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Based on medical record review, review of document and staff interview, in 3 of 3 susceptible patients, it was determined the facility failed to ensure that patients received care in a safe setting. Specifically, the facility failed to (1) provide adequate training on EPIC to the dialysis staff, (2) ensure that dialysis staff verified the patient's HBV status in EPIC prior to hemodialysis and, (3) implement a corrective action plan to prevent recurrence of the incident. This findings were noted in medical records for patients #y, #z and #k. The failure to document the patient's HBV status and to implement appropriate isolation precautions placed other patients, visitors, and staff at risk for infection.

Findings include:

(1) A review of patient MR #1 revealed this patient was admitted to the facility on November 4, 2015 with a diagnosis of Colon Cancer. Patient #1 received a hemodialysis treatment on November 7, 2015 for 1 ½ hours, which began at 3:59 PM and ended at 5:29 PM. The patient's (Hepatitis B Virus) HBV status was posted in EPIC as positive at 7:15 PM on November 7, 2015.

Review of the Acute Care Electronic System [ACES - a billing document for Fresenius Medical Care [FMC], the dialysis provider), revealed a nurse incorrectly documented that the patient #1's HBsAg result was negative instead of positive on November 7, 2015.

(2) The HBsAg + patient (Patient #x) was dialyzed using machines #2, #3 and #7 for 4 treatments on November 7, November 8, November 9, and November 12, 2015. The facility failed to disinfect these machines with the proper chemical disinfectant in accordance with the facility policies and procedures and CDC guidelines. The facility used machines #2, #3, and #7 to dialyze other patients.

(3) These findings were verified during an interview with Staff C, the Acute Program Manager, FMC on December 9, 2015 at 12:20 PM. Staff C also verified at this point that machine #3 was not dedicated to Patient #1.

(4) A review of Patient #y ACES documents revealed Patient #2 who is not immune to the virus received hemodialysis treatments on November 9 and 10, 2015 on machine #3, which potentially exposed this patient to the Hepatitis B Virus (HBV).

(5) A review of Patient #z ACES record revealed this patient received hemodialysis treatments on machine # 3 on November 10 and 11, 2015 and machine #7 on November 13, 2015 after Patient #1 received treatment on these machines without the appropriate disinfection after his treatment. Patient #3 was also not immune to the Hepatitis B Virus and he was also potentially exposed to the virus.

(6) A review of Patient #k medical record in ACES revealed this patient received hemodialysis on machine #3 on November 13, 2015, without the proper disinfection of the machine and he was not immune to the virus.

The FMS policy titled "Dialyzing Patients with Positive Hepatitis B Antigen" which was last revised 3/20/13 states PPE (personal protective equipment-gowns, gloves, shields); a dedicated machine and dedicated supplies should be used when dialyzing HBV positive patients.

The facility failed to follow their procedure.

See also Tag 756.

Based on observation and staff interview, the hospital did not adequately implement infection control practice that will prevent the spread of infections.

Findings include:

During a tour of the hospital on 12/14/2015 approximately at 11:57 AM, the following observations were made in the presence of the Director of Accreditation who accompanied the State Surveyor during the tour.

1- The Anteroom of the isolation room #40 was used to store a wheelchair and many boxes that contained hospital gowns and paper supplies. The comingling of clean and dirty supplies poses a risk for cross infection.

2- The soiled room 1058 was found to have positive air pressure instead of the required negative air pressure for this type of room.

3- Sharp containers were stored obstructing access to hand-washing sinks in eight (8) procedure rooms observed. This practice may deter staff from hand washing and poses infection control concern.

4- Used saline bag was observed in the scrubbing sink of the procedure room #3, which is a potential for cross contamination.

5- The gaskets of two Olympus OER-Pro machine that are used for high level Disinfection were observed not sealed properly which may cause spill and splashes of contaminated water. In addition, the surfaces of the two machines were dirty with greenish discoloration.

These issues were brought to the attention of the Director of Accreditation who accompanied the State Surveyor during the tour and she acknowledged these problems.

Based on medical records reviews, reviews of documents, policies and procedures and staff interviews, it was determined the medical staff did not provide oversight in the management of the contracted organization that provided dialysis to the facility's patients.

Findings include:

(1) There was no documented evidence that the Medical Director provided oversight to the dialysis service by not conducting a thorough investigation of the incident and implement an appropriate plan of correction. Issues related to medical staff involement in the incident were not adequately addressed. Specifically, the medical doctors were unaware of the patient's HBV status and that they did not document an order for isolation for a HBsAg+ patient (patient #x) during his dialysis treatments from November 7, 2015 to December 10, 2015.

(2) Reviews of the facility's investigation of the incident which was identified on November 14, 2015, revealed there was no documented evidence that the medical staff had an active role in addressing all of the circumstances that contributed to the breach in infection control practices.


(3) During staff interviews which were conducted with the Chief Quality Officer on December 9, 2015 at 3:00 PM, she confirmed that the medical staff failed to identify and address the significance and complexities of documenting and reviewing the HBV status of its patients in ACES, the contracted agency's (FMC) billing system and EPIC, the facility's electronic medical record system. Consequently up to December 8, 2015, which is the onset of this survey, the dialysis contracted staff were not re-inserviced and trained on which system to utilize in order to prevent recurrence of the staff's error and failure to review the HBV status in EPIC.

(4) The medical staff did not approve the policies which the contracted provider (FMC) had been using at the facility. In addition, policies for the protocol and procedures to dialyze patients that had been exposed to the HBV were inadequate and they had not been approved by the hospital's medical staff.

(5) The medical staff also failed to identify that FMC had conflicting policies for dialyzing its patients. Specifically, the policy titled "Dialyzing Patients with Positive Hepatitis B Antigen" which was last revised 3/20/13, states patients should not be dialyzed without a known Hepatitis status unless in a disaster. Whereas the policy titled "Hepatitis Policy" which was last revised 9/25/13 states patients with unknown status must be dialyzed with the precautions that are used for Hepatitis positive patients. The precautions included wearing personal protective equipment and using a dedicated machine and dedicated supplies.

These findings were verified with Staff A, the Chief Quality Officer during an interview which was conducted on December 10, 2015 at 12:00 PM.