Davita Linden Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 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 Strip K100-0118, 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 monitored and tested for Total Chlorine, to provide safe treatments for all patients. On 1/7/26 at 1:40 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40 - Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to 15 of 15 hemodialysis patients who were receiving hemodialysis treatment at Station (S)1, S6, S10, S11, S12, S15, S16, S17, S19, S20, S21, S22, S23, S24, and S25, at the time of this observation, when one of one Patient Care Technician (PCT CC) observed, who was assigned the task of testing the water quality, failed to 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). The Regional Operations Manager and the Group Facility Administrator were informed of the IJ finding on 1/7/26 at 1:40 p.m. The noncompliance related to the IJ was identified to have existed on 1/7/26 at 1:40 p.m. The IJ situation was abated on 1/8/26 at 9:30 a.m., when the facility implemented their “IJ Abatement Plan” that included but not limited to: a Governing Body meeting, a review of the manufacturer’s DFU and facility P & P, staff training, return demonstration, and a successful completion of skills competency checklists. The facility also failed to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC), one of one Registered Nurse (RN AA), and one of one Licensed Practical Nurse (LPN BB) observed, verified/tested the machine’s final dialysate (dialysis solution) for pH (acidity) according to the manufacturer’s DFU and facility P&P. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 41. Findings include: Cross References: V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT CC) observed, who was assigned the task of testing the product water (ultra-pure water for dialysis), performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V 250 - Failure of the facility to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC), one of one Registered Nurse (RN AA), and one of one Licensed Practical Nurse (LPN BB) observed, verified/tested the machine’s final dialysate for pH (acidity), according to the manufacturer’s DFU and facility P&P, before each patient’s hemodialysis treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, staff interviews, review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), 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 all 41 patients who dialyzed at this facility. Findings include: Cross References: V 196 - Failure of the facility to ensure that one of one Patient Care Technician (PCT CC) observed, who was assigned the task of testing the water quality, performed the Total Chlorine Test according to the manufacturer’s DFU and facility P&P. V 250 - Failure of the facility to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC), one of one Registered Nurse (RN AA), and one of one Licensed Practical Nurse (LPN BB) observed, verified/tested the machine’s final dialysate pH, according to the manufacturer’s DFU and facility P&P. V757 - Failure of the Facility Administrator to ensure that the facility had adequate number of assigned and qualified staff to meet the needs of all patients and provide safe patient care; 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 dialysis caregiver 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: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) recommendations, and a review of facility Policy and Procedures (P & P), it was determined that the Infection Control Committee (ICC) failed to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) and one of one Registered Nurse (RN AA), and two of two Licenced Practical Nurses (LPN AA and LPN BB) observed, wore gloves when touching dialysis machines and performed hand hygiene (wash hands or use an alcohol based hand sanitizer), after removal of contaminated gloves or between glove changes. The ICC also failed to ensure that seven of seven patients who were seated at Station (S) 14, S16, S24, S25, and (S17, S19, S20 - stations inside the Isolation Room), who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, performed hand hygiene after glove removal and prior to leaving the treatment area. Failure to perform hand hygiene increased the risk for cross contamination with the potential to expose all patients and staff to bloodborne pathogens in the dialysis environment. The facility census was 41. Findings include: During observation in the Patient Treatment Room on 1/7/26 between 9:15 a.m. and 11:30 a.m., the following was revealed: - RN AA removed a contaminated blue pad (liner) from S26 and placed it in the biohazard box. Wearing the same contaminated gloves and without performing hand hygiene, RN AA went back to S26 and applied bandage (clean) to the patient’s access site. - LPN BB was wearing a pair of gloves and gave the patient at S27 her cell phone (considered dirty). Then without changing gloves and without performing hand hygiene, LPN BB opened sterile fistula (access) needles and gauze, and