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Based on observation, interview and record review, the facility failed to:
- Respond to a potentially harmful situation in an appropriate and timely manner;
- Ensure that patients were assessed for injury;
- Event reports were processed; and
- Patient's equipment was maintained for one patient (#18) of one patient observed at risk for injury. (Refer to A-0395)

The cumulative effect of these systemic failures resulted in the facility's non-compliance with 42 CFR 482.43 Condition of Participation: Nursing Service. These failures had the potential for harm to all patients in the facility should medical equipment fail. The facility census was 36.

Based on observation, interview, record review and policy review, the facility failed to ensure staff followed infection control policies when staff failed to:
- Follow facility policies for Hand Hygiene (cleaning hands), glove changes, and proper utilization of Personal Protective Equipment (PPE) and supplies for seven of nine patients (#8, #6, #7, #9, #18, #10 and #19) observed in isolation (precautions taken in the hospital to prevent the spread of infection) and for one Housekeeper (Staff W) of one housekeeper observed.
- Follow the manufacturer's insert and infection control standards for urinary catheter and condensation trap drainage bags (from an aerosol drainage unit that traps liquid accumulated from continuous in-line aerosol therapy. The bags attach to a tracheostomy (an artificial opening through the neck into the windpipe) for two of two patients (#4 and #2) observed to prevent cross-contamination.
- Follow facility and Food and Drug Administration (FDA) Time/Temperature Control for Safety (TCS) for all patients in the facility.
These failed practices of not following facility policies, manufacturer's recommendations, and FDA standards to prevent the spread of infection had the potential to cause harm by healthcare associated infections for all patients. The facility census was 36.
(Refer to A-749)

The cumulative effect of these systemic failures resulted in the facility's non-compliance with 42 CFR 482.42 Condition of Participation: Infection Control and resulted in the facility's failure to ensure safe infection control practices to prevent infections and communicable disease.

Based on observation, interview, record review and policy review, the facility failed to ensure the safety and assessment of one patient (#18) when:
- The patient's bed abruptly dropped approximately three inches toward the floor while the patient was in bed.
- The nurse in proximity to the patient failed to assess the patient for injury.
- The nurse that witnessed the equipment failure did not process an event report.
- The facility failed to examine or replace the failed equipment.
- The facility failed to act on the same event two to three days earlier.
The facility census was 36.

Findings included:

1. Record review of the facility policy titled, "Event Reporting System," dated 08/2014, showed:
- That "In order to understand the causes of these events and opportunities to prevent them, (the facility) requires that all patient and visitor events be reported using the (facility) Hospital Division's Event Reporting System".
- Event reporting is to improve patient care and improve patient safety.
- The event reports are used to understand how and why an event occurred and to prevent a similar event from occurring in the future.
- An "event" is defined as any occurrence or situation not consistent with the routine operation of the facility and which may have caused or may have the potential for causing injury to patients, visitors, or loss or damage to property.
- Events include any threat to patient safety; can include physical injury, patient dissatisfaction, and near misses.

2. Record review of Patient #18's History and Physical dated 03/26/16, showed that the patient had a diagnosis of paraplegia (partial or complete paralysis of the lower half of the body with involvement of both legs) with complete cord dissection, chronic pain, chronic bilateral ischial (back lower portion of the hip bone/buttocks) ulcers and osteomyelitis (inflammation/infection of the bone).
The patient's diagnoses would make him unable to feel an injury below his waistline.

3. Observation on 04/13/16 at 9:55 AM showed Patient #18's room as number 7544. Staff V, Wound Care Nurse, and Staff X, Medical Doctor (MD), were across the hall outside of an adjacent patient's room. A loud crashing noise was heard coming from Patient #18's room and Staff X stated, "Sounds like somebody lost their transmission". Staff V, went to Patient #18's door and asked, "Are you okay"? After a short pause Patient #18 answered, "Yes". Staff V was unable to visualize Patient #18 because the privacy curtain was pulled. She then walked down the hall and did not return for five minutes.

