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Based on observation, interview, and record review, the facility did not meet the condition of participation (CoP) for Governing Body by failing to:

1. Oversee the facility plan for addressing Legionella outbreak including: following recommendations of the Public health department; and implementing Center for Disease Control (CDC) guidelines in surveillance of the facility; and monitor the safe and effectiveness of the water management plan. (See A 747).

2. Assure a contractual agreement with the water management company conducting the water management plan, and to assure the facility had a method to monitor the company's services for safety, effectiveness, and Quality assurance. (See A 084; A 747)

3. Have an ongoing Quality Assessment Performance Improvement (QAPI) program that had implemented studies that monitored: the recommendations for Legionella outbreak; services provided by the water management company; Infection including: incorporating the water management plan; legionella outbreak; and the water management company as contracted Hemodialysis Services at Hospital A and Hospital B. (See A 263)

4. Maintain equipment to ensure the safety of the patients. The facility staff failed to: monitor for the presence of Legionella bacteria from ice machines; ensure filters on ice machines were appropriate membrane rating, to prevent passage of Legionella bacteria into the ice and drinking water and ensure the filters were changed on a quarterly basis per the facility's Utility Water Safety Management Plan. (See A 700)

5. Coordinate and oversee hospital wide infection control program including: Implementing an infection control program that followed acceptable standards of practice for overseeing the Sterile Processing Department (SPD); assure the facility followed recommendations of the Acute Communicable Disease Control and Centers for Disease Control and Prevention (CDC) guidelines, when implementing a remediation and water management plan to address the Legionella outbreak at the facility. (See A 747)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe and sanitary environment.

Based on observation, interview and record review, the governing Body failed to:

1. Provide a contract agreement for the services provided by the water management company.

2. Oversee and monitor the contracted company's services, including the Legionella Management plan, validation service, and Quarterly Legionella Analytical Sampling, in order to ensure the services were conducted in a safe and effective manner.

Findings:

A review of the facility's Contracted Services indicated the water management company was not included in the contracted services. A review of the Water Management reports and plan for the facility indicated the water management company provided services in 2016 that included reports regarding Quarterly Legionella Analytical Resampling on 3/29/16,7/25/16, and 1/16/17; Quarterly Legeonella Analytical Sampling on 6/2016, 10/11/16, and 12/27/2016; Quarterly Legionella Analytical Sampling on 3/2016; and, Utility Water Safety Management Plan program validation October -December 2016.

On 1/25/17 at 3:50 p.m., during an interview, the Regulatory Services manager was asked to provide the facility's contract agreement with the water management company, documentation of how the company was monitored, and Quality Assurance Performance Improvement (QAPI) evaluation for the services the company provided. The Regulatory Services manager indicated the facility did not have a contractual agreement with the water management company, and did not have any documentation of how the facility monitored quality assurance for the company's services. The manager further indicated that the company's services were rendered through purchase orders.

The Director provided a document and indicated the document was the purchase order for the services provided by the water management company. The undated document, titled, "[Company Name] Program Cost Summary - [Facility Name]", indicated that the water management company would, "Develop an effective management plan" ... and "[Provide] a safe environment." The document also indicated that the company's services included, "Legionella Management Plan Validation service, Quarterly Legionella Analytical Sampling", and "Utility Water Safety Management Plan Program". There was no contractual agreement between the facility and the water management company.

Based on record review and interview, the facility did not meet the condition of participation (CoP) for quality assessment and performance improvement (QAPI) program by failing to:

1. Monitor services, effectiveness, and quality assurance of the water management company. (See A 273)

2. Implement a plan to evaluate the facility's plan to address the Legionella outbreak including risk assessment; following Centers for Disease Control and Prevention (CDC) guidelines and Acute Communicable Disease Control recommendations and the facility Water Management plan. (See A 283)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe and sanitary environment.

Based on interview and record review the facility failed to monitor services, effectiveness, and quality assurance of the water management company.

Findings:

During an interview with the director of QAPI on 1/25/17 at 11:45 a.m. when asked for the quality assurance and performance improvement (QAPI) plan for evaluating and monitoring the facility plan for addressing the Legionella outbreak she indicated there were no QAPI studies. She indicated there were no QAPI studies for the water management company. She indicated there were no QAPI studies monitoring the effectiveness of the water managment plan or the risk assessment for Legionella.

