Davita Fourth Street Dialysis

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure medications and nutrition stored in the facility were within the manufacturer’s expiration date. This deficient practice had the likelihood to result in a patient receiving IDPN (Intradialytic Parenteral Nutrition) and medication that had expired. During a tour of the facility’s in-center treatment area on 06/25/2024 at 3:00 PM, the surveyor observed 4 expired bags of IDPN ( Intradialytic Parenteral Nutritionin) the medication refrigerator. Two bags of IDPN had expired on 06/11/2024 and 2 bags had expired on 06/18/2024. The surveyor observed a multi-dose vial of Tuberculin Purified Protein that was not labeled with the date it had been opened. The surveyor and staff were unable to determine if the multi-dose vial had expired. Multi-dose vials are required to be labeled with the date of opening and expire 30 days after the open date. A review of the facility’s policy, “Medication Policy” with a revision date of October 2023 revealed, “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. POLICY: 1. The Facility Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory. 2. New teammates must successfully complete the medication administration portion of the DaVita orientation program before administering medications. 3. Medications administered during the hemodialysis treatment are given via the medication infusion line whenever possible. 4. Safety needle devices and/or needleless devices are utilized whenever there is the potential for bloodborne pathogen exposure. In instances when the medication infusion line cannot be used or is not available, safety needles and/or needleless devices will be used as required by Occupational Safety and Health Administration (OSHA) regulations .... 7. Heparin, lidocaine, and normal saline may be drawn up and administered by licensed nurse teammates and patient care technicians, if allowable by their state and they have met their state’s educational requirements. All other medications are given by licensed nurse teammates whose scope of practice includes administration of parenteral medications. 8. All teammates administering medications must utilize aseptic technique. 9. Medications are administered as prescribed and then documented in the patient’s medical record. No medications are given without an order from the physician or non-physician practitioner (NPP). Medication orders must include the patient name, drug name, dose, route, frequency, date and time the order was received. 10. Prior to administration of medication, verify physician or NPP order. Check for patient allergies when receiving or entering a medication order and prior to administering any medication. 11. All refrigerated medications, for example erythropoietin stimulating agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 12. Controlled medications require completion of the medication formulary management process. If approved, daily accounting and disposition of these medications are documented in a log specifically for this purpose. Controlled medications, if administered in the facility, are stored in a safe, locked location that is not accessible to persons other than licensed nurse teammates and the Facility Administrator/designee. 13. All open or unopened medication packages (i.e. vials, ampules etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired. 14. It is expected that when saline syringes are required for vascular access care or to flush medications, facilities should obtain syringes pre-filled with sterile saline from the procurement department (PRISM). 15.When saline syringes must be prepared in an End Stage Kidney Disease (ESKD) facility for administration, the following safe injection practices must be followed: Fill syringes with sterile saline for an individual patient in a dedicated clean area removed from the patient treatment area. Although not required, a clean room separate from the patient treatment area is the preferred location. Prepare syringes for an individual patient as close as possible to the time of administration to prevent compromised sterility or stability. Use aseptic technique for disinfection of saline vials prior to entry when preparing saline flushes including: Medication containers labeled single-dose or single-use (e.g., saline bags, single- dose vials, ampules) may not be used to prepare flush syringes for more than one patient. Any unused saline in the opened single-dose or single-use container must be discarded and may not be stored for future use on the same patient. If multi-dose vials are used to prepare saline flush syringes, they must be dated upon opening and discarded within 28 days unless the manufacturer specifies a different date for that vial. The beyond-use date should never exceed the manufacturer’s expiration date. 16. Medication labels are to be printed on the patients’ treatment day(s). 17. Medication preparation should be performed only for the current shift of patients, i.e. do not prepare medications for more than one shift of patients. 18. All syringes prepared from single use vials/ampules (without preservatives) or multidose vials should be prepared and administered within a four (4) hour [within one (1) hour for States of New Jersey and South Carolina] period, unless there is specific testing and documents on file which extends dating. 19.Medications administered via infusion are to be prepared and administration started within four (4) hours. In the States of New Jersey and South Carolina, medications administered via infusion must be prepared and administration started within one (1) hour of preparation. 20. If medications are prepared and administered immediately, by the same licensed nurse teammate, the medications do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. 21. An aseptic environment and aseptic technique is used when preparing medications. Careful attention to proper hand washing is performed at this time. 22. Upon receipt of medication shipments, they are visually inspected for damage, integrity, expiration date, proper labeling and any special storage or handling requirements. 23.Medications and needle/syringe storage are done in accordance with state regulations. 24. Upon use ampules and vials are visually inspected to verify that the top of the ampule or vial is sealed and intact, the content is clear, and without evidence of particulate matter. 25. A sterile 21g x 1” or smaller gauge needle and syringe should be used for all non-EPO dose preparations when entering a vial or ampule. The product is drawn up into the syringe, and a determination should be made that the volume in the syringe equals the dosage prescribed by the physician or NPP. 26. Single use vials/ampules must be used for only one (1) patient, should not be entered more than once, and if entered, may not be stored for future use. If both vials are single use and are discarded after the single entry into each, the same syringe may be used. 27.Multi-dose vials used for IV administration must be entered each time with a new sterile syringe and needle due to Centers for Disease Control (CDC) guidance that states residual amounts of medication from a multi-dose vial (either in vial or syringe) must never be pooled with medication from another vial or syringe. 28. Document the name of the medication, dose, route, time, patient response and signature of the teammate administering the medication. For medications administered over a period of time additional documentation is necessary. Include the infusion start time and end time in the patient’s treatment record. 29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date. Medications are stored in the original vial and are not drawn up and stored overnight in a syringe or any other container .... 30. All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates. 31.Medications are ordered and replaced prior to expiration. Unless an exact expiration date is specified, medications with an expiration date of month/year are considered expired the last day of the state month. For example, a drug that expires 6/08 will be considered expired after 6/30/08. 32. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations .... 34. The Facility Administrator/designee is responsible for notifying all teammates regarding similarities in product labeling and/or appearance and methods utilized to verify that teammates are able to appropriately differentiate between medications with similar appearance. 35. Each DaVita facility will have in place a quality assurance (QA) program that verifies compliance with this policy and procedure. This QA program must include: infection surveillance of dialysis patients and unannounced practice audits which monitor compliance with stated policy and procedure .... 37. The Facility Administrator/designee will be responsible, after consultation with the physician, for implementing any necessary action to counteract the error and prevent a reoccurrence. 38. Adverse drug reactions will be reported to the patient’s attending physician, the Facility Medical Director and nurse responsible for clinical care or designee before the patient leaves the facility. Significant adverse drug reactions resulting in serious injury, hospitalization or death must be immediately called to Risk Management ....” During an interview with Staff # 4 on 06/25/2024 at 3:00 PM, Staff # 4 confirmed the facility had expired IDPN in the refrigerator and failed to date the multi-dose vial of Tuberculin Purified Protein. Also, the staff had not followed the facility’s medication policy.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s Bio-medical technician failed to ensure that the dialysis stations’ wall boxes (acid dispensing outlets) had no leaks. This deficient practice has the likelihood to cause nonbacterial contamination and evaporation in the wall boxes and infect the patients receiving in-center hemodialysis at the facility. Findings include: A tour of the in-center treatment area on 06/25/2024 at 2:00 PM observed at station #6 that the inside of the wall chase had a moderate amount of dried crusted white sediment around the acid plumbing and had leaked onto the other pipes in the plumbing system. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease the risk of patient infections.” An interview with Staff #17 on 06/25/2024 at 2:00 PM confirmed the acid outlets and plumbing in the wall chase had dried crusted white sediment at station #6.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s Bio-medical technician failed to ensure that the dialysis stations’ wall boxes (Bicarbonate dispensing outlets) had no leaks. This deficient practice had the likelihood of causing bacterial growth in the wall boxes and infecting the patients who were receiving in-center hemodialysis at the facility. Findings include: A tour of the in-center treatment area on 06/25/2024 at 2:00 PM observed at station #9 that the inside of the wall chase had a moderate amount of dried crusted white sediment around the Bicarbonate connector and water plumbing where the bicarbonate had leaked onto the other plumbing pipes. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease the risk of patient infections.” An interview with Staff #17 on 06/25/2024 at 2:00 PM confirmed the bicarbonate connector and plumbing in the wall chase had dried crusted white sediment at station #9.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interviews, the facility staff failed to A. ensure the in-center treatment area was maintained to provide a clean and sanitary environment for staff and patients. (Cross Refer to Tag V0111) B. change gloves and perform hand hygiene in between contact with the patient and the dialysis equipment and computers. (Cross Refer to Tag V0113) C. ensure the biohazard waste storage area was clearly labeled and legible. (Cross Refer to Tag V0121) D. ensure Hepatitis B immunizations were administered according to the manufacturer’s guidelines. Also, the facility staff failed to test monthly antigens for 2 (# 10 # 11) of 3 Hepatitis B core-positive patients. (Cross Refer to Tag V0124) E. ensure 1 (Staff # 10) of 1 Licensed Vocational Nurse provided CVC (central venous catheter; a catheter that is inserted into a central vein that leads directly to the heart) care following the facility’s policy and procedure for CVC care. The facility failed to follow facility policy “Central Venous Catheter Procedure”. (Cross Refer to Tag V0147)”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48653 Based on record review and interview, A. the Registered Nurse failed to ensure the pre-treatment nursing assessments were completed and documented within (1) hour of treatment initiation on 2 (#3, #8) of 5 patient medical records reviewed. Also, the Registered Nurse failed to ensure the post-treatment nursing assessments were completed and documented before the patient was discharged on 4 (# 1, # 3, # 5, # 8) of 5 patient medical records reviewed. The facility staff failed to follow the facility policy “Pre-Intra-Post Treatment Data Collection Monitoring and Nursing Assessment”. (Cross Refer to Tag V0502) B. the facility staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) and dialysate flow rate (DFR) in 4 (# 1, # 2, # 5, # 8) of 5 medical records reviewed. The facility staff failed to verify the ordered prescription matched the prescription the patient was receiving prior to treatment initiation. Also, the facility staff failed to follow the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. (Cross Refer to Tag V0503) C. the facility staff failed to ensure direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 3 (# 1, # 3, #8) of 5 patient charts reviewed. The facility staff failed to follow the facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. (Cross