The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

KAISER FOUNDATION HOSPITAL-SANTA CLARA 700 LAWRENCE EXPRESSWAY SANTA CLARA, CA 95051 Dec. 12, 2019
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interview and record review, the hospital failed to comply with the Conditions of Participation for Patient Rights as evidenced by:

1. Failure to inform expectant mothers of a Methicillin-resistant Staphylococcus aureus (MRSA, a bacterial infection that is difficult to treat because of resistance to some antibiotics) outbreak in the NICU prior to a planned delivery at the hospital (refer to A130).

2. Failure to timely inform parents of NICU patients of a MRSA outbreak delaying their opportunity to participate in the plan of care (refer to A130).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: PATIENT RIGHTS: PARTICIPATION IN CARE PLANNING Tag No: A0130
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to notify the parents (responsible parties) of 4 patients (Patients 9, 10, 20, and 21) of an infectious disease outbreak in the Neonatal Intensive Care Unit (NICU, an intensive care unit designed for premature and ill newborn babies) in a timely manner. This failure resulted in denying the parents the opportunity to make health care delivery choices and fully participate in the plan of care.

Findings:

On 11/4/19, the Department received a report from the hospital regarding MRSA outbreak in the NICU, with 7 affected patients.

1. During an interview with Patient 9 on 12/10/19 at 12:25 p.m., she stated her birth plan was to deliver at this hospital. When asked if anyone from the hospital had spoken to her either before or after delivery regarding a MRSA outbreak in the NICU, she stated no. Patient 9 confirmed her baby (Patient 13) was admitted to the hospital's NICU after delivery at the hospital on [DATE].

During an interview with Patient 10 on 12/10/19 at 1:45 p.m., she stated her birth plan was to deliver at this hospital. When asked if anyone from the hospital had spoken to her either before or after delivery regarding a MRSA outbreak in the NICU, she stated no. Patient 10 confirmed her baby (Patient 14) was admitted to the hospital's NICU after delivery at the hospital on [DATE].

2. A review of Patient 20's clinical record on 12/11/19 at 4:05 p.m., indicated he was admitted on [DATE].

During an interview with the parents of Patient 20 on 12/11/19 at 11:36 a.m., with Quality Nurse Consultant A (QNC A), when asked if anyone from the hospital had spoken to them regarding a MRSA outbreak in the NICU, they said a social worker from the hospital had told them "yesterday". When asked if they had any concerns, the father of Patient 20 stated "absolutely".

A review of Patient 21's clinical record on 12/11/19 at 4:05 p.m., indicated he was admitted on [DATE].

During an interview with the mother of Patient 21 on 12/11/19 at 11:11 a.m. with QNC A, when asked if anyone from the hospital had spoken to her regarding a MRSA outbreak in the NICU, she stated no. The mother of Patient 21 further stated, "it doesn't sound good for preemies".

A review of the hospital's policy, "Patient Rights and Responsibilities for Kaiser Members and Patients", dated 11/7/2017, indicated "Members have a right to participate with practitioners in decision making regarding their health care."
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and record review, the facility failed to ensure the quality assessment and performance improvement (QAPI) committee had identified, analyzed, and/or revised action plans, regarding Methicillin-Resistant Staphylococcus Aureus (MRSA, a bacterium that causes infections in different parts of the body. MRSA is very contagious and can be spread through direct contact with a person who has the infection. It can also be contracted by coming into contact with an object or surface that's been touched by a person with MRSA) outbreak (the occurrence of cases of disease in excess of what would normally be expected) in 2018. This failure resulted in missed opportunities for the QAPI committee performance to maintain or improve patient health.

Findings:

Review of the hospital's report, dated 12/17/18, indicated a MRSA outbreak between 10/24/18 and 11/20/18, in the Neonatal Intensive Care Unit (NICU, an intensive care unit designed for premature and ill newborn babies).

Review of the hospital's report, dated 11/4/19, indicated a MRSA outbreak in NICU with 7 affected patients.

During a concurrent interview and record review on 12/12/19 at 3 p.m., with the area quality leader, the hospital's QAPI minutes, dated 11/30/18, were reviewed. There was no documented evidence the QAPI committee discussed the NICU's MRSA outbreak, which occurred in 2018.

Review of the hospital's PROFESSIONAL STAFF BYLAWS, dated 2018, indicated the Maternal Child Performance Improvement Resource Management Committee has the responsibility for setting direction and evaluating care provided to maternal-child patients in the hospital and the continuing care area with the goal of providing clinical excellence to the patients. Areas of oversight include processes and outcomes related to both quality and patient safety.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to develop and maintain a current and individualized nursing care plan for 11 patients (Patients 3, 4, 5, 6, 7, 8, 13, 14, 19, 20, and 21) in the Neonatal Intensive Care Unit (NICU, an intensive care unit designed for premature and ill newborn babies). This failure had the potential to result in nursing staff delaying or failing to deliver all necessary care and services, resulting in further compromise of medical status during a Methicillin-resistant Staphylococcus aureus (MRSA, a bacterial infection that is difficult to treat because of resistance to some antibiotics) outbreak in the NICU.