During a review of the facility Policy and Procedure titled, "Quality Management program Description 2016" indicated "[Facility Name] is responsible for the oversight and monitoring of quality improvement activities ...ensure the provision of appropriate, safe, and effective care" and "[Facility Name] evaluates the performance of quality activities of the Contracting Parties" and "[Facility Name] Board of Directors has ultimate accountability and responsibility for the accessibility, quality of care and service provided to members"

Based on interview and record review, the facility failed to implement a plan to evaluate the facility's plan to address the Legionella outbreak including risk assessment; following Centers for Disease Control and Prevention (CDC) guidelines and Acute Communicable Disease Control recommendations and the facility Water Management plan.

Findings:

During an interview with the director of QAPI on 1/25/17 at 11:45 a.m. when asked for the quality assurance and performance improvement (QAPI) plan for evaluating and monitoring the facility plan for addressing the Legionella outbreak she indicated there were no QAPI studies. She indicated there were no QAPI studies for the water management company. She indicated there were no QAPI studies monitoring the effectiveness of the water managment plan or the risk assessment for Legionella.

During an interview with the Infection Control (IC) director on 1/25/17 at 1:30 p.m., when asked if risk assessment surveillance resulted in filters being placed anywhere else in the hospital besides the emergency department (ED) she indicated no filters were placed on faucets or sinks anywhere else in the hospital. When asked if she could provide documentation of meetings with the Governing body the Medical executive committee, the legionella out break and plans that were implemented including the water management plan she indicated there were none. There was no documentation for review of a policy and procedure for the water management plan or meeting minutes documenting approval for the water management company to participate in the water managment plan.

During a review of the facility Policy and Procedure titled, "Quality Management program Description 2016" indicated "[Facility Name] is responsible for the oversight and monitoring of quality improvement activities ...ensure the provision of appropriate, safe, and effective care" and "[Facility Name] evaluates the performance of quality activities of the Contracting Parties" and "[Facility Name] Board of Directors has ultimate accountability and responsibility for the accessibility, quality of care and service provided to members"

The hospital must be maintained to ensure the safety of the patient. Based on observations, interviews, and record reviews, the facility failed to maintain equipment to ensure the safety of the patients. The facility staff failed to:

1) Provide a sanitary environment in order to prevent/control infections and communicable diseases (Refer to A747/Infection Control).

2.) Monitoring for the presence of Legionella bacteria from ice machines.

3.) Ensure filters on ice machines were appropriate membrane rating, to prevent passage of Legionella bacteria into the ice and drinking water.

4.) Ensure the filters were changed on a quarterly basis per the facility's Utility Water Safety Management Plan.

(See A724)

Based on observation, interview, and document review the facility staff failed to ensure equipment was maintained to ensure an acceptable level of safety and quality during a Legionella outbreak by 1) not monitoring for the presence of Legionella bacteria from ice machine including ice machines located in the Emergency Room (ED), 2) Ensure that the filters on the ice machines were appropriate membrane rating, in order to prevent passage of Legionella bacteria into the ice and drinking water, and 3) failed to ensure the filters were changed on a quarterly basis, per the facility's Utility Water Safety Management Plan.

Legionella is a type of bacteria found in water and moist places, such as soil and man-made water systems, including hot tubs, fountains, cooling towers and large scale plumbing systems. Legionella bacteria can cause illness, especially in an immuno-compromised population (people who have underlying conditions that make them especially vulnerable to bacteria-borne illnesses).

Findings:

1.) On 1/23/17 between 10:35 a.m. and 10:45 a.m., there were functioning ice machines in the pantry rooms 2231 and 2429 in the Emergency Department (ED). Both ice machines had a pre filter and primary filter.

On 1/24/17 at 11:15 a.m., during an interview the Chief Operating Officer (COO) stated that no filtration for Legionella was in place on the ice machines because tests for Legionella were conducted at the water main. That there was no concern for Legionella at the ice machines based on the facility's assessment. That tests from water branch lines providing water to ice machines had not come back positive for Legionella. That the ice machines were not found to be a concern during the facility's assessment. That he did not know why the potable water for the sinks was a concern for Legionella, while the potable water for the ice machine was not since they were both supplied by the same water branch lines.

Review of the facility's Utility Water Safety Management Plan Program Validation Report dated January 2017 indicated that no improvements on the current systems were necessary. The Report also included a table (page 11) summarizing the tasks planned for 2016, that included Quarterly Ice Machine Legionella Sampling for March, June, September, and December.

Review of analysis reports for water samples, taken from 3/3/16 to 1/6/17, did not indicate that water samples were obtained for cultures from any ice machine.

2.) On 1/25/17 at 9:30 a.m., the Director of Facilities Services stated that 3 ice machines located in the N.E pantry room 6537, S.E. pantry room 3354, and N.W. Cardio Cath N. station B room 3604, had 0.5 micron filters as their primary filters.

