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 FONTANA 9961 SIERRA AVE FONTANA, CA 92335 Dec. 27, 2013
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview and record review, the hospital failed to provide an active
program for the prevention, control, and investigation of infections and communicable
diseases that maintained a sanitary environment, when:

1. The disinfectant wet times (the time the disinfectant stays wet on the equipment being cleaned that is needed for the disinfectant to inactivate or kill germs) was not maintained in accordance with manufacturer ' s instructions. (Refer to A-0749)

2. One operating room (OR) table was observed to have tape residue on the pad of an OR table. (Refer to A-0749)

3. The facility failed to place an identification label and the date of mixture on a container of chemicals used for cleaning ORs in accordance with nationally recognized infection controls and prevention guidelines. (Refer to A-0749)

4. The ventilator (a breathing machine) heat sensors (a cord attached to the ventilator and the patient ' s oxygen tubing to monitor the temperature of the oxygen delivered to the patient) used in the Neonatal Intensive Care Unit (NICU) were not disinfected and stored according to the manufacturer ' s instructions. (Refer to A-0749)

5. A large brownish stain, involving an entire ceiling tile, in the hallway at the entrance of operating room (OR) #3 was observed. The hospital failed to identify the potential for moisture to aid the spread of infection. (Refer to A-0749)

6. A spray bottle of air freshener was observed in patient room #4, labeled " Do Not Remove from Room #28 " and there was a spray bottle in the housekeeping closet in the NICU that was labeled " 4 West " . The new hospital building did not have a unit 4 west. (Refer to A-0749)


7. The hospital failed to have influenza prevention signage (signs or posters) visible, respiratory and hand hygiene supplies (tissue, face masks and hand sanitizer) available to all persons entering the hospital. This failure had the potential to aid the spread of influenza. (Refer to A-0749)

8. The hospital Infection Control Preventionist failed to provide effective infection control oversight. (Refer to A-0748)

The cumulative, systemic effects of these problems compromised the facility's ability to
ensure the provision of quality health care in a safe environment in accordance with the
Condition of Participation for Infection Control.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, staff interview, and document review, the hospital failed to provide a sanitary environment, in a universe of 212 patients, to avoid sources and transmission of infections and communicable diseases when:

1. The disinfectant wet times (the time the disinfectant stays wet on the equipment being cleaned that is needed for the disinfectant to inactivate or kill germs) was not maintained in accordance with manufacturer's instructions.

2. One operating room (OR) table was observed to have tape residue on the pad of an OR table.

3. The facility failed to place an identification label and the date of mixture on a container of chemicals used for cleaning ORs in accordance with nationally recognized infection controls and prevention guidelines

4.The ventilator (a breathing machine) heat sensors (a cord attached to the ventilator and the patient's oxygen tubing to monitor the temperature of the oxygen delivered to the patient) used in the Neonatal Intensive Care Unit (NICU) were not disinfected and stored according to the manufacturer's instructions.

5. A large brownish stain, involving an entire ceiling tile, in the hallway at the entrance of operating room (OR) #3 was observed. The hospital failed to identify the potential for moisture to aid the spread of infection.

6. A spray bottle of air freshener was observed in patient room #4, labeled "Do Not Remove from Room #28" and there was a spray bottle in the housekeeping closet in the NICU that was labeled "4 West". The new hospital building did not have a unit 4 west.

7. The hospital failed to have influenza prevention signage (signs or posters) visible, respiratory and hand hygiene supplies (tissue, face masks and hand sanitizer) available to all persons entering the hospital. This failure had the potential to aid the spread of influenza.


These failures exposed patients to the potential for the spread of infectious disease. These failures had the potential to increase the risk for contamination and infections.

Findings:

1a. During a tour of the NICU an interview was conducted on December 23, 2013, at 9:15 AM, with Respiratory Therapist (RT 1). RT 1 explained the procedure for cleaning NICU respiratory transport equipment and stated that the disinfecting wet time of Oxivir (a hydrogen peroxide based disinfectant cleaner) is 10 or 30 seconds.

A review of the Oxivir manufacturer instructions for use showed the following: " For use as a one-step cleaner / disinfectant ...Use a 5 minute contact time ... "

A review of the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) showed the following:

" By law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the surface description.