Findings:

During a concurrent interview and record review on 12/10/19 at 3:00 p.m. with the Clinical Informatics Educator (CI), the clinical records for Patients 3, 4, and 5 were reviewed. The records indicated the following:

1. Patient 3 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 10/31/19 indicated positive results. Patient 3's clinical record did not have a nursing care plan for infection.

2. Patient 4 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 10/31/19 indicated positive results. Patient 4's clinical record did not have a nursing care plan for infection.

3. Patient 5 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 10/31/19 indicated positive results. Patient 5's clinical record did not have a nursing care plan for infection until 11/5/19.

The CI confirmed the record observations.

During an interview on 12/11/19 at 9:06 a.m. with the Maternal Child Health Director (MCHD), when asked if an infection care plan should have been initiated for Patients 3, 4, and 5, the MCHD stated, "yes".

During a concurrent interview and record review on 12/11/19 at 9:32 a.m. with both the CI and MCHD, the clinical records for Patients 6, 7, and 8 were reviewed. The records indicated the following:

4. Patient 6 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 10/31/19 indicated positive results. Patient 6's clinical record did not have a nursing care plan for infection.

5. Patient 7 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 11/3/19 indicated positive results. Patient 7's clinical record did not have a nursing care plan for infection.

6. Patient 8 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 11/5/19 indicated positive results. Patient 8's clinical record did not have a nursing care plan for infection.

Both the CI and MCHD confirmed the record observations. When asked if nursing care plans for infection were located in the clinical records for Patients 6, 7, and 8, the CI stated, "no".

During a concurrent interview and record review on 12/11/19 at 4:05 p.m. with both the CI and Quality Nurse Consultant A (QNC A), the clinical records for Patients 13, 14, 19, 20, and 21 were reviewed. The records indicated the following:

7. Patient 13 was admitted on [DATE] with a diagnosis of observation for genetic condition. A MRSA test on 12/8/19 indicated negative results. Patient 13's clinical record did not have a nursing care plan for risk for infection until 12/11/19.

8. Patient 14 was admitted to the NICU on 12/9/19 with a diagnosis of prematurity. A MRSA test on 12/9/19 indicated negative results. Patient 14's clinical record did not have a nursing care plan for risk for infection.

9. Patient 19 was admitted to the NICU on 8/25/19 with a diagnosis of prematurity. A MRSA test on 10/31/19 indicated positive results. Patient 19's clinical record did not have a nursing care plan for infection until 11/5/19.

10. Patient 20 was admitted to the NICU on 11/27/19 with a diagnosis of prematurity. A MRSA test on 11/27/19 indicated negative results. Patient 20's clinical record did not have a nursing care plan for risk for infection.

11. Patient 21 was admitted on [DATE] with a diagnosis of prematurity. A MRSA test on 12/1/19 indicated negative results. Patient 21's clinical record did not have a nursing care plan for risk for infection.

Both the CI and QNC A confirmed the record observations.

A review of the hospital's policy, "Interdisciplinary Plan of Care", dated 11/27/18, indicated "A Patient Plan mush be initiated no later than eight hours following admission to the hospital. The care planning process is individualized based on patient assessments and reassessment beginning upon admission and continuing throughout hospitalization ."
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and record review, the hospital failed to comply with the Conditions of Participation for Infection Control as evidenced by:

1. Failure to maintain, clean, and disinfect the work station on wheels (WOW, a mobile computer cart used for beside nursing documentation) in the Neonatal Intensive Care Unit (NICU, an intensive care unit designed for premature and ill newborn babies) (refer to A749).

2. Failure to ensure staff received training regarding Methicillin-Resistant Staphylococcus Aureus (MRSA, a bacterium that causes infections in different parts of the body. MRSA is very contagious and can be spread through direct contact with a person who has the infection. It can also be contracted by coming into contact with an object or surface that's been touched by a person with MRSA) outbreak (the occurrence of cases of disease in excess of what would normally be expected) in the NICU. (refer to A749)

3. Failure to maintain clean and ready for use pods in a clean condition in the NICU. (refer to A749).

4. Failure to follow the manufacturer's dwell time (the contact time the disinfectant is required to remain wet on the surface to effectively kill bacteria and germs) of a disinfectant when staff cleaned the Neopuff machines (gas-powered infant resuscitators which provide controlled and accurate resuscitation) in the NICU. (refer to A749)

5. Failure to clean and sanitize Neopuff gas line tubing (tubings attached to the Neopuff machines) between patient use and verify the tubings were multi-patient use or single-patient use in the NICU. (refer to A749)

6. Failure to clean the NICU infant beds according to manufacturer's instructions. (refer to A749)

7. Failure to evaluate an environmental services (EVS) staff's competency of cleaning NICU infant beds, according to manufacturer's instructions and hospital policy. (refer to A749)

8. Failure to clean brushes which were used for cleaning infant beds, between use and to verify the brushes were for multi-patient use. (refer to A749)