Refer to Tag V0504) D. the facility nursing staff failed to evaluate for the determination of the individual anemia management needs. (Cross Refer to Tag V0507) E. the facility’s Interdisciplinary Team failed to ensure Plan of Care meetings were held 3 months after the initial comprehensive assessments of the patient in 1 (# 5) of 8 patient medical records reviewed. (Cross Refer to Tag V0517) F. the facility’s Interdisciplinary Team failed to ensure Plan of Care meetings were held annually after the patient’s admission to the dialysis center for 1 (#6) of 8 patient medical records reviewed. (Cross Refer to Tag V0519)”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 29191 Based on record review and interview, the Governing body failed: A. to provide the facility with a full-time Facility Administrator during operational hours. Also, the governing body failed to submit the required data electronically to the Network for this region. In addition, the Governing body has allowed 2 patients with “Bed Bugs “ to be treated on different days and different shifts exposing multiple patients to the “Bed Bug” infestation This deficient practice had the likelihood of causing harm to patients due to no continuity of care for the patients in this dialysis facility. Findings include: This facility has 56 patients. It is open 6 days a week with 3 shifts on Monday, Wednesday, and Friday and 2 shifts on Tuesday, Thursday, and Saturday. The facility’s Governing Body failed to ensure the facility had a full-time facility administrator on-site during operation hours. The interim-appointed Facility Administrator (#2) was the facility administrator for another dialysis clinic which was 23 miles away. Staff #2’s full-time dialysis unit has approximately 50 patients and operates 6 days a week. Interim-Facility Administrator #2 does not have a clinical background and has been employed for less than 2 years. The Interim-Facility Administrator was hired on October 4, 2022, and went out on maturity leave 5 months later. In June of 2023, Facility Administrator #2 returned to her full-time facility administrative position. In July 2023 she was appointed the Interim-Facility Administrator for this unit. Staff #2 has the responsibility for caring for over 106 patients. An interview with Staff #2 on 05/15/2024 at 2:00 PM revealed that Staff #17 was the nurse manager in July 2023. An interview with Staff #2 on 05/15/2024 at 2:00 PM revealed that Staff #18 was the nurse manager in August 2023. A review of the Governing Body meetings from September 2023 revealed that Staff #20 was the nurse manager in September 2023. Staff #20 ( Clinical Specialist) holds the position of being accountable for 22 dialysis clinics in this region. A review of the Governing Body meetings from October 2023 revealed that Staff #19 was the nurse manager in October and November 2023. Staff #19 ( from the state of Alabama ) holds the position of Clinical Coordinator in her full-time facility. There were no Governing body meeting minutes provided for the month of December 2023. An interview with Staff #2 on 05/15/2024 at 2:00 PM revealed that there was no nurse manager for the clinic in the month of December 2023. The Interim-Facility Administrator #2 was a non-clinical manager. A review of the Governing Body meetings from January 2024 revealed that Staff #5 was appointed the nurse manager on January 23, 2024. Staff #5 must be the Charge nurse due to there were no charge-capable registered nurses full-time in the facility. Staff #5 was responsible for the anemia and hepatitis management of the facility patients. Staff #5 turned in his resignation on 5/013/2024. A review of the personnel file and interview revealed Staff #7 a registered nurse was hired on 7/24/2023 and just completed training to be charge-capable on 4/25/2024. The facility has an Interim-Facility Administrator (non-clinical), a charge-capable registered who just got out of training on 4/25/2024 (2 weeks ago), a registered nurse in training, and no nurse manager as of May 27, 2024. The facility has had 5 different Clinical Nurse Managers between July 2023 and May 2024. There has been no consistent clinical leadership at the facility since July of 2023. There was no full-time nurse manager who worked 40 hours a week to have continuity of care and oversight with the 56 in-center patients. Failure of the facility to provide full-time nursing personnel for the facility to operate puts the patients at great risk of missing dialysis treatments due to no continuity of nursing coverage. A review of the report received from the network revealed that the “EMResouce” Monthly Update was last updated on June 16, 2023, and the facility has not met State requirements for 11 months. The facility failed to post in the lobby the “Speak it Up” poster in English and Spanish with grievance processes posted. Also, the leadership for the facility had not been updated to show the current leadership. The facility has two patients with confirmed bed bugs. One patient is treated on Mondays, Wednesdays, and Fridays. The second patient is treated on Tuesdays, Thursdays, and Saturdays. The patients are treated on opposite days, thus exposing all patients at the facility to bed bugs. There have been no attempts to ensure the patient’s homes are treated for bed bugs. Staff members at the facility have reported being bitten by the bed bugs. There was no isolation room present at the facility for the patients to be treated in. An interview with Staff #2 on 05/16/2024 at 3:00 PM confirmed the facility did not currently have a full-time Facility Administrator at the facility and when the current nurse manager leaves on May 27, 2024, there was no nurse manager trained to take the position. Also, Staff #2 confirmed there are two patients with the “Beg Bug” infestation being dialyzed at the facility on opposite days, and a staff member has been bitten. B. ensure that Interim Facility Administrator Staff #2 had a signed job description with work responsibilities. (Cross Refer to V760)”

“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: 29191 Based on observation, record review and interview, the facility’s staff failed to ensure A. five oxygen E-cylinders were secure in a holder. B. the emergency code cart was checked weekly for supplies and expiration dates. The facility staff failed to follow the policy, “Emergency Equipment Checks”. A. Findings include: This deficient practice had the likelihood to cause harm to a dialysis patient if the oxygen cylinder fell over and exploded in the facility. During a tour of the facility on 05/13/2024 at 11:51 AM, it was observed that 5 oxygen E-cylinders were free-standing and not secured in a holder in the water room storage area. Also, one rack of the oxygen E cylinders was stored next to the electrical computer system. An interview with Staff #20 on 05/13/2024 at 11:51 AM confirmed the 5 oxygen E-cylinders were not secure in a holder. 48653 B. A review of the facility document “Emergency Equipment Checklist” revealed the facility staff were not documenting the contents of the emergency code cart located on the in-center treatment floor. There was no documentation to support that the contents of the emergency code cart were checked for accuracy and expiration dates. A review of the facility policy, “Emergency Equipment Checks” with a revision date of April 2024 revealed, “PURPOSE: To verify that emergency equipment is maintained in a ready-to-use condition. POLICY: 1. Emergency equipment, including, but not limited to, oxygen, airways, suction, automated external defibrillator (AED), artificial resuscitator (ambu bag), and emergency drugs will be on the premises at all times. 2. Recommended emergency medications to stock in the facility are medications to treat allergic reactions, anaphylactic reactions, hypoglycemia, and chest pain. Medications that treat cardiac arrest or other emergencies are provided by and administered by Emergency Medical Services (EMS). 3. The following equipment checks will be performed by a licensed nurse teammate to verify the designated equipment is available and functional ... Weekly: Oxygen supply is adequate ... Airways are available. Suction is operational. AED is operational and pads are compatible with AED devices. Follow the manufacturer’s guidelines for any additional equipment check needed. Artificial resuscitator (ambu bag) is operational. The emergency cart (crash cart) is clean and operational, and supplies/medications have not expired. 4. The Emergency Equipment Checklist may be used for documentation of emergency equipment checks ...” An interview with Staff # 4 on 05/13/2024 at 11:30 AM confirmed the staff had not completed the Emergency Equipment Checklist. Staff # 4 stated, “The nurse should have been filling this form out to ensure what was in the code cart was supposed to be and that includes checking expiration dates of supplies and medications”.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interviews, the facility failed to ensure the in-center treatment area was maintained to provide a clean and sanitary environment for staff and patients. Findings include: During a tour of the facility’s in-center treatment area on 05/13/2024 at 11:00 AM, the surveyor observed the following: *Expired hand sanitizer outside of the patient bathroom with an expiration date of, “03/2023”. *Expired laboratory specimen tubes with an expiration date of, “04/2024”. *Expired Antacid tablets (Tums) with an expiration date of, “04/2024”. A review of the facility’s policy, “Infection Control for Dialysis Facilities” with a revision date of April 2023 revealed, “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. Refer to the Infection Control Quick Reference Guide for further detail on implementation steps. POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B and are included in the policy: Infection Control and Isolation Measures for Known or Suspected Hepatitis B Antigen Positive Patients. Hand Hygiene: All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes (i.e., plugging/unplugging acid/bicarb lines form dialysis machine, changing acid types, when exchanging a dialysis machine) f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse 2. Patients and caregivers will be encouraged to a. Wash their hands and access the extremity upon entering the treatment area before the initiation of dialysis. b. Perform hand hygiene after treatment before leaving the treatment area ... 8. Supplies will be stored in a manner that maintains their integrity. a. Patients and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until the time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet, or contaminated, the package and its contents must be disposed of and not used.” During an interview with Staff # 6 on 05/13/2024 at 11:00 AM confirmed the facility had expired supplies and medications on the in-center treatment floor.”

“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, record review, and staff interview, the facility staff failed to change gloves and perform hand hygiene in between contact with the patient and the dialysis equipment and computers. This deficient practice had the likelihood to lead to the transmission of infectious agents between staff members and the patients. During a tour of the facility’s in-center treatment area on 05/13/2024 at 10:00 AM, the surveyor observed Staff # 10 performing patient care. Staff # 10 was observed touching the patient and the patient’s bloodlines with the same gloves used to touch the computer and dialysis machine. Staff # 10 did not change gloves or perform hand hygiene on multiple occasions in between performing patient care and touching the dialysis equipment. A review of the facility’s policy, “Infection Control for Dialysis Facilities” with a revision date of April 2023 revealed, “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B and are included in the policy: Infection Control and Isolation Measures for Known or Suspected Hepatitis B Antigen Positive Patients. HAND HYGEINE: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes (i.e., plugging/unplugging acid/bicarb lines form dialysis machine, changing acid types, when exchanging a dialysis machine) f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse 2. Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area. 3. Use of an alcohol-based hand rub may be substituted for handwashing. Refer to procedure: Use of Alcohol-Based Hand Rubs. a. Hand washing will be performed if hands are visibly contaminated with blood or body fluids and when caring for patients on isolation precautions for Clostridium difficile. Refer to procedure: Handwashing ... PE (i.e., gown, gloves, eye protection, face shield) 5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas. PPE is to be: a. Removed prior to leaving the treatment area. b. Removed as soon as possible if overtly contaminated and i. Disposable, deposit in a biohazard waste container ii. Non-disposable, properly disinfect and place in designated area c. PPE is not to be worn in non-treatment areas, for example, teammate lounge, teammate offices. 6. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area. 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-cannulation or holding access sites. a. Gloves should be changed when: i. When soiled with blood, dialysate or other body fluids ii. When going from a “dirty” area or task to a “clean” area or task iii. When moving from a contaminated body site to a clean body site of the same patient; and iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system ...” During an interview with Staff # 2 on 05/13/2024 at 10:30 AM, Staff # 2 confirmed Staff # 10 was seen going between patient and dialysis equipment without changing gloves and performing hand hygiene.”

