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Based on observation, staff interviews, medical record review, and review of facility documents, it was determined the facility failed to ensure that methods for preventing and controlling the transmission of infectious diseases within the facility are implemented.

Findings include:

The facility failed to ensure that all chemicals used for cleaning and disinfection of the internal pathways of the hemodialysis machines, including after use on a Hepatitis B positive patient, is used by the manufacturer's best by date. (Cross-refer A-0749)

Based on staff interviews, medical record review, and review of facility documents, it was determined the facility failed to ensure that respiratory services performed by respiratory therapists, are available 24 hours a day, seven days a week.

Findings include:

1. The facility failed to ensure that respiratory services provided by a respiratory therapist are available at all times. (Cross refer to Tag A-1154)

2. The facility failed to ensure that patients on mechanical ventilation receive reassessments by a respiratory therapist at least daily, in accordance with facility policy. (Cross refer to Tag A-1160)

Based on observation, medical record review, staff interview, and facility document review, it was determined the facility failed to ensure that chemicals utilized for the cleaning and disinfection of the internal pathways of the hemodialysis machines, including after use on a Hepatitis B positive patient, is used by the manufacturer's best by date.

Findings include:

Reference #1: Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Recommendations for Preventing Transmission of Infections Among chronic Hemodialysis Patients, April 27, 2001/Vol. 50/No. RR-5, stated, "HBV-Infected Patients ... designate a separate room for their treatment and dedicate machines, ... If a machine that has been used on an HBsAG-positive patient is needed for an HBV-susceptible patient, internal pathways of the machine can be disinfected using conventional protocols ..."

Reference #2: Fresenius Medical Care 2008T Hemodialysis Machine Operator's Manual, states, "... Cleaning and Disinfection ... Acid Clean Daily ... vinegar ...Heat Disinfect Daily ... Chemical/Rinse Weekly ... bleach ..."

On 11/6/23 at 10:20 AM, a tour of the 5th floor was conducted in the presence of Staff #6 (S6), Director of Nursing, and S9, Charge Nurse for Hemodialysis. S9 stated that the hemodialysis machine designated for Hepatitis B positive (HBsAG+) patients has been broken. S9 stated he/she thought the machine was put out of service sometime in August 2023, but was not sure of the actual date. S9 stated they are using Machine #2 to dialyze the HBsAG+ patient at the end of the day. S9 also stated they do use Machine #2 on Hepatitis B Surface Antigen negative (HBsAG-) patients prior to performing hemodialysis on the HBsAG+ patient. S9 stated that all hemodialysis patients are in private rooms. S9 stated that after every treatment, staff will do an external cleaning of the machines, using bleach wipes at the end of the day, and that the machine will be internally cleaned using 5% vinegar and a heat disinfect. S9 stated that all hemodialysis machines are cleaned internally with bleach weekly. S9 stated that after Machine #2 is used on the HBsAg+ patient, it is cleaned externally using a bleach wipe, and is internally cleaned using 5% vinegar, heat disinfect, and cleaned internally with bleach.

Upon review of P3's medical record on 11/6/23, in the presence of S9, it was revealed that P3 was admitted on 10/29/23 and was receiving hemodialysis at the facility. On 10/30/23, P3's lab result indicated the following: HBsAG (hepatitis B surface antigen) reactive, HBsAB (Hepatitis B surface antibody) 0.72, Hepatitis B Core Total Antibody Reactive. These lab results indicated that P3 was Hepatitis B positive.

Review of P3's Hemodialysis Flowsheets revealed that P3 received hemodialysis using Machine #2 on the following days:

On 10/30/23, the treatment was started at 1545 (3:45 PM) and ended at 1845 (6:45 PM).
On 11/1/23, the treatment was started at 1545 (3:45 PM) and ended at 1845 (6:45 PM).
On 11/3/23, the treatment was started at 17:25 (5:25 PM) and ended at 20:25 (8:25 PM).
On 11/6/23, the treatment was started at 19:40 (7:40 PM) and ended at 2240 (10:40 PM).

Review of P1's medical records on 11/6/23, in the presence of S9, revealed P1 was admitted on 10/10/23 and was receiving hemodialysis at the facility. On 10/11/23, P1's lab results indicated the following: HBsAG Nonreactive; HBsAG 13.25; Hepatitis B Core Total Antibody Nonreactive. These lab results indicated that P1 was Hepatitis B negative and had antibodies (protection) against Hepatitis B.

A review of P1's Hemodialysis Flowsheets revealed that P1 received hemodialysis using Machine #2 on 11/6/23. The treatment started at 1555 (3:55 PM) and ended at 1855 (6:55 PM).

