Fmc Renal Care Center of North Georgia Bma

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 03383 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis) using RPC Ultra-Low Total Chlorine Test Strips, and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients, when one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, did not perform the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis) and could potentially cause harm to 45 patients who dialyzed at this facility. Findings include: Cross-reference: V196 - Failure of the facility to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on observation, facility record review, staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 45 patients who were under the care of this facility. Findings include: Cross-References: V196 - Failure of the facility to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients. V757 - Failure of the Governing Body to ensure that the facility had adequate number of qualified staff to meet the needs of all patients; and to be in compliance with the minimum State required staffing ratios of one licensed and qualified nurse for every 12 patients who were receiving dialysis care and one qualified patient care giver for every four patients.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 03383 Based on observation, a review of Center for Disease Control and Prevention (CDC) recommendations, a review of facility Policies and Procedures (P&P), and staff interview, it was determined that the Governing Body failed to ensure that the Infection Control Committee implemented P&P as evidenced by five of 14 patients (P) (P#2, P#6, P#9, P#11 and P#15) who held pressure to their access sites for hemostasis (stopping of the flow of blood after hemodialysis), did not perform hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal and prior to leaving the facility. This deficient practice had the potential for cross contamination and increased risk of infection in the hemodialysis unit. The facility census was 45. Findings include: During observation in the Patient Treatment Room on 1/6/25 between 11:58 a.m. and 1:05 p.m., the following was observed: - P#2, P#6, P#9, P#11 and P#15 who were seated at Stations, 3, 8, 9, 12 and 13, and 16 respectively, held pressure to their dialysis access sites and left the facility without performing hand hygiene. P#2, P#6, P#9, P#11 and P#15 were not reminded by the staff to wash their hands nor were offered to use hand sanitizer after glove removal. During staff interviews on 1/6/25 at 1:02 p.m. and 1:04 p.m., LPN CC and PCT DD were informed of the above findings and acknowledged the importance of hand hygiene. The FA was informed about observation on 1/8/25 at 1:30 p.m. and stated staff will receive retraining. According to CDC, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. A review of Policy: 8-04-01 titled, “Infection Control for Dialysis Facilities” with last revision date of April 2020 showed: Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 03383 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis) using RPC Ultra-Low Total Chlorine Test Strips, a review of the facility’s Policy and Procedures (P&P), and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004(RD52: 2004), it was determined that the facility failed to ensure that the water used for dialysis was accurately tested for Total Chlorine, to provide safe treatments for all patients, when one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality, did not perform the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. Residual levels of Total Chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis) and could potentially cause harm to 45 patients who dialyzed at this facility. Findings include: - PCT BB who was observed during the performance of Total Chlorine Testing (testing the water used for dialysis for the presence of chlorine) on 1/7/25 at 5:01 a.m., using RPC Ultra-Low Total Chlorine Test Strip did not perform chlorine test according to manufacturer’s DFU and facility P&P. PCT BB swished the strip in the sample dialysis water for 60 seconds then immediately compared the test strip to the color chart without waiting 20 seconds for the color to develop. This test was the first chlorine check done upon arrival of the opener and allowing the water system to run for at least 15 minutes. 100 mL (milliliter) of water was taken from the RO (Reverse Osmosis: water treatment system) and post carbon for chlorine testing. - A second set of chlorine tests was performed at 6:24 a.m. with RN EE present to verify results before approval was given to allow patients to begin dialysis. PCT BB performed chlorine check using RPC Ultra-Low Total Chlorine Test Strip. PCT BB swished the strip in the sample RO dialysis water for 60 seconds then immediately compared the test strip to the color chart without waiting for 20 seconds for the color to develop. PCT BB repeated the same procedure for post carbon water. According to the manufacturer’s DFU, it takes 20 seconds for the color to develop. RN EE did not inform PCT BB that she must wait 20 seconds before comparing strip to color chart after observing PCT BB performed chlorine test on two samples. - After this surveyor informed Charge Nurse AA and PCT BB that PCT BB did not wait