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Based on review of administrative records and staff interviews, the Condition of Quality Assessment and Performance Improvement was not met. The hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program for infection control in the Dialysis Unit evidenced by the hospital's governing body's failure to ensure that the program reflected the inclusion of data from audits provided under contract. The cumulative effect of deficient practice in the Dialysis Unit resulted in the hospital's failure to ensure the provision of quality health care in a safe environment.



The Findings include:

See A749

Based on staff interview and review of administrative records, infection control and quality activities documentation, it was determined the governing body failed to demonstrate an effective infection control program was established to ensure the provision of quality health care in a safe environment.


The findings include:


An interview was conducted on 5/15/2018 at 2:30 PM with Employee F, Registered Nurse (RN), who stated the company performed audits on both the hospital and the staff and that information was used in the Performance Improvement (PI) information given to the hospital quarterly.


On 5/16/2018 at 9:05 AM with Employee G, RN, it was confirmed the company, Mobil Dialysis has Quality Assistants that go into the hospitals every day to make sure staff were doing what the Policy and Procedures state and to ensure staff were following hand hygiene; She stated they looked up patients' Hepatitis B status, observe placing a patient on/off dialysis treatment; giving report and cleaning/disinfecting the machine. She stated," All of these indicators are used for data that are given to the hospital for PI."


On 5/16/2018 at 2:20 PM, Employee G, RN confirmed they ideally want to see every nurse at least monthly. She said, "We have realized we have fallen behind in going to the hospitals and doing audits, so we are trying to make a live document in order to have better tracking and to ensure all facilities are observed."


An interview with Employee H, RN on 5/16/2018 at 2:23 PM, confirmed the company had no documentation of audits for the hospital for at least the past 4 months. She said, "We have to take care of pressing issues before we can do the daily audits and observations."


An interview with Employee B, RN on 5/16/2018 at 11:38 AM, confirmed Hospital Administration received quarterly PI information from the contracted dialysis company. She confirmed PI was never put in place related to dialysis, as there was never any identified concerns with the data received.


A review was conducted of the contract agreement with the contracted outside provider for dialysis, which revealed the company would conduct 50+ audits monthly and then report to the hospital quarterly.

A review of the 1st quarter data submitted to the facility dated 5/1/2018 revealed no concerns with Central Line Associated Bloodstream Infection (CLABSI), water monitoring, use of Protective Personal Equipment (PPE) or access safety.


An interview with Employee G, RN on 5/16/2018 at 2:33 PM confirmed that the data the hospital received was a random sample from all of the hospitals they worked in (almost 30). Employee G, RN stated that they could not confirm if even one patient from their hospital was included in the audit. Employee G, RN stated the data the facility received and the Quality Improvement process was not effective due to the company not giving hospital specific data.


An interview with the Chief Nursing Officer on 5/16/2018 at 3:30 PM confirmed the hospital was not aware the contracted dialysis company information that was provided was inclusive data from all facilities they serviced. She said, "Just recently, we have been concerned and have asked them for more facility-specific data, which they tell us they will look into."

Based on observations of care of the dialysis unit, record review of policies and procedures, and staff interviews, the facility failed to follow hospital policy and procedures for identifying, reporting, investigating and controlling infections to prevent the spread of blood borne pathogens; failed to perform hand hygiene for 2 (#2 & #5) of 4 patients; Failed to apply Personal Protective Equipment (PPE) for 2 (#1& #5) of 4 patients observed during dialysis treatment; failed to properly clean and sanitize reusable equipment for 2 observations and failed to clean and sanitize the Rapid 500 Arterial Blood Gas machine for 1 observation. (A749). These failures have the potential to result in nosocomial infections and poor outcomes for patients and resulted in the Condition of Participation for Infection Control.


The Findings include:


See A749.

Based on observations, record reviews of clinical records, policies and procedures and staff interviews, the hospital failed to follow the hospital policy and procedures for identifying, reporting, investigating and controlling infections to prevent the spread of blood borne pathogens evidenced by the failure to perform hand hygiene for 2 (#2 ) of 4 patients; failed to apply Personal Protective Equipment (PPE) for 2 (#1 ) of 4 patients observed during dialysis treatment. In addition, the hospital staff failed to properly clean and sanitize reusable dialysis equipment for 2 observations and for 1 of 2 observations of the Rapid 500 Arterial Blood Gas (ABG) equipment housed in the hospital for patient treatment and care.

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The findings include:


1) An observation was conducted on 5/15/2018 at 10:38 AM of Employee D, Registered Nurse (RN) accessing Patient #1's Arteriovenous (AV) fistula located on the patient's left upper arm. While cannulating the fistula, the nurse obtained blood to her gloves. The nurse proceeded to wear the visibly soiled blood for the entire access of the patient's fistula. The nurse was then observed touching the dialysis machine, obtaining a temperature, writing notes and touching the patient wearing the same soiled gloves.


