Ara Kaweah Dialysis Center, LLC

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 47734 Definitions: Arteriovascular fistula - (AVF) surgically connected vein and arterial vessels. Arteriovascular graft (AVG) - surgically inserted tube connecting the vein and arterial vessels for dialysis treatment. Cannulation - flexible tube inserted into blood vessel. Central Venous Catheter (CVC) - thin, flexible tube inserted into a vein. Conductivity - ensures proper water-to-concentrate ratio of the dialysate. The unit of conductivity is millisiemens (mS) per centimeter. The normal range is 12 to 16 mS/cm; Hemodialysis (HD) - a treatment that filters waste and water from the blood of people whose kidneys are not functioning properly. Peritoneal dialysis (PD) - a treatment for kidney failure that uses the lining of the abdomen, a natural filter to remove waste and extra fluid from the blood. pH - concentration of hydrogen, normal pH for human blood 7.4. Dialysate (fluid used in dialysis to remove waste products and balance electrolytes [potassium, calcium and bicarbonates]) meter is a device used to independently measure the quality of the water by measuring the conductivity and pH of the dialysate used for hemodialysis treatment. It is important to monitor dialysate conductivity for safety and to ensure the proper mixing of water, acid concentrate, and bicarbonate. Immediate Jeopardy (IJ) - a situation in which recipient(s) of care has suffered or is likely to suffer serious injury, harm, impairment or death as a result of a provider’s noncompliance with one or more health safety requirements. The facility failed to meet the regulatory compliance for § 494.40 Condition for Coverage: Water and Dialysate Quality as evidenced by: Based on observation, interview and record review, the facility failed to ensure conductivity and pH were checked prior to initiating dialysis treatments for 73 of 73 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 27, Patient 28, Patient 29, Patient 30, Patient 31, Patient 32, Patient 33, Patient 34, Patient 35, Patient 36, Patient 37, Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 57, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, Patient 65, Patient 66, Patient 68, Patient 69, Patient 70, Patient 71, Patient 72, Patient 73, Patient 74, Patient 75, Patient 76, Patient 77, Patient 78). This failure had the potential to compromise the safety of 73 sampled patients who were currently receiving hemodialysis treatment and had the potential to compromise the safety of all 93 in-center hemodialysis patients. (Refer to V250) Based on observation, interview, and record review, the facility failed to ensure one of one sampled Licensed Vocational Nurse (LVN) was competent to perform total chlorine testing (test performed to verify chlorine and other chemical disinfectants had been removed from the water before using water for hemodialysis treatment). This failure had the potential to place all 93 In-Center Hemodialysis patients at risk for hemolysis (destruction of red blood cells), septic shock (blood pressure drops to a dangerous level), or death. (Refer to V260)”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 42744 Based on observation, interview, and record review, the facility failed to: 1. Follow its policy and procedures (P&P) for monthly review of emergency supplies and medication expiration dates for one of one Emergency Crash Cart (ECC), one of one sampled Emergency Supply Box (ESB) and one of one medication preparation area. 2. Ensure four of 79 sampled patients (Patient 58, Patient 79, Patient 80, and Patient 81) Hemodialysis Machine #1 had an emergency hand-crank readily available for an emergency discontinuation of treatment. 3. Have emergency “Clamp and Disconnect” kits at nine of 17 sampled dialysis station (Station 2, Station 5, Station 6, Station 7, Station 8, Station 9, Station 14, Station 15, and Station 17). These failures had the potential for patients to not have readily available emergency supplies or receive expired medications. Findings: 1. During a concurrent observation and interview on 8/12/24 at 10:25 a.m. with Clinical Manager (CM) at the ECC, the ECC had a breakaway lock on the medication and supply drawers of the cart, a suction machine, a defibrillator (device that shocks the heart to restore a normal heartbeat), and three-ring binder on top of the cart. The forms in the three-ring binder indicated the last date the facility checked the ECC for outdated medication and supplies was July 2024. CM stated the ECC should have been checked in August. During a concurrent observation and interview on 8/12/24 at 10:27 a.m. with CM at the ESB (orange tote). A three-ring binder on the counter next to the orange tote contained a form titled “Emergency Box Supplies.” The forms in the binder indicated the facility checked the ESBs for outdated medication and supplies July 2024. CM stated the ESBs should have been checked in August. During a concurrent observation, interview, and record review, on 8/12/24 at 10:35 a.m. with CM at the medication preparation area, medications were locked in four upper cabinets and in a small refrigerator. The medication area contained a three-ring binder used to hold documentation of medication checks. The “Facility Medication List,” dated 2024, indicated the last time the facility checked the medications for outdated expiration dates was 7/3/24. CM stated the medications should have been checked at the beginning of the month of August. During a review of the facility’s P&P titled, “Crash Cart,” dated 9/2017, the P&P indicated, “The crash cart will be checked monthly. . . Documentation that the cart has been checked and that the emergency equipment has been tested needs to be on file. The person doing the checks needs to sign his/her name and title.” During a review of the facility’s P&P titled, “Emergency Evacuation Box,” dated 1/2021, the P&P indicated, “7. A designated associate will review the contents of the box and replace missing or expired supplies at least monthly. The date and initials of the staff checking the contents should be placed on a label outside the box.” During a review of the facility’s P&P titled, “Medications: Handling, Administration, Storage, & Disposal,” dated 6/2023, the P&P indicated, “37. Medications stocked in the inventory area and in the treatment area, including over the counter medications and nutritional product samples as applicable, are checked at least monthly for expiration dates.” 47734 2. During a concurrent observation and interview on 8/14/24 at 3:50 p.m. with Charge Nurse (CN) on the treatment floor, Hemodialysis Machine #1 did not have an emergency hand-crank (tool on a hemodialysis machine to manually return blood to the patient) at the back of the hemodialysis machine. CN stated the hand-crank should be present in case of an emergency. During an interview on 8/15/24 at 3:00 p.m. with CM, CM stated all hemodialysis machines needed to have hand-cranks for emergencies. During a review of the facility’s Patient Schedule (PS), dated 8/12/24 and 8/13/24, PS indicated, Patient 58, Patient 79, Patient 80, Patient 81 had their dialysis treatment on Hemodialysis Machine #1 while the machine did not have the emergency hand-crank present. During a review of the facility’s P&P titled, “Emergency Discontinuation of Treatment,” dated 9/1/21, the P&P indicated, “If there is a power failure, rinse the blood back manually using a hand-crank.” 3. During a concurrent observation and interview on 8/14/24 at 3:50 p.m. with CN on the treatment floor, CN stated there was no emergency “Clamp and Disconnect” kit at Station 10; Stations 2, 5, 9, 14, and 15 had emergency “Clamp and Disconnect” kits but with only one clamp inside; and Stations 6, 7, 8, and 17 had empty emergency “Clamp and Disconnect” kits. CN stated there should be more than one clamp inside the emergency kit. During an interview on 8/14/24 at 4:48 p.m. with CM, CM stated there should be at least two clamps inside the emergency “Clamp and Disconnect” kits for all hemodialysis stations. During a review of facility’s P&P titled, “Emergency Discontinuation of Treatment,” dated 9/1/21, the P&P indicated, “Clamp both blood lines and access line and connect a sterile syringe on the end of the access line. Repeat this step with the second access line.” During a review of Centers for Medicare & Medicaid Services (CMS) guide titled, “Emergency Preparedness for Dialysis Facilities,” undated, CMS guide indicated, “Clamp and Cap” should be simulated during the drill ...clamp and cap lines with the emergency kit available on the patient’s machine at the chairside.””