“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: 48653 Based on observation and staff interview, the facility staff failed to ensure the biohazard waste storage area was clearly labeled and legible and that the dumpster was secured from the public and rodents pilfering through the hazardous waste. Findings include: During an tour of the facility’s outside area on 05/14/2024 at 11:00 AM with Staff # 6 and # 20, the surveyor observed an outdoor storage shed. When questioned, Staff # 20 reported it was for biohazard waste. The surveyor observed the signs and markings on the storage shed were not clearly labeled and legible. The facility had two dumpsters on-site that were unsecured without physical confinement secured around them. There was a rotten wooden fence around one of the dumpster and the wood fence had fallen down. Some of wooden boards were leaning over and some had fallen to the ground. The unsecured dumpster allowed the public and rodents to pilfer through the hazardous trash. Surveyor observed a pile of trash at back of the building by the exit door to the water room. There was large piece wet rolled up cardboard, wooden pallet, and debris lying in the corner at the back of the building. During an interview with Staff # 20 on 05/14/2024 at 11:00 AM, Staff # 20 acknowledged the signs were not clear and legible, the dumpster were unsecured, and there was a pile of trash at the back of the building by the water room exit door.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility staff failed to ensure Hepatitis B immunizations were administered according to the manufacturer’s guidelines. Also, the facility staff failed to test monthly antigens for 2 (# 10 # 11) of 3 Hepatitis B core-positive patients. This deficient practice had the likelihood of resulting in a seroconversion of the Hepatitis B virus to the 23 susceptible patients (negative anti-HBs with less than 10 mIU/ml antibodies) at the facility. Findings include: The patient had a total patient census of 56. 23 of the 56 patients were susceptible to the Hepatitis B virus. Only 8 of those susceptible patients were in the Engerix vaccine series. During a review of the facility’s, “Vaccinations and Surveillance Report” printed on 05/14/2024, the surveyor observed the following deficient practices: Patient # 7 Patient # 7 had an HBsAb of <3 mIU/ml result on 09/13/2023. There is no documentation that Patient # 7 was offered the vaccine until 04/10/2024. The patient was susceptible for more than 7 months without a vaccine offered to the patient. Patient # 9 Patient # 9 had an HBsAb of <3 mIU/ml result on 06/06/2023. The patient was given the Engerix vaccine on 06/15/2023, 11/18/2023, 01/11/2023, and 04/11/2024. The facility staff did not give the Engerix vaccine according to the manufacturer’s recommended timeline and dosing schedule. The patient’s HBsAb result was still <3 mIU/ml on 01/11/2024. Patient # 10 Patient # 10 had a positive core antibody result on 01/12/2023. The patient did not receive monthly antigen testing in March of 2024 to ensure the patient was not infectious and could potentially pass the virus to another patient. Patient # 11 Patient # 11 had a positive core antibody result on 04/02/2020. The patient did not receive monthly antigen testing in April of 2024 to ensure the patient was not infectious and could potentially pass the virus to another patient. Patient # 12 Patient # 12 had an HBsAb of 7 mIU/ml on 02/14/2024. The patient was not offered an Energix vaccine until 04/17/2024. There was a delay of 2 months between the patient being identified as susceptible and receiving the 1st vaccine in the series. Patient # 13 Patient # 13 had an HBsAb of 4 mIU/ml on 01/10/2024. The patient was not offered a Hepatitis B vaccine and the facility staff did not draw a monthly antigen in January and February of 2024. A review of the facility’s policy, “HEPATITIS B SURVEILLANCE, VACCINATION, INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE” with a revision date of April 2024 revealed, “PURPOSE: To prevent the spread of hepatitis B infections in the dialysis setting. NOTES: For questions regarding interpretation of laboratory results, patient disposition, and the information in this policy, please reach out to your group Infection Preventionist Manager (IPM) for assistance. Refer to the Hepatitis B Quick Reference Guide for further detail on implementation steps. POLICY: 1. HBV serological status (i.e., the results of Hepatitis B Surface antigen [HBsAg], Total Hepatitis B Core Antibody [total anti-HBc or HBcAb], and Hepatitis B Surface Antibody [anti-HBs or HBsAb]) of all patients should be known before admission to the hemodialysis facility. 2. If the hepatitis B surface antigen (HBsAg) status is unknown, the facility Medical Director will be notified and the patient treated as a suspect patient for hepatitis B infection. For further guidance refer to DIALYZING CONFIRMED POSITIVE OR SUSPECTED/UNKNOWN STATUS section below. 3. The facility Medical Director will be made aware of pending admissions for all hepatitis B surface antigen (HBsAg) positive patients. 4. All patients will be routinely tested [as required by the schedule for routine surveillance testing for Hepatitis B Virus (refer to Routine Surveillance Testing table)]. 5. Results will be reviewed promptly to verify that patients are managed appropriately based on their testing results. 6. Documentation of the following will remain in the patient’s current active medical record: a. HBV serology results such as Hepatitis B surface antibodies (HBsAb or anti-HBs); Hepatitis B total core antibody (total anti-HBc or HBcAb) and Hepatitis B Surface antigen (HBsAg) b. If a patient has received the hepatitis vaccination series, a copy of the vaccination record 7. Results from Hepatitis B surface antigen drawn within 30 days is required prior to first treatment date. 8. All permanent patients including AKI patients will have HBV serologic testing drawn immediately upon admission to the facility and results known within seven (7) days of admission (i.e., Hepatitis B Surface antigen [HBsAg], Total Hepatitis B Core Antibody [total anti-HBc or HBcAb], and Hepatitis B Surface Antibody [anti-HBs or HBsAb]) a. Review results and determine status and next steps (refer to Admission Screening table) b. Obtain orders for routine surveillance testing (refer to Routine Surveillance Testing table) ... 10. An order will be obtained for hepatitis B vaccination. The patient is provided the Vaccination Information Sheet (VIS) and a consent form (included in Patient Registration Packet found in Reggie). The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s health record. 11. Patients who start hemodialysis may have a history of vaccination against hepatitis B. These persons should have responded to the vaccine when their immune status was normal, but if their hepatitis B surface antibody (HBsAb or anti-HBs) levels are less than (<) 10 mIU/mL when they begin dialysis, they should be revaccinated with a complete primary series. 12. Vaccinate per manufacturers guidelines. (Note: Hepatitis B vaccine is to be administered by the intramuscular route in the deltoid muscle for adult patients). 13. Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of the full vaccine series (adequate response is defined as greater than or equal (?) 10 mIU/mL). a. If hepatitis B surface antibody (HBsAb) is less than (<) 10 mIU/mL, consider the patient susceptible, revaccinate with an additional full series, and retest for HBsAb one (1) to two (2) months after the last dose of the second series. i. No additional doses of vaccine are warranted for those patients who do not respond to a full second series. ii. Such patients are considered vaccine non-responders. They remain susceptible to hepatitis B infection and monthly hepatitis B surface antigen (HBsAg) testing is required. b. If the hepatitis B surface antibody (HBsAb) is greater than or equal to (>) 10 mIU/mL, consider patient immune, and retest annually for HBsAb. c. On annual retesting of immune patients due to vaccination, HBsAb less than (<) 10 mIU/mL, with nephrologist order, administer a booster dose of vaccine. i. Retest for HBsAb one (1) to two (2) months after the booster dose 1. If HBsAb is greater than or equal (?) 10 mIU/mL continue to retest annually for HBsAb. 2. If the HBsAb is less than (<) 10 mIU/mL following the booster dose, no subsequent/future doses of vaccine will be provided. Patient will be considered a non-responder and managed as a susceptible patient. ii. There is no limit to the number of annual boosters although future doses should be discontinued if at any time, the patient fails to respond with HBsAb greater than or equal (?) 10 mIU/mL ...” During an interview with Staff # 20 on 05/14/2024 at 3:30 PM, Staff # 20 acknowledged the facility staff were not monitoring the hepatitis B virus and surveillance according to the facility’s policy. Staff # 20 stated, “there are a lot of issues, but they have started to work some of them out this month”.”

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure 1 (Staff # 10) of 1 Licensed Vocational Nurse provided CVC (central venous catheter; a catheter that is inserted into a central vein that leads directly to the heart) care following the facility’s policy and procedure for CVC care. The facility failed to follow facility policy “Central Venous Catheter Procedure”. This deficient practice had the likelihood to put all patients with a CVC at increased risk for infection. Failure to provide a clean field, perform hand hygiene, and change gloves at the appropriate intervals during procedures with the central venous catheter can lead to cross-contamination (infection) of the catheter. Findings include: During a tour of the facility’s in-center treatment area on 05/13/2024 at 11:30 AM, the surveyor observed Staff # 10 performing CVC care. Staff # 10 only changed gloves 3 times during the CVC access and dressing change and did not perform hang hygiene in between changing gloves. The patient did not keep their head turned away from the CVC site during the access and dressing change and Staff # 10 did not instruct the patient to turn their head away from the CVC exit site. The facility’s policy instructs the staff to change gloves a total of 5 times. A review of facility policy, “Central Venous Catheter Procedure” dated, April 2022 revealed, “Procedure: 1. Check for patient sensitivity to preferred skin antiseptic/skin disinfectant listed in table above. If patient has sensitivity refer to Central Venous Care (CVC) Care Policy for alternate skin antiseptic or skin disinfectants. 2. Perform hand hygiene per procedure. Put on PPE (personal protective equipment). 3. Use Dialysis Precautions and aseptic technique throughout procedure. 4. Set-up clean field with supplies. 5. Instruct patient to turn head to opposite side of CVC exit site. 6. Patient and teammate will wear face masks covering the nose and mouth during the procedure. Rationale: 1. (no rational listed). 2. Hand hygiene protects patient and teammate from cross-contamination. PPE is worn to protect teammate. 3. Reduces risk of infection to patient, teammate, and others. 4 ... 5. Decreases the risk of aerosolized bacteria contaminating site. 6. These measures are vital to preventing the exposure of the catheter and exit site to nasal droplets and infectious bacteria such as methicillin-resistant staph aureus (MRSA).” During an interview with Staff # 10 on 05/13/2024 at 11:30 AM, Staff # 10 stated, “They gave us these cards that say to change gloves 3 times during the procedure. I did not know I was supposed to change gloves 5 times.” During an interview with Staff # 6 on 05/13/2024 at 11:45 AM, Staff # 6 stated, “I have given education on this before.” Staff # 6 acknowledged Staff # 6 did not change gloves a minimum of 5 times.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 29191 Based on observation and interviews, the facility’s governing body failed to ensure that access to the water purification system was restricted to those responsible for monitoring and maintaining the purification system. This deficient practice finding had the likelihood to cause harm to all dialysis patients by allowing unauthorized individuals access to the water purification room. Findings include: During a tour of the water room on 05/14/2024 at 11:04 AM, the water room was found to be unsecured. The room to water purification room back door was propped open and unsecured. The surveyor was touring the outside of the building and walked behind the building and found the back door propped open. There were 2 men in the water room with no identification discussing where to place the water hook-up. The door was open allowing access to the water room and insects to enter the building. An interview with Staff #20 on 05/14/2024 at 11:30 PM confirmed the water room (water purification room) was unsecured allowing unauthorized access and insects to enter the building.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that the acid storage tank did not contain contaminated acid solution from the acid connection outlet valve leak at the bottom of the acid storage tank. Also, observed dried acid (a white substance) on the blue pump connections next to the acid storage tank. This deficient practice had the likelihood to cause harm to all patients receiving contaminated acid at the chairside through the dialysis machine at the facility. Findings include: On a tour of the water room on 05/13/2024, observed there was a white substance build-up around the acid housing connection tubing underneath the acid storage tank. Observed drippings of white substance from beneath the acid storage tank. also, observed dried acid (a white substance) on the blue pump connections next to the acid storage tank. Tthere was cracked tile, and dried brown and black particles on the floor beside the acid storage tank. An interview with Staff #6 on 05/32/2024 at 11:46 AM confirmed there was a large amount of acid (white substance) build-up drippings from beneath the acid storage tank housing and the connection valve. Also, Staff #6 acknowledged there was cracked tile, and dried brown and black particles on the floor beside the acid storage tank.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 29191 Based on observation and staff interviews, the facility staff failed to ensure; A. the emergency pull cord (a call light strategically placed throughout the facility to provide a user with a convenient means of summoning help in an emergency) was accessible for a patient in the event of an emergency. The emergency pull cord should be within 6 inches of the floor, hanging freely, and accessible to patients. B. the metal guard rail at the back and side of the building located by the generator was bolted down to the newly laid cement sidewalk. C. the generator was secured from public pilfering with the operations of the generator. D. the handicap and fire lanes in the front of the building were visible to patients, families, and visitors to park and not block the fire lanes. Findings Include: A. During a tour of the in-center treatment patient’s bathroom on 05/13/2024 at 10:30 AM, the surveyor observed the emergency pull cord wrapped around the bathroom rail located by the commode. In an interview with Staff #20 on 05/15/2024 at 10:30 AM Staff # 20 acknowledged the pull cord was wrapped around the bathroom rail and inaccessible to patients in the event of an emergency. B. the metal guard rail at the back and side of the building located by the generator was not bolted down to the newly laid cement sidewalk. Surveyor was able to move the metal railing. The metal rail protected staff and the public from falling into to the city drain. The dirt was eroding from the building. The erosion was 2 feet from the newly laid cement sidewalk. In an interview with Staff #20 on 05/15/2024 at 10:30 AM Staff #20 acknowledged the metal guard rail at the back and side of the building located by the generator was not bolted down to the newly laid cement sidewalk. C. There were 3 separate doors to the front of the generator. One of the doors was off the generator lying on the ground. Observed a locking mechanism on the doors, but none of the doors were locked which allowed the public to pilfer with the operations of the generator. There was a pair of working gloves lying on top of the generator, but the staff did not know anything about the generator or why the gloves were there. An interview with Staff #6 on 05/14/2024 at 11:10 AM acknowledged the door was off the generator and the other doors were not locked. D. the handicap and fire lanes in the front of the building were faded and not visible for patients, families, and visitors to park and not block the fire lanes. An interview with Staff #20 on 05/14/2024 at 11:20 AM acknowledged the handicap and fire lanes in the front of the building were faded and not visible for patients, families, and visitors to park and not block the fire lanes.”