Review of P7's medical records on 11/6/23, in the presence of S9, revealed P7 was admitted on 10/2/23 and was receiving hemodialysis at the facility. P7's lab results, dated 11/8/23, indicated the following: HBsAG Nonreactive; HBsAG 48.31; Hepatitis B Core Total Antibody Nonreactive. These lab results indicated that P7 was Hepatitis B negative and had antibodies (protection) against Hepatitis B.

P7's Hemodialysis Flowsheets revealed that P7 received hemodialysis on Machine #2 on 11/6/23. The treatment started at 6:57 AM and ended at 10:27 AM.

Review of P26's medical records on 11/6/23, in the presence of S9, revealed P26 was admitted on 10/28/23 and was receiving hemodialysis at the facility. P26's lab results on 10/30/23 indicated the following: HBsAG Nonreactive; HBsAG 18164.68; Hepatitis B Core Total Antibody Nonreactive. These lab results indicated that P26 was Hepatitis B negative and had antibodies (protection) against Hepatitis B.

P26's Hemodialysis Flowsheets revealed that P26 received hemodialysis using Machine #2 on the following days:

On 10/30/23, the treatment was started at 11:30 AM and ended at 1430 (2:30 PM).
On 11/1/23, the treatment was started at 7:06 AM and ended at 10:06 AM.
On 11/3/23, the treatment was started at 7:13 AM and ended at 10:13 AM.

Review of P27's medical records on 11/6/23, in the presence of S9, revealed P27 was admitted on 11/1/23 and was receiving hemodialysis at the facility. P27's lab results on 11/3/23 indicated the following: HBsAG nonreactive; HBsAG 0.88 susceptible non-immune; Hepatitis B Core Total Antibody Nonreactive. These results indicated P27 was Hepatitis B negative, was susceptible (non-immune) to Hepatitis B and did not have antibodies (protection) against the disease.

A review of P27's Hemodialysis Flowsheets indicated P27 received hemodialysis using Machine #2 on the following days:

On 11/3/23, the treatment was started at 11:40 AM and ended at 1450 (2:50 PM).
On 11/6/23, the treatment was started at 11:50 AM and ended at 14:50 (2:50 PM).

On 11/6/23 at 10:25 AM, S9 confirmed P27 was not immune to Hepatitis B and was dialyzed on the same machine as P3, who is Hepatitis B positive.

On 11/8/23 10:05 AM, a tour of the 5th floor was conducted in the presence of Staff #6 (S6), Director of Nursing. At the time of the tour, there were two patients on dialysis; one patient was using Machine #2 and one is using Machine #3. Both patients were in single rooms. Both patients on dialysis were Hepatitis B surface Antigen (HBsAg) negative (-).

In an interview on 11/8/23 at 10:10 AM, S9 stated that the HBsAg positive (+) patient, P3, gets dialyzed last because there were only two available machines; Machine #2 and #3. Per S9, the dialysis machine dedicated for the Hepatitis B + patient was broken sometime in August or September 2023. S9 stated, that to prevent other dialysis patients from getting infected with Hepatitis B, the staff internally disinfects the machine that is used by P3, with bleach after his/her treatment.

The machine disinfection logs for Machine #2 and #3 for the month of October and November were reviewed, and indicated Machine #2 and #3 were internally disinfected with 5% vinegar and a heat disinfection at the end of each day patients were dialyzed.

On 11/8/23, a review of the Dialysis Machine Logs for Machine #2 indicated the machine was internally cleaned with bleach on the following days:

On 11/3/23 at 15:30 (3:30 PM) and again at 2100 (9:00 PM), after P3's treatment
On 11/6/23 at 23:13 (11:13 PM)

A review of the Dialysis Machine Log for Machine #3 indicated the weekly internal cleaning and disinfection of the machine, with bleach, on 11/3/23 at 2100 (3:00 PM).

The machine disinfection log for Machine #2 contained documentation that it was internally cleaned with bleach after the Hepatitis B positive patient was dialyzed on 10/30/23 at 19:35 (7:35 PM) and on 11/1/23 at 19:25 (7:25 PM), although, it is not known if the bleach used to internally clean and disinfect Machine #2 on these days was used by the Manufacturer's Best By Date, as the bleach solution used on these days was not present.