inserted the fistula needles into the patients left upper arm dialysis access. - LPN AA was observed during discontinuation of dialysis treatment of a patient in the Isolation Room (S19). LPN AA did not change her contaminated gloves and did not perform hand hygiene between discontinuing dialysis treatment (such as removing contaminated extracorporeal circuit, contaminated dialyzer, touching the contaminated hemodialysis machine...) and entering data in the computer (considered clean). In addition, LPN AA was touching her goggles with the same contaminated gloves during the above procedures. When LPN AA left the Isolation Room, she was still wearing the same contaminated goggles (without disinfecting them), while assisting the patient at S16 (which was located outside of the Isolation Room). - PCT AA was observed silencing the hemodialysis machines’ alarms at S13, S16, S14, and S6 respectively, repeating the same breach in infection control techniques, by holding a glove (not wearing the glove) to silence each machine’s alarm. PCT AA did not perform hand hygiene after silencing each machine’s alarms and before silencing the other machine’s alarms. - Seven of seven patients who were seated at S14, S16, S24, S25, and (S17, S19, S20 - stations inside the Isolation Room), who held pressure to their access sites for hemostasis after dialysis, did not perform hand hygiene after glove removal. At the weighing station, these seven patients touched the scale (clean), without performing hand hygiene. In addition, these seven patients were not offered a hand sanitizer and were not reminded by the staff (PCT AA, PCT BB, PCT CC, RN AA, LPN AA and LPN BB) who were working on this date, to wash their hands after glove removal and prior to leaving the treatment room. According to CDC recommendations, 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 #1-05-01 titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, showed the following: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse 2. 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: 49321 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 Strip K100-0118, 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 monitored and tested for Total Chlorine, to provide safe treatments for all patients. On 1/7/26 at 1:40 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40 - Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to 15 of 15 hemodialysis patients who were receiving hemodialysis treatment at Station (S)1, S6, S10, S11, S12, S15, S16, S17, S19, S20, S21, S22, S23, S24, and S25, at the time of this observation, when one of one Patient Care Technician (PCT CC) observed, who was assigned the task of testing the water quality, failed to 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). The Regional Operations Manager and the Group Facility Administrator were informed of the IJ finding on 1/7/26 at 1:40 p.m. The noncompliance related to the IJ was identified to have existed on 1/7/26 at 1:40 p.m. The IJ situation was abated on 1/8/26 at 9:30 a.m., when the facility implemented their “IJ Abatement Plan” that included but not limited to: a Governing Body meeting, a review of the manufacturer’s DFU and facility P & P, staff training, return demonstration, and a successful completion of skills competency checklists. The facility cencus was 41. Findings include: During observation of PCT CC’s performance of the Total Chlorine test on 1/7/26 between 11:20 a.m. and 11:26 a.m., the following was observed: - PCT CC was observed performing the Total Chlorine Testing (testing the water used for dialysis for the presence of chlorine), using RPC Ultra Low Total Chlorine Test strip (K100-0118). PCT CC collected the water sample in a 100 milliliter (mL) cup from the Dialysate Preparation Room then brought the water sample to the Patient Treatment Room. PCT CC walked over to LPN BB at S13, then swished the test strip for 120 seconds and did not compare the test strip to the color chart after removing the test strip from the water sample. PCT CC documented in the Total Chlorine Log, 0.1 ppm (parts per million), as the result of the test even without comparing the test strip to the color chart. When asked why she did not compare the test strip to the color chart, PCT CC stated that she performed Total Chlorine testing so much that she did not have to compare the test strips to the color chart. When asked by this surveyor on 1/7/26 at 11:26 a.m., how many seconds was she supposed to wait before comparing the test strip to the color chart, PCT CC answered, “60 seconds”. The Group Facility Administrator was present during the interview and offered no comment. A review of the manufacturer’s DFU for Total Chlorine Testing using K100-0118 or K100-0118F, showed the following: Test Procedure 4) Wait 20 seconds for the test strip color to develop.K100-0118 or K100-0118F 5) After the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample. A review of Procedure: 1-18-05 titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip” with latest revision date of October 2023, showed the following: 1. Fill the sample cup to the line marked 100 mL with the sample. NOTE: Be sure to collect sample just prior to performing the test as chlorine has a tendency to dissipate. 