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 32234 Based on interview and record review, the facility failed to ensure: 1. Fire drills were completed quarterly for all patients and staff on all shifts (first, second, and third shifts). 2. Disaster drills were completed annually for all patients and staff for all shifts. These failures had the potential to result in the facility’s staff and patients not being prepared in case of a fire or disaster causing harm to patients, staff, and visitors. Findings: 1. During a concurrent interview and record review on 8/15/24 at 12:57 p.m. with the Clinical Manager (CM), the quarterly fire drills for 2022, 2023, and 2024 were reviewed. The following months had missing fire drills for all patients and staff: a. 2022 - Missing quarterly fire drills for all patients and staff for all p.m. shifts (8/2022 and 11/2022). Last fire drills were completed on 1/7/22 for a.m. shift and 5/24/22 for pre-opening staff. b. 2023 - Missing quarterly fire drill for patients and staff for the third shift (8/2023). Last fire drills were completed on 2/8/23 for the first shift and on 5/25/23 for the second shift. c. 2024 - Missing Fire drill for patients and staff for all shifts on 5/2024. Last fire drill was completed on 2/8/24 third shift for patients; and second shift for staff. A Fire Drill Evaluation dated 6/18/24 at 1:30 p.m. with no staff signatures who attended the fire drill and no patients’ names. CM stated the facility should complete fire drills quarterly. 2. During a concurrent interview and record review on 8/15/24 at 12:57 p.m. with CM, the annual disaster drill for the year 2022 and 2023 was requested. CM was unable to provide documented evidence the facility completed disaster drills in 2023. During a review of the facility’s policy and procedure (P&P) titled, “Fire Safety Preparedness,” dated 12/22/23, the P&P indicated, “4. Fire drills will be conducted quarterly. All shifts will have a minimum of one fire drill annually.””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 32234 Based on observation, interview, and record review, the facility failed to follow the facility’s policy and procedure (P&P) titled “Infection Control,” to provide a sanitary environment during hemodialysis treatment when: 1. One of one unlabeled and unused (clean) oxygen (O2) concentrator (a medical device used to deliver oxygen) was stored in the Isolation Room next to the hemodialysis machine currently not being used by Patient 10. 2. One of one mechanical lift (equipment used by facility staff to lift non-ambulatory patients) was stored with the patients’ personal wheelchairs and walkers. These failures had the potential to spread infections to patients and staff. Findings: 1. During a concurrent observation and interview on 8/12/24 at 10:15 a.m. with Clinical Manager (CM) in the Isolation Room, next to the hemodialysis machine, an O2 concentrator was not labeled for Isolation. CM stated the O2 concentrator was not designated to be used by Patient 10 and Patient 10 was not on O2 therapy. CM stated the O2 concentrator should have been cleaned and disinfected after being use by the patient and returned to the clean area for storage. 2. During a concurrent observation and interview on 8/12/24 at 10:20 a.m. with CM in the designated dirty area, a mechanical lift was stored next to the used patients’ personal wheelchairs and walkers. CM stated the staff should clean and disinfect the mechanical lift, then store the mechanical lift in the designated clean area readily available for use for the patients when needed. CM stated the facility did not have another mechanical lift available for patients who needed to be transferred from the wheelchair to the dialysis chair and from dialysis chair back to the wheelchair. CM was unable to determine if staff had cleaned and disinfected the mechanical lift. During a concurrent observation and interview on 8/15/24 at 9:15 a.m. with Charge Nurse (CN) in the designated dirty area, the mechanical lift was next to the patients’ personal wheelchairs. CN was unable to determine if staff had already cleaned and disinfected the mechanical lift after patient’s use. CN stated staff should clean and disinfect the mechanical lift after use and moved to the clean area. During a review of the facility’s policy and procedure (P&P) titled “Infection Control,” dated 11/29/22, the P&P indicated, “1. Standard precautions and infection control measures as outlined in this policy will be used by all associates at all times. . . 12. Only the supplies and equipment needed for the current patient treatment will be placed on the dialysis machine or in the patient’s treatment area. . . 16. . . Depending on the center layout and configuration, clean and dirty areas will be designated in a manner that decreases the risk of cross-contamination.””