Use germicides registered by the EPA for use as hospital disinfectants ...in accordance with label instructions to decontaminate ... "

1b. During observation of the NICU and interview, on December 23, 2013, at 9:40 AM, RN 1 cleaned a glucometer (a device to test the amount of sugar in blood) with a Gluco-Chlor (disinfectant wipes that are pre-moistened disposable cloths containing a solution to disinfect surfaces). RN 1 said the glucometer was ready for reuse less than 1 minute after applying the Gluco-Chlor and the glucometer was completely dry in 3 minutes. A review of the Gluco-Chlor manufacturer ' s instructions for use noted the following: " Contact time: Allow surface to remain wet for 5 minutes. "


During an observation and interview in the Intensive Care Unit (ICU), the North Unit, on December 24, 2013, at 11:20 AM, RN 3 cleaned a glucometer with a Sani-Cloth AF3 (disinfectant wipes that are pre-moistened disposable cloths containing a solution to disinfect surfaces). The glucometer device was completely dry in less than two (2) minutes. RN 3 said the glucometer would be ready for reuse after letting the device for three (3) minutes after applying the Sani-Cloth AF3. A review of the Sani-Cloth AF3 manufactures instructions for use listed on the dispenser packaging noted the following: " To Disinfect: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treaded surface are must remain visibly wet for a full three (3) minutes. Use additional wipes(s) if needed to assure continuous 3 minute wet contact time.

During an observation and interview in the Emergency Department, on December 26, 2013, at 2:20 PM, RN 4 cleaned a glucometer with a Sani-Cloth AF3. The glucometer device was completely dry in less than 1 minute. RN 4 said the glucometer would be ready for reuse after letting the device dry for three (3) to five (5) minutes after applying the Sani-Cloth AF3.

A review of the Sani-Cloth AF3 manufactures instructions for use, with RN 4, noted the following: " To Disinfect: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treaded surface are must remain visibly wet for a full three (3) minutes. Use additional wipes(s) if needed to assure continuous 3 minute wet contact time. "

During an observation and interview in the Medical/Surgical Unit, Seventh (7th) floor South, with the Infection Control Preventionist (ICP) present, on December 26, 2013, at 2:50 PM, RN 5 cleaned a glucometer with a Sani-Cloth AF3. RN 5 said the glucometer was ready for reuse after wiping the device for one (1) minute after applying the Sani-Cloth AF3.

A review of the Sani-Cloth AF3 manufactures instructions for use listed on the dispenser noted the following: " To Disinfect: Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treaded surface are must remain visibly wet for a full three (3) minutes. Use additional wipes(s) if needed to assure continuous 3 minute wet contact time. "

A review of the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) showed the following:

" By law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the surface description.

Use germicides registered by the EPA for use as hospital disinfectants ...in accordance with label instructions to decontaminate ... "

1c. During an interview on December 23, 2013, at 9:45 AM, RN 1 stated the facility's portable phones were cleaned with Oxivir wipes and required a 1 minute wet contact time.

A review of the Oxivir manufacturer instructions for use showed the following: "For use as a one-step cleaner / disinfectant ...Use a 5 minute contact time ..."

A review of the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) showed the following:

"By law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the surface description.

Use germicides registered by the EPA for use as hospital disinfectants ...in accordance with label instructions to decontaminate ..."

1d. During an observation and interview on December 23, 2013, at 10:10 AM, with Environmental Services worker (EVS 1), she stated the wet contact time of Oxivir is 3 minutes and it is used to disinfect sinks, table tops, and floors. EVS 1 indicated that Oxivir was contained in a non-labeled bucket on a cleaning cart.

A review of the Oxivir instructions for use listed on the dispenser packaging noted: " For use as a one-step cleaner / disinfectant ...Use a 5 minute contact time ... "

A review of the Oxivir manufacturer instructions for use noted the following: " For use as a one-step cleaner / disinfectant ...Use According to the Association of perioperative Registered Nurses (AORN), Perioperative Standards and Recommended Practices, Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013) noted the following:

Chemicals placed into a secondary container must be labeled with the chemical and the solution ' s concentration.

Policies and procedures for environmental cleaning and disinfection should include, but not be limited to ...labeling of secondary containers. "

1e. During observation and interview in the surgical area, on December 23, 2013, at 11:05 AM, EVS 2 wiped a procedure table pad and a bassinet pad with Oxivir. The bassinet pad was completely dry after 3 minutes and the procedure table pad was almost completely dry after 4 minutes.