On 5/15/2018 at 10:40 AM, Employee D, RN performed hand hygiene, donned new gloves and picked up trash from the floor. The nurse then used the same gloved hands and increased the patient's blood flow rate (BFR) on the dialysis machine.


On 5/15/2018 at 10:45 AM, Patient #2 entered the dialysis room and Employee D was observed donning new gloves, but did not perform hand hygiene. The nurse prepared to cannulate the patient's AV fistula located in her left upper arm. The nurse accessed the patient's fistula in which blood was visible on her gloves. The nurse then secured the tubing with tape, and with the same visibly soiled gloves, touched the dialysis machine and the patient. The nurse touched the machine and patient multiple times without removing the gloves and performing hand hygiene.


An observation was conducted of Employee D, RN, on 5/15/2018 at 10:57 AM, as she demonstrated to this Surveyor how a crit line level was obtained. The nurse was observed as she demonstrated the process, never donning gloves and went back and forth from the dialysis machine for Patient #1 & Patient #2, without donning gloves.


An interview was conducted with Employee D, RN on 5/15/2018 at 10:59 AM. She was asked if she should be wearing gloves when touching patient dialysis machines. She replied, "Sometimes I don't wear them if I'm just entering numbers. If I am setting the machine up, I wear them." She was asked when she should perform hand hygiene and she replied, "When they are visibly soiled." The nurse confirmed she had blood on her gloves after accessing Patient #1's fistula and did not perform hand hygiene nor change her gloves.


An interview with Employee G, RN on 5/15/2018 at 2:30 PM, confirmed the company has a Quality Manager Assistant who conduct daily visits and saw as many nurses as possible to gather data. She stated that the Number 1 goal was to be there for our nurses, then record and report data and give it to the hospital.


An interview with Employee E, LPN on 5/15/2018 at 2:37 PM, confirmed nurses were to perform hand hygiene anytime there was visible blood on their gloves and should always have clean gloves on when touching a dialysis machine. The nurse confirmed that nursing staff should not touch the patient and the machine without removing gloves, sanitizing hands, and donning new gloves.


An interview with Employee F on 5/15/2018 at 2:43 PM confirmed that all staff were audited on how they handled Hepatitis B patient status, hand hygiene, disinfection of the machine, and initiating and terminating treatment of a patient. The Employee was asked how frequently this was done, and she said, " we do it every day and all staff have a certain marker they have to hit and they must visit all nurses. Even though we may not be able to watch a full visit, the Quality Assistants will document what they observe."


An interview was conducted on 5/15/2018 at 3:45 PM with Employee E, LPN, who confirmed when she observed Employee D, RN, the employee did not perform proper hand hygiene, evidenced by her touching the patients and touching the dialysis machines without removing her gloves and sanitizing her hands. The nurse was asked if there was documentation of her observation and she said, "Yes." The nurse was asked by this Surveyor to see the documentation of her observation.


A review of the Quality Management Clinical Observation Form completed on 5/15/2018 for Employee D, RN revealed no concerns documented by Employee E for hand hygiene, which had an overall rating of "Satisfactory." The nurse stated, "Employee D, the nurse needs to be observed frequently for hand hygiene and overall infection control."


An interview with Employee H, RN on 5/16/2018 at 9:05 AM, confirmed Quality Assistants went into the hospitals every day to make sure the staff were doing what their policy and procedures stated. She stated, "We make sure they are following for hand hygiene, and make sure they look at patients' Hepatitis B status, taking a patient on/off dialysis, cleaning/ disinfecting the machine, documentation, etc." The nurse confirmed audits were done on staff who received either a pass or fail, and it was documented on the company's website. The nurse confirmed nursing staff will be immediately educated at the time of a failed observation or will be taken to Administration if it's eggregious. Employee H confirmed nurses would receive a failed grade for (lack of) cleaning of equipment and hand hygiene.


An interview with Employee G, RN on 5/16/2018 at 1:15 PM confirmed the company had no further audits or documentation of Employee D, RN's performance since January 2018. She said, "I can go back and look, but it's been a while since the employee had an audit."


An observation was conducted on 5/16/2018 at 11:00AM of Employee D, RN performing dialysis at the bedside for Patient # 10 with no supervision nor observations being conducted.


An interview with Employee G. RN on 5/16/2018 at 1:45 PM confirmed there was no documentation for observations being conducted on 5/16/2018, of Employee D, RN, even after documentation by staff on 5/15/2018 of frequent observation, and no evidence was given on education to the Employee.


