Cherokee Community 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: 49894 Based on observations and staff interview, it was determined the facility failed to prepare saline syringes for use during the dialysis procedure in a clean area separate from the dialysis station. This deficient practice affected Patient Identifier (PI) # 4 and had the potential to negatively affect all patients requiring saline flushes during the dialysis procedure. Findings include: An observation was conducted on 12/18/24 at 10:15 AM with Employee Identifier (EI) # 2, Registered Nurse, performing initiation of dialysis with a Central Venous Catheter (CVC) and CVC exit site care for PI # 4 at station 4. After performing exit site care and hub disinfection, EI # 2 handed EI # 5, Certified Clinical Hemodialysis Technician, two ten milliliter (ml) syringes, in the packaging, and asked EI # 5 to draw up saline from the tubing connected to the saline bag hanging at the patient’s station. EI # 5 cleaned the port on the saline tubing, removed the first syringe from the package, connected it to the port on the saline tubing and withdrew ten ml of saline from the line, then handed it back to EI #2. EI # 5 then repeated the process with the second syringe. EI # 2 flushed the CVC limbs with the saline drawn from the saline bag and tubing. An interview was conducted on 12/18/24 at 3:34 PM with EI # 1, Facility Administrator, who confirmed this was the procedure they were currently using for saline flushes due to the lack of availability of pre-filled saline syringes. EI # 1 also confirmed the facility failed to prepare saline syringes in a clean area away from the dialysis station.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 49894 Based on facility policy, facility Medication Discrepancy Report, and patient and staff interviews, it was dertermined the facility failed to inform patients of all aspects of his/her care, which included failure to administer medications ordered by the Medical Director and included in the patient Plan of Care. Failure to inform patients of changes to their medication treatments, the failure to administer prescribed medication for the management of anemia, did not allow the patients’ rights and the ability to exercise their rights to to be protected. This failure did affect twenty-five of twenty-five patients with a physican’s order to receive medications for the management of anemia, including Patient Identifiers (PI) # 1, PI # 2, PI # 3, PI # 4, PI # 5, PI # 6, PI # 7, PI # 8, and had the potential to not allow all thirty patients receiving in-center hemodialysis the opportunity to make informed decisions about his/her care. Findings include: Facility Policy: Patient Rights and Responsibilities Policy Number: Hemodialysis- Policy 403 Effective Date: Not listed Policy: ...Patient rights and the ability to exercise these rights must be protected by the facility. ...The Conditions for Coverage, 494.70 Condition: Patient rights: 1. To be informed of these rights, ...by the patient’s written acknowledgement, or by documentation by staff in the medical record...in terms the patient could understand... 2. To be fully informed of all services available in the facility... ...4. To receive from the patient’s physician(s) or clinical practioner(s), in terms that the patient understands, an explanation of his/her complete medical/health condition or diagnosis, recommended treatment, treatment options,...and expected result(s). If this information would be detrimental to the patient’s health, or if the patient is not capable of understanding the information, the explanation shall be provided to the next of kin or guardian. 5. To participate in the planning of the patient’s care and treatment, and to refuse medication and treatment..documented in the patient’s medical record. ...8. To receive a full explanation of the nature of and necessity for recommended treatment..., including the risks and side effects, and other treatment options before giving consent... 49603 Review of the Medication Discrepancy Report (MDR) revealed PI # 1 had missed two doses of Venofer from 11/8/24 to 11/27/24 due to the medication not being stocked at the facility. Further review of the MDR revealed PI # 2 missed two doses of Venofer from 11/8/24 to 11/27/24 due to lack of stock at the facility. Further review of the MDR revealed PI # 3 missed one dose of Venofer on 11/8/24 due to lack of stock at the facility. Further review of the MDR revealed PI # 4 missed one dose of Venofer from 11/21/24 to 11/27/24 due to the medication not being stocked at the facility. Further review of the MDR revealed PI # 5 missed one dose of Venofer from 11/21/24 to 11/27/24 due to lack of stock at the facility. Further review of the MDR revealed PI # 6 missed one dose of Venofer due to lack of stock at the facility on 11/26/24. Futher review of the MDR revealed PI # 7 had missed one dose of Venofer due to lack of stock at the facility on 11/22/24. Further review of the MDR revealed PI # 8 had missed one dose of Venofer on 11/27/24 due to the medication not being stocked at the facility. Interviews were conducted on 12/17/24 and 12/18/24 with five of five patients (PI # 1, PI # 4, PI # 6, PI # 7, PI # 8) receiving dialysis treatments. The patients were asked if they had been informed of any medications they had not been given? No patients reported missed medications due to the medications not being available and out of stock at the dialysis clinic. An interview was conducted on 12/18/24 at 10:20 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed ordered medications were not in stock/available at the facility from 11/21/24 through 11/27/24. EI # 1 also confirmed none of the patients were informed of the missed medication doses.