Lorien Dialysis LLC

“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: 44367 Based on observations and interviews with facility staff and the governing body, the facility’s administration failed to ensure that all emergency supplies were secured and free from expired medication and supplies. This failure placed patients at potential risk of harm and danger during a life threatening situation. Finding includes: At a minimum, the policies and procedures must address the following: 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. Review on 1/18/2024 of the facility’s policy entitled “Emergency Equipment Checks” states that “Emergency supplies that are kept in a secured area will be checked monthly; Explanation: Keeping supplies in a secured area ensures the availability of needed emergency supplies.” 1. Inspection of the facility’s crash cart on 1/18/2024 revealed the following: · The crash cart was an open four tiered red cart without the ability to be locked and secured. The cart did not have locks or latches in place, which allowed easy access. The Facility Administrator corroborated with the surveyor that the crash cart was not secured and easily accessible. · Two (2) nasal cannula, lot number 201156-2, expired 11/27/2023. The Facility Administrator was informed of the findings on 1/18/2024.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. 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 common supply carts remain a sufficient distance from patients’ stations while initiating treatment.This failure posed a risk of exposure to infectious diseases and blood borne pathogens to patients. Staff: #4 Findings include: Review on 1/17/2024 of the Center for Disease Control (CDC) recommendation for “Preventing Transmission of Infection Among Chronic Hemodialysis Patients” revealed that “If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies.” Observation of the clinical treatment area on 1/17/2024 at 12:43 p.m., revealed that Staff #4 brought the common supply cart containing several clean supplies used for multiple patients to station 3, while actively initiating treatment of a patient. Staff #4 used the same gloves used to work with the patient’s catheter and bloodlines to take supplies from the cart. The Facility Administrator was informed of the findings on 1/17/2024.”

“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 facility’s administration and Medical Director failed to ensure that the clinical staff followed safe practices and ensuring that the sharps containers were disposed of when three quarters (3/4) or greater full. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Findings included: A sharps container is a hard-plastic container that is used to safely dispose of hypodermic needles and other sharp medical instruments such as IV catheters and disposable scalpels. Sharps containers must be discarded when they are “three-quarters full”, according to the Food and Drug Administration, in order to prevent staff and patients from getting injured by a sharp object. Observation of the clinical treatment area on 1/17/2024 at 10:20 a.m. revealed that the sharps containers at stations #3, #7 and #9 were greater than three-quarters (¾) full. The Facility Administrator was informed of the findings on 1/17/2024.”

“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 inspection of the water treatment system maintenance documentation, the governing body failed to ensure that the Biomedical (BioMed) staff followed the standard regulations in the disinfection of the water treatment system using the sterilant Minncare and that the residual checks are being done after the use of Minncare.This failure put patients at risk for harm and/or death. Findings included: Failures in environmental cleaning and disinfection have led to transmission of bloodborne pathogens and other infections from one patient to another in Hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces) must be performed between patient uses to prevent transmission of dangerous pathogens. Inspection of the water treatment disinfection logs on 1/17/2024 revealed no documentation for the placement of the sterilant minncare in the water treatment system and the residual checks of the water treatment system after the sterilant has been rinsed from the system. On 1/17/2024, interview with BioMed revealed minncare is used monthly to disinfect the facility’s water treatment system. The surveyor requested the documentation that detailed how often minncare is placed, who placed the minncare, what time and where the minncare was placed. The Surveyor also requested the same documentation for the residual checks. BioMed was not able to provide the surveyor with documentation stating that they do not have a form to document the monthly minncare. The Facility Administrator and BioMed were informed of the findings on 1/17/2024.”