9. Failure to clean a test lung which was used for preventative maintenance of the Neopuff, per manufacturer's instructions. (refer to A749)

10. Failure to store gas cylinders (oxygen tanks) in a dirty supply room and to monitor temperature and humidity of the clean supply room, in the NICU. (refer to A749)

11. Failure to clean and maintain surgical instrument sterilizer machines according to manufacturer's instructions. (refer to A749)

12. Failure to maintain sink faucet areas in a sanitary condition, in the sterile processing department (SPD) and ceiling vent in the Ambulatory Surgical Unit (ASU). (refer to A749)

13. Failure to clean and process surgical instruments according to nationally recognized infection control standards. (refer to A749)

14. Failure to process surgical tray sets according to the hospital policy and the nationally recognized infection control standards the hospital followed. (refer to A749)

15. Failure to locate endoscopes scopes (a reusable patient instrument, used to visualize an interior organ) not in a gastrointestinal (G.I.) procedure room. (refer to A749)

16. Failure to separate the eye wash station and the sink used for cleaning probes in the hospital's radiology department. (refer to A749)

17. Failure to clean autoclaves per manufacturer's instructions for use (IFUs). (refer to A749)

18. Failure to ensure multiple previously processed surgical instruments were not stiff (hard to open) and identification tape were not lifting in the inspected surgical trays in ASU. (refer to A749)

19. Failure to report and resolve outranged temperature and humidity per the hospital's policy in the operating rooms. (refer to A749)

20. Failure to wear proper personal protective equipment (PPE) when handling a hazardous trash bag in a telemetry unit (refer to A749).

21. Failure to separate clean and dirty items in the utility rooms and disinfect surgical instruments before sending out to the third party company in the emergency department. (refer to A749)

22. Failure to maintain multiple drinking fountains in a sanitary condition. (refer to A749)

23. Failure to follow-up the detectable positive Legionella (bacteria that can cause a serious type of pneumonia [lung infection] called Legionnaires' disease) as recommended.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. Staff did not maintain, clean, and disinfect the work station on wheels (WOW, a mobile computer cart used for beside nursing documentation) in the Neonatal Intensive Care Unit (NICU, an intensive care unit designed for premature and ill newborn babies).

2. In the NICU, there was no documented evidence staff received trainings regarding Methicillin-Resistant Staphylococcus Aureus (MRSA, a bacterium that causes infections in different parts of the body. MRSA is very contagious and can be spread through direct contact with a person who has the infection. It can also be contracted by coming into contact with an object or surface that's been touched by a person with MRSA.) outbreak (the occurrence of cases of disease in excess of what would normally be expected).

3. In the NICU, four (4) of 4 pods (neonatal intensive care unit rooms), which were cleaned and ready for use, contained trash and previously used and soiled patient supplies.

4. In the NICU, the manufacturer's dwell time (the contact time the disinfectant is required to remain wet on the surface to effectively kill bacteria and germs) of a disinfectant was not adhered to by hospital staff when they cleaned the Neopuff machines (gas-powered infant resuscitators which provide controlled and accurate resuscitation).

5. In the NICU, the hospital used 26 of 26 Neopuff gas line tubing (tubings attached to the Neopuff machines) as a multi-patient use and they were not clean and sanitized between patient use. Also, the hosptial could not verify the tubing was multi-patient use or single-patient use.

6. The NICU infant beds were not cleaned according to manufacturer's instructions.

7. In the NICU, an environmental services (EVS) Staff (EVS 4)'s competency was not evaluated to ensure she was competent to perform her task of cleaning NICU infant beds, according to manufacturer's instructions and hospital policy.

8. In the NICU, brushes which were used to clean infant beds, were not cleaned between uses and the hospital did not have documented evidence indicating the brushes were multi-patient use.

9. A test lung, which was used for preventative maintenance of the Neopuff, was not cleaned per manufacturer's instructions.

10. In the NICU, eight (8) of 8 gas cylinders (oxygen tanks) were stored in the clean supply room and temperature and humidity of the clean supply room were not monitored.

11. Three (3) of 3 surgical instrument sterilizer machines were not cleaned and maintained according to manufacturer's instructions.

12. There were large amounts of white deposits around eight (8) sink faucet areas and four (4) cart tables in the hospital's decontamination area and around three (3) sink faucet area in the Ambulatory Surgical Unit (ASU) sterile processing department, and ten (10) of 10 ceiling vents contained rust color stains in (ASU).

13. Surgical instruments were not cleaned and processed according to nationally recognized infection control standards.

14. Two (2) of 2 surgical tray sets containing a total of 169 surgical instruments which were previously cleaned, sterilized and ready to be used for patient surgical procedures, were not processed according to the hospital policy and the nationally recognized infection control standards the hospital followed.

15. Three (3) of three scope cabinets containing 16 flexible endoscopes scopes (a reusable patient instrument, used to visualize an interior organ) were located in a gastrointestinal (G.I.) procedure room.

