Fmc Dialysis Services of Spirit Valley

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 40945 Based on record review and interview, the facility failed to add implement prescription changes which were made by the physician for 1 of 10 patients (P-6) in the sample who had co-morbid conditions which could impact individual care needs. Findings included: P-5 had the diagnosis of end stage renal disease, chronic kidney disease and diabetes type 2. During review of P6’s medical record, it was noted that the patient’s access current orders dated 11/16/23, included the following: access AV Fistula, upper left arm, arterial needle size 16 g 1”, venous size needle size 16g 1”. On 11/29/23, at 7:50 a.m., P6 was observed to have his AV Fistula, upper left arm, accessed with an arterial needle size 17 g 1”, and venous size needle size 17g 1”. P6 ’ s current orders indicted P6 was to have his AV Fistula located on his left upper arm, accessed by an arterial needle size 16 g 1”, venous size needle size 16g 1”. During interview on 11/29/23 at 11:33 p.m., the Facility Administrator (FA) stated that P-6 ’ s order was changed for access AV Fistula, upper left arm, arterial needle size 17 g 1”, venous size needle size 17g 1” to access AV Fistula, upper left arm, arterial needle size 16 g 1”, venous size needle size 16g 1” on 11/16/23. FA stated the error was made by the patient care technicians (PCTs) preparing the treatment packs the night prior and the PCT who initiated P6 ’ s AV access this morning did not verify the orders prior to accessing P6 ’ s AV fistula. FA stated the facility had updated P6 ’ s physician of the error related to P6 ’ s AV Fistula, located in his left upper arm, being accessed with an arterial needle size 17 g 1”, and venous size needle size 17g 1” verses the current order of AV access by an arterial needle size 16 g 1”, venous size needle size 16g 1”. FA stated that both the PCT preparing the treatment packets as well as the PCT accessing P6 ’ s AV fistula should have verifed the correct access size of the needle to ensure the physician orders were implemented correctly. The facility policy Pre-Treatment dated 2/6/2023, directed the clinician initiating treatment must verify the prescribed set up matches the patient prescription to the following: dialyzer, dialysate composition, dialysate flow rate, time, goal set, needle size, and temperature.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 34087 Based on observation, interview, and document review, the facility failed to ensure correct blood flow rates occurred during dialysis treatments for 2 of 7 patients (P3 and P7). Findings include: P3’s Patient Transfer sheet (Kardex) showed an admission date of 3/18/23, with primary cause of renal failure identified as type 1 diabetes mellitus with chronic kidney disease. P3’s Kardex indicated hemodialysis orders including blood flow rate (BFR) of 400 for 3 hours of treatment time, and treatment access through a central venous catheter (CVC). However, a review of P3’s treatment sheets showed that on 11/22/23, P3 dialyzed with a BFR of 450 for the entirety of the treatment from 10:12 a.m. through 1:15 p.m. (3 hours). P7’s Kardex showed an admission date of 3/20/20, with primary cause of renal failure noted as type 2 diabetes mellitus with chronic kidney disease. P7’s Kardex showed hemodialysis orders including treatment time of 4 hours, with a BFR of 450, and treatment access through an arteriovenous fistula (AVF). During prescription verification on 11/27/23 at 1:18 p.m., observation showed P7 running dialysis treatment with BFR of 500. The dialysis machine indicated P7 had been into treatment for two hours with the 500 BFR. On 11/27/23 at 1:20 p.m., registered nurse (RN) A, who was present during the observation, verified that P7 was on dialysis treatment with the incorrect BFR. RN A stated P7 should be on 450 BFR as ordered, and not 500. P7’s treatment sheets dated 11/27/23, also indicated P7 dialyzed with a BFR of 500 for two hours (from 11:21 a.m. to 1:32 p.m.) or until it was pointed out during surveyor’s observation at 1:18 p.m. On 11/28/23 at 1:18 p.m., the area team lead (ATL) acknowledged the importance of verifying prescriptions to ensure dialysis treatment orders, such as blood flow rates are followed. Review of the 7/6/21, Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer policy directed staff to turn the BFR as prescribed by the physician to achieve optimal clearances. Review of the 7/6/21 Initiation of Treatment Using Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer policy directed staff to turn the BFR as prescribed by the physician to achieve optimal clearances.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 34087 Based on observation, interview, and document review, the facility failed to ensure staff secured, assessed, and monitored the blood line of a central venous catheter (CVC) connection during and after initiation of dialysis treatment, resulting in death of 1 of 26 patients (P1) with CVC access. The immediate jeopardy began on 10/28/23, when the facility failed to ensure staff secured, assessed, and monitored the connection site of P1’s dialysis line and CVC during and after initiation of treatment. The director of operations, area team lead, clinic manager, regional director, and senior regional quality manager were notified of the immediate jeopardy on 11/2/23 at 3:10 p.m. The immediate jeopardy was removed on 11/3/23 at 3:10 p.m., but non-compliance remained at the condition level. Findings