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 49894 Based on medical records reviewed (MR), hemodialysis standing orders, facility policies, the Anemia Management Report, the Venofer ordered/given Report, Quality Assessment Performance Improvement (QAPI) data, observations, and staff interviews, it was determined the Medical Director failed to ensure the facility implemented patient care policies directly affecting patient care outcomes in Emergency Preparedness, Infection Control, Water and Dialysate Quality, Patient Assessment, Patient Plan of Care, and the QAPI Program. Refer to E 0028, V 111, V 113, V 116, V 122, V 184, V 250, V 260, V 506, V 543, V 544, V 547, V 550, V558, V 628, V 637, V 639, V 712, and V 715”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49894 Based on medical records (MR) reviewed, observations, hemodialysis standing orders, facility policies and procedures, Quality Assessment and Performance Improvement (QAPI) data, and staff interviews, it was determined the Governing Body failed to ensure the governance of the health and safety of patients by ensuring implementation of patient care policies directly affecting patient health and safety in Emergency Preparedness, Infection Control, Water and Dialysate Quality, Patient Assessment, Patient Plan of Care, and the QAPI Program. Refer to E 0028, V 111, V 113, V 116, V 122, V 184, V 250, V 260, V 506, V 543, V 544, V 547, V 550. V 558, V 628, V 637, V 639, V 712, V 715, and V 751”

“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: 49603 Based on review of facility policy, observation and staff interview, it was determined the facility failed to ensure emergency supplies on the Emergency Cart were ready for immediate use and not expired. This deficient practice had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings Include: Facility Policy: Emergency Equipment and Medication Checks Policy Number: Hemodialysis: Policy 630 Purpose: To make sure that daily clinic operations include a check that all emergency drugs and equipment are available, not expired and in good working order. Policy: 1. Every facility will have emergency equipment and supplies available, in date, and in proper working order every operating day. Facility Procedure: Emergency Equipment and Medication Checks Procedure Number: Hemodialysis: Procedure 630A Procedure: ...The following equipment should be checked each operating day: Automated External Defibrillator (AED)...to verify proper functioning. ...Medications and supplies are checked for expiration dates and discarded if expired...These items must be ordered and replaced before the actual expiration date. An observation of the Emergency Cart and contents was conducted on 11/5/24 at 11:28 AM. The AED Pad-Pak, Battery and Defib Pads were found in the Emergency Cart ready for immediate patient use with expiration date of 6/1/24. An interview was conducted on 11/5/24 at 11:30 AM with Employee Identifier (EI) # 3, Registered Nurse, who confirmed staff had failed to ensure all Emergency Cart supplies were ready for immediate patient use and not expired. 49894”

“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: 49603 Based on observation, review of facility policy, and staff interview, it was determined the facility failed to maintain a clean, safe, and aesthetically pleasant environment for patients and prevent the possible spread of infectious disease. This deficient practice had the potential to negatively affect all thirty-one patients dialyzing at the facility. Facility Policy: Cleaning and Disinfection Policy Number: Hemodialysis Policy 787 Date Published: None Listed ...All equipment and work surfaces shall be cleaned and decontaminated after completion of procedure. ...Clean dialysis station (chairs,...) after each patient treatment...with 1:100 bleach solution... An observation of care was conducted on the treatment floor on 11/5/24 at 12:30 PM. Tears in the vinyl on the following patient treatment chairs were observed: 1. On the treatment floor, not at a station, an approximate four-inch-long tear in the vinyl on the chair head rest. 2. At station five, two vinyl tears, one approximate two-inch- long and one approximate four-inch-long in the chair head rest. An interview was conducted on 11/7/24 at 2:20 PM with Employee Identifier # 1, Facility Administrator, who confirmed the vinyl tears on the patient treatment chairs. 49894”

“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: 49894 Based on observations, review of facility policies, and staff interviews, it was determined the facility failed to ensure: 1. Staff performed hand hygiene prior to donning gloves. 2. Patients performed hand hygiene after removing gloves. This affected Patient Identifier (PI) # 9 in one of two observations of discontinuation of dialysis with a Central Venous Catheter (CVC), PI # 10 and PI # 11 in two of two observations of initiation of dialysis with an Arteriovenous Fistula/Graft (AVF/AVG), PI # 8 in one of one observation of initiation of dialysis with a CVC, which included CVC exit site care, and PI # 7 and PI # 2 in two of two observations of discontinuation of dialysis with an AVF/AVG, and one unsampled patient, and had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings include: Facility Policy: Infection Control: Exposure Task List, Guidelines for Dialysis Precautions Policy Number: Hemodialysis: Policy 723 Date Published: None Listed Hand hygiene should be performed: After each patient contact, Entering patient care area to do patient care, Before putting on gloves, After removing gloves, After holding needle sites. Facility Policy: Infection Control Dialysis Precautions Policy Number: Hemodialysis: Policy 722 Date Published: Not Listed ...Policy: Computer Use Use clean hands without gloves on touch screen computers and keyboards. 1. During observations on the treatment floor on 11/5/24 at 11:30 AM, the surveyor observed Employee Identifier (EI) # 3, Registered Nurse, on two separate occasions, reach into a box and obtain and don clean gloves without first performing hand hygiene. EI # 3 proceeded to enter the dialysis station and perform care. An interview was conducted on 11/7/24 at 2:00 PM with EI # 1, Facility Administrator, who confirmed staff should perform hand hygiene prior to donning gloves. 