“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: 32234 Based on observation, interview, and record review, the dialysis center failed to follow the facility’s policy and procedure (P&P) titled “Infection Control,” when three of 79 sampled patients (Patient 15, Patient 24, and Patient 71) did not perform hand hygiene, after dialysis treatment, before leaving the treatment area. This failure had the potential to spread infections to patients, staff, and families. Findings: 1. During a concurrent observation and interview on 8/12/24 at 11:40 a.m. with Charge Nurse (CN) in the treatment area by the weighing scale, CN weighed Patient 71 post (after) - dialysis. Patient 71 left the treatment area after being weighed by CN without performing hand hygiene. CN stated Patient 71 should have performed hand hygiene before leaving the dialysis treatment area. 2. During a concurrent observation and interview on 8/12/24 at 12:35 p.m. with Registered Nurse (RN) 1 in the treatment area by the weighing scale, RN 1 weighed Patient 15 post-dialysis. Patient 15 left the treatment area after being weighed by RN 1 without performing hand hygiene. RN 1 stated Patient 15 should have performed hand hygiene before leaving the dialysis treatment area. 3. During a concurrent observation and interview on 8/13/24 at 8:55 a.m. with RN 2 in the treatment area by the weighing scale, RN 2 weighed Patient 24 post-dialysis. Patient 24 left the treatment area after being weighed by RN 2 without performing hand hygiene before leaving the dialysis treatment area. During a review of the facility’s policy and procedure (P&P) titled “Infection Control,” dated 11/29/22, the P&P indicated, “17. Patients will be educated and encouraged to. . . wash their hands before entering and leaving the patient area.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 47734 Based on observation, interview, and record review, the facility failed to follow the facility’s policy and procedure (P&P) titled, “Cleaning & Disinfecting of Equipment, Supplies & Treatment Area,” for cleaning and disinfecting three of 17 hemodialysis treatment stations (Station 8, Station 2, and Station 3) between patients. This failure had the potential to result in the spread of infection to patients. Findings: During a concurrent observation and interview on 8/12/24 at 11:55 a.m. with CHT 1 in Station 8’s treatment area, CHT 1 did not clean and disinfect the prime bucket. CHT 1 stated she should have included the prime bucket while cleaning and disinfection. During a concurrent observation and interview on 8/12/24 at 12:15 p.m. with CHT 2 on the treatment floor at Station 2, CHT 2 did not wipe the prime bucket with bleach cloth inside and outside. CHT 2 stated he did not wipe the prime bucket with bleach cloth inside and outside. During a concurrent observation and interview on 8/12/24 at 12:25 p.m. with CHT 4 in the treatment floor at Station 3, CHT 4 did not wipe the prime bucket with bleach cloth inside and outside. CHT 4 stated she did not wipe the prime bucket with bleach cloth inside and outside. 42744 During an observation on 8/13/24 at 9:10 a.m. across from Station 8, Certified Hemodialysis Technician (CHT) 3 cleaned Station 8 with bleach-soaked cloths. CHT 3 did not wipe down the television set or its connecting arm, acid line tubing, prime bucket, back of the dialysis machine, or back counter. During an interview on 8/13/24 at 9:22 a.m. with Licensed Vocational Nurse (LVN), LVN stated everything should be wiped down between patients, including front and back of the television, back of the dialysis machine, back counter, acid line tubing, and prime bucket. During an interview on 8/13/24 at 9:30 a.m. with CHT 3, CHT 3 stated while cleaning Station 8, she did not wipe down the back of dialysis machine, back counter, or acid line tubing. CHT 3 stated she had not wiped down the television. During a review of the facility’s policy and procedure (P&P) titled, “Cleaning & Disinfecting of Equipment, Supplies & Treatment Area,” dated 6/20/24, the P&P indicated, “POLICY: . . . 7. All routinely touched reuseable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come into contact with the bleach solution. This includes, but is not limited to the: dialysis machine; chair, including the top and bottom of the chair-side table; bedside table; television, phone; counters and wall boxes. . .13. Containers used to discard saline prime from dialyzers will be disinfected after each treatment and when visibly contaminated with blood. The external and internal surfaces of the container will be wiped with a disposable cloth soaked with the bleach/water mixture used to disinfect the rest of the machine. The cloth is discarded after use.””

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 47734 Based on observation, interview, and record review, the facility failed to follow its policy and procedure (P&P) titled, “AVF-AVG Cannulation, Treatment Initiation & Termination Closed Procedure,” when staff did not check two out of 79 sampled patient’s (Patient 47 and Patient 64) needle access sites for bleeding and did not replace the soiled gauze bandage. Findings: a. During an observation on 8/14/24 at 8:45 a.m. on the treatment floor at Station 9, Licensed Vocational Nurse (LVN) removed needles from Patient 47, applied a gauze bandage and pressure, taped the gauze, and assisted Patient 47 leave the treatment floor. LVN did not check the needle site for bleeding and did not replace the gauze bandage prior to Patient 47 leaving the facility. During an interview on 8/14/24 at 11:00 a.m. with LVN, LVN stated she removed Patient 47’s needles, applied a gauze bandage, and taped it. LVN stated she did not change the gauze bandage before Patient 47 left the facility. b. During a concurrent observation and interview on 8/14/24 at 9:00 a.m. with Certified Hemodialysis Technician (CHT) 5 on the treatment floor at Station 3, CHT 5 removed needles from Patient 64, applied a gauze bandage and pressure, taped the gauze bandage, and assisted Patient 64 leave the treatment floor. CHT 5 stated he removed Patient 64’s needles, placed a gauze bandage and taped over the needle site. CHT 5 stated he did not replace the gauze bandage on the needle site prior to Patient 64 leaving the facility. During a review of the facility’s policy and procedure (P&P) titled, “AVF-AVG Cannulation, Treatment Initiation & Termination Closed Procedure,” dated 6/20/24, the P&P indicated, “After confirming that bleeding has stopped, replace blood-soiled bandage/gauze on the needle sites...The bandage/gauze on each needle site must be clean & dry prior to discharge.””

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 42744 Based on observation, interview, and record review, the facility failed to follow the facility policy and procedure (P&P) titled “CVC: Initiation & Discontinuation of Treatment,” to place a clean barrier field (chux) under the CVC ports when discontinuing (stopping) treatment for two of 79 sampled patients (Patient 4 and Patient 71). This failure had the potential to result in infection to dialysis catheter sites. Findings: During a concurrent observation and interview on 8/12/24 at 12:05 p.m. with Licensed Vocational Nurse (LVN) in the dialysis treatment area by Station 6, LVN discontinued (stopped) Patient 71’s hemodialysis with Central Venous Catheter (CVC). During the discontinuation of dialysis, LVN did not place a new and clean chux under the CVC ports and while applying the new sterile caps. LVN stated she should have used a new and clean chux under the CVC ports during the procedure and while changing and applying the new sterile caps to the CVC lines. During an observation on 8/12/24 at 3 p.m., LVN discontinued hemodialysis on Patient 4. Patient 4 had a CVC. LVN did not place a clean chux under the CVC ports prior to discontinuing dialysis. During a review of the facility’s policy and procedure (P&P) titled, “CVC: Initiation & Discontinuation of Treatment,” dated 9/1/23, the P&P indicated, “DISCONTINUATION OF TREATMENT Actions At the end of the treatment. . . Place a new clean field under the catheter limbs/caps.””