“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 record review and staff interview, the facility staff failed to ensure that out-of-parameter temperatures in the laboratory refrigerator were promptly addressed and corrected to ensure laboratory specimens were not compromised. Findings include: A review of “Daily Temperature Record-Laboratory” for January 2024 through May 2024 revealed, “Tolerance Limits: Refrigerator: 35.6-46.4 degrees Celsius” On January 1, 2024 the temperature was documented as, “66.0 degrees Celsius”. There was no corrective action documented. On February 12, 2024 the temperature was documented as, “65.0 degrees Celsius”. There was no corrective action documented. On March 16, 2024 the temperature was documented as, “30.0 degrees Celsius”. There was no corrective action documented. On May 7, 2024 the temperature was documented as, “28.0 degrees Celsius”. There was no corrective action documented. During an interview with Staff # 2 on 05/13/2024 at 3:30 PM, Staff # 2 acknowledged the staff were documenting the temperature of the refrigerator but there was no corrective action documented when the temperature was out of range.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility failed to ensure a properly executed informed consent for hemodialysis treatment was completed for 5 (# 2, # 3, # 5, # 6, # 7) of 5 patient medical records reviewed. Also, the facility staff failed to follow the policy, “INFORMED CONSENT FOR DIALYSIS TREATMENT”. Findings: Patient # 2 During a review of Patient # 2’s medical record, the surveyor observed the patient signed “CONSENT-HEMODIALYSIS TREATMENT” on 10/08/2022. The Registered Nurse witnessed the informed consent. The Registered Nurse’s signature was illegible and there was no date or time. It was unknown if the consent was signed before the patient’s first dialysis treatment. There was no documentation in the medical record by the physician confirming risks and benefits had been explained to the patient before the initiation of hemodialysis treatment as required by the facility’s informed consent policy. Patient # 3 During a review of Patient # 3’s medical record, the surveyor observed the patient signed “CONSENT-HEMODIALYSIS TREATMENT” on 08/15/2021. The Registered Nurse witnessed the informed consent. The Registered Nurse’s signature was illegible and there was no date or time. It was unknown if the consent was signed before the patient’s first dialysis treatment. There was no documentation in the medical record by the physician confirming risks and benefits had been explained to the patient before the initiation of hemodialysis treatment as required by the facility’s informed consent policy. Patient # 5 During a review of Patient # 5’s medical record, the surveyor observed the patient signed “CONSENT-HEMODIALYSIS TREATMENT” on 04/14/2023. There was no signature by a witness on the consent. There was no date or time. It is unknown if the consent was signed before the patient’s first dialysis treatment. There was no documentation in the medical record by the physician confirming risks and benefits had been explained to the patient before the initiation of hemodialysis treatment as required by the facility’s informed consent policy. Patient # 6 During a review of Patient # 6’s medical record, the surveyor observed the patient signed “CONSENT-HEMODIALYSIS TREATMENT” on 04/08/2022. The Registered Nurse witnessed the informed consent. The Registered Nurse’s signature was illegible and there was no date or time. It was unknown if the consent was signed before the patient’s first dialysis treatment. There was no documentation in the medical record by the physician confirming risks and benefits had been explained to the patient before the initiation of hemodialysis treatment as required by the facility’s informed consent policy. Patient # 7 During a review of Patient # 2e’s medical record, the surveyor observed the patient signed “CONSENT-HEMODIALYSIS TREATMENT” on 09/07/2022. The Registered Nurse witnessed the informed consent. The Registered Nurse’s signature was illegible and there was no date or time. It was unknown if the consent was signed before the patient’s first dialysis treatment. There was no documentation in the medical record by the physician confirming risks and benefits had been explained to the patient before the initiation of hemodialysis treatment as required by the facility’s informed consent policy. During an interview with Staff # 1 (Administrative Assistant) on 05/13/2024 at 1:30 PM, Staff # 1 stated, “I obtain the consent forms for all of the patients. I read the consent for hemodialysis form to the patient and the patient signs the form. If the patient has any questions, I send the patient to the Registered Nurse for questions related to the informed consent.” Staff # 18 was asked if she has any training or licenses that qualify her to assess the patient’s competence and cognitive function. Staff # 18 stated, “No, I do not and I do not assess the patient’s competence or cognitive function before reading the consent forms to the patient.” A review of the Job Description for “Administrative Assistant- Clinical III Job Code: O329” with an effective date of March 2014 revealed, “The Administrative Assistant- Clinical III provides clerical, communication, and administrative support to a dialysis facility. This position reports to the Facility Administrator. Essential Duties and Responsibilities ... Prepares patient charts and obtains consents on all new admissions ... Minimum Qualifications: a. High School diploma or equivalent required, medical secretary experience a plus. b. Demonstrated abilities in basic clerical skills, filling, and all office machines. c. Intermediate to advanced computer skills (Microsoft Office products and Outlook). d. Knowledge of purchasing and inventory control methodologies preferred.” A review of the facility policy, “INFORMED CONSENT FOR DIALYSIS TREATMENT” with a revision date of April 2023 revealed, “PURPOSE: To provide guidance for the informed consent for dialysis treatment. POLICY: 1. This policy applies to all patients receiving dialysis treatment within a DaVita Inc. facility (including visiting patients). This does not pertain to any home training programs or other procedures that require separate consent. 2. A statement signed by the patient will be placed in the patient’s chart. 3. To guarantee that every patient is fully informed regarding dialysis treatment, prior to the first dialysis treatment in the facility he/she must have the following: a. Explanation of ESRD diagnosis, risks, benefits, complications, and alternatives to treatment explained to them by the patient’s physician. b. An opportunity to ask questions of the dialysis facility teammates relating to the facility operation. c. An informed consent (Authorization for the Verification of Consent to Hemodialysis Procedure or Authorization for and Verification of Consent to Peritoneal Dialysis Procedure) signed by the patient or personal representative and witnessed by the Registered Nurse. 4. If a patient or the patient’s personal representative is unable to sign the informed consent in person, the registered nurse will send an encrypted email with the informed consent to the patient or the Davita approved video platform for web conferencing to fully inform the patient or the patient’s representative of the patient’s dialysis treatment including 3(a)-(b) above. a. Using the DaVita-approved platform for web conferencing, the Registered Nurse must then verbally obtain the patient or the patient’s personal representative’s informed consent. The RN must then document that verbal consent was obtained from the patient or the patient’s personal representative via a DaVita-approved platform for web conferencing and provide the reason for obtaining verbal consent (e.g., out of town, unavailable, etc). 5. The consent, original signed consent form must be filed in the patient’s current medical record at all times. 6. A new consent form must be signed: a. When a patient transfers to another Davita facility. b. When the patient is readmitted to DaVita after discharge/transfer c. When the patient changes modalities. 7. If a patient is officially discharged or transferred to another facility, the patient must review and sign a new consent form prior to returning for treatment in the original DaVita facility.” During an interview with Staff # 4 and # 20 on 05/16/2024 at 4:00 PM, Staff # 4 and # 20 acknowledged there was no documentation from the physician stating risks and benefits had been explained to the patient before obtaining consent. Also, Staff # 20 confirmed the Administrative Assistant’s job description included the duty of obtaining consent from the patients and the facility failed to follow the informed consent policy.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48653 Based on record review and interview, the Registered Nurse failed to ensure the pre-treatment nursing assessments were completed and documented within (1) hour of treatment initiation on 2 (#3, #8) of 5 patient medical records reviewed. Also, the Registered Nurse failed to ensure the post-treatment nursing assessments were completed and documented before the patient was discharged on 4 (# 1, # 3, # 5, # 8) of 5 patient medical records reviewed. The facility staff failed to follow the facility policy “Pre-Intra-Post Treatment Data Collection Monitoring and Nursing Assessment”. Patient # 1 A review of 2 of 6 treatment sheets for Patient # 1 revealed that post-treatment nursing assessments were not completed prior to the patient was discharged. A review of the treatment sheet dated 04/23/2024 revealed Staff #5 did not complete the post-treatment nursing assessment (documented at 4:33 PM) before the patient was discharged. Treatment ended at 3:12 PM. A review of the treatment sheet dated 04/27/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented at 2:29 PM) before the patient was discharged. Treatment ended at 1:03 PM. Patient # 3 A review of 3 of 6 treatment sheets for Patient # 3 revealed that pre-treatment nursing assessments were not completed within (1) hour of treatment initiation. A review of the treatment sheet dated 05/01/2024 revealed Staff # 5 did not complete the pre-treatment nursing assessment (documented at 1:01 PM) within 1 hour of the initiation of treatment. Treatment began at 11:25 AM. A review of the treatment sheet dated 05/03/2024 revealed Staff # 7 did not complete the pre-treatment nursing assessment (documented at 12:02 PM) within 1 hour of the initiation of treatment. Treatment began at 10:56 AM. A review of the treatment sheet dated 05/06/2024 revealed Staff # 18 did not complete the pre-treatment nursing assessment (documented at 7:12 PM) within 1 hour of the initiation of treatment. Treatment began at 11:58 AM. A review of 2 of 6 treatment sheets for Patient # 3 revealed that post-treatment nursing assessments were not completed prior to the patient was discharged. A review of the treatment sheet dated 05/06/2024 revealed Staff #18 did not complete the post-treatment nursing assessment (documented at 7:11 PM) before the patient was discharged. Treatment ended at 3:02 PM. A review of the treatment sheet dated 05/10/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented at 6:21 PM) before the patient was discharged. Treatment ended at 2:29 PM. Patient # 5 A review of 2 of 6 treatment sheets for Patient # 5 revealed that post-treatment nursing assessments were not completed prior to the patient was discharged. A review of the treatment sheet dated 04/30/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented at 3:52 PM) before the patient was discharged. Treatment ended at 2:46 PM. A review of the treatment sheet dated 05/07/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented at 2:29 PM) before the patient was discharged. Treatment ended at 1:03 PM. Patient # 8 A review of 1 of 6 treatment sheets for Patient # 8 revealed that pre-treatment nursing assessments were not completed within (1) hour of treatment initiation. A review of the treatment sheet dated 05/03/2024 revealed Staff # 21 did not complete the pre-treatment nursing assessment (documented at 3:56 PM) within 1 hour of the initiation of treatment. Treatment began at 10:49 AM. A review of 2 of 6 treatment sheets for Patient # 8 revealed that post-treatment nursing assessments were not completed prior to the patient was discharged. A review of the treatment sheet dated 05/06/2024 revealed Staff #18 did not complete the post-treatment nursing assessment (documented at 9:12 PM) before the patient was discharged. Treatment ended at 4:02 PM. A review of the treatment sheet dated 05/10/2024 revealed Staff #7 did not complete the post-treatment nursing assessment (documented at 5:51 PM) before the patient was discharged. Treatment ended at 3:03 PM. A review of the facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with a revision date of April 2024 revealed, “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: i. Measurement of patient temperature ii. Measurement of Blood Pressure (B) 1. Sitting and standing blood pressure measurement required pre and post-treatment ... 