That the other 28 ice machines located throughout the hospital including the 3 ice machines in the Emergency Department (ED) and 1 in 4 North had 1.0 micron filters as their primary filters.

On 1/25/17 at 10:30 a.m., the Regional Practice Specialist stated that the facility had changed ice machine primary water filters based on the micron rating of the filters. That they changed from 0.5 micron filters to 1.0 micron filters thinking that they were going in the right direction. That they erroneously thought they were replacing the 0.5 micron filters with 0.1 micron filters, and now realized that they went in the opposite direction by replacing the 0.5 micron filters with 1.0 micron filters.

Review of the filter manufacturers specification sheets indicated that one of the filters was rated as 0.5 micron, and the other filters were rated at 1 (1.0) micron.

On 1/25/17 at 2:13 p.m., the Director of Emergency Services stated that in the ED, the water provided for the patients to drink is supplied from the ice machine located in the clean utility room.

Review of the Ice Machine Maintenance 2016 sheet indicated that the facility had 31 ice machines in house in building 4867 with 3 of 31 ice machines in the ED.

The California Department of Public Health Healthcare-Associated Legionnaires' Disease Investigation Quicksheet dated February 2017, indicates as control measures to avoid tap water for drinking by patients/resident; substitute with bottled water or water collected from a faucet with a point-of -use filter (0.2 micron), and to avoid using ice from ice machine(s) until ice machine culture results are available.

3.) On 1/25/17 at 10 a.m., the Director of Facilities Services stated that the ice machine filters were replaced by a contracted service, as recommended by the manufacturer's specifications, that the 0.5 micron filters were replaced every six months, and that 1.0 micron filters were replaced yearly.

Review of the filter manufacturer's specification sheets did not indicate how often the 0.5 micron filters had to be replaced. The manufacturer's specification for the 1.0 micron filters indicated that the filter must be disposed every 12 months.

Review of the facility's Utility Water Safety Management Plan, dated 2014, indicated for ice machine quarterly service to change filters in Ice machines quarterly.

The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. The condition of participation (CoP) for infection control was not met as evidenced by:

Based on observations, interviews, and record reviews, the facility failed to provide a sanitary environment, and failed to have an active infection control program, in order to prevent, control, and investigate infections and communicable diseases.

These failures placed the patient population at risk for hospital-acquired infections when the facility's infection control program failed to:

1. Ensure the Acute Communicable Disease Control (ACDC) division recommendations were followed during a Legionella outbreak. (Legionella is a type of bacterium that can become a health concern,when it grows and spreads in human-made water systems i.e. showers, faucets, large plumbing systems, and hot water tanks and heaters), especially in an immuno-compromised patient population. The facility failed to ensure filters were placed on all sinks in the Emergency Department (ED), including hand washing sinks and Swivette units (a sink and toilet combination unit. (See A 749)

2. Ensure the bedpan washer hoses on the Swivette units (a sink and toilet combination unit) were capped off, in order to prevent Legionella growth from stagnant water. (See A749)

3. Provide ongoing surveillance for presence of Legionella bacteria on three ice machines in the ED. (See A749)

4. Ensure there was no pooling of stagnant water under the flooring adjacent to the ice machine in the ED Pantry (See A749)

5. Ensure the filters on the ED ice machines were changed on a quarterly basis, per facility policy and procedure. (See A749)

6. Ensure a phlebotomy tray (a tray that contains equipment necessary for obtaining blood samples) was not stored on top of the ice machine in Clean Utility Room 2. (See A749)

7. Ensure signage was posted to alert staff not to administer patients water to drink from the ED Medication Room sink. (See A749)

8. Ensure a filter was placed on the Swivette sink faucet and anteroom sink in Room 6105 in Intensive Care Unit (ICU) West, identified by ACDC as a source of Legionella bacteria. (See A749)

9. Ensure the toilet and shower in Room 7777 in ICU East, identified as a Legionella source, were covered, in order to prevent usage. (See A749)

10. Ensure the Neonatal Intensive Care Unit (NICU- an intensive-care unit specializing in the care of ill or premature newborn infants) environment received frequent, scheduled high-level dusting and terminal cleaning of patient care areas, and ensure terminal cleaning logs were maintained, in order to prevent potential infection in the patient population, and contamination of the NICU environment. (Refer to A749)

11. Ensure that six of six dirty bedside commodes (portable toilets) were not stored in a clean utility storage area of the hospital (Refer to A-0749).