2) An observation was conducted on 5/15/2018 at 11:10 AM of the Storage Room located on the first floor of the hospital, where the mobile dialysis machines were housed. Two dialysis machines were observed with 1 of the 2 stored machines found to have a reddish/brown substance found on the right side of the dialysis machine. (Photographic evidence obtained)


An interview with Employee A, Registered Nurse (RN) on 5/15/2018 at 11:11 AM confirmed the substance appeared to be dried blood. The employee confirmed the machines were cleaned by the staff employed by an outside contracted agency that came into the hospital and provided dialysis services to patients within the hospital.


An interview with Employee E, Licensed Practical Nurse (LPN) on 5/15/2018 at 2:35 PM, confirmed that one of the 2 dialysis machines stored at the hospital was found soiled and not clean. She confirmed to the Surveyor and Employee A, that when she observed the dialysis machine, it was found to have "splattered blood" on it. Employee F, RN also confirmed that Employee E, LPN, had previously told her about the soiled dialysis machine and had it cleaned.


An interview with Employee F, RN on 5/15/2018 at 2:36 PM confirmed all dialysis machines should be cleaned on all of it surfaces after use with each patient, with Alcavis 1:100 wipes manufactured by Angelini.


3) An observation was conducted on 5/15/2018 at 2:30 PM of Employee E, LPN cleaning the dialysis machine after Patient #2's treatment. The LPN was observed using the approved Alcavis 1:100 wipes, but was not observed wiping down the back of the unit.


An observation was conducted on 5/15/2018 at 2:35 AM of the dialysis machine that was just cleaned for Patient #2, which revealed a small, reddish/brown substance (which resembled blood) found on the back of the machine. (Photographic evidence obtained).


An interview with Employee E, LPN on 5/16/2018 at 2:36 PM, confirmed all the surfaces of the dialysis machines should be cleaned and disinfected, and both of the machines would be cleaned thoroughly.


An observation was conducted on 5/16/2018 at 11:40 PM of Patient #5 receiving dialysis in her room with the dialysis machine currently used the day before (5/15/2018) by Patient #2.


An interview with Employee D, RN on 5/16/2018 at 11:41 PM confirmed the dialysis machine she was using for Patient #5's treatment was the same unit she used for Patient #2 on 5/15/2018. The employee confirmed the machine was cleaned and disinfected yesterday by the staff and she brought the unit upstairs this a.m. to perform the treatment.


An observation was conducted of Employee D, RN on 5/16/2018 at 1PM as she cleaned and disinfected the dialysis machine used for Patient #5's treatment.


An observation on 5/16/2018 at 1:45 PM of Patient #5 revealed the cleaned/disinfected dialysis machine was still at the bedside of the patient, with no dialysis staff present in the room. This Surveyor entered the room and observed the dialysis machine. An observation of the back of the machine revealed a reddish/brown substance (which resembled blood) on the back of the machine. (Photographic evidence obtained)


An interview with Employees G & H, RNs on 5/16/2018 at 2:30 PM, confirmed the dialysis machine in Patient #5's room had what appeared to be dried blood on the back of the unit. They replied, "There is some residue from tape that was on the back of the unit and it looked like the blood adhered to the tape residue." Employee G, RN confirmed that staff carry Goo-Gone in case it needs to be used on the back of the machines when they notice the sticky residue to ensure the machines get cleaned & disinfected properly.


4) A second observation was conducted on 5/16/2018 at 9:45 AM of the storage room on the 1st Floor of the hospital, which housed the dialysis machines used for patients in the hospital. One machine that was observed revealed a dark colored substance to the tubing of the machine that was attached and hanging on the right side of the machine. (Photographic evidence obtained)


The observation was conducted on 5/16/2018 at 10:30 AM, along with Employee E, LPN and Employee H, RN who confirmed the substance found on the dialysis machine. Employee E said "It doesn't look like blood; I think it's a stain from Betadine" and proceeded to scrape the substance with her fingernail. The substance started to scrape off and she replied, "I don't know what that is, but I'll clean it off." The LPN was then observed taking a towel and placing it on the floor to dry some water that had come out of the tubing; she then picked up the dirty towel, folded it up and held it her hands. The employee then exited the room without performing hand hygiene.


An interview with Employee G on 5/16/2018 at 11:45 AM confirmed Employee E, should have applied gloves before touching the substance on the dialysis machine, and should have performed hand hygiene after scraping the substance off the tubing. The employee also confirmed all machines should be thoroughly cleaned after use and before storing.


5) An observation was conducted on 5/16/2018 at 12:45 PM of a contact isolation sign on the door entering Patient # 5's room. Employee I, (Anesthesia Tech) was observed standing at the bedside of Patient #5 wearing no personal protective equipment (PPE).


