West Tyler Dialysis

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that fire extinguishers were checked monthly to ensure they had not been tampered with and were in working order. This facility had 75 patients being dialyzed and operated Monday, Tuesday, Wednesday, Thursday, and Friday. This deficient practice had the likelihood to cause harm to a dialysis patient in the event of a fire due to fire extinguishers not being checked monthly to know if the fire extinguishers were in working order. Findings include: During a tour of the facility on 11/14/2023 observed 5 of 5 fire extinguishers at the facility had not been checked monthly. The last check was conducted in August of 2023. There was no notation on any of the tags documenting that the fire extinguishers had been checked monthly by staff members. A review of the facility’s policy titled, “FIRE PREVENTION & PORTABLE FIRE EXTINGUISHERS” dated 8/2/2004 revealed the following: “GENERAL REQUIREMENTS 1. The Company will provide portable fire extinguishers and shall mount, locate, and identify them so that they are readily accessible to all employees. 2. The Company will ensure that portable fire extinguishers are maintained in a fully charged and operable condition and always kept in their designated position. MONTHLY FIRE EXTINGUISHER INSPECTION Fire extinguishers are to be visually inspected monthly by the Warehouse Supervisor. During the inspection, extinguishers should be inspected for leaks, secure nozzles and hoses, unplugged hoses and nozzles, rusts, and intact nameplates and pin. If the extinguisher has been tampered with or requires recharging, it should be reported immediately. Extinguishers that fail inspection must be removed for repairs and replaced immediately. Fire extinguishers should receive a maintenance inspection annually by a qualified person or a company certified by the Materials Transportation Board, the Department of Transportation or fire extinguisher service companies licensed by the state and recognized by the National Association of Fire Equipment Distributors in Chicago, Illinois. Fire extinguishers requiring a 12-year hydrostatic test must be emptied and subjected to applicable maintenance procedures every six years by a certified fire extinguisher service company.” An interview with Staff #1 on 11/14/2023 at 10:40 PM confirmed that 5 of the fire extinguishers in the facility had not been checked monthly. The last fire extinguisher check was conducted in August of 2023.”

“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: 48653 Based on observation, policy review, and staff interview, the facility staff failed to change gloves and perform hand hygiene between patient encounters and before touching dialysis equipment and sterile supplies. The facility staff failed to follow the facility policy titled, “Hand Hygiene”. Findings include: During a tour of the facility’s in-center treatment area with Staff # 1 and # 2 on 11/14/2023 at 11:00 AM, the surveyor observed Staff # 5 don a pair of gloves at Patient # 12’s dialysis station. Staff # 5 did not perform hand hygiene before donning the gloves. Staff # 5 touched the dialysis machine and dialysis tubing then proceeded to walk over to the counter which contained sterile supplies. Staff # 5 gathered supplies from the counter and then walked back to Patient # 12’s dialysis station and touched the patient with the same gloves. Staff # 5 did not perform hand hygiene or change gloves before touching the patient and the dialysis machine and equipment. A review of facility policy titled, “Hand Hygiene” dated 11/06/2023, revealed, “PURPOSE: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross-contamination. RESPONSIBILITY: All staff, patients, patient caregivers, including physicians and non-physician practitioners, social workers, dietitians, and any other indirect patient care staff must follow the same requirements for hand hygiene. POLICY: Hand hygiene includes either washing hands with soap and water or using waterless alcohol-based antiseptic hand rub ... Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediately after removing gloves, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain, or water lines, and after contact with other objects within the patient station or treatment space.” According to the CDC (Centers for Disease Control), “Wear gloves, according to Standard Precautions, when it can be reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin or contaminated equipment could occur. Gloves are not a substitute for hand hygiene. If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient’s environment. Perform hand hygiene immediately after removing gloves. Change gloves and perform hand hygiene during patient care, if gloves become damaged, gloves become visibly soiled with blood or body fluids following a task, moving from work on a soiled body site to a clean body site on the same patient, or if another clinical indication for hand hygiene occurs. Never wear the same pair of gloves in the care of more than one patient. Carefully remove gloves to prevent hand contamination.” An interview with Staff # 1 on 11/14/2023 at 12:00 PM confirmed staff member # 5 did not change gloves and complete hand hygiene at the appropriate times and intervals as required in the facility policy, “Hand Hygiene”.”