2. Intradialytic BP in the sitting/reclined or supine position. iii. Heart or pulse rate, noting also if the beat is regular or irregular. iv. Patient weight v. Patient’s report of well-being, level of pain or discomfort, complaints, hospitalization vi. Vascular access status. 2. The Nursing Assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse or if performance of a nursing assessment is permitted by state law, a licensed practice nurse a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters iv. Verification that the patient access is visible and face is not covered v. Review of documentation for accuracy, completion and patient data vi. A physical assessment of the patient which includes 1. Apical heart rate and rhythm 2. Auscultation of the lungs 3. Evaluation of volume status including edema 4. Bruising or bleeding 5. Patient statement of well-being, level of pain or discomfort 6. And other components which if observed/informed will be documented, including but not necessarily limited to the following: o Change in the normal level of consciousness, mobility, or mental status o Complaint of nausea, vomiting, diarrhea, constipation, skin changes, headache, respiratory distress, angina, weakness, fever, cramping, dizziness o Reports of illness and/or injuries, falls, conditions/complications or other problems the patient has experienced since the last dialysis treatment. 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting) PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. 6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. 7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated. INTRADIALYTIC DATA COLLECTION/ASSESSMENT 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring i. Nocturnal Programs: Treatment checks should be completed at least every 30 minutes prior to the established “lights out” time for the nocturnal program. ii. After the established “lights out” time, treatment checks will remain every 30 minutes with the exception of blood pressure and heart rate. After “lights out” time, blood pressure and heart rate checks will be performed every 60 minutes while the patient is awake and then every three (3) hours once the patient is noted to be sleeping. iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate iii. Blood and dialysate flows, arterial and venous pressures iv. Fluid removal and/or replacement v. Vascular access is visible and line connections are intact vi. Patient subjective statement(s) i.e., patient report on overall health, any complaints c. The vascular access site, bloodline connections, and the patient’s face should be visible throughout the dialysis treatment. d. Hourly heparin infusion ordered by the physician/NPP should be monitored every 60 minutes. e. The arterial and venous drip chamber levels should be observed and adjusted as needed. f. External transducer protectors will be inspected for the presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process. If blood or saline is observed in the external transducer protector, refer to policy: Changing Transducer Protectors OR if Streamline bloodlines are used, and if POD membrane rupture occurs, the whole Streamline bloodline needs to be changed. i. The treatment can continue for this patient on this dialysis delivery system if accurate pressures are observed. Document events and patients’ responses in the electronic treatment record. ii. Upon completion of treatment, the delivery system is to be removed from service and labeled with the date, time, description of the problem, and the name of the teammate reporting the problem. The internal transducer protector will be changed only by a trained Biomed teammate and the dialysis delivery system will be disinfected prior to return to use. 10. If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record. 14. Additional documentation if applicable includes the following: a. All medications including time administered, dose, route, and initials of the person administering the medication (Insulin is verified with a second patient care teammate) b. Indication and patient response to PRN medication c. Lab work POST TREATMENT DATA COLLECTION/ASSESSMENT 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. a. If the patient has received Korsuva (difelikefalin) during the treatment, the licensed nurse will assess the patient prior to discharge. 16. If an abnormal finding(s) or concern is identified post-treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17.Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. ABNORMAL FINDINGS Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Signs/symptoms of hypotension may include: Nausea and vomiting Cold and clammy skin Restlessness Rapid, shallow respirations Excessive yawning Diaphoretic Blood Pressure Post Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg If patient is not able to stand, document reason and sitting BP Sitting BP for patient’s that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg Signs/symptoms of hypotension may include: Nausea and vomiting Cold and clammy skin Restlessness Rapid, shallow respirations Excessive yawning Diaphoretic Dizziness Feeling faint Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat Temperature Pre/Post/PRN: Greater than 100? F or 2 degree rise over baseline Respirations Pre/PRN: Patient complaints of shortness of breath, difficulty breathing Pre/Intra/Post Patient Reports/ Complaints and/or teammate observation of: Pain, chest pain Bleeding or blood in stool Diarrhea, nausea or vomiting Chills New onset of rash, skin lesions, ulcers or change in skin color, new bruising or cuts Weakness or numbness Cramping Changes in mobility, ambulation, or reports of falls Changes in level of consciousness, ability to communicate ...” During an interview with Staff # 20 on 05/14/2024 at 10:00 AM, Staff # 20 acknowledged there were issues with the staff documenting pre and post nursing assessments within the appropriate timeframe.”

“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 (# 1, # 2, # 5, # 8) of 5 medical records reviewed. The facility staff failed to verify the ordered prescription matched the prescription the patient was receiving prior to treatment initiation. Also, the facility staff failed to follow the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. 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 66 in-center hemodialysis patients receiving care at this facility. Findings Include: Patient # 1 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for DFR. A review of the treatment sheet dated 05/01/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 10 and # 12 documented the following DFR throughout the patient’s treatment, “11:06 AM: DFR: 500 11:12 AM: DFR: 500 11:16 AM: DFR: 500 11:30 AM: DFR: 500 12:02 PM: DFR: 500 12:32 PM: DFR: 500 1:01 PM: DFR: 500 1:30 PM: DFR: 500 2:00 PM: DFR: 500 2:18 PM: DFR: 500” Staff # 7 documented the following on 05/02/2024 at 12:00 PM: “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment” There was no documented order from the physician to adjust the DFR for this treatment date. Patient # 2 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR. A review of the treatment sheet dated 04/01/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 500.00 ml/min” Staff # 9 and # 12 documented the following BFR throughout the patient’s treatment, “3:12 PM: BFR: 300 3:32 PM: BFR: 300 4:02 PM: BFR: 300 4:32 PM: BFR: 300 5:02 PM: BFR: 300 5:32 PM: BFR: 300 6:02 PM: BFR: 300 6:32 PM: BFR: 300 7:02 PM: BFR: 300 7:13 PM: BFR: 300” Staff # 7 documented the following on 04/01/2024 at 4:08 PM: “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 5 A review of 2 of 6 treatment sheets revealed facility staff did not follow the physician’s order for BFR and DFR. A review of the treatment sheet dated 04/30/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 9 and # 11 documented the following DFR throughout treatment, “11:07 AM: DFR: 500 12:01 PM: DFR: 500 12:32 PM: DFR: 500 1:16 PM: DFR: 500 1:31 PM: DFR: 500 2:06 PM: DFR: 500 2:41 PM: DFR: 500” Staff # 5 documented the following on 04/30/2024 at 11:41 AM: “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 05/11/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 12 documented the following BFR and DFR throughout treatment, “10:46 AM: BFR: 400; DFR: 500 11:01 AM: BFR: 400; DFR: 500 11:33 AM: BFR: 400; DFR: 500 12:01 PM: BFR: 400; DFR: 500 12:31 PM: BFR: 400; DFR: 500 1:01 PM: BFR: 400; DFR: 500 1:31 PM: BFR: 400; DFR: 500 2:02 PM: BFR: 400; DFR: 500” Staff # 5 documented the following on 05/11/2024 at 11:15 AM: “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” There was no documented order from the physician to adjust the BFR and DFR for this treatment date. Patient # 8 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR. A review of the treatment sheet dated 05/06/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 500.00 ml/min” Staff # 13 documented the following BFR throughout the patient’s treatment, “3:02 PM: BFR: 325 3:32 PM: BFR: 325 4:02 PM: BFR: 325” Staff # 18 documented the following on 05/06/2024 at 9:11 PM: “I verify that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with a revision date of April 2024 revealed, “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: i. Measurement of patient temperature ii. Measurement of Blood Pressure (B) 1. Sitting and standing blood pressure measurement required pre and post-treatment ... 2. Intradialytic BP in the sitting/reclined or supine position. iii. Heart or pulse rate, noting also if the beat is regular or irregular. iv. Patient weight v. Patient’s report of well-being, level of pain or discomfort, complaints, hospitalization vi. Vascular access status. 2. The Nursing Assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse or if performance of a nursing assessment is permitted by state law, a licensed practice nurse a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters iv. Verification that the patient access is visible and face is not covered v. Review of documentation for accuracy, completion and patient data vi. A physical assessment of the patient which includes 1. Apical heart rate and rhythm 2. Auscultation of the lungs 3. Evaluation of volume status including edema 4. Bruising or bleeding 5. Patient statement of well-being, level of pain or discomfort 6. And other components which if observed/informed will be documented, including but not necessarily limited to the following: o Change in the normal level of consciousness, mobility, or mental status o Complaint of nausea, vomiting, diarrhea, constipation, skin changes, headache, respiratory distress, angina, weakness, fever, cramping, dizziness o Reports of illness and/or injuries, falls, conditions/complications or other problems the patient has experienced since the last dialysis treatment. 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting) PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. 6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. 