“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: 47734 Based on observation, interview and record review, the facility failed to ensure conductivity and pH were checked prior to initiating dialysis treatments for 73 of 73 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7, Patient 8, Patient 10, Patient 11, Patient 12, Patient 13, Patient 14, Patient 15, Patient 16, Patient 17, Patient 18, Patient 19, Patient 20, Patient 21, Patient 22, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, Patient 28, Patient 29, Patient 30, Patient 31, Patient 32, Patient 33, Patient 34, Patient 35, Patient 36, Patient 37, Patient 38, Patient 39, Patient 40, Patient 41, Patient 42, Patient 43, Patient 44, Patient 46, Patient 47, Patient 48, Patient 49, Patient 50, Patient 51, Patient 52, Patient 53, Patient 54, Patient 55, Patient 56, Patient 59, Patient 60, Patient 61, Patient 62, Patient 63, Patient 64, Patient 65, Patient 66, Patient 67, Patient 69, Patient 70, Patient 71, Patient 72, Patient 73, Patient 74, Patient 75, Patient 76, Patient 77, Patient 78). This failure has the potential to cause serious adverse outcomes including but not limited to: - Out of range pH (normal pH 7.4) can cause severe acidosis (high pH) or alkalosis (low pH) to patients on dialysis. - Out of range conductivity can cause hyponatremia (low salt) or hypernatremia (high salt). Effects on patients can be excessive thirst or swelling of the cells, fluid retention. - Out of range pH can cause rapid breathing, seizures, prolonged muscle spasms, arrythmias, lightheadedness, confusion that can lead to coma. On 8/13/24 at 6:20 p.m., a situation of Immediate Jeopardy was declared with Clinical Manager (CM) for the facility’s failure to ensure the safety of 73 sampled In-Center Hemodialysis patients when facility staff did not perform conductivity and pH verifications with a dialysate meter. On 8/15/24 at 5:15 p.m., while onsite the surveyors confirmed by observation, interview, and record review, the facility had submitted and implemented an acceptable written plan of correction and the IJ was abated with CM, Regional Operations Manager (ROM), Clinical Regulatory Manager (CRM) , Group Vice President (GVP), Manager of Technical Services (MOTS), Corporate Regulatory Director (CRD), and Facility Technical Manager (FTM). Findings: During an observation on 8/13/24 at 8:50 a.m. in the treatment area, at Station 15, Certified Hemodialysis Technician (CHT) 2 did not check the pH and conductivity using the dialysate meter prior to initiating dialysis treatment for Patient 21. During a concurrent observation and interview on 8/13/24 at 9:09 a.m. with CHT 1 in the treatment floor at Station 4, CHT 1 did not perform the conductivity and pH check prior to initiating hemodialysis treatment for Patient 18. CHT 1 stated she did not perform the conductivity and pH check prior to initiating hemodialysis treatment. CHT 1 stated she did not need to do the conductivity and pH check . During a concurrent observation and interview on 8/13/24 at 9:15 a.m. with CHT 1 in the treatment floor at Station 2, CHT 1 did not perform the conductivity and pH check prior to initiating treatment for Patient 84. CHT 1 stated she did not perform the conductivity and pH check prior to initiating hemodialysis treatment and she should have performed the checks. During an interview on 8/13/24 at 10:02 a.m. with FTM, FTM stated the conductivity and pH was done with the dialysate meter before the start of patient hemodialysis treatments. FTM stated all staff should be using the dialysate meter before starting the hemodialysis treatments. During an interview on 8/13/24 at 11:35 a.m. with CHT 2 and Clinical Manager (CM), CHT 2 stated he did not perform the pH and conductivity check using the dialysate meter prior to initiating dialysis treatment for his assigned patients (Patient 24, Patient 3, Patient 14, Patient 19, Patient 7) today. CHT 2 stated his documentation in the dialysis treatment flowsheets was inaccurate for the pH and conductivity values because he did not use the dialysate meter. During a review of the facility’s policy and procedure (P&P) titled, “Checking Conductivity & pH of Dialysate,” dated 6/20/24, the P&P indicated, “PURPOSE: To Ensure: Safe dialysis treatment for patients (Improper conductivity could result in patient injury (crenation or hemolysis of red blood cells) or death ...3. It is mandatory that independent testing of conductivity of dialysate is performed prior to the start of each patient treatment and whenever there is a change in the dialysate during treatment ...8. The pH of dialysate should be between 6.9-7.6. If readings from independent testing are not within the specified limits, do not initiate treatment.””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 47734 Based on observation, interview, and record review, the facility failed to ensure one of one sampled Licensed Vocational Nurse (LVN) was competent to perform total chlorine testing (test performed to verify chlorine and other Chloramine [chemical disinfectants] had been removed from the water before using water for hemodialysis treatment). This failure had the potential to place all 93 In-Center Hemodialysis patients at risk for hemolysis (destruction of red blood cells), septic shock (blood pressure drops to a dangerous level), or death. Findings: During a concurrent observation and interview on 8/12/24 at 2:50 p.m. with LVN, and Facility Technical Manager (FTM), in the water room (water purification area), LVN performed the total chlorine testing. LVN did not perform the following steps: - Rinse the sample cup with the water to be tested, - Swish (move slowly in a back and forth motion) strip in the cup for 60 seconds, - Shake the strip once briskly to remove the excess water, - Wait 20 seconds to check the test strip color, - Fold the strip completely flat. FTM stated the LVN did not perform the necessary steps to complete a correct total chlorine testing procedure. FTM stated LVN should have followed the steps correctly. During a review of the journal Seminar in Dialysis, the article titled “Hemodialysis and Water Quality” dated 7/17/13, the article stated “The quality of water and associated dialysis solutions have been implicated in adverse patient outcomes and is therefore critical...Chemical contaminants can cause chemical toxicity and adverse effects if present at high enough concentrations. Chemical toxicity leads to a range of clinical outcomes, including but not limited to, speech and motor difficulties, seizures, nausea, hypotension, and diarrhea. Each chemical produces a specific reaction; for example, sulfate...is associated with nausea, vomiting, and metabolic acidosis, while lead...has caused abdominal pain and muscle weakness.” During a review of the journal Nephrology Dialysis Transplantation article “Chloramine, a sneaky contaminant of dialysate”, dated 11/1/1999, the article indicated “Chloramines, derived from chlorine and ammonium, are added to water as disinfectants and may contaminate dialysis fluid and enter the blood of dialysis patients causing haemolytic [hemolytic] anaemia [anemia, condition in which red blood cells are destroyed faster than they can be made].” During a review of facility’s document titled, “Ultra-low Total Chlorine Test Strips Instructions for Use,” undated, the document indicated, “rinse the clean sample cup with the water to be tested ...Remove one test strip from its foil package and swish it in the sample for the amount of time indicated ...swish time = 60 seconds ...Remove the strip and shake once, briskly, to remove excess water ...Wait 20 seconds for the test strip color to develop ...fold the white plastic handle of the test strip under the reagent area aperture [opening] so that it provides a consistent viewing background.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 32234 Based on observation, interview, and record review the facility failed to follow the facility’s policy and procedure (P&P) titled, “Monitoring & Documentation of Patient Care During Treatment,” when three of 79 sampled patients (Patient 10, Patient 31, and Patient 55) receiving hemodialysis treatments had their vascular access sites covered during treatment. This failure had the potential to result in undetected accidental needle or blood line disconnection, which could result in massive blood loss and death of a patient. Findings: During a concurrent observation and interview on 8/12/24 at 11:15 a.m. with Registered Nurse (RN) 1 in the Isolation Room, Patient 10’s blanket covered the vascular access site on the left forearm covered up to her neck. RN 1 stated Patient 10’s blanket should not be covering the access site. RN 1 stated the dialysis access site should be visible at all times. During a concurrent observation and interview on 8/12/24 at 11:59 a.m. across from Station 9, Patient 31’s hemodialysis vascular access site was covered. Certified Hemodialysis Technician (CHT) 2 stated Patient 31’s hemodialysis access site was covered. CHT 2 stated the access site should not be covered. During a concurrent observation and interview on 8/12/24 at 2:45 p.m. with Licensed Vocational Nurse (LVN) in the dialysis treatment area by Station 9, Patient 55’s Central Venous Catheter (CVC - a soft flexible tube surgically inserted into a large blood vessel) access site was located to her right upper chest. The CVC access site and the bloodlines connecting tubings were covered with her blanket during dialysis treatment. LVN stated Patient 55’s access site was covered. 42744 During a review of the facility’s P&P titled, “Monitoring & Documentation of Patient Care During Treatment,” dated 11/29/22, the P&P indicated, “12. The patient’s vascular access should remain uncovered and readily visible throughout the course of the patient’s treatment.””