“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: 48653 Based on observation, policy review, and staff interview, the facility failed to ensure staff members wore appropriate PPE (personal protective equipment) to protect the eyes from possible body fluid contamination. Findings include: During a tour of the facility’s in-center treatment area with Staff # 1 and # 2 on 11/14/2023 at 10:00 AM, Staff # 6 was observed performing care to a patient at the dialysis station without proper eye protection. Staff # 6 was not wearing a face shield or goggles to protect from possible body fluid contamination. An interview with Staff # 1 on 11/14/2023 at 12:00 PM confirmed the staff member was not wearing the appropriate PPE to protect the eyes from possible contamination of body fluids.”

“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: 29191 Based on observation and interviews, the facility failed to monitor and provide a safe environment to store outside infectious waste. This deficient practice had the likelihood to cause harm by increasing the risk of infectious waste being made available to the public outside of the facility. The facility had a dumpster on-site that was unsecured without a physical confinement surrounding it. The unsecured dumpster allowed the public and rodents to pilfer through the trash. The facility had left two old dialysis chairs by the dumpster to be carried off with the trash. The dialysis chairs were found at the opposite end of the building behind a storage shed and in a reclining position. The facility has homeless people who sleep around the building. The building backs up to some woods. An interview with Staff # 1 on 11/14/2023 at 11:30 AM confirmed the dumpster was unsecured and that homeless people were living around the building. The building had outside cameras available for review.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility failed to ensure the staff changed the filter on the acid mixer after the 6th batch of acid was mixed per the dry acid dissolution unit 132-gallon Technician’s manual. This deficient practice had the likelihood of causing harm by mixing the wrong mixture of acid for the dialysis patient due to a dirty acid filter. Findings include: During a tour of the water room on 11/14/2023 at 11:00 AM observed the acid filter on the acid mixer was dark brown. A review of the Granuflo Mixing log for August, September, and October 2023 revealed that the acid filter was not changed after the 6th batch of acid was mixed. There was some inconsistency in the documentation; if the staff documented that the acid filter was changed the filter change was on the granflo mixing log. When the bio-medical technician documented the filter change it was created on a work order form. There was no way for the clinical staff to know that the acid filter had been changed. A review of the dry acid dissolution unit 132-gallon Technician’s manual revealed the following procedure for changing the acid filter. “4.4 Filter maintenance The I-micron filter should be changed under the following conditions: 1. After mixing 6 batches of Dry Acid concentrate. 2. When the Dry Acid Dissolution Unit (DADU) requires disinfection. NOTE: IT IS RECOMMENDED TO REPLACE THE FILTER AFTER MIXING 6 BATCHES OR IF THE TANK REQUIRES DISINFECTION.” An interview with the Bio-Medical Director (ATOM) #10 on 11/15/2023 at 11:00 AM confirmed the acid filter was not being changed after the 6th batch of acid was mixed.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 29191 Based on observation and interviews, the dialysis facility failed to monitor and provide a sanitary environment for the facility. These findings have the likelihood to cause harm to the patients due to the unclean and safety issues that were observed inside and outside the facility. Findings Include: During a tour of the facility inside and outside of the facility, there were unclean and safety issues observed on November 14, 2023, with staff members #1 and #10 IN-CENTER TREATMENT AREA: * Observed that the drawers in the cabinets on the treatment floor had dust, trash, and particle board shavings in with the sterile patient supplies. OUTSIDE THE FACILITY: * Two dialysis chairs were sitting outside of the building behind the shed at the back of the building. Staff members were interviewed and reported that the chairs were old and had been placed by the dumpster to be discarded. It was unknown how the old dialysis chairs got moved to the back of the building. Staff #1 reported that the homeless people may have moved. * Observed the green trim on the building was rusted and the paint was peeling off and giving the building an unkempt appearance. The rusted places in the trim of the building had the likelihood of causing water leakage into the building. * Two electric wall boxes were hanging off the building and were unsecured. * There were large pine trees that had large limbs hanging directly over the electric wires going from the building to the electrical transformer. The limbs were touching the wiring. * Observed lying on the ground at the back of the building by the dumpster was a large, rusted piece of metal. During an interview on 11/14/23 at 11:00 AM Staff #1 and #10 acknowledged the safety issues at the end-stage renal facility. Staff #1 and #10 were on the tour with the surveyors when the safety issues were pointed out.”