16. The eye wash station was shared with the sink used for cleaning probes in the hospital's radiology department.

17. Two (2) of 2 autoclaves were not cleaned daily and weekly per manufacturer's instructions for use (IFUs).

18. Multiple previously processed surgical instruments were stiff (hard to open) and identification tape were lifting in two (2) of 2 inspected surgical trays at the Ambulatory Surgical Center (ASU).

19. Temperature and humidity from 10/28/19 to 10/31/19, in OR rooms 1-7, were out of ranges and there was no documented evidence those occurrences were reported and resolved.

20. In the telemetry unit, staff did not wear proper personal protective equipment (PPE, protective clothing, gloves, goggles, or other garments or equipment designed to protect the wearer's body from injury or infection) when handling a hazardous trash bag.

21. In the emergency department, clean and dirty items were not separated in a utility room and surgical instruments were not disinfected before sending out to the third party company.

22. Six (6) of 6 drinking fountains were observed with white and black substances in the faucets.

23. The detectable positive Legionella (bacteria that can cause a serious type of pneumonia [lung infection] called Legionnaires' disease) was not followed-up, as recommended.

These failures had the high potential to spread infection in the hospital.

Findings:

On 12/11/19 at 1:45 p.m. the survey team called Immediate Jeopardy (IJ) concerning infection control, in the presence of the hospital's administration. The noncompliance, in the NICU, which were listed Failures 1-10 above, placed 17 critically ill babies at risk of MRSA infection.

The hospital provided the acceptable removal plan and the IJ was removed on 12/11/19 at 7:00 p.m. The removal plan, dated 12/11/19, included immediate cleaning and disinfecting of WOWs, immediate EVS and NICU staff training and on-going re-training regarding MRSA outbreak, and equipment management.

During an observation and interview with the NICU staff, on 12/11/19 and 12/12/19, the survey team verified and confirmed the IJ was removed.

1. On 11/4/19, the Department received a report from the hospital regarding MRSA outbreak in the NICU, with 7 affected patients.

During a concurrent observation and interview on 12/11/19 at 10:06 a.m. with the NICU Nurse Manager (NICUM) and the Infection Preventionist Coordinator (IPC), multiple WOWs including an WOW which was used for patients with MRSA infection, in the NICU, had peeling rubberized material on the barcode scanner; computer keyboards were encrusted with particulate between the keys; velcro strips used to hold keyboards in place were stained; tape residue was stuck to the computer cart tables and barcode scanners; and, keyboard wrist rest pads had torn with holes. When asked when and how the WOWs were cleaned, the NICUM stated nurses clean them at the change of shift (monitor, table, handle, keyboard, mouse, and scanner) using a Sani-Cloth (a germicidal disinfectant cloth) and environmental services (EVS) clean them when the patient is discharged . NICUM stated staff could use any WOWs.

During an interview on 12/11/19 at 10:10 a.m. with the Maternal Child Health Director (MCHD), he stated EVS would not clean the WOW of a discharged patient if the nurse is still using it for another patient.

During an interview on 12/11/19 at 10:44 a.m. with Environmental Services B (EVS B), she stated she had been employed with the hospital for more than 15 years and only worked in the NICU. When asked how the WOWs were cleaned, she stated, "We clean only the bottom, not the top. Nurses clean the top."

During an observation on 12/11/19 at 11 a.m., there was one WOW designated for physicians with a signage, "For MD (Doctor of Medicine, from the Latine Medicinae Doctor) use" on it.

During a concurrent interview with Physician P, she stated she used the "for MD use" WOW during her rounds (to be passed from one patient to another patient) and did not wipe down regularly before she used it.

During an interview on 12/11/19 at 10:50 a.m. with the IPC, when asked if the velcro strip on the WOW was able to be cleaned and disinfected, she stated "no".

During a concurrent interview, the IPC stated staff could not effectively disinfect or clean the uneven surfaces when asked about cleaning of torn keyboard wrist rest pads or peeling rubberized material on the barcode scanner.

During a review of the hospital's policy, "Computers and Mobile Computer Carts, Cleaning and Disinfection of", dated 11/5/2019, indicated "Discharge, Transfer or Terminal Cleaning by EVS Staff: EVS will use dry cloth to wipe computer screen. EVS staff will use a cloth dampened with hospital approved disinfectant, such as peracetic acid/hydrogen peroxide based formula (Oxycide), for cleaning all areas of the computer keyboard, mouse, barcode scanner and computer cart."





2. On 12/9/19, multiple interviews were conducted with the following NICU nursing staff regarding MRSA education in the presence of the Quality Consultant.

During an interview on 12/9/19, at 1:45 p.m. with NICU Registered Nurse 1 (RN 1), RN 1 stated the manager informed staff of a MRSA outbreak. RN 1 received MRSA outbreak education which included contact isolation and hand gel use for the parents in their huddles which lasted about 5 minutes. However, RN 1 did not receive any education from the educator assigned to the unit, and she did not sign any attendance sheets.

