Western Maryland Regional Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, it was determined that the facility’s governing body failed to maintain an effective Infection Control Program, as evidenced by wide-spread non-compliance of the facility’s staff with the infection control standards and facility’s policies. The cummulative effect of these failures negatively impacted the quality of care in the facility and placed the facility patients and staff at potential risk for infections. The findings included: 1. The facility failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who came in contact with the dialysis patients in the facility. Cross reference to tag V0113. 2. The facility’s governing body failed to ensure that personal protective equipment (PPE)’s was worn in the treatment area where there was potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces. Cross reference to tag V0115. 3. The facility’s governing body failed to ensure that the clinical staff followed safe practices when handling infectious wastes. Cross reference to tag V0121. 4. The facility’s governing body failed to ensure that the clinical staff followed the standard infection control procedures in the cleaning and disinfection of hemodialysis machine and its prime bucket. Cross reference to tag V0122. 5. The governing body failed to ensure that the clinical staff complied with the catheter care techniques outlined in the facility’s policies. Cross reference to tag V0147.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 44367 Based on observations, staff interview and record review, the facility’s administration and the Medical Director failed to ensure that supplies were available to provide care during an emergency evacuation for Peritoneal Dialysis (PD) patients. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency. Findings included: Review on 09/12/2024 of the facility’s policy entitled “Emergency Evacuation/Readiness” revealed: “The Charge Nurse is responsible for the following: Review each day the Emergency Supply Tote. Use the checklist for documentation to maintain current supplies within the Tote.” Review on 09/12/2024 of the facility’s policy entitled “Facility Emergency Plan” determined that page 2 stated, “If it becomes necessary to evacuate, The Charge Nurse on Duty will be responsible for mobilizing the Emergency Supply Cart that contains post treatment care supplies.” On 09/12/2024 at 12:30 p.m., inspection of the PD emergency equipment revealed that the department did not have emergency supplies to accommodate the two PD rooms in the event of an emergency evacuation. The facility had enough supplies to cover the 34 in-center hemodialysis stations; however, those supplies were not sufficient supplies for PD patients’ supply needs. The PD Charge Nurse informed the surveyor that they were unaware that emergency evacuation supplies were needed. The PD Nurse corroborated that the PD unit did not have an emergency supply tote for it’s patients in the event of an emergency.”

“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: 44367 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who came in contact with the dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: #2 Findings included: According to the Centers for Disease Control and Prevention (CDC), infection can be spread in a dialysis center through the passing of microorganisms from one patient to another by the hands of the caregiver; or if the environmental surfaces are contaminated and touched by a caregiver or patient. Even with glove use, hand hygiene is necessary before gloves are put on and after gloves are removed because hands can become contaminated through small defects in gloves and from the outer surface of the gloves during glove removal. Observation of the clinical treatment area on 09/11/2024 at 11:34 a.m. revealed Staff #2 removed gloves after discontinuing the patient’s treatment at station #18. Staff #2 did not perform hand hygiene before manipulating the clean supply cart. The Clinician was informed of the findings on 09/11/2024.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies, the governing body failed to ensure that personal protective equipment (PPE) is worn in the treatment area where there is potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Staff: #2 and #6 Findings included: Personal protective equipment (PPE) is defined by the Occupational Safety and Health Administration (OSHA) as “specialized clothing or equipment, worn by an employee for protection against infectious materials.” Review on 09/11/2024 of the facility’s policy entitled “ Infection Control Guidelines” revealed: “Personnel will wear scrubs suits and required PPE (gloves, disposable gown, eye protection and masks when appropriate) while on duty.” Observation of the clinical treatment area on 09/11/2024 revealed the following: 1. At 06:43 a.m., during the treatment initiation process at station #31, Staff #6 did have a gown on; however, the gown was not closed exposing Staff #6’s scrub suit. 2. At 11:15 a.m., Staff #2 did not have on protective eyewear while removing dirty bloodlines from the machine located at station #18.