A review of the Oxivir instructions for use listed on the dispenser packaging noted the following: " For use as a one-step cleaner / disinfectant ...Use a 5 minute contact time ... "

A review of the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) noted the following:

"By law, users must follow all applicable label instructions of products registered by the Environmental Protection Agency, including the surface description.

Use germicides registered by the EPA for use as hospital disinfectants ...in accordance with label instructions to decontaminate ..."

2. During observation and interview in the surgical area on December 23, 2013, at 11:10 AM, tape residue was observed on the pad of an OR procedure table. RN 2 stated the facility follows AORN infection control guidelines.

A review of AORN Perioperative Standards and Recommended Practices, the Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013) noted the following:

"The patient should be provided a clean, safe environment. Health care-associated infections have been linked to external sources, which can include environmental surfaces. The perioperative registered nurse should assess the perioperative environment frequently for cleanliness and take action to implement cleaning and disinfection procedures if needed. Cleanliness means the absence of visible ...debris ...Environmental surfaces can serve as a means of secondary transmission by providing a reservoir for infectious organisms ...showing the importance of environmental cleaning and disinfection as part of an infection prevention process in reducing microbial bio-burden in the environment, thereby interrupting microorganism transmission."

A review of the Healthcare Infection Control Practices Advisory Committee, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) noted the following:

"Environmental surfaces can become contaminated with infectious agents and contribute to the spread of health-care-associated infections ...Surface type ...affects cleaning effectiveness because the surface irregularities can shield microorganisms from disinfection products."

3. During an observation and interview in the surgical area on December 23, 2013, at 11:20 AM, EVS 2 indicated that Oxivir was contained in a non-labeled bucket on a cleaning cart.

During an interview in the surgical area on December 23, 2013, at 11:10 AM, RN 2 stated the facility follows AORN infection control guidelines.

During a review of the AORN Perioperative Standards and Recommended Practices, the Recommended Practices for Environmental Cleaning in the Perioperative Setting (2013) noted the following:

"Chemicals placed into a secondary container must be labeled with the chemical and the solution ' s concentration.

Policies and procedures for environmental cleaning and disinfection should include, but not be limited to ...labeling of secondary containers."





4. During an interview with the Assistant Director of Respiratory (ADR) for the NICU, on December 24, 2013, at 10:50 AM, he stated that the procedure for cleaning the Ventilator Heat Sensor on NICU ventilators was recently changed. He stated that the respiratory staff used to wipe down the sensor with a Sani-wipe and then placed the sensors together in a drawstring plastic bag and stored them in a drawer. He stated that the heat sensors are now sent down to sterile processing to be cleaned with a different disinfectant and then individually packaged for future patient use.
During an interview on December 24, 2013 at 11:35 AM, with the Manager of Sterile Processing, he stated that they changed the cleaning method to follow the manufacturer ' s instructions for the Ventilator heat sensors (a device that measures the temperature of the ventilator air) used in the NICU.

During an interview with the ICP (O) on December 26, 2013, at 12:05 PM, she stated that the heat sensor cleaning was changed to the new procedure was December 9, 2013.

Review of the manufacturer's "Humidifier Temperature Probe Disinfection Instructions," revised 11/2010, indicated "2. Wipe Method 2a. With a soft bristle brush remove any excess soil in sterile water and a mild non -abrasive detergent. 2b. Rinse with sterile water. Do not submerge the swivel plug end of the probe. 2c. Dry with a non-shedding cloth. 2d. Follow the wiping instructions supplied by the manufacturer of the Wipes as listed in 2d overleaf (Tuffie 5 Wipes or Tristel Wipes system (contains pre-clean, Sporicidal and Rinse wipes). 2e. Product can be packaged for re-use."

5. During an observation on December 23, 2013, at 11:10 A.M., in the hallway outside of OR3, one large white ceiling tile was noted to have a large brown colored stain that involved the entire ceiling tile. The staff indicated that they had not noticed the stained tile until it was pointed out to them.

Review of the "Round/ Survey Inspector Field Report" form for the 3rd floor NICU, dated 7/25/2013, indicated no space to record an observation of whether or not the ceiling tiles or other ceiling fixtures were monitored for cleanliness and safety.