During an interview on 04/13/16 at 2:15 PM Staff V stated that she heard the big bang that came from Patient 18's room. Staff V stated that she went to the doorway, did not go in the room, could not see the patient but did ask if the patient was okay and a few seconds later the patient responded that he was okay. Staff V stated that she left the doorway and went to call the supervisor. She returned to the room (five minutes later), went in and told the patient they were going to switch out the bed frame. Staff V stated that she never actually assessed the patient because she knew the patient well and would know by the tone of his voice if he was injured. She also stated that the patient was aware of his condition and would know if he was hurt. Staff V stated that in retrospect she should have gone into the patient's room at the time of the incident, and assessed the patient's condition.

During an interview on 04/13/16 at 10:45 AM, Patient #18 stated that the same thing happened a few days ago, "Dude, yeah. I was just lying here, just like awhile ago, and all of a sudden, it was just like, bam! Just fell right down! Scared me to death! But I wasn't hurt then or nothing either". Patient #18 stated that the bed just fell about two to three inches with a loud bang. Patient #18 stated when the very same thing happened two to three days ago, the wound vacuum-assisted closure (V.A.C., a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds) fell on the floor. He stated that he told the nurse about it at the time but didn't know the nurses name. Patient #18 stated that no one ever came to inspect the bed or replace it.

4. Record review of the facility's Event Report Log through 04/12/16 did not show an event reported for Patient #18 or his bed malfunction before the one observed on 04/13/16.

During an interview on 04/13/16 at 3:15 PM, Staff K, Respiratory Therapist, stated there was no event reported about the bed and no documentation about the event. She stated that Staff O, Maintenance Mechanic, was contacted but could find nothing wrong with the bed in room 7546. Staff K stated that she didn't realize until now that she had reported the incorrect room number and maintenance had checked the wrong bed.

During an interview on 04/13/16 at 4:20 PM, Staff G, Nurse Manager, stated that she would have expected Staff V or anyone that had heard the loud noise in a patient's room to visualize the patient and make sure they were okay, especially a patient that was paralyzed from the waist down and wouldn't be able to feel an injury.

During an interview on 04/14/16 at 10:00 AM, Staff C, Wound Care Nurse, stated that Patient #18's wound suction was compromised (lost suction) on Monday (04/11/16) but she was never told it had anything to do with his bed falling.



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Based on observation, interview, record review and policy review, the facility failed to:
- Follow facility policies for Hand Hygiene (cleaning hands), glove changes, and proper utilization of Personal Protective Equipment (PPE) and supplies for seven patients (#8, #6, #7, #9, #18, #10 and #19) of nine patients observed in isolation (precautions taken in the hospital to prevent the spread of infection) and for one Housekeeper (Staff W) of one housekeeper observed.
- Follow the manufacturer's insert and infection control standards for urinary catheter and condensation trap drainage bags (from an aerosol, or fine spray, drainage unit that traps liquid accumulated from continuous in-line aerosol therapy. The bags attach to a tracheostomy (an artificial opening through the neck into the windpipe) for two of two patients (#4 and #2) observed to prevent cross-contamination.
- Follow facility and Food and Drug Administration (FDA) Time/Temperature Control for Safety (TCS) for all patients in the facility.
These failed practices of not following facility policies, manufacturer's recommendations, and FDA standards to prevent the spread of infection had the potential to cause harm by healthcare associated infections for all patients. The facility census was 36.

Findings included:

1. Record review of facility's policy titled, "Hand Hygiene," dated 05/2015, showed the directives for staff to perform hand hygiene:
- Before touching patient;
- After touching patient;
- After touching a patients surroundings/environment;
- After documenting on the computer;
- Between patients;
- Before putting on and after removing gloves;

Record review of the facility policy titled, "Donning (putting on) and Doffing (taking off) Personal Protection Equipment (PPE- gloves, barrier gown), dated 05/2015, showed directives for staff to utilize PPE to reduce the risk of transmission of infection from patient to healthcare worker and from healthcare worker to patient. When putting on a gown secure the ties around the waist with the ties at the back of the gown.

2. Record review of facility document titled, "Infection Control Log," showed that Patient
#8 was on contact precautions (requires health care providers to put on gown and gloves to prevent the transmission of contagious diseases) for Methicillin Resistant Staphylococcus (staph) Aureus (MRSA- an infection that does not respond to many antibiotics-medications used to treat infections).