“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: 32234 Based on interview and record review, the facility failed to follow the facility’s policy and procedure (P&P) titled, “Orders for Patient Care,” for two of 79 sampled patients (Patient 8 and Patient 69) when: 1. The physician Order for Blood Flow Rate (BFR - the rate at which blood passes through the artificial kidney) for one of 79 sampled patients’ (Patient 8) was not followed. 2. The physician was not notified for one of 79 sampled patients’ (Patient 8) dry weight (target weight post-dialysis treatment) was not met consistently. 3. The physician was not notified one of 79 sampled patients (Patient 69) had multiple missed treatments. These failures had the potential for dialysis patients not receiving effective dialysis and not achieving their target goals which could adversely affect their overall health condition leading to weakened bones, heart problems and ultimately death. Findings: 1. During a review of Patient 8’s “Dialysis Order Report (DOR),” dated 7/6/24, the DOR indicated, “Blood Flow Rate: 350.” During a concurrent interview and record review on 8/15/24 at 9:20 a.m. with Clinical Regulatory Manager (CRM), Patient 8’s “HD [Hemodialysis] Treatment Flowsheet (HTF),” dated 7/22/24 to 8/12/24 were reviewed. The prescribed BFR order of 350 was not consistently followed. CRM was unable to find documentation why prescribed BFR was not followed. CRM stated, “The arterial pressure goes up and the machine starts to alarm. The staff should have documented it and addressed anything they have done. They should have documented the problem with access line.” During a review of Patient 8’s DOR, dated 7/6/24, the DOR indicated, Dialysis Flow Rate: 700. During a concurrent interview and record review on 8/15/24 at 11:20 a.m. with CRM, Patient 8’s HTF, dated 8/9/24 was reviewed. The DFR was 500 from the start of the treatment at 1:39 p.m. to 4:32 p.m. CRM verified the findings and stated, “I can’t see any order for the 500 DFR.” CRM stated the prescribed DFR order of 700 was not followed for Patient 8. 2. During a review of Patient 8’s DOR, dated 7/6/24, the DOR indicated, “Dry Weight (kg): 84.” During a concurrent interview and record review on 8/15/24 at 11:20 a.m. with CRM, Patient 8’s “Dry Weight [Wt] Report (DWR),” dated 7/22/24 to 8/12/24 were reviewed. The “Post Dialysis Weight (PDW),” indicated the following wts on the following dialysis treatment dates: 7/22/24 - PDW = 84.8 kg. - > [more than] 0.8 kg from the dry wt. 7/24/24 - PDW = 84.4 kg. - > 0.4 kg from the dry wt. 7/26/24 - PDW = 85.6 kg. - > 1.6 kg from the dry wt. 7/27/24 - PDW = 84.5 kg [extra treatment]. - > 0.5 kg from the dry wt. 7/29/24 - PDW = 85.5 kg. - > 1.5 kg from the dry wt. CRM stated if the “PDW” were not achieved, the charge nurse should evaluate and notify the physician if the dry weight order could be changed. CRM was unable to find documentation of a change in the dry weight order from the physician from 7/22/24 to 7/29/24. 3. During a review of Patient 69’s DOR, dated 7/10/24, the DOR indicated, “[Dialysis] Schedule: Tu [Tuesday], Th [Thursday], Sa [Saturday]. During a concurrent interview and record review on 8/15/24 at 1:05 p.m. with CRM, Patient 69’s HTF, dated 7/20/24 to 8/10/24 were reviewed. Patient 69 had missed treatments (no hemodialysis treatments) as scheduled dated 7/23/24, 8/1/24, and 8/8/24. The “No Show Treatment (NST),” indicated the following: 7/23/24 - Treatment Reason: No Call, No Show. 8/1/24 - Treatment Reason: No Call, No Show. 8/8/24 - Treatment Reason: No Call, No Show. CRM stated the physician should have been notified. During a review of the National Kidney Foundation website, dated 2024, the article titled “Missing Dialysis Treatment Is Dangerous for Your Health” indicated “Skipping dialysis can be risky. It can cause fluid overload, high potassium (required mineral), and high phosphorus (required mineral) levels, leading to severe health problems...Missing dialysis treatments places you at risk for building up high levels of these 2 minerals: High potassium, which can lead to heart problems including arrhythmia, heart attack, and death. High phosphorus, which can weaken your bones over time and increase your risk for heart disease.” During a review of the facility’s policy and procedure (P&P) titled, “Orders for Patient Care,” dated 11/15/23, the P&P indicated, “To ensure that orders for patient care: are provided in a timely manner. . . are properly documented, transcribed, verified and implemented in a timely manner. . . 19. Any change of the dialysis machine out of pre-set default values requires a physician order. . . Dialysate flow rate. . .””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 42744 Based on interview and record review, the facility failed to follow the facility’s policy and procedure (P&P) titled, “Monitoring & Documentation of Patient Care During Treatment,” to monitor, document and initiate high blood pressure (hypertension) interventions for one of 79 sampled patients (Patient 65). This failure had the potential for Patient 65 to have a heart attack, stroke (blood flow is cut off to the brain), or other complications. Findings: During a review of Patient 65’s “Dialysis Order Report (DOR),” dated 8/7/23, the DOR indicated, Clonidine HCL Tablet [medication used to treat high blood pressure] . . . Dose: 0.1 milligrams (mg, unit of measurement) by mouth as needed for Essential (primary) hypertension. During a concurrent interview and record review on 8/14/24 at 4:27 p.m. with Clinical Manager (CM), Patient 65’s “HD (hemodialysis) Treatment Flowsheet (HTF),” dated 8/9/24 was reviewed. The HTF indicated Patient 65’s blood pressures after her dialysis at 4:23 p.m. was 201/94 and repeated blood pressure of 200/89. CM reviewed Resident 65’s medical record for other nursing notes related to the high blood pressure and stated none were found. CM stated the Registered Nurse (RN) should have had the patient sit and then retaken the patient’s blood pressure. RN should have offered to give the patient