During an interview on 12/9/19 at 1:50 p.m., RN 2 stated the manager, the assistant manager, and a shift leader provided MRSA updates in the huddles. However, the unit educator was not involved in the MRSA education, and RN 2 did not sign any attendance sheet.

During an interview on 12/9/19 at 1:55 p.m., RN 3 stated the manager provided education at huddles. However, RN 3 stated she did not receive any education from the educator assigned to the unit, and did not sign any attendance sheet.

During an interview on 12/9/19 at 2 p.m. RN 4 stated the manager updated the MRSA plan in huddles. However, RN 4 did not recall signing an attendance sheet.

During an interview on 12/9/19 at 2:05 p.m., RN 5 stated the manager provided the MRSA plan in huddles. However, RN 5 did not recall signing an attendance sheet.

During an interview on 12/9/19 at 2:10 p.m., RN 6 stated the manager provided MRSA education at huddles. However, RN 6 did not sign any attendance sheets, and because she needed more information on MRSA, she looked it up.

During an interview on 12/9/19 at 2:15 p.m., the NICU educator stated she did not provide any MRSA outbreak training in 2019, as well as, staff competencies from 10/7/19 to 11/4/19, did not include MRSA outbreak, and did not include or contact the NICU staff to provide MRSA outbreak education.

During an interview on 12/9/19 at 2:30 p.m., the NICUM stated there was no documented evidence of MRSA training or updates, she did not know the total number of NICU or EVS staff who were educated on MRSA outbreak, and did not include the NICU educator or the education department.

During an interview on 12/10/19 at 9 a.m. with the Infection Control Team and the Leadership Team, the Infection Control Coordinator stated the infection control team provided MRSA education to the NICU staff during NICU huddles and to the EVS Manager, who provided MRSA education to the assigned EVS staff. However, she did not have documented evidence of any MRSA outbreak training. She stated they were unaware the total number of NICU or EVS staff who received or missed the training regarding MRSA outbreak.

During an interview on 12/11/19 at 4:40 p.m., the Director of Environmental Services (DEVS) stated he was not trained specifically on the MRSA outbreak. The DEVS stated the infection control team educated his assigned staff regarding the MRSA outbreak, and there was no documented evidence indicating his assigned staff received the MRSA training.

During a review of the facility's policy, "Staff Education and Competency", revised on 11/2018, indicated, " ...5.13.3 Specific topics maybe identified that require competency assessment or reassessment, to ensure clinical competency based on new technology or information, new equipment, new procedures, new rules/regulations or new standards of practice ...5.15.3.2. Annual/Ongoing Education and Competency Summary 5.15.3.2.1 Specific documentation and detail of educational offerings, mandatory education summaries, certifications, etc.-are compiled and maintained in employee's regulatory file."

3. During a concurrent observation and interview on 12/9/19 at 12:45 p.m. with the NICUM, NICUM stated that 4 of 4 NICU pods toured, had been cleaned and were ready to admit new patients. The following were observed.

a. In 2 of 4 pods, trash cans were not empty and were filled with paper and plastic.
b. In 2 of the 4 pods, soiled linen receptacles were not empty and contained linen.
c. Four (4) of 4 pods contained "Dual Caps" (a uniquely designed disinfecting cap system for use at the end of the IV tubing and the needle-free valve) per NICUM the caps were used for Intravenous lines.
d. Two (2) of 4 pods contained Neopuffs with clear tubings attached to the machines.
e. Four (4) of 4 pods contained Neopuffs with green tubings attached to the machines.

During a concurrent interview with the NICUM, she stated that 4 of 4 pods observed would be considered "dirty" and would have to be re-cleaned. NICUM stated the trash should have been discarded, the soiled linen receptacles contained linen were from the previous patients, the "Dual Caps" were used for the previous patients and should have been discarded, and the clear tubing of the Neopuffs were used by the previous patients. NICUM also stated that the green tubes attached to the Neopuffs were used by the previous patients, was unsure if they were multi-patient use and were cleaned by EVS staff and nursing.

During a review of the hospital's policy, "Cleaning Procedure for Patient Room After Discharge, dated 12/6/16, indicated "Procedure for Cleaning Patient Room 5.3.2 Empty wastebasket, soiled linen hamper, and bio hazardous waste (red bag). Disinfect wastebasket, hamper, and bio hazardous waste container using disinfectant solution. Insert into wastebasket a clean clear liner, linen hamper with clean blue liner ..."

During a review of the hospital's policy, "Cleaning and Storage of Reusable Equipment", dated 1/24/19, indicated, "5.1 Single-use, disposable patient care supply, equipment and instrument must be disposed of after use and not be cleaned or reprocessed ..."

During an interview on 12/10/19 at 11:20 a.m., an Infection Control Preventionist Coordinator (IPC) stated that the hospital followed infection control guidelines from "Joint Commission" "Centers for Disease Control" (CDC) and other guidelines.