for 20 seconds before comparing the strip to color chart, PCT BB repeated the chlorine test at 6:35 a.m. using RPC Ultra Low Chlorine Test Strip test strip. Only at this time that PCT BB performed the procedure correctly. PCT BB swished the strip in the sample dialysis water for 60 seconds and waited for 20 seconds for the color to develop before comparing the strip to color chart. A review of the manufacturer’s DFU and facility’s policy titled, “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips Procedure” dated 4/5/21 revealed the following: - Collect a fresh 100 mL sample of water in a plastic sample cup. - Be sure to collect the sample just prior to performing the test as Chlorine tends to dissipate (decrease) out of the sample quickly. - Remove one test strip from its foil package and dip it in the sample for 60 seconds. Important Note: The 60 second dip time maximizes the sensitivity of the test strip. No adjustment of the dip time is necessary for water that is within the temperature range of the test strip (42°-93°F). - While dipping the strip, move it back and forth at a constant gentle rate of approximately two, 1-2-inch-wide strokes (one forward-one backward) per second. - Remove the strip and shake once, briskly, to remove excess water. - Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a 1 consistent viewing background. - After the 20 second wait period, immediately compare the strip color to the K100- 0118F color chart to determine the Total Chlorine level in the sample. The color block that most closely resembles the color of the test strip is the total chlorine level of the sample.” According to AAMI RD52: 2004, Section 6.2.5, “Carbon adsorption”, intensive monitoring of carbon adsorption beds is recommended because of the long history of adverse events related to chloramine contamination of dialysate. Chloramine concentrations in municipal water may change from day to day and the capacity of carbon adsorption beds to remove chloramine can vary with the pH and temperature of the water, the nature of the chloramine compounds present, and the presence of other substances in the water. The dependence of chloramine removal on multiple factors makes the performance of carbon adsorption beds unpredictable. Patient safety can only be ensured by intensively monitoring the performance of the carbon adsorption bed. The Director of Operations, Facility Administrator, and Charge Nurse were notified of the above findings on 1/7/25 at 1:35 p.m.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the facility failed to ensure that one of one double doors in the Supply Room was maintained to prevent entry of insects and vermin; and to provide a safe environment for 45 patients who were dialyzing at this facility. Findings include: During a tour on 1/6/25 between 10:58 a.m. and 11:30 a.m., the following was observed: In the Supply Room: - The delivery double doors leading to the outside had an approximately 1 to 1 1/2-inch gap at the lower part of the door between the right and left double doors where doors met in the middle, that could allow insects and vermin to enter the building. The Charge Nurse was present during the tour and confirmed the above findings on 1/6/25 at 11:15 a.m. A tour on 1/8/25 at 1:30 a.m. revealed gap was not repaired prior to exit meeting on 1/8/25.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 03383 Based on a review of medical records, staff interviews, and review of Policy and Procedures (P&P), it was determined that the interdisciplinary team (IDT) failed to ensure that two of two patients sampled (P#1 and P#3) who experienced extremely elevated blood pressure (BP), received medical care/interventions appropriate to the patient’s dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg before dialysis and below 130/80 mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services (CMS) - Version 2.5. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. The facility census was 45. Findings include: A review of “Treatment Sheet” dated 12/11/24 showed the following: P#1 presented to the facility with a pre-dialysis weight of 65.3 kg (kilogram). P#1’s estimated dry weight (EDW) was 58.3 kg. - P#1’s BP was 161/101 mmHg (millimeters of mercury) during initiation of dialysis treatment at 11:14 a.m. LPN CC initiated dialysis treatment on this patient. - At 11:30 a.m., P#1’s BP was 185/109 mmHg per LPN CC. - At 12:09 p.m., P#1’s BP was 165/114 mmHg per LPN CC. - At 12:34 p.m., P#1’s BP was 180/111 mmHg per LPN CC. - At 1:00 p.m., P#1’s BP was 165/101 mmHg per LPN CC. - At 1:33 p.m., P#1’s BP was 196/105 mmHg per LPN CC. - At 2:03 p.m., P#1’s BP was 172/114 mmHg per PCT DD. Registered Nurse (RN) notified. - At 2:33 p.m., P#1’s BP was 170/107 mmHg per PCT GG. - At 3:05 p.m., P#1’s BP was 167/111 mmHg per LPN CC. - There was a lack of documented evidence of interventions performed by a licensed nurse. - The patient had an order for Clonidine (medication used to treat high BP). There was a lack of documented evidence that Clonidine was offered. - There was a lack of documentary evidence that the physician was notified of the persistently elevated BP readings before, during, and after dialysis treatment. - P#1’s post weight was 62.8 kg., which was 4.5 above EDW. - There was also a lack of