“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: 48653 Based on observation, interview, and record review, the facility failed to ensure that 3 of 4 glucometers (a device used to check a patient’s blood sugar) were labeled and had quality control checks completed daily. The facility staff failed to consistently document the expiration date of the test strips and control solutions and failed to recognize that 2 boxes of lancets were expired. During a tour of the facility’s in-center treatment area on 11/14/2023 at 9:50 AM, the surveyor observed 4 glucometers at the nurse’s station. The glucometers were not labeled and had been opened and taken out of the original packaging. Also, 2 boxes of 21 gauge Embrace Safety Lancets were expired with an expiration date of, “10-14-2023”. In an interview with Staff # 2 on 11/14/2023 at 9:50 AM, the surveyor asked Staff # 2 if the staff was using four glucometers or just one. Staff # 2 confirmed they were only using one of the glucometers and the others were for backup. A review of the facility’s glucose meter documentation for September, October, and November revealed the staff was not consistently documenting the expiration date of the test strips and control solutions. An interview with Staff # 1 on 11/15/2023 at 11:00 AM confirmed the facility had glucometers that did not have quality control checks completed and the facility staff were not consistently documenting the expiration dates of the test strips and control solutions.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 48653 Based on record review and interview, the facility failed to inform the patients that they were receiving a hepatitis vaccine that had not been studied for safety and effectiveness in the adult hemodialysis population, according to the FDA (Food and Drug Administration). The facility did not inform the patients that they were receiving a dosing schedule of HEPLISAV-B vaccine that had not been recommended by the CDC (Centers for Disease Control) and manufacturer. The patients at the facility were unknowingly receiving a hepatitis vaccine dosage of Heplisav-B that was considered “off-label” by the facility’s Medical Director. Findings include: During a review of the facility’s hepatitis vaccine documentation, it was revealed the facility staff were administering four, 20 mcg (microgram) doses of the Heplisav-B vaccine to the patients receiving care at the facility. The patients at the facility were unknowingly receiving 2 doses more than what was recommended by the manufacturer, CDC and FDA. A review of the manufacturer’s package insert revealed the following, “Dosing and Administration For Intramuscular administration: Administer two doses (0.5 ml each) of Heplisav-B intramuscularly one month apart ... 8.6 Adults on Hemodialysis: Safety and effectiveness of Heplisav-B have not been established in adults on hemodialysis.” A review of the facility’s policy titled, “Special Considerations: Heplisav-B Vaccination for Patients” with a published date of 1/25/2022 revealed, “Purpose: The purpose of this policy is to provide direction on administering HEPLISAV-B for patient vaccination against Hepatitis B ... Policy: A physician order and signed consent form must be obtained prior to administration of HEPLISAV-B .... Dosing and Administration: Dialysis Dependent Patients 18 years or older: 20 mcg (0.5 ml) at 0, 1, 2, and 4 months ... References: Centers for Disease Control and Prevention (CDC). Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. Morbidity and Mortality Weekly Report, April 20, 2018/Vol.67/No.15., www.cdc.gov/mmwr HEPLISAB-B, Package Insert, May 2020, Dynavax Technologies Corporation, Emeryville, CA, 94608.” Upon review of the facility’s hepatitis policy references, it was determined the policy does not include references that support the use of a 4-dose vaccine series. A review of the facility’s “Heplisav-B Vaccination Patient Consent” published 04/05/2021 revealed the following, “As a dialysis patient, I understand that I am at an increased risk of contracting viral Hepatitis. This illness is caused by the Hepatitis B virus. This infection can damage or destroy the liver and impair its normal function. My liver helps my body use several nutrients such as iron, glycogen (sugar) and vitamin B12. It assists in the removal of poisonous chemicals and destroys old