Clonidine, then made her wait to repeat the blood pressure after medication. CM stated if Patient 65 was symptomatic then the physician should have been notified. CM stated the RN should have documented all interventions in the medical record. During a concurrent interview and record review on 8/15/24 at 4:05 p.m. with Regional Operations Manager (ROM), the facility’s “Standing Order Report (SOR),” dated 5/31/24 was reviewed. The SOR indicated give Clonidine 0.1 mg for systolic blood pressure greater than 190 and diastolic blood pressure greater than 110 after the first hour of dialysis. The SOR indicated if the pulse rate was equal to 60, then give the Clonidine. The SOR indicated the Clonidine could be repeated in 30 minutes and to call the physician if the high blood pressure persisted. ROM stated RNs were to follow the standing orders and may do so without first contacting the physician because these orders were already approved. During a review of the facility’s policy and procedure (P&P) titled, “Monitoring & Documentation of Patient Care During Treatment,” dated 11/29/22, the P&P indicated, “PURPOSE: To ensure: that patients are monitored to ensure safety during the hemodialysis treatment. Proper documentation of all patient care activities before, during and after each hemodialysis treatment. That all data collected and documented accurately reflects what occurred during each hemodialysis treatment. . . 10. Data that must be documented . . . at least every 30 minutes and PRN [as needed] depending on the patient’s condition includes, but is not limited to: . . . Patient status- some notes must be entered to indicate how the patient is tolerating the treatment, and any patient problems, complaints, or observation about the patient status must be documented. In addition, any interventions provided to the patient and the patient response must be documented.” 47734”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 32234 Based on observation and interview, the facility failed to ensure Registered Nurse (RN) 1 did not leave medication in a cup at one of 79 sampled patients’ (Patient 82) chairside. This failure had the potential for medication contamination, medication not taken by patient, and medication taken by another patient. Findings: During a concurrent observation and interview on 8/12/24 at 12:50 p.m. with Certified Hemodialysis Technician (CHT) 6 in Station 9, a medication cup with one medication inside was at Patient 82’s chairside. CHT 6 instructed Patient 82 to take the medication inside the medication cup left at his chairside before leaving the facility. CHT 6 stated RN 1 left Patient 82’s medication at Patient 82’s chairside. During an interview on 8/12/24 at 3:55 p.m. with RN 1, RN 1 stated the medication inside the medication cup by Patient 82’s chairside was Calcitriol (used to treat low calcium levels caused by kidney disease) 0.5 mcg (microgram). RN 1 stated Patient 82 refused to take his Calcitriol medication and Patient 82 told her the medication caused him to have an upset stomach. RN stated, “When medications are refused by the patient, it [the medication] should not be left on the patient’s chairside. I should have discarded it when he was not ready for the medication.” During a review of the facility’s policy and procedure (P&P) titled, “Orders for Patient Care,” dated 11/15/23, the P&P indicated, “To ensure that orders for patient care: are provided in a timely manner. . . are properly documented, transcribed, verified and implemented in a timely manner.””

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 32234 Based on interview and record review, the facility failed to: 1. Ensure one of 79 sampled patients (Patient 71) received his Mircera (medication for anemia) consistently as ordered. This failure resulted in Patient 71 not receiving his Mircera two times a week during his scheduled hemodialysis treatment from 7/24/24 to 8/12/24. 2. Ensure one of 79 sampled patients (Patient 78) received his Venofer (intravenous [IV] iron in the vein) as ordered. This failure resulted in Patient 78 not receiving his Venofer consistently during his dialysis treatment days from 7/23/24 to 8/10/24. Findings: 1. During a review of Patient 71’s “Dialysis Order Report (DOR),” dated 7/19/24, the “DOR” indicated, “Mircera. . . 30 mcg [microgram, a unit of measurement] IVP [Intravenous Push] 1st [first] tx [treatment] every 2 wks [weeks].” During a concurrent interview and record review on 8/15/24 at 2:40 p.m. with Clinical Regulatory Manager (CRM), Patient 71’s “HD [Hemodialysis] Treatment Flowsheet (HTF),” dated 7/24/24 to 8/12/24 were reviewed. The HTF indicated the Mircera 30 mcg IVP was not administered every two weeks from 7/24/24 and the next dose was administered on 8/12/24. The HTF dated 8/5/24 indicated, “Mircera. . .30. . . Medication Unavailable.” CRM stated, “They [the facility] ran out of the Mircera and was ordered on 8/5/24.” 2. During a review of Patient 78’s “Dialysis Order Report (DOR),” dated 7/20/24, the DOR indicated, “Venofer 50 mg [milligram] IVP 1st tx every two weeks.” During a concurrent interview and record review on 8/15/24 at 11:50 a.m. with CRM, Patient 78’s HTF dated 7/23/24 to 8/10/24 were reviewed. The HTF indicated Venofer medication was not administered on the first treatment every two weeks as ordered. CRM stated, “Venofer was ordered on 7/20/24 and the first dose was administered on 8/1/24 [11 days after it was first ordered on 7/21/24].” No additional information was provided. During a review of the facility’s policy and procedure (P&P) titled, “Anemia Management,” dated 2/2021, the P&P indicated, “To ensure the patient obtains the maximum benefit from the administration of erythropoietin [hormone -stimulates red blood cells production]-stimulating agents (ESAs) and iron.” During a review of the facility’s P&P titled, “Orders for Patient Care,” dated 11/15/23, the P&P indicated, “To ensure that orders for patient care: are provided in a timely manner. . . are properly documented, transcribed, verified and implemented in a timely manner.””