During a review of the CDC guideline, it indicated, "1. Principles of Cleaning and Disinfecting Environmental Surfaces - The transferal of microorganisms from environmental surfaces to patients is largely via hand contact with the surface. Although hand hygiene is important to minimize the impact of this transfer, cleaning and disinfecting environmental surfaces as appropriate is fundamental in reducing their potential contribution to the incidence of healthcare-associated infections".

4. During a concurrent observation and interview on 12/9/19 at 1 p.m. with the NICUM, she stated that EVS staff cleaned the Neopuff machines but the registered nurses also cleaned them as needed, using the Sani-Cloths (purple top disinfectant wipes).

A review of the manufacturer's instructions for the Neopuff machine indicated to "Not" clean the machine with products that contain greater than "30% alcohol base." The "Sani-Cloths" the hospital staff used to clean the Neopuff, contained 55% alcohol according to NICUM.

During an interview on 12/10/19 at 4:10 p.m. with a NICU EVS Staff (EVS 5), who's responsibility included cleaning the Neopuff machines in the NICU, EVS 5 stated she cleaned the Neopuff with Oxycide but did not know what the contact time was and did not see the manufacturer's instructions on how to clean them. EVS 5 also stated they used the Sani-Cloths, "Purple tops", in the NICU.

A review of the manufacturer's instructions of the disinfectant EVS 5 used, indicated the contact time to be "3 minutes".

5. During an interview, on 12/9/19, at 1 p.m., with the NICUM regarding the Neopuff machines, she stated staff used "green gas line tubings", which were attached to the Neopuff machines, for multi-patient use and she was unsure if the tubings were single-patient use or multi-patient use. According to NICUM, the hospital had 26 Neopuff machines in the NICU.

During an interview on 12/11/19 at 12:30 p.m., the Quality Director (QS), stated they contacted the vendor of the Neopuff machines, they were unaware if the "green gas line tubings" were multi-patient use, and they would be using them for single-patient use.

6. During a concurrent observation and interview on 12/9/19 at 1:40 p.m., in the NICU, Environmental staff 4 (EVS 4) cleaned an infant bed and was asked regarding the cleaning disinfectant she used and the contact time of the disinfectant. EVS 4 stated she used "Oxycide" (disinfectant cleaner and deodorant designed for general cleaning of hard, nonporous inanimate surfaces) and did not know what the contact time was "but if it dries before 5 to 10 minutes, it is okay as long as it is dried before I reassemble the bed."

EVS 4 wiped the clear plastic sides of the bed with the disinfectant and dried them with a pillow case. EVS 4 stated the purpose for drying following the cleaning was to prevent streaks on the plastic, "So the nurses can see the baby."

EVS 4 cleaned the infant bed from the bottom to the top. When asked why she did not clean the bed from top to bottom, she stated because she was taught to clean from bottom to top and after cleaning the top, "I wipe the bed area where the baby lays down, again or else the dirty part I cleaned at the top falls to the bottom, so I wipe it again."

During a review of the hospital's policy, "Cleaning and Storage of Reusable Equipment", dated 1/24/19, indicated, "1.1 Reusable patient care equipment will be cleaned, disinfected or sterilized following manufacturer's instructions to decrease the risk of transmission of infection to patients and staff ..."

During a review of the manufacturer's instructions of the disinfectant which EVS 4 used, indicated the contact time to be "3 minutes" (the contact time the disinfectant is required to remain wet on the surface to effectively kill bacteria and germs).

During a review of the hospital's policy, "Cleaning Procedure for Patient Room After Discharge", dated 12/6/16, indicated "4.5 Clean in the order of top to bottom and clean to dirty ..."

7. During a concurrent interview and record review on 12/10/19 at 10:45 a.m. with the EVS Manager (EVSM) who evaluated EVS 4, EVS 4's "Competency Validation Tool: Giraffe NICU Specialty Bed", dated 11/20/19, indicated EVS 4's competency was check marked as, "Able to teach others and the Final Rating as Expert -teaches others in this area." The checkmark under "Expert" was whiten out and "Independent - performs independently" was checked with a different colored pen and hand writing which indicated, "Validation to be set by 12/20/19."

During a concurrent interview, the EVSM stated she evaluated EVS 4 and assessed her to be competent and an expert in cleaning the "Giraffe" but she did not observe her. EVSM stated she should have observed her but, "I was under the impression she taught others in the past." The EVSM also stated "Someone whited out" her evaluation and check marked the "Independent" category and "It's not my writing."

During a review of the hospital's policy, "Staff Education and Competency", dated 11/6/19, indicated "1.1 This policy outlines standards, expectations and procedures for ensuring staff are clinically competent ...5.14 Performance Evaluation 5.14.1 Competency-Based Performance Appraisal: Competency of the staff is evaluated initially and on a periodic basis. This competency based performance appraisals include an objective assessment of the individual's performance and ability to perform the duties outlined in their job description ..." There was no documented evidence and EVSM confirmed that EVS 4 did not receive an objective assessment when EVSM provided the evaluation.