An interview with Employee I on 5/16/2018 at 12:47 PM confirmed he did not apply (PPE) when he was in the room, for Patient #5. He said, "I don't usually wear PPE when I go into a patient's room on isolation. I'm just helping in the room and getting the patient ready for transport to surgery and I'm not allowed to wear the PPE while I'm transporting, so I don't put it on." Employee I then left to obtain an oxygen tank for Patient #5. Upon returning to the patient's room, the employee asked Employee A, RN, if it was necessary to wear PPE, since he was just putting her on oxygen. The employee was instructed again of hospital P&P by Employee A, that if he was in contact with the patient, he must put on the PPE. The employee verbalized understanding and said, "Ok, I never knew that."


An interview with Employee A, RN on 5/16/2018 at 12:53 PM confirmed all staff were to apply PPE when entering a patient's room that was on any type of isolation.


An interview on 5/16/2018 at 12:54PM was conducted with Patient #5's nurse who confirmed the patient was on contact isolation due to Methicillin Resistant Staff Aureus (MRSA) in her blood.


A record review for Patient #5 revealed a date of admission of 5/10/2018 and positive blood cultures for MRSA.


An observation was conducted of Employee D, RN on 5/16/2018 at 1PM cleaning the dialysis machine used for Patient #5's treatment. The employee said she was going to take the machine back down to Dialysis when she was finished cleaning it.


An observation on 5/16/2018 at 1:45 PM of Patient #5's room, of the cleaned and disinfected dialysis machine at the bedside of the patient and no dialysis staff present in the room. This Surveyor then entered the room (after donning PPE) and observed on the dialysis machine, a small reddish/brown substance (which resembled blood) found on the back of the machine. (Photographic evidence obtained)


An interview with Employees G & H, RNs on 5/16/2018 at 2:30 PM confirmed the dialysis machine in Patient #5's room had what appeared to be dried blood on the back of the unit. They replied, "There is some residue from tape that was on the back of the unit and it looks like it was adhered to the tape residue." Employee G, RN confirmed that staff carry Goo-Gone to use on the back of the machines as needed, if they see that there is sticky residue to ensure the machines get cleaned & disinfected properly.


6) On 5/16/2018 at 10:15 AM an observation was conducted of a RapidPoint 500 machine (used to perform readings on Arterial blood gasses) with a large amount of dried blood seen on the outside of machine, as well as on the inside of the machine. (Photographic evidence obtained)


An observation of the room the machine was stored in on 5/16/2018 at 10:15 AM revealed a reddish/brown substance which resembled blood on the cabinet above the machine, on the wall adjacent from the machine and on the left side of the wall located near the door before entering/exiting the room.


An interview with Employee A, on 5/16/2018 at 10:16 AM confirmed the substances appeared to be blood and would get staff to come and clean it right away.


A 2nd observation on 5/16/2018 at 10:50 AM was conducted along with Employee A, of the blood-like substance to still be on the RapidPoint 500 machine, cabinet and walls.


An interview with Employee J, (Respiratory Manager) on 5/16/2018 at 10:53 AM confirmed all respiratory staff should clean all machines once they have used a RapidPoint 500 machine with the orange top Sani-cloth PDI wipes. The employee confirmed the machine was used for both ED and 1st Floor patients.


A review of hospital's policy and procedures (P&P) for Standard and Transmission Based Precautions for staff, Policy #2000-303, Issue Date June 2011 - Revision date 2/2018 Reads, "Hand Hygiene should be done if contaminated with blood, body fluids, or other contaminates. The hands (and any skin surface involved) should be immediately washed using proper technique. Perform hand hygiene after removing gloves, Perform hand hygiene before and after contact with patient. May use approved alcohol-based hand rubs when appropriate and hands are not visibly soiled; Any use of PPE; And, when touching any equipment during treatment, staff must wear disposable gloves, then remove them and perform hand hygiene. "(Photographic evidence obtained)


A review conducted of the hospital's P&P for External Disinfection/Cleaning of Dialysis Machine, Policy # 2000-301.
After removing the bloodlines and dialyzer, the exterior surface of the dialysis machine will be cleaned with an approved EPA registered disinfectant approved for use in healthcare settings. The machines will be cleaned with Alcavis 1:100-dilution bleach wipes. Both wipes have a contact time of 5 minutes to air dry. Remove PPE, wash hands, assure that the area is dry and with no evidence of spills." (Photographic evidence obtained)


A review of the hospital's P&P for Isolation Precautions Transmission Based Index NO 0500.000 IC reads, "For Contact isolation, staff must wash hands by washing or sanitizer, gown and gloves. Gowns and protective apparel are worn by personnel during the care of patients infected with epidemiology. (Photographic evidence obtained)