12. Ensure that the ice machine in the ED pantry (Room 2439) that was used for patients, did not contain a black substance that was easily wiped off (Refer to A-0749).

13. Ensure the facility had an effective, active and a systematic infection control surveillance program in place for identifying, investigating, and controlling infections in their Sterile Processing Department (SPD). (Refer to A749)

14. Ensure nine of nine transport carts in the SPD, used to transport clean surgical instruments, did not contain black, brown, blue, pink matter and debris. (Refer to A 749)

15. Ensure the processing and sterilization of surgical instruments in the Sterile Processing Department (SPD) followed nationally accepted standards, by ensuring spotting and staining was not present on multiple instruments in two of two processed surgical trays, (one major and one minor tray) that contained previously cleaned, disinfected and sterilized surgical instruments (Refer to A-0749).

16. Ensure a workspace used to perform high level disinfecting of instruments (a cleaning process performed to complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores), had a method for obtaining temperature and humidity levels (Refer to A-0749).

17. Ensure a SPD staff member performed cleaning and disinfecting of reusable patient instruments, in accordance with one of the National Infection Control Standards the hospital chose to follow (Refer to A-0749).

Because of the facility's failure to ensure appropriate actions were implemented following an outbreak of Legionella (a type of bacteria found in water and moist places, such as man-made water systems that can cause illness, especially in patients who have underlying conditions that make them especially vulnerable to bacteria-borne illnesses), and failure to ensure adequate infection control practices were in place in the Sterile Processing Department, according to nationally recognized standards of practice, the survey team declared an Immediate Jeopardy (IJ) regarding Infection Control on January 23, 2017 at 2:03 p.m., in the presence of the Chief Executive Officer (CEO), Chief Operating Officer (COO), and Chief Nurse Executive (CNE).
On January 25, 2017 at 5 p.m., in the presence of the CNE, CMO, COO, and other senior leadership, the survey team removed the IJ after the survey team verified the submitted corrective action plan was implemented.

The cumulative effect of these systemic problems resulted in the hospital's inability to provide an effective hospital wide Infection Control Program that resulted in the hospital's inability to provide patient care in a safe and effective manner, and in accordance with §482.42 Condition of Participation for Infection Control Services.

Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations.

The facility's infection control program failed to:

1. Ensure the Department of Public Health Acute Communicable Disease Control (ACDC) recommendations were implemented following a Legionella outbreak (according to the Centers for Disease Control and Prevention [CDC], Legionella is a type of bacterium that can become a health concern when it grows and spreads in human-made water systems, like showers and faucets, large plumbing systems, and hot water tanks and heaters). One of the recommendations, to place water filters on all Emergency Department (ED) hand washing sinks, including the Swivette units (a sink and toilet combination unit) in each patient room, was not done for ED rooms 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 23, 25, X-ray room # 1, and Medication room # 2304.

2. Ensure the bedpan washer hoses on the Swivette units in the ED patient rooms were capped off, in order to prevent promotion of Legionella growth from stagnant water.

3. Ensure ongoing surveillance of three ice machines in the ED for the presence of Legionella bacterial growth.

4. Ensure there was no pooling of stagnant water under the flooring adjacent to the ice machine in the ED Pantry.

5. Ensure the filters on the ED ice machines were changed on a quarterly basis, per facility policy and procedure, in order to prevent potential of bacterial growth.

6. Ensure a phlebotomy tray (a tray that contains equipment necessary for obtaining blood samples) was not stored on top of the ice machine in Clean Utility Room 2 in order to prevent cross-contamination.

7. Ensure signage was posted in the ED medication room in order to alert staff not to give patients water from the sink for drinking, and to ensure there were no drinking cups available in the ED Medication Room.

8. Ensure a filter was placed on the Swivette sink and anteroom sink in a patient room in the Intensive Care Unit (ICU) that was identified by the Acute Communicable Disease Control (ACDC) team as a source of Legionella bacteria.

9. Ensure that an ice machine, located in a pantry in the ED (Room 2439) , did not contain a black substance that was easily wiped off.

10. Ensure that six of six commodes (portable toilets) were not found dirty, and were not stored in a clean utility storage area of the ED.

11. Ensure the Neonatal Intensive Care Unit (NICU- an intensive-care unit specializing in the care of ill or premature newborn infants) environment received frequent, scheduled high-level dusting and terminal cleaning of patient care areas, and ensure terminal cleaning logs were maintained, in order to prevent potential infection in the immuno-suppressed patient population, and contamination of the NICU environment.

12. Ensure nine transport carts in the Sterile Processing Department (SPD) that were used to transport clean surgical instruments, did not contain black, brown, blue, pink matter and debris.