red blood cells. The liver regulates many metabolic processes needed for life and aids in the digestion of fats. HEPLISAV-B is a vaccine which stimulates the body’s immune system to produce antibodies. These antibodies enable the body to fight off the Hepatitis B virus if an exposure should occur. The vaccine is a sterile product which contains not more than 5% yeast protein. HEPLISAV-B is indicated for vaccination of dialysis patients against infection caused by all known subtypes of Hepatitis B virus. The vaccination series consists of four (4) doses. The first dose is given very soon after the decision to be vaccinated is made. The second, third, and fourth doses are administered at one month, two months and four months respectively. Each 0.5 ml (20 mcg) dose is given as one injection administered into the upper arm (deltoid muscle). It is important to receive all four doses to ensure that immunity is achieved. HEPLISAV-B is generally well tolerated according to the manufacture (Dynavax Technologies Corporation). I understand that some pain, redness, and/or swelling at the site of administration can be experienced. Other side effects that I need to be aware of include fatigue, headache, fever, malaise, and myalgia. If I have an allergy to yeast, the vaccine is not recommended for my use. HEPLISAV-B is effective in producing protection against Hepatitis B in 89.3% of the dialysis patients sampled. The vaccine is designed to prevent infection before it occurs. The vaccine is not used to treat the infection itself. HEPLISAV-B is free from association with human blood or blood products so it therefore cannot lead to the contraction of Acquired Immune Deficiency Syndrome (AIDS). Deciding whether or not to receive a vaccine is a highly personal choice. I have considered the potential risks and potential benefits carefully. I understand that medicine is not an exact science, and that there is no guarantee that HEPLISAV-B Vaccine will be effective in protecting me against Hepatitis B. I have discussed my concerns with my physician and/or his/her associates, and all my questions have been answered to my satisfaction. I believe that I have adequate knowledge upon which to base an informed consent to the proposed vaccination and agree to notify my physician or his/her associates immediately in the event of the occurrence of side effects. The vaccine information sheet must be given to be prior to each dose of vaccine including booster doses if needed. If a booster dose is necessary, a new consent should be obtained and the documentation of giving the VIS for this booster dose as well as the administration of each dose will be documented in my electronic medical record.” According to the CDC Advisory Committee on Immunization Practices (ACIP), “In February 2018, ACIP approved recommendations for Heplisav-B vaccine as an option for previously unvaccinated or incompletely vaccinated persons ... Administer the vaccine correctly. Schedule: Administer 2 doses at least 4 weeks apart ...” During an interview with the Medical Director on 11/29/2023 at 11:00 AM, this surveyor asked the Medical Director if they were aware that the patients had been receiving an off-label dose of the vaccine and were not properly informed of the off-label use before signing consent. The Medical Director stated, “Yes, I was aware, but off-label drugs are used when prescribing medication. I was told that the manufacturer will be updating the package insert next year in April of 2024 but cannot verify that.” This surveyor called the manufacturer, Dynavax Technologies to verify the package insert was being updated. In an interview with the Medical Science Liaison for Dynavax Technologies on 11/30/2023 at 11:00 AM, Liaison stated, “Dynavax has submitted an application to SBLA (supplemental Biologics License Application) this year (2023) but does not have any timeline or idea when approval for changing the package insert will occur.”Liaison stated he was surprised a corporation would give a dosing schedule that differs from manufacturer recommendations to all patients. In an interview with Staff # 1 on 11/14/2023 at 3:00 PM, Staff # 1 confirmed the facility policy included a dosing schedule that was different from the manufacturer’s package insert and that the patients were not made aware of this difference in dosing during informed consent.”

