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Based on documentation review, interviews, and observations, it was determined that the governing body failed to demonstrate that it is effective in ensuring that hemodialysis services offered by the hospital are provided to hemodialysis patients. It did not provide necessary oversight and leadership as evidenced by the lack of compliance with the Condition of Participation:

482 CFR 482.13 Patient Rights

Based on medical record review, staff interviews, and review of facility documents, it was determined that the governing body failed to demonstrate that it is effective in ensuring that hemodialysis services offered by the hospital are provided to hemodialysis patients.

Findings include:

A review of the facility's reverse osmosis machines indicated that all seven machines were removed from service due to machine alarms and high calcium test results on 12/19/23. This left the facility unable to provide hemodialysis to patients. A review of medical records for hemodialysis patients at the facility from 12/19/23 through 12/29/23 indicated that Patient (P) 1 was not able to receive two hemodialysis treatments prior to transferring out to a rehabilitation facility on 12/21/23. (Cross refer to Tag A-144)

During an interview on 1/11/24 at 10:05 AM, Staff (S) 5, a Hemodialysis Registered Nurse (RN), stated that the portable reverse osmosis (RO) machines have been "suffering" as of late and that for two weeks (12/19 through 12/29/23), the hospital was not able to provide hemodialysis treatments to patients. S5 stated that patients in the Emergency Department were transferred to other facilities that were able to provide hemodialysis treatments during this time. S5 stated that this was the first time that a problem like this occurred.

During an interview on 1/11/24 at 10:44 AM, S6, the Hemodialysis Charge RN, stated that when the problem was reported, he informed S3, the Senior Director of Nursing, in addition to the nephrologists.

During an interview on 1/11/24 at 1:26 PM, S16, the Biomedical Technician, stated that in December 2023, six of the seven portable RO machines tested for calcium levels resulted with high levels. One portable RO was not functioning due to a "no water" alarm. S16 stated that he sends out the needed lab samples and S17, the Unit Director of Biomedical, would perform any repairs or maintenance. As per S16, the membranes for three RO machines (RO 6, RO 9, and RO 10) were replaced on 1/2/24 and retested for calcium levels. The machines were then released back for use after passing calcium levels were received. When asked who reviews and oversees his work, S16 indicated that S3, the Director of Nursing, was responsible for reviewing his work and lab results. A review of S16's education indicated that S16 was trained on a different Machine System in 2005. Upon request for further verification of competency in maintaining and fixing the portable reverse osmosis machines, S16 was unable to provide.

During an interview on 1/12/24 at 2:35 PM, S17 stated that he repairs the machines and performs maintenance as recommended by manufacturer. S17 stated that the hospital staff complete regular disinfections, collect samples for water quality, and report the results of testing to him. When the RO's reported a high calcium multiple times, S17 consulted with the manufacturer on treatment, which consisted of a pH treatment to try and clear out any build up within the system. S17 stated that if the pH treatments do not work, then the membranes would need to be replaced. Upon request, S17 was able to provide data reports provided to the Governing Body that indicated a knowledge of multiple repeat results of high calcium with pH treatment interventions as follows:

Portable RO 4 had a high calcium reported for August, September, October, and November 2023. Interventions reported were pH treatments. Documented lab results for 12/7/23 indicated a high calcium result.

Portable RO 5 had a high calcium reported for June, August, September, October, and November 2023. Interventions reported were pH treatments. Documented lab results for 12/7/23 indicated a high calcium result.

Portable RO 6 had a high calcium reported for November 2023 with a high and low pH treatment completed. Documented lab results for 12/18/23 indicated a high calcium result.

Portable RO 7 had a high calcium reported for August 2023 with a high pH treatment completed. Documented lab results for 12/7, 12/15, and 12/26/23 indicated high calcium results.

Portable RO 8 had a high calcium reported August and September 2023 with a disinfection treatment completed. Documented lab results for 12/18 and 12/26/23 indicated high calcium results.

Portable RO 9 had a high Calcium reported in June and July 2023 with a low pH treatment and disinfection treatment completed.

Documented lab results for Portable RO 10 on 12/9 and 12/30/23 indicated high calcium results.

Upon request for documentation for which machines had membranes replaced and on what days, S17 was only able to provide documentation that membranes had been ordered. A review of S17's education file revealed that he was trained on a centralized RO system on 5/5/21.