On 11/8/23 at 10:45 AM, a tour of the dialysis storage room was conducted in the presence of S6 and S9. There were two hemodialysis (HD) machines and two portable RO (reverse osmosis) machines in the room, Machine #5 containing a round red sticker on the top of the machine, which indicated it was dedicated for an isolation patient, and Machine #1. One of the two portable RO's had a red sticker, also indicating it was for isolation only. Per S9, these machines were fixed on November 6, 2023, and were waiting for the results of cultures and endotoxins. The dialysis supply room also contained dialysate jugs, bicarbonate jugs, and two jugs of bleach solution with a label that read, "Pure Bright Germicidal Ultra Bleach," which contained dates of opening of: 11/3/23 and 11/6/23 handwritten by the facility staff. Both Bleach containers contained a manufacturer's label that read, "Best by December 2, 2022." Both containers did not contain storage instructions. Per S9, these were the bleach solutions being used to internally disinfect the machines (Machine #2 and #3), that were currently in use on patients. There were no other bleach containers in the storage room. S9 confirmed the "Pure Bright Germicidal Ultra Bleach," which contained dates of opening of: 11/3/23 and 11/6/23 and a "Best by December 2, 2022," were used to perform the internal cleaning and disinfection on Machine #2 and #3 on 11/3/23 and 11/6/23.

Upon interview on 11/8/23 at 12:00 PM, S21, Vice President of Facilities, when asked about the 'Best By date,' stated the bleach might be less effective for disinfecting the machines. S21 could not provide evidence that the bleach solution with the Best By Date of December 2, 2022 was still effective. Per S21, they will dispose of the old solutions. Two new bleach solution jugs were brought to the conference room by S21 at the end of the day on 11/8/23.

The facility policy titled, Dialyzing Patients with positive Hepatitis B Antigen (HBsAg+), dated 3/29/23, stated, "... If there are current HBsAg positive patients on census, ... equipment cannot be used for HBV [Hepatitis B Virus] negative patients on other shifts or days due to risk of cross contamination. ... Equipment and Supplies ... Separated dedicated supplies and equipment, ... must be used to provide care to the HBsAg positive patient. ... Equipment used for the HBsAG positive patients should be reserved for the HBsAG positive patient unless repair or maintenance is needed ... Follow manufacturer's instructions to carry out routine disinfection of the dialysis machine. EMERGENCY SITUATION IN WHICH A SEPARATE MACHINE IS NOT POSSIBLE ... disinfect internal components of the machine using conventional procedures for internal bleaching. ... Avoid using this on HBV negative patients. It is recommended to use the machine on patients who are Hepatitis B antibody positive. ..."

On 11/8/2023, the Immediate Jeopardy (IJ) was identified regarding the facility's failure to ensure an effective bleach solution is used to clean and disinfect the internal pathways of the hemodialysis machine after being used to provide hemodialysis on a Hepatitis B positive patient. Staff #1 (Quality and Compliance Officer), Staff #2 (President and Chief Operating Officer), and Staff #14 (Advisor to the Board) were informed of the IJ and provided the IJ template on 11/8/23 at 2:48 PM.

Two new bleach solution jugs were brought to the conference room by S21 at the end of the day on 11/8/23 at 2:55 PM.

On 11/13/23, the facility submitted an acceptable removal plan and verification of the implementation of the removal plan was conducted while surveyors were on-site. Verification included: a tour of the dialysis supply room, staff interviews, review of Hepatitis B lab results for dialysis patients, and review of staff re-education regarding the new facility policy "Bleach Disinfectant for Hemodialysis." A copy of the form titled, "BLEACH DISINFECTANT FOR HEMODIALYSIS INSERVICE November 8th, 2023," was provided to the surveyors. The IJ was removed on 11/13/23 at 11:10 AM.

On 11/13/23 at 10:40 AM, a tour of the 5th floor in the presence of S6, a tour of the dialysis supply room at 10:50 AM, revealed a new container of Clorox Bleach with expiration date of April 2025. Per S6 and S21, Machines #2 and #3 were internally disinfected by the new bleach solution. On 11/9/23, the facility received the culture results for Machine #5, the dedicated machine for the Hepatitis B positive patient, and it was cleared to be used. On 11/10/23, Machine #5 was used to provide hemodialysis for P3, the Hepatitis B positive patient. The facility had educated all dialysis staff members, biomed technicians, and material management staff. Proof of a staff inservice dated November 8, 2023, was provided to the surveyors. On 11/13/23 at 10:40 AM, an interview with S17 and S18 was conducted, and both stated they received education on checking for bleach disinfectant integrity per manufacturer's instructions and the new policy, "Bleach Disinfectant for Hemodialysis." On 11/13/23, a review of P1, P6, P7, P26, and P27's Hepatitis B Surface Antigen lab results, dated 11/8/23, indicated all patients were nonreactive (negative) for Hepatitis B.