2. An observation was conducted on 11/5/24 at 12:15 PM to observe EI # 5, Certified Clinical Hemodialysis Technician (CCHT), discontinue dialysis and perform post dialysis care for an AVF/AVG for PI # 7 at station 5. PI # 7 donned a glove and held pressure to the cannulation site after removal of the needle. After hemostasis was achieved, PI # 7 removed the glove, walked to the scales to weigh, then left the treatment floor without performing hand hygiene. An interview was conducted on 11/7/24 at 2:00 PM with EI # 1, who confirmed staff failed to ensure the patient performed hand hygiene after removing the glove. 3. An observation was conducted on 11/5/24 at 12:45 PM to observe EI # 5 discontinue dialysis and perform post dialysis care for an AVF/AVG for PI # 2 at station 3. PI # 2 donned a glove and held pressure to the cannulation sites after removal of the needles. After hemostasis was achieved, PI # 2 walked to the scales, then left the treatment floor while wearing the contaminated glove. An interview was conducted on 11/7/24 at 2:00 PM with EI # 1, who confirmed staff failed to ensure patients removed contaminated gloves and performed hand hygiene prior to exiting the treatment floor. 4. During observations on the treatment floor on 11/5/24 at 1:45 PM, the surveyor observed an Unsampled Patient at station 6, holding pressure on his/her arm with a gloved hand. After hemostasis was achieved, the patient removed the glove and left the treatment floor without performing hand hygiene. An interview was conducted on 11/7/24 at 2:00 PM with EI # 1, who confirmed staff failed to ensure patients performed hand hygiene after glove removal. 5. An observation was conducted on 11/6/24 at 8:25 AM with EI # 3, discontinuing dialysis with a CVC for PI # 9 at station 4. EI # 3 failed to perform hand hygiene prior to donning gloves. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, who confirmed staff failed to perform hand hygiene prior to donning gloves per facility policy. 6. An observation of care was conducted on 11/6/24 at 9:10 AM with EI # 4, CCHT, accessing the AVF/AVG and initiating dialysis for PI # 10 at station 4. After palpating the patient’s access, EI # 4 failed to perform hand hygiene and change gloves before cleaning the patient’s access for cannulation. After initiating treatment, EI # 4 removed his/her gloves, and without performing hand hygiene, retrieved gloves from the glove box and donned them. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 7. An observation was conducted on 11/6/24 at 9:40 AM with EI # 4 accessing the AVF/AVG and initiating dialysis for PI # 11 at station 9. After palpating the patient’s access, EI # 4 failed to perform hand hygiene and change gloves before cleaning the patient’s access for cannulation. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 8. An observation was conducted on 11/6/24 at 10:00 AM with EI # 3 initiating dialysis with a CVC for PI # 8 at station 1. After performing exit site care, EI # 3, attached the patient’s heparin to the dialysis machine and then assessed the patient. Without removing gloves and performing hand hygiene, EI # 3 documented on the chairside computer. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy. 39098”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 49894 Based on observations, review of facility policy, and staff interview, it was determined the facility failed to ensure: 1. Staff dedicated supplies taken to the dialysis station for single patient use. 2. Staff did not place contaminated items in clean areas designated for the storage and handling of unused supplies and equipment. This practice had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings include: Facility Policy: Infection Control: Dialysis Precautions Policy Number: Hemodialysis: Policy 722 Date Published: Not listed Application of Dialysis Precautions: The components of Dialysis Precautions are described below...to prevent transmission from exposure to...blood Policy: ...The patient treatment area shall have designated “clean” and “dirty” areas.. Clean area: An area designated for clean and unused equipment and supplies and medications. Examples are...areas where clean supplies are stored. Dirty area: An area where there is a potential for contamination with blood...and where contaminated or “used” supplies...are handled. Examples of dirty areas include...the entire patient station where the patient is dialyzing. Clean versus Contaminated Areas: Clean areas shall be clearly marked and designated for the handling and storage of...unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies...are stored. Items taken to the dialysis station should be disposed of, dedicated for use only on a single patient, or cleaned and disinfected as appropriate before they are taken to a common area or used on another patient. An observation was conducted on 11/6/24 at 8:30 AM of urine specimen cups in a plastic container on the countertop in the clean area. Each specimen cup was labeled with a patient name and contained a roll of tape. The specimen cup was taken to the patient station at the time of treatment. Before returning the cups containing the tape to the clean area, the specimen cups were not disinfected per facility policy. An interview was conducted on 11/7/24 at 2:10 PM with Employee Identifier # 1, Facility Administrator, who confirmed the specimen cups were not disinfected per policy before returning to the designated clean area.