7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated. INTRADIALYTIC DATA COLLECTION/ASSESSMENT 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring i. Nocturnal Programs: Treatment checks should be completed at least every 30 minutes prior to the established “lights out” time for the nocturnal program. ii. After the established “lights out” time, treatment checks will remain every 30 minutes with the exception of blood pressure and heart rate. After “lights out” time, blood pressure and heart rate checks will be performed every 60 minutes while the patient is awake and then every three (3) hours once the patient is noted to be sleeping. iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate iii. Blood and dialysate flows, arterial and venous pressures iv. Fluid removal and/or replacement v. Vascular access is visible and line connections are intact vi. Patient subjective statement(s) i.e., patient report on overall health, any complaints c. The vascular access site, bloodline connections, and the patient’s face should be visible throughout the dialysis treatment. d. Hourly heparin infusion ordered by the physician/NPP should be monitored every 60 minutes. e. The arterial and venous drip chamber levels should be observed and adjusted as needed. f. External transducer protectors will be inspected for the presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process. If blood or saline is observed in the external transducer protector, refer to policy: Changing Transducer Protectors OR if Streamline bloodlines are used, and if POD membrane rupture occurs, the whole Streamline bloodline needs to be changed. i. The treatment can continue for this patient on this dialysis delivery system if accurate pressures are observed. Document events and patients’ responses in the electronic treatment record. ii. Upon completion of treatment, the delivery system is to be removed from service and labeled with the date, time, description of the problem, and the name of the teammate reporting the problem. The internal transducer protector will be changed only by a trained Biomed teammate and the dialysis delivery system will be disinfected prior to return to use. 10. If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record. 14. Additional documentation if applicable includes the following: a. All medications including time administered, dose, route, and initials of the person administering the medication (Insulin is verified with a second patient care teammate) b. Indication and patient response to PRN medication c. Lab work POST TREATMENT DATA COLLECTION/ASSESSMENT 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. a. If the patient has received Korsuva (difelikefalin) during the treatment, the licensed nurse will assess the patient prior to discharge. 16. If an abnormal finding(s) or concern is identified post-treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17.Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. ABNORMAL FINDINGS Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Signs/symptoms of hypotension may include: Nausea and vomiting Cold and clammy skin Restlessness Rapid, shallow respirations Excessive yawning Diaphoretic Blood Pressure Post Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg If patient is not able to stand, document reason and sitting BP Sitting BP for patient’s that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg Signs/symptoms of hypotension may include: Nausea and vomiting Cold and clammy skin Restlessness Rapid, shallow respirations Excessive yawning Diaphoretic Dizziness Feeling faint Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat Temperature Pre/Post/PRN: Greater than 100? F or 2 degree rise over baseline Respirations Pre/PRN: Patient complaints of shortness of breath, difficulty breathing Pre/Intra/Post Patient Reports/ Complaints and/or teammate observation of: Pain, chest pain Bleeding or blood in stool Diarrhea, nausea or vomiting Chills New onset of rash, skin lesions, ulcers or change in skin color, new bruising or cuts Weakness or numbness Cramping Changes in mobility, ambulation, or reports of falls Changes in level of consciousness, ability to communicate ...” During an interview with Staff # 20 on 05/14/2024 at 10:00 AM, Staff # 20 acknowledged the staff was not following the physician’s orders for dialysis treatment.”

“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: 48653 Based on record review and interview, the facility staff failed to ensure direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 3 (# 1, # 3, #8) of 5 patient charts reviewed. The facility staff failed to follow the facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. Findings include: Patient # 1 A review of the treatment sheet dated 05/02/2024 for Patient # 1 revealed Staff # 12 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff # 12 documented the following on 05/02/2024: “11:12 AM: BP (blood pressure): 61/37” There is no documentation from Staff # 12 to support the charge nurse being made aware of these abnormal vital signs during Patient # 1’s treatment on 05/02/2024. Patient # 3 A review of the treatment sheet dated 05/06/2024 for Patient # 3 revealed Staff # 13 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff # 13 documented the following on 05/06/2024: “11:58 AM: BP: 192/64 12:32 PM: BP: 196/87” There is no documentation from Staff # 13 to support the charge nurse being made aware of these abnormal vital signs during Patient # 3’s treatment on 05/06/2024. Patient # 8 A review of the treatment sheet dated 04/29/2024 for Patient # 8 revealed Staff # 12 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff # 12 documented the following on 04/29/2024: “11:01 AM: BP: 170/104 11:31 AM: BP: 177/102” There is no documentation from Staff # 12 to support the charge nurse being made aware of these abnormal vital signs during Patient # 8’s treatment on 04/29/2024. A review of the treatment sheet dated 05/01/2024 for Patient # 8 revealed Staff # 9 and Staff # 10 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff # 9 and Staff # 10 documented the following on 05/01/2024: “10:41 AM: BP: 192/112 11:09 AM: BP: 193/114 11:39 AM: BP: 178/105 12:09 PM: BP: 185/111 12:39 PM: BP: 188/111 1:09 PM: BP: 188/108 1:42 PM: BP: 195/106 2:09 PM: BP: 189/111 2:39 PM: BP: 199/108” There is no documentation from Staff # 9 and Staff # 10 to support the charge nurse being made aware of these abnormal vital signs during Patient # 8’s treatment on 05/01/2024. The patient was discharged with an elevated BP of 214/117. The Medical Director was not called and made aware of these vital signs. A review of the treatment sheet dated 05/10/2024 for Patient # 8revealed Staff # 10 and Staff # 13 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff # 10 and Staff # 13 documented the following on 05/10/2024: “11:02 AM: BP: 170/113 12:03 PM: BP: 173/104 12:33 PM: BP: 171/100 2:32 PM: BP: 185/105” There is no documentation from Staff # 10 and Staff # 13 to support the charge nurse being made aware of these abnormal vital signs during Patient # 8’s treatment on 05/10/2024. A review of the facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with a revision date of April 2024 revealed, “PURPOSE: To obtain and document baseline and ongoing information about the patient before, during, and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment, and for reviewing the patient’s response to the treatment and status prior to discharge. POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: i. Measurement of patient temperature ii. Measurement of Blood Pressure (B) 1. Sitting and standing blood pressure measurement required pre and post-treatment ... 2. Intradialytic BP in the sitting/reclined or supine position. iii. Heart or pulse rate, noting also if the beat is regular or irregular. iv. Patient weight v. Patient’s report of well-being, level of pain or discomfort, complaints, hospitalization vi. Vascular access status. 2. The Nursing Assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse or if performance of a nursing assessment is permitted by state law, a licensed practice nurse a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters iv. Verification that the patient access is visible and face is not covered v. Review of documentation for accuracy, completion and patient data vi. A physical assessment of the patient which includes 1. Apical heart rate and rhythm 2. Auscultation of the lungs 3. Evaluation of volume status including edema 4. Bruising or bleeding 5. Patient statement of well-being, level of pain or discomfort 6. And other components which if observed/informed will be documented, including but not necessarily limited to the following: o Change in the normal level of consciousness, mobility, or mental status o Complaint of nausea, vomiting, diarrhea, constipation, skin changes, headache, respiratory distress, angina, weakness, fever, cramping, dizziness o Reports of illness and/or injuries, falls, conditions/complications or other problems the patient has experienced since the last dialysis treatment. 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting) PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. 6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. 7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated. INTRADIALYTIC DATA COLLECTION/ASSESSMENT 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring i. Nocturnal Programs: Treatment checks should be completed at least every 30 minutes prior to the established “lights out” time for the nocturnal program. ii. After the established “lights out” time, treatment checks will remain every 30 minutes with the exception of blood pressure and heart rate. After “lights out” time, blood pressure and heart rate checks will be performed every 60 minutes while the patient is awake and then every three (3) hours once the patient is noted to be sleeping. iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate iii. Blood and dialysate flows, arterial and venous pressures iv. Fluid removal and/or replacement v. Vascular access is visible and line connections are intact vi. Patient subjective statement(s) i.e., patient report on overall health, any complaints c. The vascular access site, bloodline connections, and the patient’s face should be visible throughout the dialysis treatment. d. Hourly heparin infusion ordered by the physician/NPP should be monitored every 60 minutes. e. The arterial and venous drip chamber levels should be observed and adjusted as needed. f. External transducer protectors will be inspected for the presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process. If blood or saline is observed in the external transducer protector, refer to policy: Changing Transducer Protectors OR if Streamline bloodlines are used, and if POD membrane rupture occurs, the whole Streamline bloodline needs to be changed. i. The treatment can continue for this patient on this dialysis delivery system if accurate pressures are observed. Document events and patients’ responses in the electronic treatment record. ii. Upon completion of treatment, the delivery system is to be removed from service and labeled with the date, time, description of the problem, and the name of the teammate reporting the problem. The internal transducer protector will be changed only by a trained Biomed teammate and the dialysis delivery system will be disinfected prior to return to use. 10. If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record. 14. Additional documentation if applicable includes the following: a. All medications including time administered, dose, route, and initials of the person administering the medication (Insulin is verified with a second patient care teammate) b. Indication and patient response to PRN medication c. Lab work POST TREATMENT DATA COLLECTION/ASSESSMENT 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. a. If the patient has received Korsuva (difelikefalin) during the treatment, the licensed nurse will assess the patient prior to discharge. 16. If an abnormal finding(s) or concern is identified post-treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17.Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. ABNORMAL FINDINGS Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Signs/symptoms of hypotension may include: Nausea and vomiting Cold and clammy skin Restlessness Rapid, shallow respirations Excessive yawning Diaphoretic Blood Pressure Post Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg If patient is not able to stand, document reason and sitting BP Sitting BP for patient’s that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg Signs/symptoms of hypotension may include: Nausea and vomiting Cold and clammy skin Restlessness Rapid, shallow respirations Excessive yawning Diaphoretic Dizziness Feeling faint Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat Temperature Pre/Post/PRN: Greater than 100? F or 2 degree rise over baseline Respirations Pre/PRN: Patient complaints of shortness of breath, difficulty breathing Pre/Intra/Post Patient Reports/ Complaints and/or teammate observation of: Pain, chest pain Bleeding or blood in stool Diarrhea, nausea or vomiting Chills New onset of rash, skin lesions, ulcers or change in skin color, new bruising or cuts Weakness or numbness Cramping Changes in mobility, ambulation, or reports of falls Changes in level of consciousness, ability to communicate ...” During an interview with Staff # 20 on 05/14/2024 at 10:00 AM, Staff # 20 acknowledged the staff was not consistently following the facility’s set parameters and notifying the charge nurse when the patient’s vital signs fell outside of those parameters.