2. Remove one test strip from the foil package and dip it in the water sample for 60 seconds .... dipping the strip, move it back and forth at a constant gentle rate. 3. Remove the test strip and shake once, briskly, to remove excess water. 4. Wait 20 seconds for the test strip color to develop... 5. After the 20 second wait period, immediately compare strip. 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 IJ was abated on 1/8/26 at 9:30 a.m., upon completion of the following: - The Group Facility Administrator immediately began conducting re-education/staff in-service with all Direct Patient Care Staff with a return demonstration, and skills competency checklists on 1/7/26 at 2:00 p.m. - PCT CC as well as PCT BB, and PCT AA demonstrated/performed the correct procedure for testing the water for Total Chlorine using RPC Ultra-Low Total Chlorine Test Strip K100-0118 according to the manufacturer’s DFU and facility P&P specifically, waiting 20 seconds for the color to develop before comparing the test strip to the color chart and obtained results of 0.1 ppm (parts per million) total chlorine in water used for dialysis. Thus, the water was determined to be safe for dialysis. - The Governing Body meeting was conducted and approved by the Facility Administrator, Regional Operations Director, and Medical Director. - Audits of staff performing chlorine testing was conducted and will be ongoing.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU), 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 there was a safe environment for 15 of 15 patients who were receiving hemodialysis treatments at Station [S] 1, S6, S10, S11, S12, S15, S16, S17, S19, S20, S21, S22, S23, S24, and S25, at the time of this observation, as evidenced by failure of three of three Patient Care Technicians (PCTs) (PCT AA, PCT BB and PCT CC), one of one Registered Nurse (RN AA), and one of one Licensed Practical Nurse ( LPN BB) observed, to verify/test the hemodialysis machine’s final dialysate for pH (acidity), according to the manufacturer’s DFU and facility P&P. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain), could result if dialysate composition is incorrect. The facility census was 41. Findings include: During observation in the Patient Treatment Room on 1/7/26 between 09:15 a.m. and 11: 30 a.m., the following was revealed: - PCT AA did not test the machine’s final dialysate for pH prior to initiation of dialysis treatment on the patient at S15. During an interview on 1/7/26 at 09:40 a. m., PCT AA stated that she was rushing. - PCT BB did not test the machine’s final dialysate for pH prior to initiation of dialysis treatment on the patient at S23. During an interview on 1/7/26 at 09:50 a. m., PCT BB stated that he was rushing. - PCT CC did not test the machine’s final dialysate for pH prior to initiation of dialysis treatment on the patient at S27. During an interview on 1/7/26 at 10:00 a. m., PCT CC stated that she was rushing. - LPN BB did not test the machine’s final dialysate for pH prior to initiation of dialysis treatment on the patient at S9. During an interview on 1/7/26 at 10:15 a.m., LPN BB stated that when she walked up to a patient to initiate a dialysis treatment, she expected everything including pH testing, to already be done by a PCT. LPN BB then said, “pH was on the list to be done”. - RN AA did not test the machine’s final dialysate for pH prior to initiation of dialysis on the patient at S6. During the interview on 1/7/26 at 10:45 a.m., RN AA stated that she did not realize that the dialysate pH had not been tested. A review of “Fresenius Medical Care 2008T Hemodialysis Machine Operator’s Manual”, showed the following DFU: Page 75 - Recirculation and Final Set-Up Procedure 2. Check the conductivity and pH of the dialysate... Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If conductivity and pH are not within these limits, do not initiate dialysis. A review of facility Procedure: 1-21-09 titled, “Testing pH for Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips”, with the latest revision date of February 2024, showed the following: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20 to 25 seconds, compare the color reaction on strip to the color chart. According to AAMI RD52:2004, Section 5.6, “Dialysate Proportioning”, it is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 49321 Based on observation, staff interview, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the facility failed to maintain a safe environment for all patients and staff as evidenced by unsanitary surfaces in 20 of 28 wall boxes (frames recessed into the wall at each hemodialysis station, which allows dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products), and in one of one exposed P- Trap (curved pipe under a sink) in the isolation room. Unsanitary environment and excessive moisture could contribute to the