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 49894 Based on observations, review of facility policy, and staff interview, it was determined the facility failed to ensure staff cleaned and disinfected the dialysis station per the facility policy. This had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings include: Facility Policy: Cleaning and Disinfection Policy Number: Hemodialysis Policy 787 Date Published: Not listed ...All equipment and work surfaces shall be cleaned and decontaminated after completion of procedures. ...Clean dialysis station (chairs, bed, table, machine, IV pole...hand sanitizer dispenser and holder, etc.) after each patient treatment and before the next patient with a 1:100 bleach solution... ...Clean and disinfect all equipment that is to be removed from the patient treatment areas. Cleaning The Dialysis Machine Externally disinfect the dialysis machine with 1:100 bleach solution... 1. During observations on the treatment floor on 11/5/24 at 1:20 PM, the surveyor observed Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician, clean and disinfect station 5. Following disinfection, a stack of 5 large rolls of tape remained on the back counter, available for patient use. EI # 5 failed to discard the tape. An interview was conducted on 11/7/24 at 2:00 PM with EI # 1, who confirmed staff failed to clean the dialysis station per policy. 2. An observation was conducted on 11/5/24 at 1:35 PM to observe EI # 5, clean and disinfect dialysis station 3. EI # 5 failed to clean and disinfect the outside of the right chair arm and beneath the side table. EI # 5 closed both side arms of the chair while the surface was glistening wet, without allowing the surface to dry. EI # 5 cleaned the blood pressure cuff and tubing, then placed them on the back of the chair, prior to cleaning the chair. When cleaning the dialysis machine, EI # 5 failed to clean all four prongs at the top of the intravenous pole, the prime bucket, Hansen connectors, and left side of the machine, including the wire basket and hand sanitizer. EI # 5 failed to clean the back counter behind the chair, and a large roll of tape was left on the counter, available for patient use, after the station had been cleaned and disinfected. An interview was conducted on 11/7/24 at 2:00 PM with EI # 1, who confirmed staff failed to clean and disinfect the dialysis station per facility policy. 3. An observation of cleaning and disinfection of the dialysis station was observed on 11/6/24 at 8:35 AM with EI # 5 at station 4. After removing the bloodlines and disposable equipment from the machine, EI # 5 emptied the prime waste receptacle in the wall box behind the patient station. EI # 5 failed to clean the machine Hansen connectors, IV pole, and the entire left side of the machine including the blood pressure cuff basket and hand sanitizer dispenser and holder. EI # 5 then wiped the blood pressure cuff and cord and placed it in the dirty basket on the side of the machine. After wiping the chair, EI # 5 failed to allow the chair to dry completely before closing the chair arms and returning the chair to the upright position and failed to wipe the countertop behind the patient station. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, Facility Administrator, who confirmed staff failed to clean and disinfect the dialysis station per facility policy. 39098”

“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: 49894 Based on observation and staff interviews it was determined the facility failed to restrict access to the water purification and storage system to only authorized users. Failure to restrict access to the water purification and storage area had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings Include: A Flash Tour of the facility was conducted on 11/5/25 at 11:45 AM. The door to access the water purification and storage area was propped open. It remained unsecured the rest of the day. On 11/6/24 at 8:30 AM, the surveyors returned to the treatment floor for observation. The access door was propped open and remained that way until 10:30 AM. An interview was conducted on 11/7/24 at 2:10 PM with Employee Identifier # 1, Facility Administrator, who confirmed the access to the water purification room should be limited to authorized users and should remain secured at all times.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 49894 Based on review of medical records (MR), facility policy, and staff interview, it was determined the facility failed to ensure independent conductivity values of the dialysate matched the value displayed by the dialysis machine by plus/minus (+/-) 0.4 milliSiemens/centimeter (mS/cm). This affected Patient Identifier (PI) # 6, PI # 1, and PI # 2 in three of six medical records reviewed, and had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings Include: Facility Policy: Independent Verification of Dialysate Conductivity Policy Number: Hemodialysis: Policy 950 Date Published: Not Listed Purpose: To ensure the delivery system provides dialysate with proper conductivity and potential for hydrogen (pH) to deliver safe hemodialysis treatments. ...3. Documentation of independent verification of dialysate conductivity will be done on the dialysis treatment log prior to every patient treatment. 4. No hemodialysis machine will be used for patient treatments if independent confirmation of dialysate conductivity indicates that the system’s dialysate composition falls outside of acceptable parameters. The independent conductivity value must match the value displayed by the delivery system within a range of +/- 0.4. 1. PI # 6 was admitted to the facility on 8/6/18 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the treatment sheet (TS) dated 10/29/24 revealed an independent conductivity value of the dialysate was documented as 14. The machine conductivity value was documented 13.5, which is 0.5 and not +/- 0.4. An interview was conducted on 11/7/24 at 2:10 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed staff failed to ensure the independent conductivity value was within a range of +/- 0.4 of the value displayed by the machine per the facility policy. 2. PI # 1 was admitted to the facility on 5/11/20 with a diagnosis of ESRD. Review of the TS dated 10/26/24 revealed an independent conductivity value of the dialysate was documented as 13.6. The machine conductivity value was documented 14.1, which is 0.5 and not +/- 0.4. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, who confirmed staff failed to ensure the independent conductivity value was within a range of +/- 0.4 of the value displayed by the machine per the facility policy. 39098 3. PI # 2 was admitted to the facility on 8/15/24 with a diagnosis of ESRD. Review of the TS dated 10/22/24 revealed an independent conductivity value of the dialysate was documented as 13.2. The machine conductivity value was documented 13.7, which is 0.5 and not +/- 0.4. Review of the TS dated 10/26/24 revealed there was no independent conductivity value of the dialysate documented, as required, prior to patient treatment. Review of the TS dated 10/31/24 revealed an independent conductivity value of the dialysate was documented as 13.5. The machine conductivity value was documented 14.0, which is 0.5 and not +/- 0.4. Review of the TS dated 11/2/24 revealed an independent conductivity value of the dialysate was documented as 13.5. The machine conductivity value was documented 14.0, which is 0.5 and not +/- 0.4. An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, who confirmed staff failed to ensure the independent conductivity value was within a range of +/- 0.4 of the value displayed by the machine per the facility policy.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 49603 Based on review of facility personnel files, Total Chlorine logs, and interview with facility staff, it was determined the facility failed to ensure staff responsible for total chlorine testing were qualified. This affected one of five personnel files reviewed, and had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings include: A review of the personnel file documentation for Employee Identifier (EI) # 6, Registered Nurse (RN), revealed a failed color-blind test on 10/12/20. Further review of the Total Chlorine Logs dated September and October 2024 revealed EI # 6 verified sample results performed by non-licensed staff. An interview conducted on 11/7/24 at 10:00 AM with EI # 1, Facility Administrator, confirmed the above findings. 49894”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 39098 Based on review of hemodialysis standing orders, observation, and interviews, it was determined the facility failed to: 1. Offer the flu vaccine to all patients per facility policy. 2. Stock Tubersol (Tuberculin Purified Protein Derivative [PPD]) per facility policy. This had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings include: Facility Policy: Hemodialysis Standing Orders Policy Number: None listed Date Revised: 1/24 ...Influenza Vaccine: Effective during influenza season. Obtain patient consent... If patient declines vaccination, obtain signature on declination form. Provide patient with vaccine information sheet... Verify patient has not received vaccination from another facility... Verify dosage...Administer appropriate dosage for current year influenza vaccination... TB (Tuberculosis) Test: ...Complete TB questionnaire. Obtain patient consent prior to administration of skin test. Administer PPD Tuberculin 0.1 milliliter intradermal on admission and annually. Read test results in 48-72 hours, document in millimeters... A tour of the treatment floor was conducted on 11/5/24 at 11:45 AM. The contents of the medication refrigerator were observed. There were no flu vaccines in the refrigerator. The Sanofi Pasteur Tubersol (Tuberculin PPD) had an opened date of 9/19/24, which is more than 28 days after opening. Employee Identifier (EI) # 3, Registered Nurse, confirmed in an interview during the tour the medication was past the 28 day expiration date. An interview conducted on 11/7/24 at 3:00 PM with EI # 1, Facility Administrator, confirmed there were no flu vaccines obtained for the 2024 - 2025 flu season, due to lack of financial resources. 49894”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 49894 Based on review of medical records (MR), facility policy, and staff interview, it was determined the facility failed to ensure staff performed vital signs and safety checks at least every thirty minutes per facility policy. This affected Patient Identifier (PI) # 6, PI # 1, PI # 2, PI # 4, and had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings include: Facility Policy: Intradialytic Treatment Monitoring Policy Number: Hemodialysis: Policy 1005 Date Published: Not Listed Policy: 1. Treatment checks should be completed at least every thirty minutes. 2. At a minimum, obtain and document the following: blood pressure, heart rate, machine parameters per flowsheet, heparinization, fluid removal and/or replacement, vascular access status and line connections, patient status and subjective well-being. 1. PI # 6 was admitted to the facility on 8/6/18 with a diagnosis of End Stage Renal Disease (ESRD). Review of the treatment sheet (TS) dated 10/24/24 revealed six vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/26/24 revealed five vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/29/24 revealed two vital signs and safety checks not verified by staff at least every 30 minutes. An interview was conducted on 11/7/24 at 2:10 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the staff failed to complete and document vital signs and safety checks at least every 30 minutes per the facility policy. 2. PI # 1 was admitted to the facility on 5/11/20 with a diagnosis of ESRD. Review of the TS dated 10/26/24 revealed three vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/29/24 revealed two vital signs and safety checks not verified by staff at least every 30 minutes. An interview was conducted on 11/7/24 at 2:15 PM with EI # 1, who confirmed the staff failed to complete and document vital signs and safety checks at least every 30 minutes per the facility policy. 