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility nursing staff failed to evaluate for the determination of the individual anemia management needs. A review of the “Interdisciplinary Rounding Report” revealed the following issues. There were 19 of 56 patients with hemoglobin below 10.0. There were 4 of 56 patients with hemoglobin below 8.0. The facility had 50 of 56 in-center patients receiving erythropoiesis-stimulating agents. An interview with the Interim Facility Administrator on 05/15/2024 at 11:00 AM revealed that she had no knowledge that the facility had 50 of 56 patients taking the erythropoiesis-stimulating agents. The surveyor questioned the Interim Facility Administrator and the Clinical Specialist on the reason for patients’ Hemoglobin fluctuating from normal hemoglobin above 10.0 to below 8.0. No full-time nurse could speak to the hemoglobin. In reviewing the “Interdisciplinary Rounding Report” there were patients with fluctuating hemoglobin. The Clinical Specialist had to review the chart with the surveyor to identify the issues with patients. There had not been an assessment by the nursing staff to evaluate the cause of the fluctuating hemoglobin. The staff had not consulted the nephrologist for further testing or discussed with the patients if they were having any health issues to had caused the low hemoglobin. An interview with the Interim Facility Administrator and the Clinical Specialist on 05/15/2024 at 11:00 AM acknowledged that the nursing staff had not evaluated the patients to determine of their individual anemia management needs.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 48653 Based on record review and staff interviews, the facility’s Interdisciplinary Team failed to ensure Plan of Care meetings were held 3 months after the initial comprehensive assessments of the patient in 1 (# 5) of 8 patient medical records reviewed. Findings include: Patient # 5 A review of patient #5’s medical record revealed an initial Plan of Care meeting was held on May 23, 2023. The 3-month follow-up Plan of Care meeting was not held until September 21, 2023. The 3-month follow-up Plan of Care meeting was greater than 3 months after the initial. A review of the facility’s policy titled, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” dated July 2023 revealed the following: “PURPOSE: To provide guidance for the development of patient assessment and plan of care for teammates. 1. The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or Non-Physician Practitioner (NPP), if allowed by state ESRD licensure regulations, treating the patient for ESRD, a social worker, and a dietitian. 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care. 3. Assessment criteria will include, but not be limited to, evaluation of: Current health status and medical condition, including co-morbid conditions Dialysis prescription, blood pressure, and fluid management needs Laboratory results, immunization history, and medication history Factors associated with anemia and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agents Factors associated with renal mineral and bone disorder Nutritional status by a dietitian Psychosocial needs by a social worker Dialysis access type and performance Patient’s abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process; the preferred modality (hemodialysis or peritoneal dialysis), and setting, (for example, home dialysis), and the patient’s expectations for care outcomes Interest in transplant Family and other support systems Current patient physical activity level Referral to vocational and rehabilitation services 10. An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. 11. After completion of the 90-day re-assessment, the Interdisciplinary Team will conduct an IDT meeting to make adjustments to the Plan of Care. This meeting and initiation of the updated Plan of Care must occur within 15 days of completion of re-assessment. 12. Subsequent interdisciplinary re-assessments should be completed within the 30 days following the initiation of the re-assessment. The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients.” During an interview with Staff # 20 on 05/14/2024 at 2:00 PM, Staff # 20 confirmed the 3-month plan of care meeting was late.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility’s Interdisciplinary Team failed to ensure Plan of Care meetings were held annually after the patient’s admission to the dialysis center for 1 (#6) of 8 patient medical records reviewed. Findings include: Patient # 6 A review of patient # 6’s medical record revealed the patient was admitted on 04/08/2022. An initial Plan of Care meeting was held on 05/03/2022. There was no Plan of Care meeting held in 2023 or 2024. A review of the facility’s policy titled, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” dated July 2023 revealed the following: “PURPOSE: To provide guidance for the development of patient assessment and plan of care for teammates. 1. The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or Non-Physician Practitioner (NPP), if allowed by state ESRD licensure regulations, treating the patient for ESRD, a social worker, and a dietitian. 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care. 3. Assessment criteria will include, but not be limited to, evaluation of: Current health status and medical condition, including co-morbid conditions Dialysis prescription, blood pressure, and fluid management needs Laboratory results, immunization history, and medication history Factors associated with anemia and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agents Factors associated with renal mineral and bone disorder Nutritional status by a dietitian Psychosocial needs by a social worker Dialysis access type and performance Patient’s abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process; the preferred modality (hemodialysis or peritoneal dialysis), and setting, (for example, home dialysis), and the patient’s expectations for care outcomes Interest in transplant Family and other support systems Current patient physical activity level Referral to vocational and rehabilitation services 10. An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. 11. After completion of the 90-day re-assessment, the Interdisciplinary Team will conduct an IDT meeting to make adjustments to the Plan of Care. This meeting and initiation of the updated Plan of Care must occur within 15 days of completion of re-assessment. 12. Subsequent interdisciplinary re-assessments should be completed within the 30 days following the initiation of the re-assessment. The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients.” An interview with Staff # 20 on 05/14/2024 at 2:00 PM, Staff # 20 confirmed there was no Plan of Care meeting documented for 2023 and 2024 for Patient # 6.”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 29191 Based on record review and interview, Interdisciplinary Team (IDT) failed to ensure an assessment and a revised plan of care was completed for 5 (# 2, # 3, # 5, #6, and # 7) of 8 patients within 15 days of the assessment date. Also, the facility staff failed to follow the facility’s policy, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” This deficient practice had the likelihood to cause harm to all patients by using outdated clinical assessments to complete the plan of care. Findings include: Patient #2 A review of patient #1’s assessment by the Registered Dietician revealed the assessment was started on 02/05/2024. The assessment by the social worker revealed the assessment was conducted on 02/06/2024. The Registered Dietician and the Social Worker assessments were greater than 15 days from the Plan of Care. The Plan of Care (POC) was conducted with the interdisciplinary team on 02/26/2024. Patient #3 A review of patient #3’s assessment by the Registered Dietician revealed the assessment was started on 12/18/2023. The assessment by the social worker revealed the assessment was conducted on 12/19/2023. The Registered Nurse revealed the assessment was started on 12/27/2023. The Registered Dietician, Social Worker, and Registered Nurse assessments were greater than 15 days from the Plan of Care. The Plan of Care (POC) was conducted with the interdisciplinary team on 01/17/2024. Patient #5 A review of patient # 5’s medical record revealed a Plan of Care was completed on 09/21/2023. The Registered Dietitian’s assessment was completed on 08/15/2023. The Social Worker’s assessment was completed on 08/16/2023. The Registered Dietitian and Social Worker’s assessments were completed greater than 15 days before the Plan of Care meeting. Another Plan of Care meeting was held on 05/13/2024. The Registered Nurse’s assessment was completed on 03/21/2024. The Registered Nurse’s assessment was completed greater than 15 days before the Plan of Care meeting. Patient #6 A review of patient # 6’s medical record revealed a Plan of Care was completed on 08/16/2022. The Registered Dietitian’s assessment was completed on 07/27/2022. The Social Worker’s assessment was completed on 07/29/2022. The Registered Dietitian’s and Social Worker’s assessments were completed greater than 15 days before the Plan of Care meeting. Patient #7 A review of patient # 7’s medical record revealed a Plan of Care was completed on 10/19/2022. The Registered Dietitian’s assessment was completed on 09/27/2022. The Social Worker’s assessment was completed on 09/27/2022. The Registered Dietitian’s and Social Worker’s assessments were completed greater than 15 days before the Plan of Care meeting. A review of the facility’s policy titled, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” dated July 2023 revealed the following: “PURPOSE: To provide guidance for the development of patient assessment and plan of care for teammates. 1. The facility’s interdisciplinary team (IDT) consists of, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or Non-Physician Practitioner (NPP), if allowed by state ESRD licensure regulations, treating the patient for ESRD, a social worker, and a dietitian. 2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care. 3. Assessment criteria will include, but not be limited to, evaluation of: Current health status and medical condition, including co-morbid conditions Dialysis prescription, blood pressure, and fluid management needs Laboratory results, immunization history, and medication history Factors associated with anemia and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agents Factors associated with renal mineral and bone disorder Nutritional status by a dietitian Psychosocial needs by a social worker Dialysis access type and performance Patient’s abilities, interests, preferences, and goals, including the desired level of participation in the dialysis care process; the preferred modality (hemodialysis or peritoneal dialysis), and setting, (for example, home dialysis), and the patient’s expectations for care outcomes Interest in transplant Family and other support systems Current patient physical activity level Referral to vocational and rehabilitation services 10. An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. 11. After completion of the 90-day re-assessment, the Interdisciplinary Team will conduct an IDT meeting to make adjustments to the Plan of Care. This meeting and initiation of the updated Plan of Care must occur within 15 days of completion of re-assessment. 12. Subsequent interdisciplinary re-assessments should be completed within the 30 days following the initiation of the re-assessment. The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients.” An interview with Staff #20 on 05/14/2024 at 2:00 PM confirmed the plan of care (POC) was conducted greater than 15 days from the start of when the first assessment was completed for patients #2, #3, # 5, # 6, # 7.”

