant neoplasm (tumor) of central portion of right breast. Patient 36 was discharged to home from the Pediatric Unit on 11/29/18.

The clinical record for Patient 37 (an adult oncology patient) indicated an admission to the hospital on 11/29/18 to the Pediatric Unit. Patient 37 was admitted with diagnoses of cancer of right breast, metastatic to brain, wound of right breast, and acute encephalopathy (brain dysfunction). Patient 37 was discharged to home from the Pediatric Unit on 12/06/18.

The clinical record for Patient 38 (an adult oncology patient) indicated an admission to the hospital on 11/29/18 to the Pediatric Unit. Patient 38 was admitted with diagnoses of esophageal (muscular passage connecting stomach to mouth) cancer. Patient 38 was discharged to home from the Pediatric Unit on 12/06/18.

The clinical record for Patient 39 (an adult oncology patient) indicated an admission to the hospital on 12/4/18 to the Pediatric Unit. Patient 39 was admitted with diagnoses of malignant neoplasm of urinary bladder and pleural effusion. Patient 39 was discharged to home from the Pediatric Unit on 12/04/18.

The clinical record for Patient 40 (an adult oncology patient) indicated an admission to the hospital on 12/4/18 to the Pediatric Unit. Patient 40 was admitted with diagnoses of chronic obstructive pulmonary disease, metastatic bone cancer, metastatic lung cancer, brain metastasis, acute encephalopathy and leukocytosis (increased white blood cells indicating infection). Patient 40 was discharged to home from the Pediatric Unit on 12/10/18.

The clinical record for Patient 41 (an adult oncology patient) indicated an admission to the hospital on 12/5/18 to the Pediatric Unit. Patient 41 was admitted with a diagnosis of abnormal uterine (womb) bleeding. Patient 41 was discharged to home from the Pediatric Unit on 12/06/18.

The clinical record for Patient 42 (an adult oncology patient) indicated an admission to the hospital on 12/5/18 to the Pediatric Unit. Patient 42 was admitted with a diagnosis ductal carcinoma in situ of right breast (abnormal cells in the milk duct). Patient 42 was discharged to home from the Pediatric Unit on 12/06/18.

The clinical record for Patient 43 (an adult oncology patient) indicated an admission to the hospital on 12/6/18 to the Pediatric Unit. Patient 43 was admitted with diagnoses of chronic lymphocytic leukemia (cancer that begins in the lymphocytes and moves to blood), respiratory failure and pneumonia (lung infection). Patient 43 was discharged to home from the Pediatric Unit on 12/07/18.

The clinical record for Patient 44 (an adult oncology patient) indicated an admission to the hospital on 12/6/18 to the Pediatric Unit. Patient 44 was admitted with a diagnosis of status post bilateral mastectomy (surgical breast removal). Patient 38 was discharged to home from the Pediatric Unit on 12/06/18.

A review of The Center for Disease Control's (CDC) document titled, "Guidelines for Environmental Infection Control in Health-Care Facilities" dated 2003, indicated " ...2. Waterborne Infectious Disease in Health-Care Facilities ...a. Legionellosis ...Patient population at greatest risk ....immunosuppressed patients (e.g., transplant patients, cancer patients ...4. Strategies for Controlling Waterborne Microbial Contamination ...d. Preventing Legionnaires Disease in Protective Environments ...Additional infection-control measures to prevent exposure of high risk patients to waterborne pathogens ...Restrict patients from taking showers if the water is contaminated with Legionella ...Provide sterile water for drinking, tooth brushing, or for flushing nasogastric tubes ..."
The hospital policy and procedure titled, "High Census Protocol/Surge Plan (Maximum Admission Capacity)" dated 7/16 indicated "Purpose: A. To maintain quality, safety and appropriateness of patient care in the event of insufficient inpatient beds:...Policy: A. Steps will be taken immediately whenever it is determined that (name of hospital) has reached maximum admission capacity which is defined by any of the following:...1. All (available) inpatient/or specialized beds are occupied by patients...2. Staff...is at or below minimum staffing criteria. 3.Emergency Department is unable to hold inpatients waiting...Definitions: A: High Census: When there are limited beds in house or nursing staff on established units...C. Plan for implementing this High Census Protocol include the following steps:...2. A physical inspection will be conducted of all patient care units by the Administrative Supervisor/Department Manager/Incident Command designee..."

A document titled, "Risk Assessment - Potable Water" dated 12/11/18 indicated patient locations on left hand of grid and the probability, severity, risk and relative threat to patients across the top of the grid. The Risk Assessment indicated "This risk assessment is derived from possible/potential risks identified at (name of hospital). The average risk score is 2. Any item scoring more than 4 or higher is considered highest risk and necessitates the use of "point-of use" filters..."