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 32234 Based on interview and record review, the facility failed to follow up for a vein mapping (finds the best blood vessels for a possible dialysis fistula [connection between a blood vessels]) for one of 79 sampled patients (Patient 71) who had a Central Venous Catheter (CVC - a tube inserted into a large blood vessel) for more than 90 days. This failure resulted in the patient’s delay of the vein mapping, possible fistula placement, and risk for infection for the prolonged use of CVC. Findings: During a review of Patient 71’s “Dialysis Order Report (DOR),” dated 7/17/24, the DOR indicated, “Access. . . Type. . .Tunneled Catheter. . . Site. . . Right IJ [internal jugular] Vein. . . Placement Date: 2/2/24.” During an interview on 8/15/24 at 3:30 p.m. with Clinical Regulatory Manager (CRM), CRM stated Patient 71 had her CVC for more than 90 days (since 2/2/24). CRM stated Patient 71 was referred for vein mapping on 5/21/24 (approximately almost three months ago) by the Charge Nurse (CN) and still waiting for an authorization from the insurance. During an interview on 8/15/24 at 4 p.m. with Medical Social Worker (MSW), MSW stated, “I was not notified the insurance was still pending for [Patient 71’s vein mapping].” A policy and procedure was requested for vascular access referral, none was provided.”

“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: 32234 Based on interview and record review, the facility failed to: 1. Ensure four of 79 sampled patients (Patient 8, Patient 34, Patient 40, and Patient 65) physician’s hemodialysis orders (includes duration of hemodialysis treatment, Blood Flow Rate [BFR - the rate at which blood passes through the dialyzer (artificial kidney)], and Dialysate [fluid used in hemodialysis to remove waste products and balance electrolytes (potassium, calcium, and bicarbonates)] Flow Rate [DFR]) were followed and physcian was notified promply of non-compliance. 2. Ensure for two of 79 sampled patients (Patient 8 and Patient 34) a “Termination of Treatment Against Medical Advice (AMA)” form was completed when patient terminated hemodialysis early. These failures had the potential to result in lack of adequacy (a measure of how well toxins and waste products are removed from the blood) of the hemodialysis treatment. Findings: 1. During a concurrent interview and record review on 8/14/24 at 4:45 p.m. with Clinical Manager (CM), Patient 65’s “HD Treatment Flowsheet (HTF),” dated 7/24/24 was reviewed. The HTF indicated Patient 65’s physician’s orders for the DFR should be 700. The HTF indicated Patient 65’s DFR was 600 during this treatment. CM stated the DFR should have been 700 per the dialysis prescription. During a review of the Patient 8’s “Dialysis Order Report (DOR),” dated 7/6/24, the DOR indicated, “Duration: 04.00 [4 hours].” During a concurrent interview and record review on 8/15/24 at 9:20 a.m. with Clinical Regulatory Manager (CRM), Patient 8’s HTF, dated 7/22/24 to 8/12/24 were reviewed. The following dates indicated Patient 8 did not complete his four hours of hemodialysis treatment as ordered. 7/31/24 - From 4:34 a.m. to 7:37 a.m. (shortened hemodialysis treatment for one hour). No notification of MD. 8/9/24 - From 1:29 p.m. to 5:02 p.m. (shortened hemodialysis treatment of 30 minutes). No notification of MD. 8/12/24 - From 1:18 p.m. to 4:34 p.m. (shortened hemodialysis treatment of 40 minutes). CRM verified the findings and stated Patient 8 was an “unstable” patient due to his non-compliance of his dialysis treatment orders. CRM stated the physician should have been notified. During a concurrent interview and record review on 8/15/24 at 1:13 p.m. with CM, Patient 34’s HTF, dated 7/22/24 was reviewed. The HTF indicated the duration of Patient 34’s hemodialysis treatment should be three hours and fifteen minutes. The HTF indicated Patient 34’s actual treatment time was two hours and fifty-one minutes. CM reviewed Patient 34’s medical record and stated the record contained no documentation of Patient 34’s early termination of treatment. CM stated there should be documentation stating early termination of dialysis and the reason why. During a concurrent interview and record review on 8/15/24 at 1:40 p.m. with CM, Patient 40’s HTF, dated 8/8/24 was reviewed. The HTF indicated the physician’s orders for BFR was 400. The HTF indicated the BFR during treatment ranged from 200 to 300. CM reviewed Patient 40’s medical record “Access Notes” and stated there was nothing indicating the reason for lowering the BFR. CM stated staff should have documented the reason why the BFR was lowered or followed the prescribed treatment. During a concurrent interview and record review on 8/15/24 at 1:43 p.m. with CM, Patient 40’s HTF, dated 8/5/24 was reviewed. The HTF indicated the physician’s orders for BFR was 400. The HTF indicated the BFR at the start of dialysis at 12:46 p.m. was 400, lowered to 350 at 1:01 p.m., lowered to 325 at 3:31 p.m., and then lowered to 300 at 4:02 p.m. CM stated there was no order to decrease the BFR and staff should have followed the hemodialysis prescription. CM stated she did not see any reason for lowering the BFR. CM stated she did not see documentation on the flowsheet or the access note indicating why the BFR was reduced. During a concurrent interview and record review on 8/15/24 at 1:52 p.m. with CM, Patient 40’s HTF, dated 7/26/24 was reviewed. The HTF indicated the physician’s orders for BFR was 400. The HTF indicated the BFR ranged from 200 to 350. CM stated she did not see documentation on the flowsheet or the access note indicating why the BFR was reduced. CM stated staff should have followed the order or contacted the physician. During a concurrent interview and record review on 8/15/24 at 1:55 p.m. with CM, Patient 40’s HTF, dated 7/24/24 was reviewed. The HTF indicated the physician’s orders for BFR was 400. The HTF indicated the BFR at the initiation of dialysis was 200 at 12:22 pm., increased to 400 at 12:31 p.m., lowered to 350 at 1:01 p.m., increased to 400 at 2:31 p.m., lowered to 300 at 3:31 p.m. throughout the rest of the treatment. CM stated she did not see any notes indicating why the BFR was reduced. CM stated staff should troubleshoot and initiated interventions if there was a problem requiring the BFR to be reduced and should also have contacted the physician. During a concurrent interview and record review on 8/15/24 at 2 p.m. with CM, Patient 40’s HTF, dated 7/22/24 was reviewed. The HTF indicated the dialysis prescription for BFR was 400. The HTF indicated the BFR ranged from 200 to 350 during the treatment. CM stated she did not see any notes indicating why the BFR was reduced. CM stated staff were not following Patient 40’s physician’s orders. During a concurrent interview and record review on 8/15/24 at 2:05 p.m. with CM, Patient 40’s “Lab Flowsheet (LF),” dated 8/14/24 was reviewed. The LF indicated Patient 40’s Kt/V (measures adequacy; should be at least 1.2) was the following: 5/31 0.80 6/5 1.19 6/10 0.96 6/14 1.49 7/3 0.93 7/8 1.14 7/10 0.77 7/15 7.77 7/19 0.82 7/22 1.71 CM stated if you lower the BFR, you will not get adequacy. 2. During a concurrent interview and record review on 8/15/24 at 9:20 a.m. with Clinical Regulatory Manager (CRM), Patient 8’s HTF, dated 8/12/24 was reviewed. The HTF indicated Patient 9 shortened the treatment time by 40 minutes and did not sign an AMA form. CRM stated an AMA form should have been signed. 42744 During a concurrent interview and record review on 8/15/24 at 1:13 p.m. with CM, Patient 34’s HTF, dated 7/22/24 was reviewed. The HTF indicated the duration of Patient 34’s hemodialysis treatment was 24 minutes short of the prescribed duration of treatment. CM stated Patient 34 should have signed an AMA form. During a review of the facility’s policy and procedure (P&P) titled, “Monitoring & Documentation of Patient Care During Treatment,” dated 11/29/22, the P&P indicated, “PURPOSE: To ensure: that patients are monitored to ensure safety during the hemodialysis treatment. Proper documentation of all patient care activities before, during and after each hemodialysis treatment. That all data collected and documented accurately reflects what occurred during each hemodialysis treatment. . . 10. Data that must be documented . . . at least every 30 minutes and PRN [as needed] depending on the patient’s condition includes, but is not limited to: . . . Patient status- some notes must be entered to indicate how the patient is tolerating the treatment, and any patient problems, complaints, or observation about the patient status must be documented. In addition, any interventions provided to the patient and the patient response must be documented. . . 15. Information that must be entered manually includes, but is not limited to: . . . interventions for unexpected situations, such as slowing blood flow for access problem . . .if the prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.” During a review of the facility’s P&P titled, “Orders for Patient Care,” dated 11/15/23, the P&P indicated, “To ensure that orders for patient care: are provided in a timely manner. . . are properly documented, transcribed, verified and implemented in a timely manner.””