13. Ensure the processing and sterilization of surgical instruments followed nationally accepted standards by ensuring there was no spotting and staining on multiple instruments, in two of two processed surgical trays (1 major and 1 minor tray), that contained previously cleaned, disinfected and sterilized surgical instruments).

14. Ensure a workspace used to perform high level disinfecting (a cleaning process performed to complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores) of instruments, had a method for obtaining temperature and humidity levels.

15. Ensure one staff member in the SPD performed cleaning and disinfecting of reusable patient instruments, according to the National Infection Control Standards that the hospital chose to follow.

Findings:

1a) On January 23, 2017 at 10:10 a.m., during a tour of the ED, bedpan washer hoses were observed on the Swivette units in the patient rooms. During an observation in Room 18 with Registered Nurse (RN) 2, she stated the bedpan washers were not used, and that the staff emptied soiled bedpans in the Dirty Utility Room. When the survey team requested that RN 2 test the bedpan washer, a small amount of water dripped out. RN 2 stated she did not realize there was water in the hose.

b) During an observation of ED Room 2408 (Clean Utility Room 1) on January 23, 2017 at approximately 10:30 a.m. with RN 2, a phlebotomy tray (a tray that contains equipment necessary for obtaining blood samples) was observed on top of an ice machine that was used to provide ice and drinking water for patients. RN 2 stated the tray should not be there due to risk of cross-contamination. RN 2 then removed the tray from the room.

2. On January 23, 2017 at 11:40 a.m., an observation was conducted with RN 3 of Room 6105, which was located in Intensive Care Unit (ICU) West, and was identified by the Acute Communicable Disease Control (ACDC) team as a location where one of the patients who tested positive for Legionella had expired.

There were no filters on the faucets of the hand washing sink, Swivette sink, or the anteroom sink. RN 3 was unable to explain why there were no filters.

3. On January 23, 1017 at 10:50 a.m., during an observation of Room 7777 (identified as a Legionella source by ACDC), with the Chief Nurse Executive (CNE), the toilet and shower were not covered as recommended by ACDC, in order to prevent usage. The CNE did not comment during the observation.

4. On January 23, 2017 at 2:50 p.m., during a tour of the Neonatal Intensive Care Unit (NICU- an intensive-care unit specializing in the care of ill or premature newborn infants) with the Neonatal Clinical Director and the Director of Environmental Services, heavy dust was observed on the observation window ledges inside seven of seven patient pods (rooms that contained anywhere from three to six patients), on ceiling vents within the pods, on top of pictures that lined the NICU hallway, and on top of employee lockers that were located adjacent to the hand washing sink at the unit entrance.

During a concurrent interview, the Clinical Director stated there should not be any dust. When questioned regarding how frequently terminal cleaning (thorough cleaning and disinfection of a patient area, including bed, surfaces around the bed, floor, walls, and ceiling vents) was conducted, the Clinical Director responded that terminal cleaning was done a minimum of every other month, and when a patient was moved out of a pod. She then stated it was difficult to clean the ceiling vents, due to potential for the spread of dust and bacteria to other patients in the room. When questioned whether the unit maintained a log regarding terminal cleaning of the NICU pods, the Director of Facility Services stated the facility did not keep terminal cleaning logs.



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5. During an observation/tour of the Emergency Department (ED) and concurrent interviews, on 1/23/17 at approximately 10:30 AM, an observation was made of an ice maker located in a pantry of the ED. The following concerns were identified by the survey team:

- The exterior surface of the ice maker had yellow/brown, thick, spotted matter
- The water/ice drain/drip pan also had yellow/brown staining
- The water/ice tray's grill rack, above the drain/drip pan, contained dried white matter
- The ice maker's drain system located on the drain/drip pan had brown, yellow, black, and green thick matter.
- A portion of the flooring beneath the ice maker was cracked, contained black matter, and was able to be lifted from the floor. Upon lifting the cracked flooring, a puddle of water was released.

The Facility Director (FD) who was present during the observation, indicated that the ice maker should not have been in that condition and that it should have been clean.

During an interview, on 1/21/17 at 11 AM, with Environmental Staff (EVS) 1, she stated that it was her responsibility to clean the ice maker. She also stated that she gets very busy and that ED staff tells her, "Patient rooms are more important and sometimes I don't have time to clean ice maker."

A review of a hospital policy, titled, "Ice Machine Maintenance and Cleaning", revised 10/13, stipulated the following:

"All ice machines shall be cleaned and maintained by Plant Services, Food Services, and Environmental Services (EVS) ...EVS shall be responsible for the daily and as needed exterior cleaning of ice machines, including the drain/drip pan ..."