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 44367 Based on observations of the clinical treatment area, the Clinical Nurse Manager and Medical Director failed to ensure that the clinical staff followed safe practices when handling infectious wastes. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Staff: #2, #4, #5, #6 and #7 Findings included: The Occupational Health and Safety Administration (OSHA) regulation at 29 CFR 1910.1030(d)(2)(xi) states: All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Carrying contaminated blood tubing, used needles, syringes and dialyzer from the patient’s station across the treatment floor to a biohazard box, or sharps container could result in unknown spattering of blood. 1. During observation of the clinical treatment area on 09/11/2024 at 11:23 a.m., Staff #2 walked dirty bloodlines removed from station #17 across occupied station #18 to discard in the biohazard trash bin in front of occupied station #21. 2. During observation of the clinical treatment area on 09/12/2024 at 10:22 a.m., Staff #7 walked dirty bloodlines removed from station #31 across occupied station #32 to discard in the biohazard trash bin. 3. During observation of the clinical treatment area on 09/13/2024 at 10:05 a.m., Staff #5 walked dirty bloodlines removed from station #7 to discard in the biohazard trash bin in front of occupied station #8. 4. During observation of the clinical treatment area on 09/13/2024 at 10:08 a.m., Staff #4 walked dirty bloodlines removed from station #9 across occupied stations #10 and #11 to discard in the biohazard trash bin in front of occupied station #8. 5. During observation of the clinical treatment area on 09/13/2024 at 10:12 a.m., Staff #6 walked dirty bloodlines removed from station #16 across occupied station #17 to discard in the biohazard trash bin at station #14. 6. During observation of the clinical treatment area on 09/13/2024 at 11:20 a.m., Staff #6 walked dirty bloodlines removed from station #16 across occupied station #18 to discard in the biohazard trash bin in front of occupied station #14. The Clinician was informed of the findings on 09/11/2024.”

“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: 44367 Based on clinical observations, the governing body failed to ensure that the clinical staff followed the standard infection control procedures in the cleaning and disinfection of hemodialysis machine and its prime bucket. This failure put patients at risk for possible cross-contamination. Staff: #4 and #7 Findings included: According to the Centers for Disease Control “Checklist: Dialysis Station Routine Disinfection,” Part B states, “Disinfect all surfaces of the emptied priming bucket. Allow the bucket to air-dry before reconnection or reuse.” 1. On 09/13/2024 at 10:08 a.m., observation of the clinical treatment area revealed that Staff #4 did not clean the prime bucket during the disinfection process of the machine located at Station #9. 2. On 09/13/2024 at 10:17 a.m., observation of the clinical treatment area revealed that Staff #4 did not clean the prime bucket during the disinfection process of the machine located at Station #7. 3. On 09/13/2024 at 10:36 a.m., observation of the clinical treatment area revealed that Staff #7 did not clean the prime bucket during the disinfection process of the machine located at Station #28. The Clinician was informed of the findings on 09/13/2024.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #1, #2 and #3 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review on 09/13/2024 of the facility’s policy “Initiation/Discontinuation of Dialysis with Catheter Access or Permcath” determined that page 1 number 2 stated: “Accessing the Catheter for Initiation of Dialysis: While holding the Hub, Scrub the catheter Hub for 30 seconds with a CHG swab.” Also, number 3 stated: “Allow to air dry for at least 30 seconds. (Do not Blot or Wipe Dry).” Review on 09/13/2024 of the facility’s policy “Initiation/Discontinuation of Dialysis with Catheter Access or Permcath” determined that page 1 number 9 stated: “If both ports are patent, connect lines to the venous and arterial ports and begin the dialysis treatment as ordered.” 1. Observation of the clinical treatment area on 09/10/2024 revealed that during treatment initiation of a CVC patient located at Station #6, Staff #1 cleaned the arterial and venous hubs for only 15 seconds. Staff #1 immediately attached a 3 ml syringe without allowing hubs to air dry. 2. Observation of the clinical treatment area on 09/13/2024 revealed the following: a. At 11:22 a.m., during treatment initiation of a CVC patient located at Station #31, Staff #3 cleaned the arterial hub for 7 seconds and cleaned the venous hub for 15 seconds. Staff #3 immediately attached a 3 ml syringe without allowing hubs to air dry. Staff #3 attached the arterial bloodline to the patient’s CVC and turned the blood pump on while holding the venous blood line in the prime bucket. Once the blood passed the venous chamber and the optical detector, Staff #3 then attached the venous bloodline to the patient’s CVC. b. At 11:35 a.m., during treatment initiation of a CVC patient located at Station #15, Staff #2 cleaned the arterial hub for 12 seconds and cleaned the venous hub for 10 seconds. Staff #2 immediately attached a 3 ml syringe without allowing hubs to air dry. Staff #2 attached the arterial bloodline to the patient’s CVC and turned the blood pump on while holding the venous blood line in the prime bucket. Once the blood passed the venous chamber, Staff #2 attached the venous bloodline to the patient’s CVC. The Clinician was informed of the findings on 09/11/2024 and 09/13/2024.