8. During a concurrent observation and interview on 12/11/19 at 12:10 p.m., with an NICU environmental staff (EVS 6), EVS 6 explained and demonstrated the process for cleaning the infant beds. EVS 6 stated she used Oxycide to clean and disinfect the beds but did not know what the contact/dwell time was and stated she allowed the bed to dry for "a few seconds" before reassembling it.

During a concurrent interview, EVS 6 stated she cleaned the infant mattress and tray pan area with a brush inside the hopper (a large wall toilet used to dispose of waste products). The brush had a long black handle with a large yellow bristle head and was lying on the top surface and near the hopper's flushing mechanism. Next to the large brush was a second short white brush with white bristles that contained brown matter. EVS 6 stated the yellow bristled brush was used for 2 months, was rinsed in hot water if it was soiled and then the brush was re-used. EVS 6 did not know if the brush was multi-patient use.

During an interview on 12/12/19 at 9:30 a.m., the NICUM stated she was not certain if the brushes were multi-patient use.

9. On 12/11/19 at 8:45 a.m., an interview with a hospital Bio-Med Engineer (BME) and a concurrent record review were conducted to review the manufacturer's instructions and discuss the cleaning and maintenance of the Neopuff machine and "test lung" (an accessory to the machine used to perform preventative maintenance). The BME stated it was his responsibility to perform the maintenance of the Neopuff. He stated he cleaned the Neopuff as needed with Sani-Cloths ("purple lid"). However, he did not know what the contact time was, and no one explained to him what it was. The BME stated he was unsure if the hospital had a standardized procedure for cleaning and maintaining the Neopuff but "I wipe it (Neopuff) and let it dry". The BME stated he did not clean the test lung, there was one test lung, and he used it to perform preventative maintenance for "other equipment" throughout the hospital.

The BME stated the test lung in use, was not a product from the Neopuff's manufacturer and he did not know the manufacturer's cleaning instructions. The BME also stated he was unaware who was the test lung's manufacturer, if the test lung was multi-patient use, and if it had any cleaning instructions.

During the interview and concurrent record review on 12/11/19 at 8:45 a.m., the manufacturer's "technical instructions" of the Neopuff, indicated "Use only recommended (manufacturer's name) Neopuff/Perivent Infant Resuscitator accessories." BME validated the instructions and stated he did not know that the manufacturer of the Neopuff machine also made "test lungs".

During a concurrent interview and record review on 12/12/19 at 5 p.m., the BME stated he found the manufacturer's cleaning instructions for the test lung, which was in use, and it indicated manual cleaning and disinfection can be carried out with the disinfectant "Gigasept FF". The BME stated it was unclear the test lung was single-patient use or multi-patient use. He further stated he ordered a test lung from Neopuff's manufacturer and the cleaning instructions should be followed.

10. During an observation in the NICU on 12/9/19 at 2:45 p.m., the following were observed.

a. The clean supply room with clean and sterile supplies had four (4) small full oxygen tanks in cylinder stands and four (4) small empty oxygen tanks attached to the wall.

b. No temperature and humidity monitoring of the clean supply room.

During an interview on 12/9/19 at 2:53 p.m., the NICUM confirmed the oxygen tanks were not cleaned and should be moved, and there were no temperature and humidity monitoring in the clean supply room.

11. On 12/10/19 at 9:15 a.m., an interview was conducted with the hospital Infection Control Coordinator, who stated they followed nationally recognized infection control guidelines from:
a. APIC - Association for Professionals in Infection Control
b. AORN - Association of Perioperative Registered Nurses
c. AAMI - Association for the Advancement of Medical Instrumentation
d. CDC -Centers for Disease Control
e. SGNA - Standard of Gastroenterology Nurses and Associates

On 12/10/19 at 12:45 p.m., a tour was conducted of the hospital "Assembly Prep and Pack" area (an area used to assemble clean reusable surgical instruments to prepare them for sterilization and patient surgical procedures). Three (3) of 3 sterilizers (machines used to sterilize reusable surgical instruments) were inspected and the following were observed.

a. Sterilizer 1 internal chamber contained black substance and paper labels were stuck to the chamber.
b. Sterilizer 2 internal chamber contained black and brown substance and paper labels adhered to the chamber.
c. Sterilizer 3 was in use and the internal chamber was not observed.

During a concurrent observation and interview with the Sterile Processing Department Supervisor (SPDS), he stated they did not have a process in place to clean the internal chambers of the sterilizers. The SPDS stated their vendor cleaned it twice a year.

During a concurrent observation and interview with Sterile Processing Technician 5 (SPT 5) who verified the above observations, SPT 5 stated they did not clean any of the internal chambers of the sterilizers.

During a concurrent interview and record review on 12/10/19 at 1:15 p.m., with SPT 5 and SPDS, the sterilizer manufacturer's instructions were reviewed. After reviewing the manufacturer's instructions, they stated they did not know that the manufacture required to clean the internal chambers and they did not have the cleaning solution or a comparable solution. There was no documented evidence that the manufactures "7.2 Weekly Maintenance" of the sterilizer was performed according to the manufacturer's instructions.