39098 3. PI # 2 was admitted to the facility on 8/15/24 with a diagnosis of ESRD. Review of the TS dated 10/22/24 revealed a vital sign and safety check was not verified by staff for 61 minutes. Review of the TS dated 10/26/24 revealed five vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/29/24 revealed two vital signs and safety checks not verified by staff at least every 30 minutes. An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, who confirmed staff failed to document the vital signs and safety checks every 30 minutes. 4. PI # 4 was admitted to the facility on 3/22/22 with a diagnosis of ESRD. Review of the TS dated 10/24/24 revealed 2 vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/26/24 revealed 5 vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/29/24 revealed 4 vital signs and safety checks not verified by staff at least every 30 minutes. Review of the TS dated 10/31/24 revealed 1 vital signs and safety check not verified by staff at least every 30 minutes. Review of the TS dated 11/2/24 revealed 1 vital signs and safety check not verified by staff at least every 30 minutes. An interview was conducted on 11/7/24 at 1:30 PM with EI # 1, who confirmed staff failed to document the vital signs and safety checks every 30 minutes.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 49894 Based on review of medical records (MR), facility policies, and staff interviews, it was determined the facility failed to ensure: 1. Staff followed the physician’s prescription for Blood Flow Rates (BFR) and documented the reason BFR was not as prescribed. 2. Staff administered Vancomycin (antibiotic used to treat infections in dialysis) over a period of not less than one hour (60 minutes) during the last half of the dialysis treatment. 3. Staff properly documented heparin administered by infusion pump in the patient’s record. 4. Staff had patients sign an Early Treatment Termination Against Medical Advice form. This affected Patient Identifier (PI) #6, PI # 4, and had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings Include: Facility Policy: Intradialytic Treatment Monitoring Policy Number: Hemodialysis: Policy 1005 Date Published: Not Listed Purpose: To provide an effective, safe, and comfortable dialysis treatment to every patient in accordance with his/her plan of care. Policy: ...2. At a minimum, obtain and document the following: ...machine parameters per flow sheet, heparinization... ...4. Appropriate action is taken and documented, including patient response. ...6. All findings, interventions, and patient response will be documented in the patient’s medical record. 7. Additional documentation should include the following: All Medications including time administered, dose, route... Facility Policy: Vancomycin Hydrochloride (Vancocin HCL) Policy Number: Hemodialysis: Policy 6030 Date Published: Not listed ...3. Vancomycin must be administered in a dilute solution slowly over a period of not less than one hour (60 minutes). ...5. Administer Vancomycin during the last half of treatment. Facility Procedure: Vancomycin Hydrochloride (Vancocin HCL) Procedure Number: Procedure 6030A Date Published: Not listed Procedure: ...Document the dose of Vancomycin given, the time administered, ...patient’s response and your legal signature on the patient record Facility Procedure: Heparin Procedure Number: Hemodialysis: Policy 6026A Date Published: Not listed Procedure The heparin dose is part of the patient’s dialysis prescription... If administering heparin using a continuous infusion pump, verify that the pump is set to deliver the proper heparin dosage ordered by the physician. Also verify that the stop time for the infusion is correct. Document the heparin dose(s) administered and any comments neccessary...on the patient’s dialysis record. Facility Policy: Against Medical Advice (AMA) Policy Number: Hemodialysis: Policy 410 Date Published: Not Listed Purpose: To be sure patients are adequately informed of the risks of their action or non-action in relation to following medical orders and to ensure documentation of communication with the patient informing him/her that the facility will not assume any further responsibility for anything that might occur from their actions of acting against medical advice. Policy: ...2. If the teammate is unable to convince the patient to follow the order, the teammate must complete the AMA form with the patient and obtain the patient’s signature. 3. The AMA form will be retained in the patient’s medical record. ...6. AMA’s should be completed for dialysis treatments shortened by the patient for more than 15 minutes. 1. PI # 6 was admitted to the facility on 8/6/18 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Dialysis Medications (DM) revealed an order with a start date of 11/1/24 for Vancomycin/vancocin 500 milligrams (mg) Intravenous (IV) Piggyback (IVPB) to be given every dialysis treatment. Review of the treatment sheet (TS) dated 10/26/24 revealed the treatment was initiated at 5:18 AM and was terminated at 9:22 AM. Further review of the TS dated 10/26/24 revealed an order for Vancomycin/vancocin 1000 mg IVPB. It was documented as given at 10:24 AM, which is after the treatment ended. Review of the TS dated 10/29/24 revealed the treatment was initiated at 5:19 AM and was terminated at 9:23 AM. Further review of the TS dated 10/29/24 revealed an order for Vancomycin/vancocin 500 mg IVPB. It was documented as given at 5:32 AM, which is not the last hour of treatment. Review of the TS dated 11/5/24 revealed the treatment was initiated at 5:12 AM and was terminated at 8:58 AM. Further review of the TS reveals the Vancomycin 500 mg IVPB is documented at 8:05 AM, which was not at least one hour before the treatment ended. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, Facility Administrator, who confirmed staff failed to document administer Vancomycin over at least an hour during the last half of treatment per the facility policy. 