During an interview with the compliance officer on December 27, 2013 at 1:30 PM, she confirmed there was no facility policy regarding the proper conduct of environment of care rounds (walking through the facility with a checklist to monitor the patient care environment).


During an observation on December 23, 2013, at 10:30 AM, in the Neonatal Intensive Care Unit (NICU), located on the third floor of the new tower, a spray bottle of "Good Sense liquid odor counteractant" was observed hanging from the sink pipe in Room 4. On the bottle was printed "Please don't remove from room 28." The bottle was observed to have 200 cc of fluid remaining in the1000 cc bottle. During a concurrent interview with the Respiratory Therapist (RT1), he stated that the nurses use the "Good Sense liquid odor counteractant" in NICU patient rooms that smell bad, because "the nurse has to smell it."

During an observation on December 23, 2013, at 10:45 AM, in the NICU Environmental Services closet (on the third floor) a spray bottle of "Good Sense" fabric deodorizer was observed to be on the shelf. The bottle appeared to be partially used. On the bottle was printed "4W" (fourth floor west). During a concurrent interview with the EVS manager, he confirmed that 4W meant the west wing of the fourth floor.

During an interview with the Environmental Services manager on December 23, 2013, at 10:45 AM, in the NICU, he stated the he did not expect his staff to be using the Good Sense deodorizer on the unit (NICU).

During an interview with the EVS staff (EVS-R) on December 23, 2013, at 11:10 AM, she stated that she used the "Good sense liquid odor counteractant" in patient rooms, but not in the Operating Rooms. She stated that she sprayed the product into the inside of the trashcan to make it smell better.

During an observation and interview with the EVS staff (EVS-L) on December 24, 2013 at 11:35 AM, on the Adult ICU unit, he showed that he had the "Good Sense liquid odor counteractant" on his cart and confirmed that he uses the product. He stated he's had the bottle for one week. The ICP was present during the interview.

Review of the policy titled "Approved Cleaning Agents" revised 4/2013, indicated "Purpose: To provide a list of cleaning, hygiene and disinfection Medical Center approved products. All cleaning and disinfection agents used for patient care equipment or for the environment in the Medical Center are reviewed and approved every two years by the Medical Center Infection Control Committee. Only agents approved by the Medical Center Infection Control Committee are permitted for usage in the (location of facility) Medical Center." Review of the list of approved products did not indicate that "Good Sense liquid odor counteractant" was on the list of approved cleaning agents.

Review of the policy titled "Patient Room, Discharge-Terminal" indicated, "Empty wastebaskets, clean with germicidal disinfectant, and replace liner."





7. During multiple observations on December 23, 24, 25 and 26, 2013, of the Hospital entrance areas there were no Respiratory Etiquette (measures to contain respiratory secretions) supplies (masks, tissue) available for patient and visitor use. There was no Respiratory Etiquette signage posted.

During an observation on December 26, 2013 at 1:30 PM, with the ICP and Director of Accreditation and Licensing (Dir A & L), the Emergency Department (ED) entrance and ED waiting areas were observed. There were no masks, tissue and hand sanitizer readily available for patient and visitor use. There was no Respiratory Etiquette signage posted in the ED entrance or waiting area. The ICP and Dir A & L both acknowledged that the Influenza Season started September 30, 2013. The ICP and Dir A & L confirmed that there were no masks, hand sanitizer and tissue readily available for patient and visitor use in the ED, the ED waiting room or the main entrance. They also confirmed that there was no Respiratory Etiquette signage posted in the ED, the ED waiting room or the main entrance areas.

A request was made, on December 26, 2013 at 1:50 PM, for the hospital's policy and procedure (P&P) regarding an Influenza (the flu, a respiratory illness) Prevention Plan. The ICP and Dir A & L stated that the hosptial did not have a policy.

A request was made, on December 26, 2013 at 1:50 PM, for the hospital's policy and procedure (P&P) regarding Respiratory Etiquette. The ICP and Dir A & L stated that the hospital did not have a policy. The ICP stated that the hospital follows the Center for Disease Control (CDC) recommendations regarding Respiratory Hygiene/Cough Etiquette during influenza season.