include: P1’s kardex showed P1 was admitted to the facility for treatment in June 2023 with a diagnosis of kidney failure resulting from diabetes and chronic kidney disease. P1’s physician’s orders identified P1 had a tunneled CVC as thier dialysis access, a blood flow rate (BFR) of 400, and autoflow for thier dialysis flow rate (DFR). P1’s plan of care (POC) dated 10/17/23, noted, “Current CVC is functioning well, no s/s [signs and symptoms of] infection noted.” The intervention indicated education was provided to caregiver related to the risks and benefits of the access type (CVC). The POC also indicated P1 continued to reside at a rehabilitation facility where thier needs were being met towards achieving goals to maintain optimum level of independent functioning and to return home. P1’s progress notes indicated that on 10/28/23 at 11:45 a.m., registered nurse (RN)-A indicated she was summoned to P1’s dialysis station where she found P1 “unresponsive, grey, with a pool of blood on the floor under the chair and all over [P1’s] chest and abdomen area.” RN-A also noted, “At the moment, appeared to look as if the CVC had displaced.” The progress notes also indicated P1’s pants and shirt were fully saturated with blood, all attempts from facility staff and emergency medical services (EMS) to revive P1 failed, and P1 remained unresponsive. RN-A further noted information from patient care technician (PCT)-A, who reported that she was the one who started P1’s treatment. PCT-A indicated P1’s machine warned with high pressure alarms during treatment initiation, and as an intervention, PCT-A reversed P1’s dialysis lines where the arterial (red line) was connected to the venous CVC (blue limb) and the venous (blue line) was connected to the arterial (red limb). PCT-A also reported that a Hemaclip (is a connector clip or a device that is used to secure connection of dialysis bloodlines) was unavailable at P1’s chairside, so PCT-A did not use a Hemaclip when she started P1’s treatment. PCT-A further reported that on her way to get a Hemaclip, she got distracted and did not return to apply a Hemaclip on P1’s dialysis line connection. P1’s treatment flowsheet dated 10/28/23, indicated treatment start time of 11:31 a.m., and at 11:34 a.m., P1 had normal blood pressure of 132/72, and pulse of 73. The flowsheet did not indicate issue related to high arterial pressures, instead, the notes section showed the treatment was “initiated without problem.” The flowsheet also indicated a Hemaclip was not used. The flowsheet further indicated that treatment ended/stopped at 12:47 p.m. On 11/1/23 at 10:29 a.m., Officer (O) stated he was among the officers who went to the facility to review the circumstances of the incident. The O indicated that when he got there, P1 was already deceased. The O stated that facility employees explained about a lead from machine to patient carrying blood in and out from the patient that had an issue with the connection port, so the staff had to switch, and was going to get supplies but got “side-tracked” and by the time the staff returned there was blood on the floor. O stated, “By looking at the blood on the scene, in my opinion, it came out from the disconnected lead.” On 11/1/23 at 3:24 p.m., PCT-B indicated she heard about an incident where “a patient passed away but that was about it.” PCT-B denied participation in any discussion related to the incident including review or re-education about procedures to prevent similar incidents from occurring. On 11/1/23 at 4:09 p.m. PCT-C stated she worked on 10/28/23 and saw P1 at about 11:00 a.m. to 11:15 a.m. and she was alert and oriented. PCT-C stated she saw PCT-A in the process of starting P1’s treatment, and then she left to go to the water room. PCT-C also stated when she returned to the treatment room at about 11:35 a.m., PCT-D called her to go and check on P1 because she was bleeding. PCT-C stated she went to P1 and saw blood on chest area, chair and drained on floor, and it appeared like the arterial (red) port/limb was disconnected from the venous (blue) line. PCT-C also stated, “When I went there... she took her last breath.” PCT-C further stated, “We don’t know how it happened or how the connection came loose” and indicated she was unsure if facility investigated and found out. When asked about any education or review of policies procedures provided to staff after the incident, PCT-C replied, “Not to my knowledge.” On 11/1/23 at 4:39 p.m., RN-A stated she responded to P1’s chairside on 10/28/23 at about 11:40 a.m. and found P1 “very gray and unresponsive” and “there was blood all over and could not tell if coming out from the catheter.” RN-A indicated that RN-B started cardiopulmonary resuscitation (CPR) until EMS took over, however, they were unable to resuscitate P1. RN-A indicated interviewing PCT-A, who reported she reversed connection of the dialysis lines because of high arterial pressure. RN-A also indicated PCT-A failed to secure the dialysis connection site with a Hemaclip. RN-A further stated the possibility for disconnection of the lines and stated the reason behind facility’s policy to use Hemaclip to prevent the line connection from inadvertent disconnection. RN-A stated PCT-A did not follow the policy. On 11/2/23 at 8:45 a.m., PCT-D stated that on 10/28/23 (unsure of exact time), she was walking by P1’s chair and saw “blood around the catheter and a pool of blood on the ground” and alerted PCT-C to the issue. PCT-D stated she is a new dialysis staff, was sent home at about 