growth of mold on surfaces and materials that could cause a range of respiratory issues, including allergic reactions, asthma attacks, and infections. Failure to maintain integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room that could negatively affect the health and safety of all direct patient care staff (nurses and Patient Care Technicians-PCTs), and 41 patients who were dialyzing at this facility. Findings include: During observation in the Patient Treatment Room on 1/7/26 from 9:15 a.m. to 11:30 a. m., the following was revealed: - The wall boxes at Station (S) 1, S2, S3, S4, S5, S6, and S7, had whitish to brownish-colored crystalline substances in them. - The wall boxes at S8, S9, S10, S11, S12, S13, S14, S15, and S16, had thick brownish-colored crystalline substances in them. - The wall boxes in the Isolation Room (S17, S18, S19, and S20), had thick, greenish brown-colored crystaline substances in them. - The P- trap under S19, had a thick accumulation of slimy greenish substance. During an interview with the Group Facility Administrator (GFA) on 1/7/26 at 1:30 p.m., she stated that staff never do as they were told... She did not elaborate further. According to the CDC, dialysis wall boxes need to be properly maintained to decrease the risk of patient infections.”

“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: 49321 Based on observation, a review of facility records, interviews, and a review of minimum state required staffing ratios, it was determined that the Governing Body failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was 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; and that each dialysis care giver was not assigned more than four patients at any given time per the minimum state required staffing ratios. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 41. Findings include: A review of “Patient and Teammate Schedule” (schedule of patients dialyzing each shift and schedule of Patient Care Technicians (PCTs) and licensed nurses providing patient care services), from December 2025 to January 7, 2026, revealed the following: The Patient Treatment Room had three Pods (sections). Pod #1 had eight stations (S) (S1, S2, S3, S4, S5, S6, S7 and S8). Pod #2 had 12 stations (S9, S10, S11, S12, S13, S14, S15, S16, S17, S18, S19, and S20). S18 was not used and S17, S19 and S20 were located at the Isolation Room. Pod #3 had eight stations (S21, S22, S23, S24, S25, S26, S27 and S28). During observation in the Patient Treatment Room on 1/7/26 from 9:15 a.m. to 11:30 a. m., the following was revealed: - Registered Nurse (RN) AA was assigned as float nurse to conduct nursing assessments, prepare and administer medications and perform other nursing tasks to patients at S21, S22, S23, S24, S25, S26, S27, and S28. PCT BB was assigned to four patients at S21, S22, S23, and S24. PCT CC was assigned to four patients at S25, S26, S27, and S28. - Licensed Practical Nurse (LPN) AA was assigned as a dialysis caregiver to four patients during the first shift and two patients during the second shift at S16, S17, S19, and S20. In addition, LPN AA was also assigned to perform nursing assessments, prepare and administer medications and perform other nursing tasks to seven patients on first shift and six patients on second shift at S9, S10, S11, S12, S13, S14, and S15, who were assigned to PCT AA. - LPN BB was assigned as a dialysis caregiver to three patients on first shift and two patients on second shift at S1, S2, S3, S4, S5, S6, S7, and S8 (some stations were not used). During an interview with LPN AA on 1/7/26 at 10:00 a.m., LPN AA stated that in the month of December she only worked on Wednesdays and was always assigned to S16 S17, S19, S20, as the dialysis caregiver. She also confirmed that in addition to her assignment as a dialysis caregiver, she also performed nursing duties (such as pre & post nursing assessments, preparation and administration of medications, and other nursing duties), to the patients seated at S9, S10, S11, S12, S13, S14, and S15. In the month of January, 2026, LPN AA was scheduled to work twice per week. During an interview with PCT AA on 1/7/26 at 10:30 a.m., PCT AA stated that whoever was assigned to Pod #2, knew that they will be responsible for patients at S9, S10, S11, S12, S13, S14, S15, S16, S17, S19 and S20, (S18, not currenty used), for both the nurse and PCT. PCT AA added that this was the reason why they missed doing other things such as testing pH (measure acidity in final dialysate), and no one will come over and help. PCT AA also added that there was a lot of responsibilities in this section owing to the number of patients assigned to them (one nurse and one PCT), in this section. During an interview with LPN BB on 1/7/26 at 10:45 a.m., LPN BB stated that LPN AA was aware of her assignment, to always take care of patients at S9, S10, S11, S12, S13, S14, S15, S16, S17, S19 and S20. During an interview with the Group Facility Administrator (GFA) on 1/7/26 at 1:30 p. m., she stated that staff never do as they were told... The GFA did not elaborate.”