A review of the Center for Disease Control (CDC) website (www.cdc.gov <http://www.cdc.gov>) regarding Respiratory Hygiene/Cough Etiquette in Healthcare Settings noted the following:

" To prevent the transmission of all respiratory infections in healthcare settings, including influenza, the following infection control measures should be implemented at the first point of contact with a potentially infected person. They should be incorporated into infection control practices as one component of Standard Precautions.

1. Visual Alerts: Post visual alerts (in appropriate languages) at the entrance to outpatient facilities (e.g., emergency departments, physician offices, outpatient clinics) instructing patients and persons who accompany them (e.g., family, friends) to inform healthcare personnel of symptoms of a respiratory infection when they first register for care and to practice Respiratory Hygiene/Cough Etiquette.

a. Printable posters " Cover Your Cough " , Tips to prevent the spread of germs from coughing.

b. Information about Personal Protective Equipment, Demonstrates the sequences for donning and removing personal protective equipment.

2. Respiratory Hygiene/Cough Etiquette

The following measures to contain respiratory secretions are recommended for all individuals with signs and symptoms of a respiratory infection.

- Cover your mouth and nose with a tissue when coughing or sneezing;

- Use in the nearest waste receptacle to dispose of the tissue after use;

- Perform hand hygiene (e.g., hand washing with non-antimicrobial soap and water, alcohol-based hand rub, or antiseptic handwash) after having contact with respiratory secretions and contaminated objects/materials.

Healthcare facilities should ensure the availability of materials for adhering to Respiratory Hygiene/Cough Etiquette in waiting areas for patients and visitors.

- Provide tissues and no-touch receptacles for used tissue disposal.

- Provide conveniently located dispensers of alcohol-based hand rub; where sinks are available, ensure that supplies for hand washing (i.e., soap, disposable towels) are consistently available.

3. Masking and Separation of Persons with Respiratory Symptoms

During periods of increased respiratory infection activity in the community (e.g., when there is increased absenteeism in schools and work settings and increased medical office visits by persons complaining of respiratory illness), offer masks to persons who are coughing. Either procedure masks (i.e., with ear loops) or surgical masks (i.e., with ties) may be used to contain respiratory secretions (respirators such as N-95 or above are not necessary for this purpose). When space and chair availability permit, encourage coughing persons to sit at least three feet away from others in common waiting areas. Some facilities may find it logistically easier to institute this recommendation year-round.

4. Droplet Precautions

Advise healthcare personnel to observe Droplet Precautions (i.e., wearing a surgical or procedure mask for close contact), in addition to Standard Precautions, when examining a patient with symptoms of a respiratory infection, particularly if fever is present. These precautions should be maintained until it is determined that the cause of symptoms is not an infectious agent that requires Droplet Precautions.
VIOLATION: QAPI Tag No: A0263
The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.

The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors.

The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.


This Condition is not met as evidenced by:

Based on interview and record review, the hospital failed to ensure that the Quality Assessment and Performance Improvement Program (QAPI) reflected the complexity of the hospital's organization and services and involved all hospital departments and services when it failed to:


A. Have an ongoing quality assessment and performance improvement (QAPI) program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practices in the Operating Room, Neonatal Intensive Care Unit (NICU) and throughout the hospital that effectively implemented change to improve patients' quality of care in a universe of 212 patients by failing to ensure the following:

1. Disinfectant wet times were not maintained in accordance with manufacturer's instructions.

2. Tape residue was observed on the pad of an Operating Room (OR) table.

3. The facility failed to label and date a container of chemicals used for cleaning ORs.

4. Good Sense bottle of cleaning related product, odor freshener, observed in the Neonatal Intensive Care Unit (NICU), patient room number four, hanging on the sink pipe labeled "Do Not Remove from Room #28". There was a spray bottle in the housekeeping closet in the NICU (third floor) that was labeled "4 West" (fourth floor west).

5. The ceiling tile in the hallway at the entrance of OR number three was observed to have a large brownish color stain involving the entire ceiling tile.

6. Ventilator heat sensors (a device to measure the temperature of the ventilator air) used in the NICU were not disinfected and stored according to manufacturer's instructions.

7. Glucometers (a device to test the amount of sugar in blood) on several medical units were not disinfected according to sani-wipe (disinfectant wipes that are pre-moistened disposable cloths containing a solution to disinfect surfaces) manufacturers wet contact time (time surface must remain wet to kill microorganisms) recommendation.