6. On 1/23/17 at 10:50 AM, an observation was made of a clean utility storage are of the hospital's Emergency Department (ED). Six of six commodes were found to have brown and yellow matter around the seats/vinyl cushions.
During an interview with the ED's Assistant Clinical Director (ACD), she stated that all the commodes were clean. However as she took a closer look at the commodes, she stated that they were all dirty and should not have been in the clean utility room.

7. An observation of the hospital SPD and a concurrent interview with the Interim Department Administrator (IDA) were conducted on 1/24/17 at 1:30 PM. The following concerns were identified:

a) Nine (9) instrument transport carts were identified to have empty bottles of "Sterile Water" placed beneath 9 of 9 transport cart openings and connected to tubing which also connected to the drain, located directly beneath the transport cart base. The IDA stated they used them to collect excess water to drain from the instruments, after they are removed from the washers.
b) Multiple bottles contained black, blue, brown and pink tinged fluid with floating matter at the bottom of the bottle. The IDA was unable to explain what the floating colored matter was.
c) Multiple tubing which connected from beneath the base of the transport cart to the bottle also contained black, blue, brown and pink matter. A white Q-Tip -like swab was provided by the IDA and used to wipe the internal portion of the tubing. Black matter was easily removed and remained on the swab, leaving it black. The IDA was unable to explain what the black matter was. In addition, on the internal surface of one of the tubings, a piece of paper wrapper and a metal surgical device were seen. The IDA cut the tubing open and was able to remove the wrapper and the metal device. IDA stated the metal device was a stylet (a long, thin surgical device) and that they must have fallen from the transport cart and into the tubing.
d) Three (3) transport carts contained various pieces of paper and labels adhered to the top base. The IDA stated that the papers should not have been there and should have been removed prior to placing instruments on transport carts.

During an interview with the IDA immediately following a tour of the SPD, he stated he did not know how long the bottles or tubing had been placed beneath the transport carts but knew it had been a long time. He also stated the SPD did not perform regular changes of the tubing or bottles, and did not have a log to indicate they were performing regular surveillance of the SPD.

An interview was conducted with the Infection Control Manager (ICM), on 1/24/17 at 4:05 PM. The ICM stated that she did not conduct regular surveillance of the hospital's SPD and only conducted rounds two times, maybe 3 times in the last year, in SPD.

A review conducted of a hospital policy titled, "Infection Prevention and Control Committee Authority, Responsibilities, and Functions", revised on 11/16, stipulated to "Develop a system for surveillance, prevention and control of infections ..."

8. During an observation in the SPD, on 1/24/17 at 1:50 PM, staff was asked to open a major and a minor tray. The following concerns were identified upon observation of the surgical instruments:

- The minor tray contained 85 previously sterilized surgical instruments (according to the itemized list of instruments provided by the facility). Approximately 43 instruments contained various concerns such as brown staining (some was removed using white gauze), chipped or peeled surgical instrument identification tape, of various colors.
- The major tray contained 99 previously sterilized surgical instruments. Approximately 50 instruments contained various concerns such as brown staining (some was removed using white gauze), chipped and peeled surgical instrument identification tape of various colors and one instrument contained etching (not from manufacturer).

An interview was conducted with Sterile Processing Technician (SPT 1) , immediately following the inspection of the surgical instruments. SPT 1 stated that the instruments should have been inspected prior to being placed in the sterilizer, and any instruments found to be "rusted" or had brown staining and peeled- off tape, should be removed from use and replaced.

A review of a hospital policy titled, "Sterile Processing Department, Processing of Instruments and Procedure Trays, revised on 7/13", stipulated the following:

" ...All objects to be sterilized must first be thoroughly cleaned to remove all organic matter (blood and tissue) and other residue ...Inspect instruments to make sure they are clean, dry and functioning properly ...Soiled objects shall be returned for decontamination."

A record review of a hospital policy, titled, "Instrument Cleaning and Decontamination, revised on 9/13, and referenced AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, CDC (Centers for Disease Control) Guidelines, AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) Recommendations", stipulated the following:

"Instruments should undergo an inspection for proper function and cleanliness.
1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects

2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

A record review of a document provided by hospital staff, titled, "Key Surgical Identification Tape", from the tape manufacturer, stipulated, " ...Replace when tape starts to discolor, chip, crack or flake ..."