documented evidence that the physician was notified of P#1’s post weight to obtain an order for extra treatment to remove excess fluids. A review of P#1’s “Patient Plan of Care” dated 12/13/24 showed the following: Current goals for Fluid/BP: Achieve BP Control as specified by the patient’s physician (MD). Interventions: - Add, adjust, or discontinue BP medications (MD Order) - Change patient’s dry weight (algorithm or MD order) - Monitor fluid gains and discuss high weight gains with patient. - Re-evaluate/Assess dry weight. The Charge Nurse (CN) was notified and confirmed the above findings on 1/8/25 at 9:31 a.m. and stated that the patient has an order for Clonidine but was not sure why it wasn’t administered to patient. The Facility Administrator and Director of Operations were notified of the above findings during the exit interview on 1/8/25. A review of Policy: 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last revised April 2024 showed the following: Pre-Treatment Data Collection/Assessment: Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment collection will be documented and immediately reported to the licensed nurse. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. Abnormal Findings: Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: Systolic greater than 180 mmHg or less than 90 mmHg Diastolic greater than or equal to 100 mmHg Blood pressure - Intradialytic: Systolic greater than 180 mmHg or less than 90 mmHg Diastolic greater than or equal to 100 mmHg or less than 50 mmHg Blood Pressure Post Treatment: - If the patient can stand: o Standing systolic BP greater than 140 mmHg or less than 90 mmHg o Standing diastolic BP greater than 90 mmHg or less than 50 mmHg If the patient is not able to stand, document reason and sitting BP: Sitting BP for patient’s that cannot stand: o Sitting systolic BP greater than 140 mmHg or less than 90 mmHg o Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 03383 Based on interviews, a review of records and observation, it was determined that the Governing Body failed to ensure that the facility had adequate number of qualified staff to meet the needs of all patients; and to be in compliance with the minimum State required staffing ratios of one licensed and qualified nurse for every 12 patients who were receiving dialysis care and one qualified patient care giver for every four patients. This deficient practice had the potential to negatively affect the health and safety of 45 patients who dialyzed at this facility. Findings include: During an interview on 1/6/25 at 11:22 a.m., Patient (P) #6 stated they could use another staff to care for patients. Stated the first shift is busy in the morning, and the administration does not consider unforeseen things that could happen. The staff is behind for the rest of the day. They have a charge nurse, but she does not work on the floor, and she stays in the office. Stated she is concerned that there isn’t enough staff at this facility to help and remove patients if there is an emergency. During an interview on 1/7/25 at 6:10 a.m., Registered Nurse (RN) II stated that on Monday, Wednesday, and Friday (MWF), there were 14 patients on first shift, at full census (14 Stations); and on Tuesday, Thursday, and Saturday (TTS), there were 11 patients if all the patients showed up. There was usually two nurses and two techs on MWF and one nurse and two techs on TTS. Patients with a catheter access on TTS included two on first shift and six on second shift. The nurse was responsible for initiating dialysis treatment on patients with catheter access. There was usually one nurse and two techs or two nurses and one tech working on TTS. RN II stated, “we have too many catheters”. During an interview on 1/7/25 at 6:18 a.m., PCT GG stated they used to have four staff on TTS, but not anymore. Stated “I have to monitor more patients because nurses must do assessments”. During an interview on 1/7/25 at 6:22 a.m., RN AA stated that she started in a Charge Nurse (CN) position a couple of days ago and is new to CN duties. The CN typically stays in the office while other nurses take care of the floor; this was what previous CNs have done. CN stated that RN II is a float staff and has been at this facility a lot lately. RN AA provided a note that showed MWF had three catheters on the first shift and four catheters on second shift; on TTS, two catheters on the first shift and six catheters on second shift. A review of “Treatment Sheets” and staff/patients assignments dated 10/16/24 and 12/26/24 revealed the following: On Wednesday, 10/16/24: A review of records showed that there were 14 patients on the first shift who dialyzed on 10/16/24. There were two RNs (RN AA and RN II), one Licensed Practical Nurse (LPN CC), and one Patient Care Technician (PCT GG) who worked on 10/16/24. - RN AA was assigned to Pod 1 patients (P#7, P#8, and P#9). In addition to the three assigned patients, RN AA performed nursing assessments for five additional patients (P#6, P#10, P#11, P#12 (post dialysis), and P#13 (post dialysis). A total of 8 patients. RN AA also administered Flu vaccines to P#6, P#10, P#11, P#13, P#14, P#15, and P#16. In addition, RN AA also prepared and administered all scheduled medications ordered for P#6, P#11, P#14, and P#16 during dialysis