12. During a concurrent observation and interview on 12/10/19, at 12:45 p.m., with Sterile Processing Technician 1 (SPT 1), Scope Oversight Coordinator (SOC), Quality Nurse Consultant, and Director of Administrative Services, a tour of the "decontamination area" in the Sterile processing department (SPD), was conducted. During the tour, eight (8) sinks faucets and four (4) cart tables were covered with a large amount of white substance. SOC acknowledged the large amount of white substance around the sink faucets and cart tables and stated housekeeping provided terminal cleaning daily and SPD staff wiped down the cart tables.

During an interview on 12/10/19 at 4:15 p.m., the Director of Environmental Services (DEVS) stated there was no specific staff training on removal of calcium buildup, removal of calcium buildup was not included in policy and procedures and in a checklist and staff competencies, and a calcium cream cleanser should be used by EVS when performing terminal cleaning.

During a concurrent observation and interview on 12/11/19 at 10:10 a.m. with the Sterile Processing Technician (SPT 2), SOC, Quality Nurse Consultant, Director of Perioperative (DOR), and the SPDS, in the "decontamination area" of SPD in Ambulatory Surgical Unit. The following were observed.

a. Three (3) sinks faucets were covered with a large amount of white substance.
b. Ten (10) of 10 ceiling vents were covered with a large amount of rust color stains.

On 12/11/19 at 10:20 a.m., the DOR and SOC acknowledged the large amount of calcium buildup (white substance) around the sink faucets and the rust colored stains on the ceiling vents. SPDS stated the housekeeping provided terminal cleaning daily. The DOR stated the white substance should have been removed and the rust stained ceiling vents should have been replaced.

During a review of the facility's policy, "Terminal Cleaning for Sterile Processing Department (SPD)," revised on 6/2019, indicated, " ...5.6 Procedural-Daily Cleaning ...5.6.2 Clean/disinfect all horizontal surfaces from top to bottom using hospital approved solution ...5.6.2.1.8 Carts ...5 ...6.2.1.10 Sinks ...5.6.6 Clean all ventilation faceplates."

Review of AORN standard, indicated it defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used."

Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms.

Review of AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas. AORN recommends that terminal cleaning and disinfection of the sterile processing? areas "be performed daily when the areas are being used." Terminal cleaning should not be performed when personnel are actively de-contaminating instruments. Cleaning should progress from cleanest to dirtiest areas.

13. During a concurrent observation and interview on 12/10/19 at 1 p.m. with the SOC, Director of Administrative Services, and the Quality Nurse Consultant, Sterile Processing Technician 1 (SPT 1) cleaned soiled surgical instruments and the following were identified.

a. While SPT 1 was cleaning soiled surgical instruments, the enzymatic dispenser tubing was left submerged in the soiled water. SPT 1 stated the vendor placed the dispensing hose in the sink which is located below the fill line of the solution to take the temperature of the solution.

b. SPT 1 proceeded to clean and rinse the instruments, place the surgical instruments in the washer, and proceeded to the computer to document without changing his gloves.

During a concurrent interview with the SOC, she stated the dispensing hose should not be submerged in the soiled water and SPT 1 should have washed his hands and changed his gloves.

During a concurrent observation and interview on 12/11/19 at 10:50 a.m. with the DOR and SPDS, Sterile Processing Technician 2 (SPT 2) cleaned soiled surgical instruments in the Ambulatory Surgery Center, and the following were observed.

a. SPT 2 did not brush or scrub any of the 19 surgical instruments in the hip arthroscopy tray prior to placing the instruments in the washer.

b. No visible brushes were observed in the decontamination area.

During a concurrent interview, SPT 2 stated she brushed instruments only when she saw visible blood on the instruments.

During a concurrent interview, the SPDS stated all surgical instruments should be brushed under submerged water and verbally acknowledged SPT 2 did not brush the surgical instruments and no visible brushes in the immediate area. Both the DOR and SPDS stated the department followed AAMI and AORN national standards.

During a review of the hospital's policy, "Hand Hygiene", dated 6/1/18, indicated, " ...5.10 Gloves shall be worn when exposure to blood or any other body fluids is likely ...Hand hygiene must be performed prior to donning and after removal of gloves ...5.11 ...When going from a dirty site to a clean site, hand hygiene must be performed between sites."

During a review of AAMI "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003" indicated "keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

During a review of IAHCSMM (International Association of Healthcare Central Service Material Management), "The Manual Cleaning Process" indicated a lint-free cloth and the recommended brush type, all areas of the device should be carefully cleaned, brushed and flushed.

During a review of APIC and CDC, "Guideline for Disinfection and Sterilization in Healthcare Facilities", indicated if cleaning is done manually, the two essential components are friction and fluidics. Friction (i.e., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a channel."

14. During a concurrent observation and interview on 12/10/19 at 1:35 p.m., with the SPDS and a Senior Lead (SL) of the department, in "Assembly Prep and Pack" area, two (2) of 2 surgical trays were made. The 2 trays were previously cleaned, sterilized and were ready to be used for surgical procedures. The following were observed.