3. Observation of medication administration, on the West hall, on 04/11/16 at 2:15 PM, showed Staff E Registered Nurse (RN) entered Patient #8's room with gown and gloves in place. Staff E adjusted the bed linens, touched the vital sign machine, pushed buttons on the cabinet to unlock the door, opened the door, obtained supplies from the cabinet, and closed the cabinet door. Staff E drew up medication from a vial into a syringe, pulled up the patient's gown to expose the abdomen and injected the medication. Staff E failed to perform hand hygiene or change gloves after she touched multiple objects in the room and before the medication was drawn up and administered.

During an interview on 04/11/16 at 3:45 PM Staff E, RN stated that she knew she should have cleansed her hands and changed gloves after objects were touched in an isolation room.

4. Observation in the West hall on 04/11/16 at 2:30 PM showed Staff U, Physician, enter Patient #8's room. Staff U spoke briefly with patient and then returned to the doorway and put on an isolation gown and gloves then went back to speak with Patient #8. Staff U failed to clean hands prior to putting on gloves or tie the back of the gown.

During an interview on 04/11/16 at 2:35 PM Staff C, Wound Care RN, stated that she noticed that Staff U did not tie the gown in the back or clean his hands prior to putting on the gown.

During a telephone interview on 04/14/16 at 8:50 AM Staff U stated that his normal practice was to enter the room prior to putting on a gown because patients rooms are often changed and he checked to be sure it was his patient in the room. Staff U stated that his normal practice was to tie the back of the gown and clean his hands prior to entry into the room. Staff U stated that he just planned to talk to the patient and that is why he forgot to wash hands and tie the back of the gown.

5. Record review of facility document titled, "Infection Control Log," showed that Patient #6 was on contact precautions for Vancomycin Resistant Enterococcus (VRE, a bacteria that has developed resistance to treatment by Vancomycin, which is a powerful antibiotic.)

6. Observation on the West hall on 04/11/16 at 3:00 PM, showed Staff E, RN and Staff D, RN, performed perineal care (cleaned the area around the genitals and rectum) on Patient #6. Both RN's used antiseptic wipes to clean the area. Staff E cleaned the urinary catheter tube (tube that drains urine from the bladder to an external bag) and Staff D cleaned the rectal area. At one point Staff D stated that she should change her glove and removed the glove on her right hand. She said to Staff E that she should change her glove too. Staff E removed glove from her right hand. Staff D retrieved two gloves from the box and both Staff D and Staff E put a clean glove on their right hand. Both Staff D and E kept their dirty glove on their left hand. Neither Staff D nor E cleaned their hands prior to clean gloves being placed on their right hands.

During an interview on 04/11/16 at 3:45 PM Staff E, RN stated that she knew she should not remove only one glove and she should have cleansed her hands before new gloves were placed.

7. Record review of facility document titled, "Infection Control Log," showed that Patient
#7 was on contact precautions for VRE.

8. Observation of medication administration, on the West hall, on 04/11/16 at 3:25 PM, showed Staff E, RN, entered Patient # 7's room with gown and gloves in place. Staff E adjusted the bed linens, repositioned the ventilator (machine used to breathe for patient) tubing, pushed buttons on the cabinet to unlock the door, opened the door, obtained alcohol swipe from the cabinet, and closed the cabinet door. Staff E reached under her gown, with gloved hands, and retrieved a vial of medication, a syringe (used to inject medication), and a pre filled syringe of flush (used to push contents injected into an intravenous (IV) port (mechanism used to put fluid/medication directly into the patient vein) from her scrub (clothing) pockets. Staff E drew out the medication from the vial into the syringe and injected the medication into the IV port. Staff E did not perform hand hygiene, change gloves or gown after she touched multiple objects in the room, reached under her gown and before the medication was drawn up and administered.

During an interview on 04/11/16 at 3:45 PM Staff E, RN stated that she knew she should never put her gloved hands under her gown and she should clean her hands after touching things in the room. Staff E stated that she really knew better but she was nervous.

9. Record review of facility's policy titled, "Administration of Medication," dated 05/2015, showed the directive for staff to open the unit dose medication package directly into the patient's hand or into a medication cup.