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44367 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the facility staff assembled and operated dialysis machines in accordance with the manufacturer’s recommendations, when 1) staff failed to ensure the closure the optical detector before and during the hemodialysis treatment, and 2) staff failed to ensure the dialysis machine was assembled correctly prior to initiating safety testing. This failure placed the affected patient at potential risk of serious injury, serious harm, and possible death. Patient: #10 Staff: #8 Findings include: 1) According to the National Association of Nephrology Technicians (NANT), “Air Embolism: Introduction of enough air into extracorporeal system to stop circulation; Causes: Air detector not armed...Pre-safety checks not done or done improperly.” Review on 09/10/2024 of the hemodialysis machine manual entitled “2008T Hemodialysis Machine Operator’s Manual “Chapter 3 “Starting Dialysis”, determined that page 136 stated, “Verify that the venous line is in the venous clamp and the optical detector. Verify that the optical detector door is closed.” Review on 09/10/2024 of the facility’s policy “Recognition/Treatment Air Embolism In Patient Receiving Hemodialysis” identified the following excerpt: “Prevention: D. Safety check each machine with each blood pressure E. Make sure the air bubble detector works and is always armed...” On 09/10/2024 at 09:10 a.m., during observations of the treatment floor, the surveyor observed that the optical detector door on machine #18 located at station #18 was partially open while Patient #10 was receiving treatment. At 09:10 a.m., the Clinician and the Charge Nurse both corroborated the findings and instructed Staff #8 to close the optical detector door after the surveyor brought the finding to their attention. At 09:28 a.m., the surveyor asked the Charge Nurse if Patient #10 will remain on machine #18 and the Charge Nurse replied “yes.” At approximately 09:40 a.m., Patient #10 was removed from machine after further investigation. 2) Review on 09/10/2024 of the hemodialysis machine manual entitled “Fresenius 2008T Machine Operator’s Manual”, determined that page 63 stated: “Warning! The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.” On 09/10/2024 at 11:49 a.m., the surveyor observed machine #7 located at station #31 was being tested without the venous line under the venous chamber inserted into the optical detector. The line was not inserted and the optical detector door was open. Due to the seriousness of the concerns that the facility staff failed to operate dialysis machines according to manufacturer’s recommendations, an immediate jeopardy (IJ) statement was issued at 10:25 a.m. on 09/10/2024 by the Office of Health Care Quality (OHCQ). On 09/11/2024 at 01:56 p.m., the OHCQ survey team verified that the facility implemented an acceptable IJ removal plan, which included the following actions: 1. On 09/10/2024, the Charge Nurse immediately assessed all the remaining twenty-two patients to ensure the optical detector was fully engaged. The staff was verbally educated on ensuring the venous line is in the venous clamp and optical detector door is closed. 2. On 09/10/2024, the Machine Testing and an Optical Detector Competency were created and education was provided to all stall that were present. The training included verifying the venous line is in the venous clamp and the optical detector door is fully closed. 3. Starting on 9/10/2024, prior to the second dialysis patient shift, the charge nurse assessed all machines to ensure the venous line was in the venous clamp and all the optical detector doors were closed prior to the start of the dialysis treatments. 4. Starting on 9/11/2024, Staff Machine Safety Check was implemented with a two-person verification prior to the initiation of the patients’ treatments. The Charge Nurse or designee began to audit and document the two-person verification using the Charge Nurse or designee Validation Audit Form. The Staff Machine Safety Check will continue until 100% compliance for three consecutive months. 5. Starting 9/11/2024, the Charge Nurse began to audit one machine from each pod daily while patients were receiving treatment, utilizing the Daily Random Spot Check to ensure compliance of the Machine Safety Check audits. The Daily Random Spot Check will continue until 100% compliance have been achieved for three consecutive months. 6. Starting 09/11/2024, the Dialysis Department Safety Huddle began reviewing the Staff Machine Safety Check and Daily Random Spot Check forms for compliance.”