A letter from Centers for Medicare & Medicaid services dated 6/2/17 indicated "...Facilities must develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduce the risk of growth and spread of Legionella and other opportunistic pathogens in water..."

A letter from Dr. Rosenberg, Public Health Medical Officer dated 10/23/18 indicated "...Avoid potable water use and consider using point-of-use (POU) filters on showers on the unit(s) where the case patient resided..."

2. On 12/11/18 at 2:10 p.m., during an observation outside of Patient 12's room, an RN was observed in the room with a N95 mask (respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles). The RN did not have a gown or gloves on.

On 12/11/18 at 2:32 p.m., during a concurrent interview and record review, RN 4 stated Patient 12 had a physician's order for airborne, contact, and droplet isolation.

The hospital policy and procedure titled, "Isolation Guidelines: Overview of Isolation Guidelines, Standard and Transmission-Based Precautions" dated 7/16, indicated "Purpose: A. To provide guidance in the use and application of the Isolation Guidelines ...Scope: A. All (name of hospital) personnel, physicians, licensed independent practitioners, contract service workers, volunteers, students, and visitors ...Policy ...C. Transmission-Based Precautions are designed to prevent transmission of infectious diseases known to be transmitted by the AIRBORNE, DROPLET OR CONTACT routes ...Procedure ...C. Airborne Precautions ...4. Personal Protective Equipment (PPE) ...a. Wear respiratory protection ...E. Contact Precautions ...4. Personal Protective Equipment (PPE) ...a. Gloves ...b. Gown ..."

3. On 12/11/18 at 9 a.m., during a concurrent observation and interview outside of Patient 11's room, a visitor was observed in the room wearing a yellow gown and no gloves. RN 2 stated Patient 11 was on "Enhanced Contact Precautions" to rule out "C Diff" (Clostridium difficile- a bacterial infection of the large intestine). RN 2 stated for patients that are on enhanced contact precautions, staff and visitors are expected to wear a gown and gloves and perform hand washing with soap and water. RN 2 stated the visitor in Patient 11's room did not have gloves on. RN 2 stated the importance of wearing a gown, gloves and performing hand hygiene with soap and water is for the protection from the organism in the isolation room.

On 12/13/18 at 11:44 a.m., during an interview, the Director of Renal/Telemetry/Ortho/Trauma/Surgical (DRTOTS) stated her expectation is when patients are on isolation precautions, visitors are to apply PPE before entering the room. The DRTOTS stated the importance of following the isolation precautions is for the protection from infection.

A review of Patient 11's clinical record indicated Patient 11 had a physician's order for Enhanced Contact Precautions.

The hospital policy and procedure titled, "Isolation Guidelines: Overview of Isolation Guidelines, Standard and Transmission-Based Precautions" dated 7/16, indicated "Purpose: A. To provide guidance in the use and application of the Isolation Guidelines ...Scope: A. All (name of hospital) personnel, physicians, licensed independent practitioners, contract service workers, volunteers, students, and visitors ...Policy ...C. Transmission-Based Precautions are designed to prevent transmission of infectious diseases known to be transmitted by the AIRBORNE, DROPLET OR CONTACT routes ...Procedure ...F. Enhanced Contact Precautions ...1 ...c ...Health care providers and visitors entering the patient room will wear gloves and gowns before touch the patient, environment, or equipment ..."

4. On 12/11/18 at 9:13 a.m., during a concurrent observation and interview outside of Patient 22's room, a visitor was observed in the room wearing a yellow gown and no gloves. RN 3 stated Patient 22 was on contact isolation for MRSA (methicillin-resistant Staphylococcus aureus) (a bacterium with antibiotic resistance) of the wound. RN 3 stated visitors are supposed to wear a gown and gloves when in a patient's room with contact precautions. RN 3 stated the visitor in Patient 22's room did not have gloves on. RN 3 stated the importance of wearing gloves is to protect the patient, family members, and others from infection.

On 12/13/18 at 9:48 a.m., during an interview, the Manager of Renal/Telemetry/Dialysis (MRTD) stated visitors are expected to follow the same precautions as staff when they are in a patient's room. The MRTD stated the importance of wearing the PPE is to prevent the spread of infection into the community.

On 12/13/18 at 11:44 a.m., during an interview, the DRTOTS stated her expectation is when patients are on isolation precautions, visitors should apply the PPE before entering the room. The DRTOTS stated the PPE for contact isolation is a gown and gloves. The DRTOTS stated the importance of wearing a gown and gloves is for their protection from infection.

A review of Patient 22's clinical record indicated Patient 22 had a physician's order for contact precautions.

The hospital policy and procedure titled, "Isolation Guidelines: Overview of Is