9. An observation in the SPD, in a work area used to perform high level disinfecting of reusable patient instruments and a concurrent interview with IDA, were conducted on 1/24/17 at 2:20 PM. The following concerns were identified:

" There was no method to determine the temperature and humidity in the room.
" There was black matter on the floor and white/grey fuzzy matter in various areas of the room.
" A floor drain contained pieces of paper and white/dark/grey matter.
" The floor and baseboard areas had various yellow matter and white/grey fuzzy matter.
" A blue plastic box used to store batteries, tape and various other small items, contained dried white and dark matter.
" There was red/brown dried matter near the faucet of a large sink, used to clean reusable instruments.

During an immediate interview with the IDA, he stated the room did not contain a method for determining the temperature or humidity of the room.
During a previous interview with the IPM, she stated that the hospital followed the infection control guidelines from AORN, CDC and AAMI.

According to "The CDC Healthcare Infection Control Practices Advisory Committee (HICPAC) Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008,": "All work areas relative humidity should not exceed 70%..."

A review of a hospital policy, titled, "Environmental Surface Cleaning and Disinfection Procedures for Sterile Processing Department (SPD), revised on 7/16 and referenced California Code of Regulation, Title 22 Section 70827(b)(2), California Health and Safety Code, AORN, CDC and AAMI", stipulated the following:

" ...Procedure - Daily. Procedure will be performed once in every 24 hour period that the SPD department is operational ....4. SPD Area (Clean from Top to bottom) ...B. Visually Inspect for dust; ...G. Clean all ventilation faceplates ...
I. Clean baseboards and detail clean along edges of baseboard. G. Dust floor to remove dust and debris ..."

10. An observation in SPD and a concurrent interview with a Sterile Process Technician II (SPT 2) were conducted on 1/24/17 at 2:30 PM. The following concerns were identified:
" SPT 2 stated he was cleaning an ureteroscope (a reusable instrument used for visually examining and passing instruments into the interior of the ureters {tubes made of smooth muscle fibers that propel urine from the kidneys to the urinary bladder}).
" He scrubbed the instrument above the water level.
" The sink had a piece of tape, labeled "X6 GAL", used to mark the water level, was peeled off of the sink.
" The top of the counter and around the rim of the counter were dried white and green matter.
" A wall adjacent to the sink and above the faucet, had a sign, labeled, "Needleholder and wire brush used to clean impacted bone in cannulated items", beneath the sign, a needleholder wired brush was uncovered and hanging from a wall which had dried, brown splashed matter.
During an immediate interview with SPT 2, following the observation, he stated that he was supposed to brush the instrument under the water level and stated that the sink was supposed to be cleaned at the end of each shift.
During an interview with the IDA, who was present during the observation, he was asked if the area around the sink appeared clean and if they kept a log to indicate when it had been cleaned. IDA stated that the area did not appear as if it was cleaned in between each use or the end of the previous shift.
A record review was conducted on 1/24/17 at 5 PM, of a hospital policy titled, "Processing of Instrument and Procedure Trays, revised on 7/13", the policy referenced "Guidelines for Disinfection and Sterilization in Healthcare Facilities AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), ST 79 2006" and stipulated the following:
" " ...The instruments and brush shall remain under water during the manual cleaning process to prevent aerosolization of contaminated water ..."

11. Interviews were conducted with the ICM and the Director of Environmental Services (DES), on 1/24/17 at 4:05 PM, to discuss the observations and concerns identified in SPD by the survey team and to inquire about surveillance in the SPD. The ICM stated that she did not conduct regular surveillance of the hospital's SPD and only conducted "rounds" in the SPD two times, maybe 3 times in the last year. She also stated that environmental services is responsible for cleaning and maintaining the walls, floors, and hand sinks. In addition, she stated that she did not conduct rounds or provide training to staff in SPD to ensure they performed their tasks to standards of care, and that it was the responsibility of the Department Managers.

A review of three documents, titled, "SPD and Endoscope Audit Tool 2015", was conducted on 1/24/17. The documents indicated staff conducted observations/audits of SPD on the following dates:
1. 4/5/16
2. 4/11/6
3. The third document did not contain a date or signature.

No other logs or audit tools were provided.



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12. During the initial tour of the Emergency department (ED), conducted on 1/23/17 at 10:30 a.m., the maintenance due date on the ice machine in the ED pantry was 3/31/16. The water filter had a date of 11/7/16.

During an interview with Registered Nurse 2 on 1/23/17 at 10:35 a.m., she indicated the patients were given water and ice from the ice machine. During an interview with the Director of EVS at the same time, he indicated the ice machine filters were changed on 3/31/16, and no new filters had been placed since then.