“PR-CAN HAVE ADVANCE DIR,TOLD FAC AD P&P CFR(s): 494.70(a)(6) The patient has the right to- (6) Be informed about his or her right to execute advance directives, and the facility ’ s policy regarding advance directives; This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patients were given information about creating an advance directive on admission. This failure denied the patients their rights to formulate treatment decisions that served their end of life needs. Patients: #2, #3, #5, #6, #7, #8, #9 and #10 Findings included: Review on 09/12/2024 of the facility’s policy entitled “Advanced Directives” revealed: “Advanced Directives will be introduced to each patient upon admission to the chronic dialysis program. Information about Advanced Directives and an Advance Directive Form will be in each “New Packet Admission Packet” and given to all new clients upon admission.” Review on 09/12/2024 of the selected patients’ charts revealed that 8 out of 10 or 80% of the selected patients did not have proof that the patients were provided information about an Advanced Directive or created an Advanced Directive.The Clinician corroborated that the patient charts did not provide information stating patients received information regarding Advanced Directives.”

“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: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were the same as what the patients received. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #6 and #7 Findings included: The treatment flowsheet is the form used to record the patient’s care during dialysis. Recorded information includes the patient’s blood flow rates (BFR) and the dialysate flow rate (DFR), the patient’s blood pressure, administration of medications, visual observations of the patient and any patient complaints. This information may be hand written or computer generated. Review on 09/12/2024 of the facility’s policy entitled “Initial and Continuous Assessment of the Hemodialysis Patient Prior to and During Dialysis Treatment” revealed: “The patient’s machine parameters will be monitored throughout the treatment. Heparin Administration, Blood Flow Rate,Venous and Arterial Pressures, the UFR, TMP, Dialysate Flow Rate and a brief statement of the patient’s status, will also be placed on the EMR every hour for chronic patients.” A review of the ten (10) selected patients’ treatment flowsheets on 09/12/2024, revealed that two (2) or 20% of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. On treatment date 09/10/2024, Patient #6’s BFR was prescribed for 300 ml/min.; however, the BFR was set at 350 ml/min from 07:32 a.m. through 09:13 a.m. There was no documentation from the clinical staff explaining why Patient #6’s BFR was not set on the dialysis machine as prescribed. On treatment date 09/10/2024, Patient #7’s BFR was prescribed for 400 ml/min.; however, the BFR was set at 350 ml/min from 08:03 a.m. through 11:14 a.m. There was no documentation from the clinical staff explaining why Patient #7’s BFR was not set on the dialysis machine as prescribed. The Clinician was informed of the findings on 09/12/2024.”