treatment. - RN II was assigned to care for three patients in Pod 2 (P#17, P#18, and P#19). RN II also performed assessments on P#12 (pre-dialysis), P#13 (pre-dialysis), P#14, and P#15. RN II also administered all routine dialysis medications to P#10 and P#15. - LPN CC was initially assigned to care for four patients (P#12, P#13, P#14, and P#15) in Pod 3. However, PCT GG ended up with P#14. P#15 experienced erratic blood pressure (BP) readings of 91/67 mmHg (millimeters of mercury) at 9:10 a.m.; 162/110 mmHg at 9:34 a.m. with no recheck; BP went down to 62/42 mmHg then 94/61 mmHg at 10:01 a.m. - PCT GG was originally assigned to care for four patients in Pod 4. However, PCT GG ended up with five patients (P#6, P#10, P#11, P#14, and P#16). RN AA functioned as a patient care giver to three patients and performed nursing care/duties such as assessments, prepared and administered routine medications and Flu vaccines to seven other patients who were assigned to PCT DD and LPN CC. PCT GG cared for five patients. On Thursday, 12/26/24: A review of records showed there were 11 patients on the first shift who dialyzed on 12/26/24. There were two PCTs (PCT DD and PCT BB) and one RN (RN AA) who worked on 12/26/24. - PCT DD was initially assigned to care for four patients in Pod 3. However, PCT DD ended up with five patients (P#13, P#22, P#23, P#24, and P#25). - PCT BB was originally assigned to care for four patients in Pod 4 (P#29, P#30, P#31, and P#32). However, P#30 did not show up for treatment. - RN AA was assigned CN’s duties and responsibilities; and functioned as a patient care giver to three patients (P#17, P#18, and P#19) in Pod 1. RN AA initiated dialysis, monitored patients during dialysis treatment, and discontinued dialysis, performed pre and post dialysis assessments, and administered medications. In addition to three assigned patients, RN AA performed nursing duties such as conducting pre and post assessments, preparation and administration of all medications for the other eight patients. RN AA was also responsible to address patients’ complaints and physician notification, deal with any unforeseen medical issues and emergency situations that could arise during dialysis treatment. On Wednesday, 1/8/25: During observation in the Patient Treatment Room on 1/8/25 between 6:47 a.m. and 8:00 a.m.; and a review of records, the following was revealed: There were two RNs (RN EE and RN FF), one Licensed Practical Nurse (LPN CC), and one Patient Care Technician (PCT DD) on the first shift and there were 14 patients who dialyzed on 1/8/25. - RN FF was assigned to care for three patients in Pod 1 (P#9, P#17, and P37). - RN EE encountered an issue with inserting needles for P#17 and RN FF ended up initiating dialysis treatment on P#17 and was later assigned to RN FF. - RN FF also conducted assessments for six additional patients (P#6, P#7, P#10, P#11, P#16, P#36) in addition to P#9, P#17, and P#37. A total of 18 assessments (nine pre treatment assessments and nine post treatment assessments). - RN FF also prepared and administered medications to four additional patients (P#6, P#10, P#11, and P#16) who were assigned to PCT DD. - RN FF was observed moving about the treatment area at a rapid pace. - RN EE was assigned to care for four patients in Pod 2 (P#2, P#13, P#14, and P15). - LPN CC was assigned to care for four patients (P#7, P#17, P#35, P#36). However, P#17 was later assigned to RN FF. - P#36’s treatment was delayed until 8:24 a.m. due to elevated BP of 183/95 mmHg and was on every 15 minutes BP checks. - RN EE administered Clonidine (medication used to treat elevated BP) to P#36 at 8:00 a.m. - PCT DD was assigned to care for four patients in Pod 4 (P#6, P#10, P#11, and P#16). - P#11’s treatment was delayed until 7:32 a.m. after he arrived with an elevated heart rate (HR) of 147 at 7:08 a.m. - RN EE was notified and monitored the patient until HR decreased to 108 at 7:32 a.m. RN FF functioned as a patient care giver to three patients and conducted pre and post assessments, prepared and administered all medications and performed other nursing duties to four other patients who were assigned to PCT DD. RN EE functioned as a patient care giver to four patients; and LPN CC functioned as a care giver to three patients. This surveyor shared concerns related to staffing with the Director of Operations (DO), Facility Administrator, and CN on 1/8/25 at 11:00 a.m. The DO stated they have always staffed this way and did not agree with staffing issues. A call was made to the Department Program Manager on 1/8/25 at 11:11 a.m. The Program Manager explained to DO, Facility Administrator, and CN the minimum state required staffing ratios of one licensed and qualified nurse for every 12 patients receiving dialysis care AND (emphasis was made on the word “AND”) one dialysis care giver for each four patients. The Program Manager further explained that when a nurse is assigned to care for patients in a Pod, the nurse is designated as a patient care giver. There must be one nurse who is not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients, who is readily available to provide nursing care, take charge and deal with unexpected complications of dialysis, other medical issues and emergencies, for every 12 patients receiving dialysis care.”