During an interview on 1/11/24 at 2:47 PM, S3 stated that he was new to this position and started on 12/23/23. S3 is in charge of the inpatient hemodialysis unit. S3 stated that the lack of usable portable RO machines was reported to senior management during the daily morning huddle meetings and patient treatment plans were discussed. A review of the "AOC Daily Huddle Checklist" dated 12/22/23 through 12/28/23, documented a row labeled, "Dialysis" with check marks indicating that the dialysis patients were discussed at the meetings on 12/22, 12/26, 12/27, and 12/28/23. When asked what was the plan to ensure that hemodialysis services would continue to be provided to patients, uninterrupted, S3 responded that a plan had not been discussed until the day of survey. Upon request, S3's training on portable Reverse Osmosis machines and their operation could not be provided.

During an interview on 1/12/24 at 12:20 PM, S1, the Chief Medical Officer, and S10, the Chief Executive Officer, stated that when the portable RO machines were unusable, all attending physicians were made aware and they were encouraged to transfer their patients more immediately. S1 and S10 stated that they expedited transfers through Case Management personnel. S10 stated that if any service provided by the hospital is not available then they should transfer the patient out. Upon request for Governing Body Meeting Minutes related to the dialysis machines not being available for patient treatments, S1 and S10 were only able to provide the above listed documentation. There was no documentation of a plan to ensure dialysis services are continued to be provided to patients.

Based on medical record review, review of facility documents, and staff interviews, it was determined that the hospital failed to protect and promote the rights of each patient by: 1. failing to ensuring the portable Reverse Osmosis (RO) machines utilized to provide hemodialysis treatment to patients are determined to be free of possible contamination prior to use on patients scheduled for hemodialysis treatments 12/29/23 through 1/11/24 (A-144); and 2. failing to ensure that hemodialysis treatments are provided to patients in renal failure who are admitted to the hospital (A-144).

Findings include:

The above findings resulted in an Immediate Jeopardy (IJ) on 1/12/24 at 3:32 PM. The IJ template was provided to Staff (S)4, Director of Risk Management, on 1/12/24 at 3:39 PM and a removal plan was requested. An IJ Removal Plan was provided by the facility on 1/12/24 at 4:00 PM, and was accepted.

On 1/12/24, it was determined that the facility took the following steps to remove the immediacy of the IJ: Education to all direct patient care staff on the removal from service of portable RO 9 until further notice from the administrator and a sign placed on portable RO 9 indicating that it was out of service. It was determined that the IJ removal plan was successfully implemented and the IJ was removed on 1/12/24 at 4:15 PM.

Cross Reference:
482.13(c)(2) Patient Rights: Care in Safe Setting

Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1. The portable Reverse Osmosis (RO) machines utilized to provide hemodialysis treatment to patients are determined to be free of possible contamination prior to use on five of five hemodialysis patients scheduled for hemodialysis treatments 12/29/24 through 1/11/24; and 2. Hemodialysis treatments are provided to patients in renal failure for one of five patients (Patient (P) 1) admitted to the hospital 12/19/23 through 12/29/23.

Findings include:

1. On 12/19/23, RO 9, a Millennium HX Reverse Osmosis Unit, was placed out of service on 12/19/23 due to a "no water" alarm. The RO membrane was replaced on 1/2/24. There was no culture or endotoxins sample drawn after the replacement to ensure the machine was safe to use, in accordance with the manufacturer's instructions for use, and before patients received hemodialysis treatments. RO 9 was returned to service on 12/29/23.

A review of the In-Patient Hemodialysis Schedule for December 2023 and January 2024, and individual patient treatment flowsheets revealed RO 9 was used for eleven hemodialysis treatments as follows:

On 12/29/23, P3 received hemodialysis treatment through RO 9 starting at 5:55 PM through 8:00 PM.

On 12/30/23, P3 received hemodialysis treatment through RO 9 starting at 9:50 AM through 12:50 PM.

On 12/30/23, P12 received hemodialysis treatment through RO 9 starting at 4:35 PM through 6:35 PM.

On 12/31/23, P12 received hemodialysis treatment through RO 9 starting at 11:35 AM through 2:35 PM.

On 12/31/23, P13 received hemodialysis treatment through RO 9 starting at 3:35 PM through 6:35 PM.

On 1/2/24, P12 received hemodialysis treatment through RO 9 starting at 9:00 AM through 12:00 PM.

On 1/3/24, P13 received hemodialysis treatment through RO 9 starting at 9:20 AM through 12:20 PM.

On 1/3/24, P14 received hemodialysis treatment through RO 9 starting at 4:50 PM through 7:50 PM.

On 1/3/24, P15 received hemodialysis treatment through RO 9 starting at 1:05 PM through 4:05 PM.

On 1/4/24, P12 received hemodialysis treatment through RO 9 starting at 9:30 AM through 12:35 PM.

On 1/6/24, P12 received hemodialysis treatment through RO 9 starting at 9:00 AM through 12:00 PM.