39098 2. PI # 4 was admitted to the facility on 3/22/22 with a diagnosis of ESRD. Review of the dialysis orders, printed on 11/5/24, revealed a BFR of 350 to 400, treatment time 4:30, and an order for Heparin 500 units/hour with “0” (zero) = (equals) No turnoff, every treatment, with a start date of 4/9/24. Review of the TS dated 10/24/24 revealed a treatment time of 3:59. The Registered Nurse (RN) documented the Heparin infusion ran for a time of 4:30. The RN failed to document the correct amount of Heparin. There was no AMA form completed for the early termination. Review of the TS dated 10/26/24 revealed a treatment time of 4:02. The RN documented the Heparin infusion ran for a time of 4:30. The RN failed to document the correct amount of Heparin. There was no AMA form completed for the early termination. Further review of the TS dated 10/26/24 revealed the BFR was 300 from 4:47 AM to 8:47 AM. There was no reason documented why the BFR was not at the ordered rate. Review of the TS dated 10/29/24 revealed a treatment time of 4:00. The RN documented the Heparin infusion ran for a time of 4:30. The RN failed to document the correct amount of Heparin. There was no AMA form completed for the early termination. Further review of the TS dated 10/29/24 revealed the BFR was 300 from 4:55 AM to 8:57 AM. There was no reason documented why the BFR was not at the ordered rate. An interview was conducted on 11/7/24 at 1:30 PM with EI # 1, who confirmed the staff failed to document the correct amount of Heparin administered, complete the required AMA forms, and document why the BFR was not at the ordered rate.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 49894 Based on review of medical records (MR), Venofer ordered/given Report, Anemia Management Report, facility policy, and staff interviews, it was determined the facility failed to administer intravenous (IV) iron to patients per the physician’s order. This deficient practice affected 21 of 31 patients with physician ordered Venofer, and had the potential to negatively affect all patients needing IV iron. This did affect Patient Identifier (PI) # 1, PI # 2, PI # 4, and 18 unsampled patients. Findings include: Facility Policy: Hemodialysis Venofer (Iron) Dosing Guidelines Policy Number: Not Listed Revised: 1/24 Iron Dosing Goal: Maintain Transferrin Saturation (T-Sat) greater than (>) 30 percent (%) and less than (<) 50% Maintain Ferritin > 200 nannograms per milliliter (ng/ml) and < 800 ng/ml Iron Therapy: Initiate iron therapy using iron sucrose (Venofer) Iron Loading: If the patient’s T-Sat is < 30% and the Ferritin is < 200 ng/ml, administer Venofer 100 milligrams ( mg) IV push every treatment times (x) 10 doses. NOTE: If the T-Sat is < 30% then the full series of Venofer loading doses should be administered prior to starting an iron maintenance program. Iron Maintenance: If the patient T-Sat is 30-50% and the Ferritin is < 800 ng/ml, administer iron therapy as indicated below: a. Venofer 100 mg IV Push every two weeks for Ferritin 200-800 OR b. Venofer 200 mg IV Push every two weeks for Ferritin <200. NOTE: Any time the patient’s T-Sat drops to < 30% and the Ferritin is < 800 ng/ml, the maintenance program should be stopped, and a full series of iron loading dose/repletion should be administered. Iron Stop: 1. If the patient’s T-Sat is > 50% OR Ferritin is > 800 ng/ml STOP the iron therapy. 2. Restart iron therapy when both the T-Sat is < 50% and the Ferritin is < 800 ng/ml. 3. If the patient has an active infection (i.e. on oral (PO) or IV antibiotics) stop the iron and restart when antibiotic therapy is completed. Notify the MD for specific orders: 1. If the T-Sat is < 50% and the Ferritin > 800. 2. If the Hemoglobin (Hgb) is > 12 with T-Sat < 50% and Ferritin > 800 ng/ml. Iron Therapy monitoring: 1. Monitor Ferritin monthly. 2. Monitor T-Sat monthly. 3. A time lapse must occur between last iron dose and drawing the specimen for Ferritin and T-Sat (Venofer > 24-48 hours). 4. Draw lab prior to dialysis. 1. PI # 1 was admitted to the facility on 5/11/20 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Anemia Management Report revealed PI # 1 had Iron (66), T-Sat (29), and Ferritin (325) values that were trending down. Review of the Venofer ordered/given Report revealed PI # 1 was ordered Venofer 100 mg on 8/1/24 and 8/8/24. Both doses were documented “Held” on the report indicating it was not administered. Further review of the Venofer ordered/given Report revealed 18 unsampled patients had not received their ordered Venofer doses since 8/1/24. An interview was conducted on 11/7/24 at 9:20 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the facility failed to administer Venofer per the physician’s order. 39098 2. PI # 2 was admitted to the facility on 8/15/24 with a diagnosis of ESRD. Review of the dialysis orders, printed on 11/5/24, revealed an order for Venofer 100 mg IV push, every treatment, with a start date 8/17/24. Review of six treatment sheets (TS), dated 10/22/24 to 11/5/24, revealed the registered nurse (RN) documented the Venofer was “Held.” The reason listed was “Out of stock” or “No stock.” An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, who confirmed the staff did not administer the ordered Venofer due to having none available in the facility. 3. PI # 4 was admitted to the facility on 3/22/22 with a diagnosis of ESRD. Review of the dialysis orders, printed on 11/5/24, revealed an order for Venofer 100 mg IV push, monthly, with a start date of 5/10/24. Review of the TS dated 10/29/24 revealed the RN documented the Venofer was “Held.” There was no reason documented why the Venofer was not administered. An interview was conducted on 11/7/24 at 1:30 PM with EI # 1, who confirmed the staff failed to administer the ordered Venofer due to having none available in the facility.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 49894 Based on observations, medical records (MR) reviewed, facility policy and procedure, and staff interviews, it was determined the facility failed to ensure: 1. Staff performed Arteriovenous Fistula/Graft (AVF/AVG) cannulation site preparation per facility policy. 