12:15 p.m. that day and did not know how it happened. On 11/2/23 at 9:02 a.m., attempted to call PCT-A but did not answer nor return the call. On 11/2/23 at 10:09 a.m., RN-C was observed in the process of initiating dialysis treatment via CVC for P4. RN-C connected the arterial (red) blood line to the arterial catheter limb lumen, and then connected the venous (blue) blood line to the blue venous catheter limb lumen. RN-C attached a Hemaclip to the venous connection site and explained that the Hemaclip should always be attached with the venous blood line even during instances when line connection would be reversed. On 11/2/23 at 9:57 a.m., the clinic manager (CM) stated facility’s findings that on 10/28/23, when P1’s dialysis machine was showing high pressure alarms, PCT-A reversed the bloodline connection. The CM added that however, PCT-A did not apply a Hemaclip before turning the blood pump on. The CM explained the Hemaclip device is important to hold the connection together so that they don’t fall apart. The CM also stated expectation that the Hemaclip should have been included in the supply kit, supplies should have been checked prior to starting the treatment, and patient should have been promptly monitored. The CM stated the facility started re-educating patients and staff about the importance of access visibility. However, the CM indicated lack of evidence to ensure staff knowledge and competency regarding initiation of dialysis with the use of CVC, and intradialytic assessment and monitoring. On 11/2/23 at 11:54 a.m., the medical director (MD) stated understanding that the incident happened when a staff member “did not put clamp and turned on the blood pump” and the connection got detached. The MD stated the facility staff started CPR and EMS arrived to take over, but they could not revive P1, and the cause of death is loss of blood. The MD indicated in addition to not applying the Hemaclip, is the presumption that the luer lock (screw in lock) connection of the blood line and the catheter limb was not securely attached or not properly attached. The MD also stated expectation for staff to follow policy and procedure for the use of CVC, and further stated “it is unfortunate” that facility policy was not followed in this case. The procedure titled, Initiation of Treatment Using Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer, dated 7/6/21, provides the steps for connecting the blood lines to the catheter, to include removing syringe from catheter limb, and then firmly insert male luer of blood line into the female luer of the catheter limb, while twisting in the opposite direction, and then attach the Fresenius Hemaclip device to the venous bloodline and to catheter connection. The procedure indicates that prior to starting the blood pump, staff are to verify safety measures including: all connections are secure, venous drip chamber is correctly positioned in its housing and venous blood line is threaded through venous occluding clamp. The procedure also provides for the steps in starting hemodialysis treatment to include the following: open the clamps on the arterial and venous blood lines and arterial and venous catheter limbs and start the blood pump and turn slowly to 100-150 milliliters/minute (ml/min) and assess to ensure that the extracorporeal circuit is correctly and securely connected, no extravasation at the catheter site, and no flow problems. The procedure titled, Use of HemaClip, dated 7/1/19, provides the background for the use of the device, as noted, “Catheter disconnections are potentially life-threatening events. Venous pressure alarms on dialysis machines are not always sensitive enough to detect a partial dislodgement or partial catheter separations, and rapid blood loss can occur at the typical dialysis blood flow rates. Catheter disconnections may result in rapid blood loss, which can result in patient death.” The procedure also provides that when Hemaclips (catheter access clamps) are properly applied, it reduces the risk of disconnections. The procedure further indicates that the facility requires the use of the Hemaclips to further secure venous catheter lines. The policy directs staff to apply Hemaclips to all blood return lines and blood return catheter lumens connections (venous bloodline to venous catheter lumen, or venous blood line to arterial catheter lumen when reversed) prior to starting the blood pump for treatment. The policy titled, Patient Assessment and Monitoring, dated 5/1/23, directs staff to observe access to ensure it is secure and visible, and that the Hemaclip device is in place. The immediate jeopardy that began on 10/28/23, was removed on 11/3/23 at 3:10 p.m., when the facility re-educated all nurses and patient care technicians (PCTs) regarding facility policies and procedures for initiation/termination of dialysis treatments using central venous catheters (CVC), assessment and monitoring of patients receiving dialysis via CVC, venous pressure monitoring, unable to achieve prescribed blood flow rate, and use of Hemaclip starting on 11/2/23 to 11/3/23; conducted an audit (observation) of staff practices related to initiation of dialysis treatment with CVC on 11/3/23; required nurses and PCTs to watch video regarding use of Hemaclips starting on 11/2/23 to 11/3/23; observations, interviews with patients and staff verified implementation of facility’s policies and procedures related to treatment initiation and care of patients with CVC; but the noncompliance remained at the condition level.”