10. Observation of medication administration, on the West hall, on 04/12/16 at 8:55 AM, showed Staff F, RN, entered Patient # 9's room with gown and gloves in place. Staff F adjusted the bed linens, applied the blood pressure (BP) cuff to the patient's arm and attached BP tubing to the automated vital sign machine (took BP, pulse rate and temperature), pushed buttons on the cabinet to unlock the door, opened the door, obtained supplies from the cabinet, and closed the cabinet door. Staff F entered information into the bedside computer. Staff F peeled open six unit dose packages of medication, dropped each pill into her gloved hand and then put each pill into the medication cup. Staff F failed to perform hand hygiene or change gloves after she touched multiple objects in the room and before the medication was placed into the cup to be administered.

During an interview on 04/12/16 at 11:00 AM, Staff F stated that she knew she shouldn't open the pills into her hands but she always seemed to drop the pills when she tried to get them from the package to the cup.

11. Observation on 04/13/16 at 9:15 AM showed Staff V, Wound Nurse, in Patient #18's room to perform a wound vacuum-assisted closure (V.A.C., a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds) change to the patient's left ischial (lower buttocks) area. With clean gloves she removed the patient's soiled blanket and placed a clean disposable pad underneath him. Staff V picked up and opened two new containers of gauze pads and picked up and opened a new bottle of wound cleanser. She sprayed the contents of the wound cleanser bottle into one of the gauze containers, sat down the bottle of wound cleanser, picked up the container of clean gauze pads, grabbed several of the wound cleaner saturated gauze pads and cleansed inside the bed of the wound. With the contaminated and dirty gauze pads she cleansed the peri (outer) wound area. After she discarded the contaminated/dirty gauze pads she picked up clean/dry container of gauze pads and dried the peri wound area and the bed of the wound with the same gauze pads. This entire procedure was completed without changing gloves or performing hand hygiene.

During an interview on 04/13/16 at 10:20 AM, Staff V stated, "Oh, I didn't realize I did that, I'll go back and change out that container".

12. Observation on 04/13/16 at 9:30 AM showed Staff E, RN, prepared to change the wound VAC for Patient #18. During the clean-up of the wound set-up table she left the contaminated wound cleanser bottle and unused supplies in the patient's room.

During an interview on 04/13/16 at 10:30 AM, Staff E stated, "Well, we talked about different ways of doing that, whether or not we should just use new bottles or how we should manage it, I assume if there's a different way they want us to do it they'll tell us". She stated that the current practice is to leave the bottles in the room.

13. Observation on 04/12/16 at 8:15 AM showed Staff I, RN, entered Patient #10's room to deliver medication for the patient. Patient #10 was in contact isolation. Staff I put on PPE and gave the medication to Staff H, RN, then wiped her nose with her gloved hand, then opened the nurse server, removed supplies, closed the nurse server, sat the supplies on the table, opened an alcohol swab packet and handed the medication to Staff H with the same contaminated gloves.

14. Observation on 04/12/16 at 8:38 AM showed Staff H put on PPE and prepared to administer medications to Patient #10. She reached under her PPE gown with her gloved hands and reached in every pocket in her uniform retrieving supplies and contaminating her clothes.

During an interview on 04/12/16 at 9:30 AM, Staff H stated she knew better than to reach under her gown and she should have all of her supplies out of her pockets when she entered the patient's room.

15. Observation on 04/12/16 at 2:00 PM showed Staff L, Respiratory Therapist (RT) in Patient #19's room to administer a breathing treatment. Patient #19 was in contact isolation. Staff L had on a PPE gown but did not tie the gown in back leaving his uniform exposed to contamination.

16. Observation in the High Acuity Unit (HAU) on 04/12 at 1:45 PM, showed Staff W, Housekeeper, cleaned Room 7522. She had on gown and gloves, but the gown was not tied in the back. Staff W exited the room, removed her gown and gloves, entered room 7524, put on gown and gloves but did not tie the gown in the back or clean her hands between rooms.

During an interview on 04/12/16 at 2:15 PM, Staff W stated, "You're right, I completely forgot to wash my hands and tie those gowns. I'm glad you pointed that out to me."