“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: 44367 Based on patient record review, the facility’s clinical staff failed to address the blood pressure and fluid management needs of Patient #7, when the staff failed to follow standard clinical practices of setting the ultrafiltration rate (UFR) to less than or equal to 13 milliliters per kilogram per hour (ml/kg/hr). This failure placed the affected patient at potential risk of harm. Findings included: According to the National Institute of Health National Library of Medicine, “Several studies have examined the increased risk of death as average UFR increases, and an upper limit of 13 ml/kg per hour has been suggested as a quality metric (8-17). Most studies place the inflection point for increased risk of death above 13 ml/kg per hour, and this finding is consistent across all groups of sex, race, dialysis session duration, and body size. Presumed mechanisms of higher mortality associated with high UFR are putative and include myocardial disease, increased risk of arrhythmias, sudden death, and intradialytic hypotension with associated consequences, among others.” Surveyor reviewed the medical record of Patient #7 on 09/11/2024 and noted the following: 1) Treatment record for 09/09/2024 revealed that Patient #7 UFR was set at 1500 ml/hr from 06:30 a.m. until 09:18 a.m. This meant that Patient #7 ’ s UFR was calculated to be 20.6 ml/kg/ml, based on Patient #7 ’ s pretreatment weight of 104.6 kilograms (kg), which exceeded the recommended UFR of 13 ml/kg/hr. At 06:30 a.m., Patient #7’s blood pressure (bp) was 182/81. At 07:18 a.m., bp was 103/46. There was no documentation acknowledging Patient #7’s bp. At 07:33 a.m., Patient #7’s bp was 86/45. There was no documentation acknowledging Patient #7’s bp. At 07:34 a.m., bp was 89/45. There was no documentation acknowledging Patient #7’s bp. At 07:36 a.m., bp was 99/46. There was no documentation acknowledging Patient #7’s bp. At 09:35 am., bp was 77/47. Patient UFR was decreased. Clinical staff documented, “bp hypotensive, 200 ml NSS [normal saline solution] given, uf [ultrafiltration] goal decreased to 6300.” At 11:15 a.m., Patient #7’s post standing bp was 87/44. Clinical staff documented, “standing bp, 200 ml NSS given for bp support.” 2) Treatment record for 09/06/2024 revealed that Patient #7 UFR was set at 1500 ml/hr from 06:27 a.m. until 09:33 a.m. This meant that Patient #7 ’ s UFR was calculated to be 16.8 ml/kg/ml, based on Patient #7 ’ s pre treatment weight of 102.9 kilograms (kg) which exceeds the recommended UFR of 13 ml/kg/hr. At 06:27 a.m., Patient #7’s (bp) was 148/68. At 07:18 a.m., bp was 103/46. There was no documentation acknowledging Patient #7’s bp. At 07:33 a.m., Patient #7’s bp was 86/45. There was no documentation acknowledging Patient #7’s bp. At 07;34 a.m., bp was 89/45. There was no documentation acknowledging Patient #7’s bp. At 07/:36 a.m., bp was 99/46. There was no documentation acknowledging Patient #7’s bp. At 09:35 am., bp was 77/47. Patient UFR was decreased. Clinical staff documented, “bp hypotensive, 200 ml NSS given, uf goal decreased to 6300.” At 11:15 a.m., Patient #7’s post standing bp was 87/44. Clinical staff documented, “standing bp, 200 ml NSS given for bp support.” 3) On treatment date 09/04/2024, Patient #7 ’ s hourly rate was calculated to be 15.2 ml/kg/hr, based on Patient #7 ’ s pre treatment weight of 102.2 kilograms (kg) which exceeds the recommended UFR of 13 ml/kg/hr. According to the treatment flowsheets for 09/09/2024 and 09/06/2024, Patient #7 became hypotensive and had to be given normal saline to provide blood pressure support, after their UFR was set above the recommended rate of < 13ml/kg/hr. The surveyor requested a policy addressing the ultrafiltration process in the facility, but, according to the Clinician and the Director, the facility did not have a policy to address the ultrafiltration process.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration and the Medical Director failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access for a bruit. This failure placed the safety and well-being of the patients at potential risk of harm in maintaining their vascular access. Staff: #3 and #10 Findings included: Review on 09/11/2024 of the facility’s policy entitled “Initiating Hemodialysis Using an AV Fistula or Graft” determined that page 1 number 7 stated, “Confirm patient assessment and access assessment has been completed a. (Assessment of access site includes-Inspection, Palpation, Auscultation, and Patient Interview).” On 09/11/2024 at 06:43 a.m., observation of the clinical treatment area revealed that at station #21, Staff #3 did not use a stethoscope to listen to the patient’s access for a bruit, prior to cannulation. On 09/13/2024 at 11:15 a.m., observation of the clinical treatment area revealed that at station #29, Staff #10 did not use a stethoscope to listen to the patient’s access for a bruit, prior to cannulation. The Clinician was informed of the findings on 09/11/2024.