“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 and #5 Findings include: The two most common routes of catheter infection as (1) migration of skin organisms through the insertion site and into the cutaneous catheter tract resulting in colonization of the catheter tip; and (2) contamination of the hub, resulting in intraluminal colonization of the catheter. The initiation and termination of the dialysis process and manipulation and tension on the catheter provide frequent opportunity for such contamination. Catheter hubs should be disinfected again after disconnecting from bloodlines. This should be done in a manner similar to that used when disinfecting the hub prior to accessing.” Review on 1/17/2024 of the facility’s policy entitled “Central Venous Catheter (CVC)Initiation and Discontinuation of Treatment” states the clinical staff must “Carefully place each catheter port in an Alcavis 50 saturated 4 x 4 gauze pad and scrub the catheter end and port for 1 minute. Explanation: This step decreases the risk of bacterial entry into the catheter.” Review on 1/17/2024 of the facility’s policy “Dressing Change: Central Venous Catheter (CVC) Using Exsept Plus” revealed the clinical staff must “Take one of the Exsept Plus saturated 4 x 4 gauze pad or one pre-package swab and clean exit site starting at the center and move in a circular motion outwards to a radius of at least 2 inches from the exit site. Repeat with the second Exsept Plus saturated 4 x 4 gauze pad or swab. Wait two (2) minutes for there site to dry. Apply Opsite or Island dressing.” 1. During observation of the clinical treatment area on 1/17/2024 at 12:45 p.m., during initiation of treatment of a CVC patient at station 3, Staff #5 cleaned the venous hub and the arterial hub for 4 seconds prior to attaching the 10 ml syringe. 2. During observation of the clinical treatment area on 1/18/2024 at 10:10 a.m., the surveyor noted that during treatment initiation of a CVC patient at station 6, Staff #1 cleaned the CVC exit site from the outward area to the center (dirty to clean) rather than cleaning the center to the outward area. The Facility Administrator was informed of the findings on 1/17/2024 and 1/18/2024.”

“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: 44367 Based on observations, the Facility’s Administration and the Medical Director failed to ensure that the Potential of Hydrogen (pH) of the dialysate for each dialysis machine is performed before starting the treatment of each patient. This failure placed the patient affected at potential risk of harm. Staff #3 and #5 Findings Included: It is necessary for the operator of the hemodialysis machine 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. Each machine must be tested for pH using a handheld meter or other appropriate testing device before every dialysis treatment and whenever a different composition of acid concentrate is used. Review on 1/17/2024 of the facility’s policy entitled PH: Independent Verification of dialysate value obtained by the Hydrogen of pH Test strips does not fall within the range of 6.5 - 7.8, the hemodialysis delivery system will not be used to provide patient treatments until the source of the discrepancy is found., analyzed and corrected.” 1. Observation of the clinical treatment area on 1/17/2024 at 12:45 p.m., revealed that during treatment initiation at station 3, Staff #5 did not check the pH of the machine’s dialysate, prior to initiating the patient’s treatment. 2. Observation of the clinical treatment area on 1/18/2024 at 10:43 a.m., revealed that during treatment initiation at station 4, Staff #3 did not check the pH of the machine’s dialysate, prior to initiating the patient’s treatment. The Facility Administrator was informed of the findings on 1/17/2024 and 1/18/2024.”

“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 observation and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the facility provided and maintained a safe and comfortable treatment environment for its patients and to ensure the facility is free of expired supplies and ensure ancillary equipment maintenance is done as required. This failure placed the patients at potential risk of harm. Findings include: When medications and supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. Inspection of the clinical treatment area on 1/17/2024 revealed the following: · 400 Purple top Blood Collection Tubes, lot number 2227126, expired 12/31/2023. · Two (2) Wound Culture Swabs, lot number 1K28A, expired 10/28/2023. · Two (2) 3 ml 23 gauge syringe, lot number 9169221, expired 6/2024 The Facility Administrator was informed of the findings on 1/17/2024.”