17. Observation on 04/12/16 at 2:05 PM showed Staff O, Maintenance Mechanic, put on PPE to enter Patient #19's room to check on the respiratory medication box. He entered the room, opened the medication box then exited the room. He then pulled his tool box inside the door. Staff O failed to remove his PPE, perform hand hygiene or put on new PPE when exiting and entering the patient's room.

During an interview on 04/12/16 at 2:30 PM, Staff O stated that he had never been trained on PPE use and wear in contact isolation rooms.

During an interview on 04/12/16 at 2:30 PM, Staff G, Nurse Manager, stated that the facility worked really hard on infection control education. She stated that the RN's are taught to never put their hands under their gowns to retrieve anything, and constantly reinforced about when to clean hands, change gloves and gowns. In addition, the supervisors watch for untied gowns or lapses in PPE protocols and they educate in real time. Staff G stated that they also educate to not touch medication in between the unit dose pack and the medication cup. She stated, "I guess we still have a lot to do."

18. Record review of the manufacturer's insert for a condensation trap drainage bag showed that the drainage bag should be attached to a hanger and hung on the patient's bed.

19. Observation on 04/11/16 at 2:30 PM in Patient #4's room showed a urinary catheter bag lying on the floor beside the patient's bed. Staff K, RT Manager, picked it up with her gloved hand and hooked it on the patient's bed frame. A condensation trap drainage bag was also lying on the floor beside the patient's bed. Observation showed that Patient #4 was ventilator dependent.

20. Observation on 04/11/16 at 3:05 PM showed Patient #2's condensation trap drainage bag lying on the floor beside her bed. The patient's urinary catheter bag was also lying on the floor beside her bed. Water drain tubes from the hemodialysis (dialysis is the process of removing waste products and excess fluid from the blood. Dialysis is necessary when the kidneys are not able to adequately filter the blood) machine going into drains across the room were lying on the floor on top of a wet blanket. All of these observations put the patient at high risk for infections of the airway, blood, and urinary system.

During an interview on 4/13/16 at 1:30 PM, Staff K stated that it was not an acceptable practice to find any water, bags or tubing on the floor.

21. Record review of the facility's document titled, "Food Temperature Measurement," dated 02/28/14, showed the following:
- The internal temperature of TCS foods is a critical control point.
- The internal temperature of TCS food is measured to assure that it is not in the "food temperature danger zone" for an unacceptable period of time during cooking, holding, cooling, and/or reheating.
- Food temperature also impacts palatability and measurements may be taken at the point of service to evaluate taste.
- Food Temperature Danger Zone is defined as 41 degrees Fahrenheit (F) to 135 degrees F by the FDA Food Code.
- TCS also known as "potentially hazardous food" (PHF).
Cold foods must be maintained at 41°F or less.
A leading cause of foodborne illness is time and temperature abuse of TCS (food requiring time and temperature control for safety) foods. TCS foods are time and temperature abused any time they're in the temperature danger zone, 41°F to 135°F.

During an interview on 04/11/16 at 2:15 PM, Patient #3 stated, "My food is cold sometimes when I get it".

22. Observation on 04/12/16 at 12:10 PM showed a test tray with the following food temperatures taken by Staff Y, Registered Dietitian (RD):
- Soup 135 degrees F;
- Shepherd's pie (ground beef and mashed potatoes) 128 degrees F;
- Low fat yogurt 48 degrees F;
- Ice cream 38 degrees F;
- Coffee 150 degrees F; and
- Apple juice 45 degrees F.
The test tray showed that all of the foods served to patients were in the Food Temperature Danger Zone according to FDA standards except the ice cream and coffee.

During an interview on 04/12/16 at 12:15 PM, Staff Y stated that she did not know what the correct safe temperatures should be when served to a patient.

During an interview on 04/13/16 at 8:55 AM, Staff M, RD, stated that the facility's policy and procedure for food temperatures should be 40 degrees F or below for cold foods and 140 degrees F or above for hot foods. She stated that she ordered a test tray every week and tracked the temperatures.

23. Record review of test tray temperatures for the last six weeks showed that there was not one meal tested where all of the foods were within the safe food temperature ranges.

This failure had the potential to serve all patients foods that contained pathogenic microorganism (bacterial) growth or toxin formation and placed all patients at risk for infection and/or food borne illnesses such as food poisoning.





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