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 44367 Based on review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and data, review of the agency’s policies and procedures and staff interviews, the governing body and Medical Director failed to ensure the facility’s interdisciplinary team (IDT) measured, analyzed and tracked data; created plans and set goals for quality indicators that continually did not meet goals. This failure compromised the quality of care being provided at the facility and denied patients’ their rights to effective care. Findings include: Review on 09/13/2024 of the facility’s policy entitled “Patient Care/Quality Assurance Policy” revealed: “The monthly meetings shall be ongoing, with evaluation of the previous issues, Minutes shall be kept.” During 09/13/2024 review of the facility’s form entitled “QAPI Indicators 2024” from January 2024 through July 2024, surveyor noted that the facility did not analyze, track, set goals for multiple areas as needed and did not document any discussions for indicators. The surveyor requested the complete documentation displaying the discussion held during the QAPI meetings; however, the Clinician informed the surveyor that they did not document the discussions. The Clinician (Clinical Manager) provided QAPI meeting minutes that displayed only percentages for indications and not the discussions or improvement plans. There was no documented proof the IDT analyzed, tracked data, created plans and set goals for quality indicators that did not meet goals. The Clinician and Director corroborated that the facility did not document discussion for QAPI. Review of the facility’s form “QAPI Indicators 2024” revealed no proof of discussion or developing improvement plants for the following areas: · Patient Hospitalizations and Readmit <30 Days of Discharge · Missed Treatments · Adequacy · Nutrition · Mineral Metabolism · Anemia · Vascular Access · Central Venous Catheter · #BSIs Vascular Access · Medication Errors and adverse Occurrences (AORs) Including Transfusions and Interdialytic weight gain >3.5% of EDW/post wt loss >5%EDW · Vaccinations · Health Outcomes · Transplant · Patient Satisfaction Survey & Grievances · Hemodialysis Team Plan (HTP) and Plan of Care (POC)”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 41168 Based on review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and data, and review of the agency’s policies and procedures, the governing body, and Medical Director failed to ensure the facility’s interdisciplinary team (IDT) analyzed, tracked and created action plans to address 1) vascular infiltrations and 2) ultrafiltration rates (UFR) exceeding the recommended rate. This failure denied patient effective and safe dialysis and placed the patients at risk for harm. Findings included: Review on 09/13/2024 of the facility’s policy titled “Patient Care/Quality Assurance Policy” revealed: “The monthly meetings shall be ongoing, with evaluation of the previous issues. Minutes shall be kept.” 1) On 09/13/2024, review of the facility’s Quality Assessment & Performance Improvement (QAPI) documentation titled “QAPI Indicators 2024” revealed there were 76 access infiltration from January 2024 through July 2024 documented under the “Vascular Access” section of the document. The surveyor requested documentation regarding the vascular access infiltration rate; however, the Clinician informed the surveyor that they did not discuss the infiltration rate as part of QAPI program. The surveyor also requested documented incident reports for all 76 access infiltrations, but none was provided. According to the Clinician, they were unaware an incident report should have been done for access infiltrations or discussion was supposed to be held in QAPI. The Clinician corroborated that incident reports or QAPI documentation were not completed for the 76 infiltrations. 2) According to the National Institute of Health National Library of Medicine, “Several studies have examined the increased risk of death as average UFR increases, and an upper limit of 13 ml/kg per hour has been suggested as a quality metric (8-17). Most studies place the inflection point for increased risk of death above 13 ml/kg per hour, and this finding is consistent across all groups of sex, race, dialysis session duration, and body size. Presumed mechanisms of higher mortality associated with high UFR are putative and include myocardial disease, increased risk of arrhythmias, sudden death, and intradialytic hypotension with associated consequences, among others.” On 09/13/2024, review of the facility’s Quality Assessment & Performance Improvement (QAPI) documentation titled “QAPI Indicators 2024” revealed that the section labeled “Medication Errors and Adverse Occurrences (AORs) stated, “% of patients w Avg UFR >13ml/kg/hr was above CMS recommended standard of 7.90 %.” The facility’s documented average was 9% - 15% from January 2024 to July 2024. Additionally, the surveyor reviewed the treatment records for Patient #7 who was receiving ultrafiltration. The surveyor noted that the patient routinely became hypotensive and required administration of normal saline for blood pressure support following an ultrafiltration session at the rate that exceeded the recommended rate of < 13 ml/kg/hr. Surveyor found no documented evidence that the facility QAPI program tracked adverse occurrences related to ultrafiltration or had a plan to address the number of patients receiving ultrafiltration at the rate above the recommended rate.”