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 42744 Based on interview and record review, the facility failed to follow the facility’s policy and procedure (P&P) titled, “Monitoring & Documentation of Patient Care During Treatment,” one of 79 sampled patients (Patient 40) the “HD [hemodialysis] Treatment Flowsheet (HTF),” indicated high arterial pressure (AP- pressure of blood flow in the arterial wall). This failure had the potential to result in a delay of of care due to the physician not being aware of Patient 40’s high AP. Findings: During a concurrent interview and record review on 8/15/24 at 1:48 p.m. with Clinical Manager (CM), Patient 40’s “HTF” dated 7/31/24 was reviewed. The HTF indicated arterial pressures were high. CM stated the nurses should have documented APs were high and what interventions were implemented to reduce the pressure. During a concurrent interview and record review on 8/15/24 at 1:50 p.m. with CM, Patient 40’s HTF, dated 7/29/24 was reviewed. The HTF indicated APs were high and no notes were written on the flowsheet. CM stated, “Nurses should be documenting, that is the expectation.” CM stated the nurses failed to document in the notes. During a concurrent interview and record review on 8/15/24 at 1:55 p.m. with CM, Patient 40’s HTF, dated 7/26/24 was reviewed. The HTF indicated APs were high and there were no nurse’s notes on the flowsheet. CM stated there was no documentation in the access notes. CM stated nurses must troubleshoot the reason for the high AP, for example the dialysis needle might be up against the artery wall. CM stated nurses must notify the physician when APs were high and dialysis prescription not followed. During a review of the facility’s policy and procedure (P&P) titled, “Monitoring & Documentation of Patient Care During Treatment,” dated 11/29/22, the P&P indicated, “PURPOSE: To ensure: that patients are monitored to ensure safety during the hemodialysis treatment. Proper documentation of all patient care activities before, during and after each hemodialysis treatment. That all data collected and documented accurately reflects what occurred during each hemodialysis treatment. . . 10. Data that must be documented . . . at least every 30 minutes and PRN [as needed] depending on the patient’s condition includes, but is not limited to: . . . Patient status- some notes must be entered to indicate how the patient is tolerating the treatment, and any patient problems, complaints, or observation about the patient status must be documented. In addition, any interventions provided to the patient and the patient response must be documented. . . 15. Information that must be entered manually includes, but is not limited to: . . . interventions for unexpected situations, such as slowing blood flow for access problem . . .if the prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.” During a review of the facility’s P&P titled, “Orders for Patient Care,” dated 11/15/23, the P&P indicated, “To ensure that orders for patient care: are provided in a timely manner. . . are properly documented, transcribed, verified and implemented in a timely manner.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 32234 Based on observation, interview and record review, the dialysis facility failed to follow the facility policy and procedure (P&P) titled, “Orders for Patient Care,” to ensure accurate medical records four of 83 sampled patients (Patient 9, Patient 21, and Patient 67). This failure had the potential for misinformation, which could negatively impact patients’ care. Findings: During an observation on 8/13/24 at 8:50 a.m. in the treatment area, Certified Hemodialysis Technician (CHT) 2 did not check the pH and conductivity using the pHoenix Meter prior to initiating dialysis treatment for Patient 21. During an interview on 8/13/24 at 11:35 a.m. with CHT 2 and Clinical Manager (CM), CHT 2 stated he did not perform the pH and conductivity check using the pHoenix Meter prior to initiating dialysis treatment for his assigned patients (Patient 24, Patient 3, Patient 14, Patient 19, Patient 7) today. CHT 2 stated it was a hectic day. CHT 2 stated his documentation in the dialysis treatment flowsheet were inaccurate for the pH and conductivity values. 47734 During a concurrent interview and record review on 8/14/24 at 2:35 p.m. with Peritoneal Dialysis Registered Nurse (PD RN), Patient 67’s “APD (automated peritoneal dialysis)/CCPD (Continuous Cycling Peritoneal Dialysis) Orders,” dated 7/26/24 was reviewed. The orders had no time value for “Dwell Time - (amount of time fluid remains in the abdomen)” and for “Treatment Time”. PD RN stated the dwell time, and the treatment time should be written in the orders for APD/CCPD for Patient 67. During a concurrent interview and record review on 8/14/24 at 2:35 p.m. with Peritoneal Dialysis Registered Nurse (PD RN), Patient 9’s “APD/CCPD Orders,” dated 7/9/24 was reviewed. The orders had no time value for “Dwell Time” and for “Treatment Time”. PD RN stated the dwell time, and the treatment time should be written in the orders for APD/CCPD for Patient 9. During a review of the facility’s policy and procedure (P&P) titled, “Orders for Patient Care,” dated 11/15/23, the P&P indicated, “To ensure that orders for patient care: are provided in a timely manner. . . are properly documented, transcribed, verified and implemented in a timely manner.””