“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: 48653 Based on record review and staff interviews, the facility’s Quality Assurance and Performance Improvement Program (QAPI) failed to identify, analyze, track, and trend data related to patient care and outcomes. Findings include: During a review of the facility’s QAPI program, the surveyor observed the following performance improvement plans: “Hep B Late or Missing Result” The performance improvement plan was created on 09/21/2023 due to 3 patients missing Hepatitis B monthly antigens, and multiple patients without the Hepatitis B vaccine administered or offered in August of 2023. The action included: “Hepatitis audit will be performed per FA or designee after monthly lab draw. All recollects will be entered as indicated.” There was no documentation in the QAPI program to support that the performance improvement plan had been updated or implemented. The action items included in the plan were not completed as of May 2024. “Percentage Phosphorus <= 5.5” The performance improvement plan was created on 12/19/2023 due to the facility having 43% of patients with elevated phosphorus levels. The facility’s goal was 70%. The action included: “The Registered Dietitian to provide education on low phosphorus diets ...” There was no documentation in the QAPI program to support that the performance improvement plan had been updated or implemented. The action items in the plan had not been updated as of May 2024. “Percentage Missed Treatments 3 Months” The performance improvement plan was created on 02/28/2024 due to 7.6% of missed treatments over 3 months. The facility’s goal was 5.8%. The action included: “Clinical team to reschedule missed treatments, IDT to meet weekly in core team to develop individualized, patient-centered treatment plans to improve outcomes and patient quality of care, invite physicians to attend weekly core team to focus on high-risk patients”. In an interview with Staff # 2 on 05/15/2024 at 3:00 PM, Staff # 2 was asked if the physicians were invited to the weekly core team meetings to discuss high-risk patients and missed treatments. Staff # 2 replied, “No we don’t invite them to the weekly core team”. The performance improvement plan’s action items were not followed or updated. There was no update to the plan as of May 2024. A review of the facility’s policy, “CONTINUOUS QUALITY IMPROVEMENT PROGRAM” with a revision date of April 2021 revealed, “PURPOSE: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. POLICY: 1. Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: *Facility Medical Director *Facility Administrator (FA)/designee *Registered Nurse *Biomed Technician *Registered Dietitian *Social Worker 2. Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly. 3. Written documentation and plans of action will be documented within the FHM application known as Facility Health Record and will be maintained in a confidential manner. Copies of the QI meeting minutes will be provided upon request to CMS. 4. The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program including implementation, continuous monitoring, development of action plans and program evaluation. The FA or designee of the facility will serve as the facility program coordinator unless otherwise appointed by the CQI Committee. 5. The facility CQI Program is organized, documented and reflects current knowledge and professional standards. 6. The facility will develop an annual CQI plan/calendar of indicators for review. Annually, a review of the CQI calendar of activities will occur and revisions/updates made as necessary. 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: *Patient Safety, including *Review of sentinel events *Review of trends of adverse patient occurrences including falls and blood loss *Review of product, equipment, or medication notices or recalls *Infection Control, including *Incidence of infections *Vaccination rates for Hepatitis B, Influenza, and Pneumococcal *Adequacy of Dialysis (Kt/V) *Nutritional Status (Albumin) *Mineral Metabolism and Renal Bone Disease *Anemia Management *Vascular Access *Growth and Capacity *Mortality - review of deaths *Hospitalizations and Emergency Ambulance Transfers *Patient Satisfaction and Grievances, including KDQOL *Other indicators as reflected in the Facility Health Record application 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 9. Each action plan will be evaluated as to priority with Patient Safety and Clinical Outcomes indicators considered for the highest level of priority.” During an interview with Staff # 20 on 05/15/2024 at 3:30 PM, Staff # 20 acknowledged the facility’s QAPI program was not tracking and trending patient care and outcome issues.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 48653 Based on record review and staff interviews, the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to address and investigate patient grievances reported to the facility. The QAPI program failed to identify opportunities to improve care through a thorough investigation of the patient grievances received by the facility. Findings include: During a review of the facility’s QAPI program, the surveyor observed that 3 patient grievances had not been reported to QAPI for further investigation and to identify performance improvement opportunities. The following grievances were received by the facility: Documentation reviewed on the “Grievance/Investigation Document” revealed the following, Staff # 2 (Facility Administrator) was reported as the investigator of the Grievance for 02/12/2024. The grievance involved a facility staff member (nurse) giving medication to the incorrect patient during hemodialysis treatment. The incident was not reported to QAPI for further investigation and performance improvement opportunities. Documentation reviewed on the “Grievance/Investigation Document” revealed the following, Staff # 3 (Social Worker) was reported as the investigator of the Grievance for 04/09/2024. The grievance involved a patient reporting issues with Staff # 10. The patient reported Staff # 10 had an attitude and swatted at his hand. The incident was not reported to QAPI for further investigation and performance improvement opportunities. Documentation reviewed on the “Grievance/Investigation Document” revealed the following, Staff # 3 (Social Worker) was reported as the investigator of the Grievance for 04/16/2024.The grievance involved a patient reporting Staff # 10 being rude and rushing through important aspects of care. The incident was not reported to QAPI for further investigation and performance improvement opportunities. Also, the same staff member was mentioned in 2 separate grievances and the QAPI program failed to recognize this trend. A review of the facility’s policy, “CONTINUOUS QUALITY IMPROVEMENT PROGRAM” with a revision date of April 2021 revealed, “PURPOSE: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. POLICY: 1. Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: *Facility Medical Director *Facility Administrator (FA)/designee *Registered Nurse *Biomed Technician *Registered Dietitian *Social Worker 2. Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly. 3. Written documentation and plans of action will be documented within the FHM application known as Facility Health Record and will be maintained in a confidential manner. Copies of the QI meeting minutes will be provided upon request to CMS. 4. The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program including implementation, continuous monitoring, development of action plans and program evaluation. The FA or designee of the facility will serve as the facility program coordinator unless otherwise appointed by the CQI Committee. 5. The facility CQI Program is organized, documented and reflects current knowledge and professional standards. 6. The facility will develop an annual CQI plan/calendar of indicators for review. Annually, a review of the CQI calendar of activities will occur and revisions/updates made as necessary. 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: *Patient Safety, including *Review of sentinel events *Review of trends of adverse patient occurrences including falls and blood loss *Review of product, equipment, or medication notices or recalls *Infection Control, including *Incidence of infections *Vaccination rates for Hepatitis B, Influenza, and Pneumococcal *Adequacy of Dialysis (Kt/V) *Nutritional Status (Albumin) *Mineral Metabolism and Renal Bone Disease *Anemia Management *Vascular Access *Growth and Capacity *Mortality - review of deaths *Hospitalizations and Emergency Ambulance Transfers *Patient Satisfaction and Grievances, including KDQOL *Other indicators as reflected in the Facility Health Record application 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 9. Each action plan will be evaluated as to priority with Patient Safety and Clinical Outcomes indicators considered for the highest level of priority.” During an interview with Staff # 20 on 05/15/2024 at 3:00 PM, Staff # 20 acknowledged the facility did not address patient grievances in the QAPI program.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility governing body failed to ensure that Interim Facility Administrator Staff #2 had a signed job description with work responsibilities. This deficient practice had the likelihood to harm dialysis patients with staff not being aware of the job responsibilities for caring for the facility patients. Findings included: A review of Staff #2’s job description revealed there was no job description in the personnel file. Staff #2 started as the Interim Facility Administrator in July of 2023. A review of the personnel file for Staff #2 revealed the only paperwork in the file was some continuing education hours files. In an interview with Administrative Assistance Staff #1 on 05/15/2024 at 10:30 AM was asked why there was no job description. Staff#1 stated, “I don’t know I looked at the electronic file system and there is nothing there.” In an interview with Clinical Specialist #20 on 05/15/2024 at 10:40 AM was asked was the staff member supposed to have a job description. Staff#20 stated, “All staff members should have a signed job description in their personnel file.”

“QAPI-INDICATOR-PT SATIS & GRIEVANCES CFR(s): 494.110(a)(2)(viii) The program must include, but not be limited to, the following: (viii) Patient satisfaction and grievances. This Standard is not met as evidenced by: 29191 Based on record review and staff interviews, the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to address and investigate patient grievances reported to the facility. The QAPI program failed to identify opportunities to improve care through a thorough investigation of the patient grievances received by the facility. Findings include: During a review of the facility’s QAPI program, the surveyor observed that 3 patient grievances had not been reported to QAPI for further investigation and to identify performance improvement opportunities. The following grievances were received by the facility: Documentation reviewed on the “Grievance/Investigation Document” revealed the following, Staff # 2 (Facility Administrator) was reported as the investigator of the Grievance for 02/12/2024. The grievance involved a facility staff member (nurse) giving medication to the incorrect patient during hemodialysis treatment. The incident was not reported to QAPI for further investigation and performance improvement opportunities. Documentation reviewed on the “Grievance/Investigation Document” revealed the following, Staff # 3 (Social Worker) was reported as the investigator of the Grievance for 04/09/2024. The grievance involved a patient reporting issues with Staff # 10. The patient reported Staff # 10 had an attitude and swatted at his hand. The incident was not reported to QAPI for further investigation and performance improvement opportunities. Documentation reviewed on the “Grievance/Investigation Document” revealed the following, Staff # 3 (Social Worker) was reported as the investigator of the Grievance for 04/16/2024.The grievance involved a patient reporting Staff # 10 being rude and rushing through important aspects of care. The incident was not reported to QAPI for further investigation and performance improvement opportunities. Also, the same staff member was mentioned in 2 separate grievances and the QAPI program failed to recognize this trend. A review of the facility’s policy, “CONTINUOUS QUALITY IMPROVEMENT PROGRAM” with a revision date of April 2021 revealed, “PURPOSE: To improve patient safety and outcomes including the reduction of medical errors in accordance with the Quality Assessment and Performance Improvement (QAPI) requirements in the CMS Conditions for Coverage. POLICY: 1. Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: *Facility Medical Director *Facility Administrator (FA)/designee *Registered Nurse *Biomed Technician *Registered Dietitian *Social Worker 2. Facility Administrators (FAs) conduct periodic Facility Health Meetings (FHM) (also known as QAPI in the CMS Conditions for Coverage) with the CQI committee to review issues and indicators regarding facility’s management and performance. FHMs are conducted monthly. 3. Written documentation and plans of action will be documented within the FHM application known as Facility Health Record and will be maintained in a confidential manner. Copies of the QI meeting minutes will be provided upon request to CMS. 4. The Facility Medical Director is responsible for verifying the execution as well as participation in the Quality Improvement Program including implementation, continuous monitoring, development of action plans and program evaluation. The FA or designee of the facility will serve as the facility program coordinator unless otherwise appointed by the CQI Committee. 5. The facility CQI Program is organized, documented and reflects current knowledge and professional standards. 6. The facility will develop an annual CQI plan/calendar of indicators for review. Annually, a review of the CQI calendar of activities will occur and revisions/updates made as necessary. 7. The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: *Patient Safety, including *Review of sentinel events *Review of trends of adverse patient occurrences including falls and blood loss *Review of product, equipment, or medication notices or recalls *Infection Control, including *Incidence of infections *Vaccination rates for Hepatitis B, Influenza, and Pneumococcal *Adequacy of Dialysis (Kt/V) *Nutritional Status (Albumin) *Mineral Metabolism and Renal Bone Disease *Anemia Management *Vascular Access *Growth and Capacity *Mortality - review of deaths *Hospitalizations and Emergency Ambulance Transfers *Patient Satisfaction and Grievances, including KDQOL *Other indicators as reflected in the Facility Health Record application 8. Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 9. Each action plan will be evaluated as to priority with Patient Safety and Clinical Outcomes indicators considered for the highest level of priority.” During an interview with Staff # 20 on 05/15/2024 at 3:00 PM, Staff # 20 acknowledged the facility did not address patient grievances in the QAPI program.”