“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: 48653 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) and dialysate flow rate (DFR) in 4 (# 4, # 9, # 10, # 12) of 8 medical records reviewed. The facility staff failed to verify the ordered prescription matched the prescription the patient was receiving before treatment initiation. Also, the facility staff failed to follow the facility policy titled, “Patient Assessment and Monitoring”. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders which could negatively impact the effectiveness and adequacy of the dialysis treatment for all in-center hemodialysis patients receiving care at this facility. Findings Include: Patient # 4 A review of 1 of 6 treatment sheets for Patient # 4 revealed facility staff did not follow the physician’s prescribed orders for DFR on treatment date 11/01/2023. A review of the treatment sheet dated 11/01/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 5 documented a DFR of “500 ml/min” throughout the patient’s entire treatment. Staff # 24 (Registered Nurse) documented the following on 11/01/2023 at 12:40 PM: “ ...orders reviewed; machine settings/bath verified correct. Will continue to monitor.” There was no documented order from the physician to adjust the DFR for this treatment date. Patient # 9 A review of 2 of 6 treatment sheets for Patient # 9 revealed facility staff did not follow the physician’s prescribed orders for BFR on treatment dates 11/07/2023 and 11/09/2023. A review of the treatment sheet dated 11/07/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350ml/min (milliliters per minute) Dialysate Flow Rate: 500.00 ml/min” Staff # 5 documented a BFR of “400 ml/min” throughout the patient’s entire treatment. Staff # 2 (Registered Nurse) documented the following on 11/07/2023 at 8:22 AM, “ ...DFR set to 500. Verified HD settings with MD orders.” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 11/09/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350ml/min (milliliters per minute) Dialysate Flow Rate: 500.00 ml/min” Staff # 19 documented a BFR of “400 ml/min” throughout the patient’s entire treatment. Staff # 16 (Registered Nurse) documented the following on 11/09/2023 at 8:23 AM, “ ...Dr. order/k+ bath/machine checked. HD started. Will continue to monitor.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 10 A review of 5 of 6 treatment sheets for Patient # 10 revealed facility staff did not follow the physician’s prescribed orders for DFR and BFR on treatment dates 11/01/2023, 11/03/2023, 11/06/2023, 11/08/2023. A review of the treatment sheet dated 11/01/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 500ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 25 documented a DFR of “500 ml/min” throughout the patient’s entire treatment. Staff # 24 (Registered Nurse) documented the following on 11/01/2023 at 1:32 PM, “ ...orders reviewed, machine settings/bath verified correct.” There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/03/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 500ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 17 documented a DFR of “500 ml/min” throughout the patient’s entire treatment. Staff # 2 (Registered Nurse) documented the following on 11/03/2023 at 2:24 PM, “ ...DFR set to 600. Verified HD settings with MD orders.” There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/06/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 500ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 7 documented a DFR of “500 ml/min” throughout the patient’s entire treatment. Staff # 16 (Registered Nurse) documented the following on 11/06/2023 at 2:03 PM, “ ...Drs orders/k+ bath/machine checked. HD started. Will continue to monitor.” There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/08/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 500ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 18 documented a BFR of “450 ml/min” throughout the patient’s entire treatment. Staff # 3 (Registered Nurse) documented the following on 11/08/2023 at 1:37 PM, “ ...All HD orders verified ...” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 11/10/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 500ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 18 documented a BFR of “400 ml/min” throughout the patient’s entire treatment. Staff # 16 (Registered Nurse) documented the following on 11/10/2023 at 9:33 AM, “ ...Drs orders/k+ bath/machine checked. HD started, will continue to monitor.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 12 A review of 3 of 6 treatment sheets for Patient # 12 revealed facility staff did not follow the physician’s prescribed orders for DFR on treatment dates 11/07//2023, 11/09/2023 and, 11/11/2023. A review of the treatment sheet dated 11/07/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 450ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 5 documented a BFR of “400 ml/min” throughout the patient’s entire treatment. Staff # 2 (Registered Nurse) documented the following on 11/07/2023 at 7:39 AM, “ ...DFR set to 800. Verified HD settings with MD orders ...” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 11/09/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 450ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 5 documented a BFR of “420 ml/min” throughout the patient’s entire treatment. Staff # 16 (Registered Nurse) documented the following on 11/09/2023 at 7:39 AM, “ ...Drs orders/k+ bath/machine checked ...” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 11/11/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 450ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 6 documented a BFR of “400 ml/min” throughout the patient’s entire treatment. Staff # 2 (Registered Nurse) documented the following on 11/11/2023 at 6:49 AM, “ ...DFR set to 800. Verified HR settings with MD orders ...” There was no documented order from the physician to adjust the BFR for this treatment date. A review of facility policy titled, “Patient Assessment and Monitoring” dated 5/01/2023, revealed, “PURPOSE: The purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during, and after treatment. RESPONSIBILITY: Direct patient care staff ... During Treatment ... 3. Machine parameters and Extracorporeal Circuit: Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered ...” An interview with Staff # 1 on 11/15/2023 at 10:30 AM confirmed the facility staff were not following the physician’s prescription for dialysis treatment and the facility staff failed to follow the facility policy, “Patient Assessment and Monitoring”.”