8. There was a lack of flu (influenza, a respiratory infection) prevention signage and supplies at every hospital entrance. (Refer to A-0273).

The cumulative effect of these systemic problems resulted in the hospital being unable to ensure the provision of quality health care in a safe environment in accordance with the Condition of Participation for QAPI.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on observation, interview, and document review, the hospital failed to have an ongoing quality assessment and performance improvement (QAPI) program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practices in the Operating Room (OR), Neonatal Intensive Care Unit (NICU) and throughout the hospital that effectively implemented change to improve patients' quality of care in a universe of 212 patients by failing to ensure the following:


1. Disinfectant wet times were not maintained in accordance with manufacturer's instructions.


2. Tape residue was observed on the pad of an Operating Room table.


3. The facility failed to label and date a container of chemicals used for cleaning ORs.


4. Good Sense bottle of cleaning related product, odor freshener, observed in the Neonatal Intensive Care Unit (NICU), patient room number four, hanging on the sink pipe labeled "Do Not Remove from Room #28". There was a spray bottle in the housekeeping closet in the NICU (third floor) that was labeled "4 West" (fourth floor west).


5. The ceiling tile in the hallway at the entrance of OR number three was observed to have a large brownish color stain involving the entire ceiling tile.


6. Ventilator heat sensors (a device to measure the temperature of the ventilator air) used in the NICU were not disinfected and stored according to manufacturer's instructions.


7. Glucometers (a device to test the amount of sugar in blood) on several medical units were not disinfected according to sani-wipe (disinfectant wipes that are pre-moistened disposable cloths containing a solution to disinfect surfaces) manufacturers wet contact time (time surface must remain wet to kill microorganisms) recommendation.


8. There was a lack of flu (influenza, a respiratory infection) prevention signage and supplies at every hospital entrance.


These failures had the potential to place all patients at risk for infections and potentially contributed to the deaths of two NICU patients (Patient 3 & Patient 4).

Findings:

On December 27, 2013, a review of Patient 4 ' s clinical record was conducted. The electronic medical record, undated, indicated that Patient 4 was delivered by cesarean section (surgical removal of a baby from the mother) on October 23, 2013 at 25 weeks gestation (normal gestational age at delivery is 40 weeks) and admitted into the NICU. Review of the Death Summary, dated November 2, 2013, indicated the Principal Diagnosis was 25 week premature infant...sepsis ... (over-whelming, life threatening infection in the blood). " Review of the List of Clinical and Surveillance (monitoring) Cultures (tests for bacteria), received on December 27, 2013 indicated that a blood test taken on November 2, 2013 showed positive results for infectious bacteria (Pseudomonas-a common bacteria found in soil, water and skin).

On December 27, 2013, a review of Patient 3 ' s clinical record was conducted. The electronic medical record, undated, indicated that Patient 3 was delivered by cesarean section (surgical removal of a baby from the mother) on October 23, 2013 at 25 weeks gestation (normal gestational age at delivery is 40 weeks) and admitted into the NICU. Review of the List of Clinical and Surveillance (monitoring) Cultures (tests for bacteria), received on December 27, 2013 indicated that a blood test taken on November 7, 2013 showed positive results for infectious bacteria (Pseudomonas) and that Patient 3 died that same day.

Review of the hospital's QAPI program on December 26, 2013, revealed it failed to measure, analyze and track quality indicators for environmental cleaning. The hospital's QAPI program failed to measure (have monitors for) the cleaning process of the NICU and Operating Rooms and failed to monitor the hospital staff to ensure the manufacturer's instructions were followed during the cleaning of patient care equipment.

During a group interview on December 26, 2013, at 4:00 PM, with the Quality Assurance Co-Chairmen (QA1) & Medical Co-Chairman (MD1) they were unaware that the hospital had been conducting incomplete environmental observations. The QAPI data collection did not include monitoring of staff competencies for following the manufacturer ' s recommendations for disinfecting patient care equipment, conducting observations of hospital environment that included all plumbing fixtures as a potential source of infection and not posting influenza prevention information or making available respiratory etiquette supplies.