On 12/19/23, RO 6, a Millennium HX Reverse Osmosis Unit, was placed out of service due to a high calcium. A portable RO membrane was replaced on 1/2/24. Culture and endotoxin lab samples were sent out from the facility on 1/6/24 and results were received on 1/11/24.

A review of the In-Patient Hemodialysis Schedule for January 2024, and individual patient treatment flowsheets revealed RO 6 was used for P 10's hemodialysis treatment on 1/9/24 starting at 9:46 AM through 12:40 PM.

Interview with the Biomedical Technician on 1/11/24 starting at 1:26 PM revealed that three RO's received new membranes on 1/2/24 (RO 6, RO 9, and RO 10). The machines were retested and once he saw the calcium was within range, he communicated with the facility that the machines were available for use.

A review of the Mar Cor Purification Millennium HX Reverse Osmosis Unit Operation and Maintenance Manual, published March 25, 2020, stated, " ... 5.2.3 Membrane Replacement ... Warning: Ensure that TDS/uS [Total Dissolved Solids / microsiemens] and membrane performance (& rejection) are normal for the regions water quality. Consult your facility physician. An appropriate AAMI [Association for the Advancement of Medical Instrumentation] and bacteria/Endotoxin test meeting AAMI or CSA requirements of the product water must be obtained and interpreted before using the RO unit for hemodialysis treatment ..."

2. A review of P1's medical record indicated that he/she was admitted to the facility on 12/16/23 with a diagnosis of weakness, dizziness, lethargy and recurrent hypotension. P1 was transferred to a physical therapy rehabilitation facility on 12/21/23. The physician's history and physical note on 12/16/23 at 10:32 AM stated, "... ESRD [end stage renal disease] on dialysis ..."

A physician's order, dated 12/18/23 at 10:37 AM stated, "... Hemodialysis treatment ..." "Hemodialysis Treatment Settings, order details: Monday/Wednesday/Friday, 3.5 hours, 400 ml [milliliters]/minute, 1 liter as tolerated, 2K [potassium] 2.5 Ca [calcium], 138 sodium, 36 degrees, 700 dialysate flow rate..."

A review of P1's hemodialysis treatments indicated that P1 did not receive hemodialysis treatment as ordered on 12/18/23 and 12/20/23. A Registered Nurse's note, dated and timed for 12/18/23 at 12:00 PM, stated, "... Hemodialysis not done due to reverse osmosis poor water quality. Nephrologist on consult and primary nurse aware ...". A Registered Nurse's note dated 12/19/23 at 11:15 AM stated, "... Hemodialysis not performed due to reverse osmosis poor water quality. Nephrologist on consult and primary nurse aware." A Registered nurse's note dated 12/20/23 stated, "... hemodialysis unavailable today ..."

A note written by Staff (S) 14, a Social Worker, on 12/21/23 at 2:19 PM, stated, "... DP [Discharge Planner] also reached out to ___ [name] HD [Hemodialysis] Center and [name redacted] the facility manager was made aware that patient was not dialyzed in the hospital due to broken hemodialysis machines. DP made her aware that as per nephrologist, [name redacted], patient is to be dialyzed on 12/22 as early as possible. Facility liaison is aware and will make arrangements. ..."

During an interview on 1/11/24 at 12:51 PM, S14 stated that when the hemodialysis machines were down, there may have been some patients that missed more than one hemodialysis treatment. When asked why P1 was not transferred to a facility that could complete hemodialysis treatments, S14 stated that insurance delayed the patient's transfer and that the physicians were aware.

During an interview on 1/11/24 at 1:26 PM, S12, a Case Manager, stated that the normal process to discharge or transfer a patient on hemodialysis would be to reach out to the nephrologist and the attending physician in an effort to facilitate discharge and get the patient to their established hemodialysis clinic. S12 stated that it was not safe to discharge P1 home as he/she needed to go to a physical therapy rehabilitation facility. Since P1 was a new placement into a physical therapy rehabilitation facility, the insurance approval process took time and delayed P1's discharge to a place where he/she could receive hemodialysis treatments.

During an interview on 1/12/24 at 3:04 PM, S15, the Nephrologist, stated, "... I don't remember details of why hemodialysis was not being done. I requested the patient to be transferred to another hospital but the patient was stable, labs looked okay, not fluid overloaded, patient was talking. The patient was not critical so no hemodialysis was needed emergently."

During an interview on 1/12/24 at 12:50 PM, S1 and S11, both administrators, stated that if any service provided by the hospital was not available then patients should be transferred out to where the service can be provided.

Review of facility policy titled, "Patient Rights and Responsibilities," revised January 2022, stated, "... As a patient in a New Jersey hospital, you have the right to: Transfers ... Be transferred to another facility only if the current hospital is unable to provide the level of appropriate medical care ..."