An observation and interview with the Director of EVS and Director of Facilities, on 1/23/17 at 9:45 a.m., indicated filters were placed on all faucets in the ED. During the meeting Director of Facilities indicated, besides the ED no filters placed on faucets or showers in any other part of the hospital. Filters were not placed in any other location in the hospital aside from the ED.

On 1/23/17 at 2:55 p.m., a tour of the 4th floor Oncology medical surgical ward indicated there were no filters on any of the faucets or showers in the patient rooms. During an interview with RN 3, she indicated that no filters were placed on any of the faucets or showers.

During an interview with the Chief Operating Officer (COO) on 1/24/17 at 9:30 a.m., he indicated the facility followed the guidelines of Public Health and the Centers for Disease Control (CDC), worked with the water management company on the water management plan and infection control, and that EOC conducted oversight of the surveillance of Legionella. When asked why the ice machines were not tested for legionellae in the ED, the COO indicated the ice machine was not considered high risk. There was no documentation of checking the ice machines in the ED for Legionella. There were no filters placed on wards with immunocompromised patients, including 4 Notrh.

During an interview with the IC director on 1/25/17 at 1:30 p.m., she indicated the ED was reopened after communication with the Public Health regarding that filters had been placed on faucets in the ED. She provided documentation indicating ED rooms 10, 22, and 29 were closed on12/23/16, and reopened 1/5/17. When asked if risk assessment surveillance resulted in filters being placed anywhere else in the hospital besides the ED, she indicated no filters were placed on faucets or sinks anywhere else in the hospital. When asked if she could provide documentation of meetings with the Governing Body, the Medical Executive Committee regarding the legionella out break, and what plans had been implemented, including the water managment plan, the IC director indicated there were none. There was no documentation for review of a policy for the water management plan, or for meeting minutes documenting approval for the water management company to participate in the water managment plan.

A review of the facility policy and procedure titled, "Infection Prevention and Control Committee Authority, Responsibilities and Functions", dated 11/16, indicated the following: "The Medical Executive Committee authorizes the Infection Prevention and Control Committee to develop a system for surveillance, prevention and control of infection; identify and analyze incidences and causes of healthcare acquired infections; assign responsibility for the ongoing data collection and analysis."

A review of the facility policy and procedure, titled, "Infection Prevention and Control Program", dated 6/14, indicated, "Infection Prevention and control program. Assessed to meet CDC guidelines, local/national standards ...Infection Prevention and control program applies to all areas of the hospital."
A review of the facility policy and procedure, titled, "Bylaws and Rules and Regulations of the Professional Staff", dated 2015, indicated, "The Governing Body of [Facility Name] has the ultimate responsibility for the proper functioning of the Hospital and all related matters."



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13. On January 23,2017 at 10:05 a.m., during a tour of the emergency department (ED), the following was observed:
a. There were no filters placed on the sinks of rooms 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 23, 25, X-ray room # 1, and Medication room # 2304.
There were no filters on the Swivette (a combination sink and toilet unit) sinks or bed pan sprayers for rooms 7, 9, 10, 11, 12, 14, 15, 16, 17, 18, and 19.
On January 23, 2017 at 11: 03 a.m., during an interview, Assistant Administrator of Operations Support stated all sinks were supposed to have filters.
On January 23, 2017 at 12:06 p.m., during an interview, the Assistant Hospital Administrator stated rooms 23 and 25 did not have filters on the sinks because those sinks required a different type of filter that required an adapter.
b. In Room 18, the Swivette faucet and the bed pan washers did not have filters, and the hot water was shut off to the Swivette, creating stagnant water conditions.
On January 23, 2017, at 11:28 a.m., during an interview, the Director of Infection Control stated the Swivette sinks worked, and the patients used them to wash their hands.
On January 23, 2017 at 11:35 a.m., during an interview, the Director of Facility Services stated all water should have been shut off to the Swivette faucets and bed pan washers.
A review of the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention's (CDC), "Developing a Water Management Program to Reduce Legionella Growth and Spread in Building," dated June 6, 2016, regarding stagnation, indicated when water does not flow well, areas of stagnant water occur, which encourages growth of biofilm and reduces temperature and level of disinfectant.
A review of the facility's, "Utility Water Safety Management Plan," dated 2014, indicated in response to domestic water Legionella (a type of bacteria found in water and moist places) counts in critical patient care areas, point- of- use filters (0.2-micron pore size) may be installed and utilized at the outlets (taps or showers). Stagnant conditions in the domestic hot water distribution system are avoided in order to reduce microbial proliferation.