“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: #1, #2, #3 and #4 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. The Hemodialysis prescription includes the number of treatments per week, the length of treatment time, the dialyzer, the primary access being used for the patient; specific parameters of the dialysis delivery system, such as the blood flow rate (BFR), dialysate flow rate (DFR), and electrolyte composition of the dialysate; anticoagulation, and the patient’s target weight. A review of the four (4) selected patients’ treatment flowsheets on 1/17/2024 revealed that all four (4) or 100% of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. 1. On treatment date 1/4/2024, Patient #1’s BFR was prescribed for 450 ml/min.; However, BFR was set at 400 ml/min from 7:20 a.m. to 9:50 a.m. There was no documentation found explaining why Patient #1 BFR was not set on the dialysis machine as prescribed. On treatment date 1/6/2024, Patient #1’s BFR was prescribed for 450 ml/min.; However, BFR was set at 350 ml/min from 7:08 a.m. to 9:38 a.m. There was no documentation found explaining why Patient #1 BFR was not set on the dialysis machine as prescribed. On treatment date 1/9/2024, Patient #1’s BFR was prescribed for 450 ml/min.; However, BFR was set at 400 ml/min from 6:55 a.m. to 9:39 a.m. There was no documentation found explaining why Patient #1 BFR was not set on the dialysis machine as prescribed. 2. On treatment date 1/4/2024, Patient #2’s BFR was prescribed for 450 ml/min.; However, BFR was set at 400 ml/min from 10:33 a.m. to 12:36 p.m. There was no documentation found explaining why Patient #2 BFR was not set on the dialysis machine as prescribed. On treatment date 1/9/2024, Patient #2’s BFR was prescribed for 450 ml/min.; However, BFR was set at 400 ml/min from 10:19 a.m. to 1:02 p.m.; On treatment date 1/9/2024, Patient #2’s DFR was prescribed for 800 ml/min.; However, DFR was set at 600 ml/min from 10:40 a.m. to 1:02 p.m. There was no documentation found explaining why Patient #2 BFR or DFR were not set on the dialysis machine as prescribed. On treatment date 1/11/2024, Patient #2’s BFR was prescribed for 450 ml/min.; However, BFR was set at 400 ml/min from 9:25 a.m. to 11:42 p.m. There was no documentation found explaining why Patient #2 BFR was not set on the dialysis machine as prescribed. 3. On treatment date 1/3/2024, Patient #3’s BFR was prescribed for 300 ml/min.; However, BFR was set at 350 ml/min from 2:25 p.m. to 4:59 p.m. There was no documentation found explaining why Patient #3 BFR was not set on the dialysis machine as prescribed. On treatment date 1/5/2024, Patient #3’s BFR was prescribed for 300 ml/min.; However, BFR was set at 350 ml/min from 2:01 p.m. to 3:35 p.m. There was no documentation found explaining why Patient #3 BFR was not set on the dialysis machine as prescribed. On treatment date 1/8/2024, Patient #3’s BFR was prescribed for 300 ml/min.; However, BFR was set at 350 ml/min from 1:18 p.m. to 3:49 p.m. There was no documentation found explaining why Patient #3 BFR was not set on the dialysis machine as prescribed. 4. On treatment date 12/22/2023, Patient #4’s BFR was prescribed for 350 ml/min.; However, BFR was set at 300 ml/min from 1:44 p.m. to 3:44 p.m. There was no documentation found explaining why Patient #4 BFR was not set on the dialysis machine as prescribed. On treatment date 12/23/2024, Patient #4’s BFR was prescribed for 350 ml/min.; However, BFR was set at 300 ml/min from 11:28 p.m. to 12:15 p.m. There was no documentation found explaining why Patient #4 BFR was not set on the dialysis machine as prescribed. On treatment date 12/27/2023, Patient #4’s BFR was prescribed for 350 ml/min.; However, BFR was set at 300 ml/min from 2:44 p.m. to 4:14 p.m. There was no documentation found explaining why Patient #4 BFR was not set on the dialysis machine as prescribed. The facility Administrator was informed of the findings on 1/17/2024.”

“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 administration failed to ensure that the clinical staff followed standard clinical practices to address blood pressure (bp) that went beyond the normal limits. This failure placed the affected patients at potential risk of injury or even death. Patient: #3 Because of the adverse effects of End Stage Renal Disease, many patients experience the instability of blood pressure and fluid management, the management of which may require reassessment of medication needs, adjustments in target weight, and changes to the plans of care. The patient’s heart rate must be monitored for abnormally high and low in addition to the blood pressure. Patients’ blood pressures must be monitored before, during and after dialysis treatment and abnormally high and low values must be addressed immediately to ensure patient safety. 1. Review on 1/17/2023 of Patient #3’s treatment flowsheet revealed that on 1/5/2023, Patient #3 was hypotensive (low blood pressure). The documentation revealed the following: · At 3:34 p.m. Patient’s #3’s bp was 68/43 · At 3:35 p.m. Patient’s #3’s bp was 69/48 · At 3:36 p.m. Patient’s #3’s bp was 56/32 There was no interventions or acknowledgement documented by the Registered Nurse addressing the low blood pressures. The Facility Administrator was informed of the findings on 1/17/2024.”