Based on review of facility documents and staff interview, it was determined the facility failed to ensure that respiratory services provided by a Respiratory Therapist are available at all times.

Findings include:

On 11/3/23, review of the respiratory therapist's staffing schedule from May 2023 to October 2023, revealed that on Monday, 10/30/23, and Tuesday, 10/31/23, during the 7:00 AM to 7:00 PM shift, there was no respiratory therapist assigned. On those dates and times, the respiratory therapist staffing schedule stated, "(Unassigned) House Officer."

During an interview on 11/3/23 at 11:30 AM, Staff #7 (S7), Respiratory Therapist (RT), stated that Advanced Nurse Practitioners (APN) were used as the House Officers.

Upon interview on 11/3/23 at 11:34 AM, S1, Quality and Compliance Officer, stated, the RT for the day shift had an emergency and called out on work on 10/30/23 and 10/31/23. S1 stated that on 10/30/23, the House Officer covered the shift from 11:00 AM to 3:00 PM and that the night shift RT stayed until 11:00 AM to help cover the shift and the RT scheduled for the night shift came in early to help cover the shift. S1 explained further that on 10/31/23, the House Officer covered the shift from 7:00 AM to 3:00 PM. S1 confirmed there was no RT working in the facility on 10/30/23 from 11:00 AM to 3:00 PM and on 10/31/23 from 7:00 AM to 3:00 PM.

Upon interview on 11/6/23 at 12:10 PM, S26, APN and self identified House Officer covering the facility from 7:00 AM to 7:00 PM, stated House Officers help out in emergencies when needed and "If we were covering for a Respiratory Therapist, we wouldn't take their assignment. We would just help out if there was a problem."

Facility policy titled, "Scope of Care Respiratory," effective 8/16/23, stated, " ... It is the objective of this department to deliver quality cardiopulmonary/respiratory care to inpatients by competent respiratory therapists under medical supervision. ... All services provided by Respiratory Therapy are delivered on a 24 hour, 7 day a week basis."

Based on staff interview, review of three of three medical records of patients (P1, P6, and P7)on mechanical ventilation, and review of facility policy and procedure, it was determined the facility failed to ensure that patients on mechanical ventilation receive reassessments by a respiratory therapist at least daily.

Findings include:

1. Review of P1's medical record on 11/8/23, in the presence of Staff #14 (S14), Advisor to the Board, revealed the following:

P1 was admitted to the facility on 10/10/23 with a diagnosis of acute respiratory failure. P1 was ventilator dependent and receiving ventilator management. Review of physician orders indicated respiratory therapy (RT) assessments were ordered twice a day.

On 10/30/23, review of the RT documentation sheets revealed a RT assessment was conducted on 10/30/23 at 9:16 PM. There was no evidence that an additional RT assessment was conducted at any other time on 10/30/23.

There was no evidence that RT assessments were conducted on 10/31/23.

2. Review of P6's medical record on 11/8/23, in the presence of S14, revealed the following:

P6 was admitted to the facility on 10/13/23 with a diagnosis of ventilator dependent respiratory failure. Review of physician orders indicated RT assessments were ordered twice a day.

On 10/30/23, review of the RT documentation sheets revealed a RT assessment was conducted on 10/30/23 at 9:23 PM. There was no evidence that an additional RT assessment was conducted at any other time on 10/30/23.

There was no evidence that RT assessments were conducted on 10/31/23.

3. Review of P7's medical record on 11/8/23, in the presence of S14, revealed the following:

P7 was admitted to the facility on 10/2/23 with a diagnosis of respiratory failure and was ventilator dependent. Review of physician orders indicated RT assessments were ordered every 12 hours.

On 10/30/23, review of the RT documentation sheets revealed a RT assessment was conducted on 10/30/23 at 9:24 PM. There was no evidence that an additional RT assessment was conducted at any other time on 10/30/23.

There was no evidence that RT assessments were conducted on 10/31/23.

On 11/8/23 at 11:30 AM, S14 confirmed that P1, P6, and P7's medical records lacked evidence of a second RT assessment on 10/30/23 and that no RT assessments were conducted on 10/31/23.

Facility policy titled, "Assessment and Reassessment - RT," effective 5/18/22, stated, " ... Patients on mechanical ventilation will be reassessed at least every (4) hours, while those receiving less intense therapy will be assessed daily. Therapy will be evaluated to determine effectiveness and noted in the patient record."