During the survey, multiple observations were made of staff disinfection of patient care equipment. The manufacturer ' s instructions for use of the disinfectants were not followed. During a tour of the NICU and adjacent OR area, tape residue was observed on the pad of the OR table and the staff failed to label and date a container of chemicals used for cleaning the OR. Also, the ceiling tile in the hallway at the entrance of OR number three (3) was observed to contain a large brownish color stain involving the entire ceiling tile as a result of the plumbing fixture. Review of an engineering report from the Chief Engineer, dated December 23, 2013 indicated that the ceiling tile stain was a result of a steam controlling valve for a humidifier located just above the ceiling tile. It formed condensation (water) that stained the tile.


During an observation tour on December 23, 2013, at 10:10 AM, in the NICU a bottle of cleaning related product was observed hanging on the sink pipe in patient room four, the room Patient 4 occupied in the NICU. The bottle was labeled "Do Not Remove from Room #28". There was also a spray bottle observed in the NICU (third floor) housekeeping closet that was labeled " 4 West " (fourth floor west).


During an observation tour on December 26, 2013 at 1:00 PM, in the Emergency Department Lobby and other hospital entrances, there was a lack of flu (influenza, a respiratory infection) prevention signage and supplies at every hospital entrance.


During an interview on December 24, 2013 at 11:35 AM, with the Manager of Sterile Processing, he stated that they changed the cleaning method to follow the manufacturer ' s instructions for the Ventilator heat sensors (a device that measures the temperature of the ventilator air) used in the NICU.
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to maintain a current and individualized nursing care plan for 2 of 11 sampled patients (Patient 1 and 2) in a universe of 13 Neonatal Intensive Care Unit (NICU) patients.

Findings:

1. During a review of Patient 2's medical record on December 23, 2013, the facesheet noted that the patient was admitted to the facility on on [DATE] with a diagnosis of pre-term 24 weeks (a premature baby).

During the initial tour of the NICU on December 23, 2013 at approximately 9:00 AM, it was observed that Patient 2 was in Contact Isolation (requiring staff and visitor to don a gown and gloves before entering the patient room to prevent the spread of infection).

A review of the patient care plan for Patient 2 noted that there was no care plan developed for the risk of infection or for contact isolation.

During an interview on December 23, 2013 at 3:30 PM with RN 6, RN 6 acknowledged that there was no active care plan in Patient 2's medical record to address the problems of infection and contact isolation and that there should have been.

A review of a hospital policy and procedure titled "Plan of Care" with a revision date of January 2013, noted the following:

"The registered nurse shall complete a review of the patient plan of care at a minimum of once per shift and make revisions as appropriate."





2. During a review of Patient 1's medical record on December 27, 2013, the facesheet noted that the patient was admitted to the facility on on [DATE] with a diagnosis of pre-term 24 weeks (a premature baby).

During the initial tour of the NICU on December 23, 2013 at approximately 9:00 AM, it was observed that Patient 2 was in Contact Isolation (requiring staff and visitor to don a gown and gloves before entering the patient room to prevent the spread of infection).

A review of the patient care plan for Patient 1 noted that there was no nursing care plan developed for the risk of infection or for contact isolation.

During an interview on December 27, 2013 at 9:20 AM with RN 7, RN 7 acknowledged that there was no individual active nursing care plan in Patient 1's medical record to address the specific problems of infection and contact isolation and that there should have been.

A review of a hospital policy and procedure titled "Plan of Care" with a revision date of January 2013, noted the following:

"The registered nurse shall complete a review of the patient plan of care at a minimum of once per shift and make revisions as appropriate."
3. During a review of Patient 9's medical record on December 24, 2013, the facesheet noted that the patient was admitted to the facility on on [DATE] with a diagnoses of urinary tract infection (bladder infection), hypokalemia (potassium in the blood is lower than normal) and possible lung mass.

During the initial tour of the Intensive Care Unit (ICU) on December 24, 2013 at approximately 11:30 AM, it was observed that Patient 9 was breathing with the assistance of a ventilator (a machine designed to mechanically move breatheable air into and out of the lungs).


A review of the patient care plan for Patient 1 noted that there was no nursing care plan developed for the use of a ventilator.

During an interview on December 24, 2013 at 11:45 AM with RN 3, RN 3 acknowledged that there was no active nursing care plan in Patient 9's medical record to address the specific problems of assisted breathing with the use of a ventilator.

A review of a hospital policy and procedure titled "Plan of Care" with a revision date of January 2013, noted the following:

"The registered nurse shall complete a review of the patient plan of care at a minimum of once per shift and make revisions as appropriate."