2. Staff documented the presence of a bruit/thrill in the patient’s medical record. This affected Patient Identifier (PI) # 11 and PI # 12 in two of two observations of accessing the AVF/AVG for initiation of dialysis, PI # 1, PI # 6, and PI # 2, in 3 of 6 MRs reviewed, and had the potential to negatively affect all patients with an AVF/AVG dialyzing at this facility. Findings include: Facility Policy: Access Needles: Placement and Removal Policy Number: Hemodialysis: Policy 4200 Date Published: Not Listed Purpose: To achieve adequate vascular access for hemodialysis. To minimize the amount of recirculation...To decrease the risk of infection via the access...To minimize trauma to the access...ensure the access achieves hemostasis and patency maintained... Policy: ...2. Initial assessment of the access will be done before needle placement each treatment and will include assessment for the following: Patency...Presence of thrill and/or bruit ...4. The access will be washed prior to prepping the skin for cannulation. 5. The assessment findings will be documented in the patient record. Facility Procedure: Access Needles: Placement and Removal Procedure Number: Procedure 4200A Date Published: Not listed. Placement of Fistula Needles: Procedure: The access extremity is washed with an antibacterial soap and water prior to prepping the site for cannulation. ...The access is palpated and inspected...Patency of the access must be established. ...The needle insertion site is identified and the area cleaned with an approved disinfectant. ...If the insertion site requires palpation after the site is disinfected, the above prepping procedure must be repeated. ...Needle placement sites, problems encountered with the access and/or needles, and condition of the access before and after treatment are documented in the patient record. 1. An observation was conducted on 11/6/24 at 9:10 AM with Employee Identifier (EI) # 4, Certified Clinical Hemodialysis Technician, initiating treatment for PI # 11 at station 4. Prior to prepping the site for cannulation, PI # 11 did not wash his/her access with antibacterial soap and water. EI # 4 did not wash the access site. After cleaning the access, EI # 4 touched the venous cannulation site without recleaning it before cannulation. An interview was conducted on 11/7/24 at 2:08 PM with EI # 1, Facility Administrator, who confirmed staff failed to perform AVF/AVG cannulation site preparation per facility policy. 2. An observation was conducted on 11/6/24 at 9:40 AM with EI # 4 initiating treatment for PI # 12 at station 9. Prior to prepping the site for cannulation, EI # 4 failed to palpate the access to establish patency. After cleaning the access, EI # 4 touched the venous cannulation site without recleaning it before cannulation. An interview was conducted on 11/7/24 at 2:08 PM with EI # 1, who confirmed staff failed to perform AVF/AVG cannulation site preparation per facility policy. 3. PI # 1 was admitted to the facility on 5/11/20 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet (TS) dated 10/24/24 revealed the patient had an AVF, left upper arm. There was no documentation of a bruit/thrill in the pre-treatment Access Assessment. Review of the TS 10/26/24 revealed there was no documentation of a bruit/thrill in the pre-treatment Access Assessment. Review of the TS dated 10/29/24 revealed there was no documentation of a bruit/thrill in the pre-treatment Access Assessment or the post-treatment Access Summary. An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, who confirmed staff failed to document the presence of a thrill or bruit. 4. PI # 6 was admitted to the facility on 8/16/24 with a primary diagnosis of ESRD. Review of the TS dated 10/24/24 revealed the patient had an AVF, left upper arm. There was no documentation of a bruit/thrill in the post-treatment Access Summary. Review of the TS dated 10/26/24 and 10/29/24 revealed there was no documentation of a bruit/thrill in the post-treatment Access Summary. An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, who confirmed staff failed to document the presence of a thrill or bruit. 39098 5. PI # 2 was admitted to the facility on 8/15/24 with a diagnosis of ESRD. Review of the TS dated 10/26/24 revealed the patient’s access was an AVF, left upper arm. There was no documentation the access was assessed for a thrill or bruit. An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, who confirmed staff failed to document the presence of a thrill or bruit.”

“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: 49894 Based on review of medical records (MR), facility policy, and staff interview, it was determined the facility failed to ensure patient comprehensive assessments and plans of care were completed per facility policy. This affected Patient Identifier (PI) # 6, PI # 2, and PI # 4, in three of six MR reviews, and had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings Include: Facility Policy: Comprehensive Patient Assessment and Plan of Care Policy Number: Hemodialysis Policy 5002 Date Published: Not listed Responsibility: Interdisciplinary Care Team (IDT): Registered Nurse (RN), Attending Physicians (or physicians extender), Social Worker (SW), Registered Dietician (RD). Plan of Care: The patient’s Plan of Care (POC) will be guided and developed based on the Comprehensive Patient Assessment. ...Comprehensive Patient Assessment/Plan of Care Frequency: An initial assessment must be conducted on all new patients and a POC developed and implemented within the latter of 30 calendar days or 13 outpatient hemodialysis treatments... A follow-up comprehensive assessment must occur on all new patients within three months after completion of the initial assessment to adjust the patient’s POC...The POC must be updated and implemented within 15 days of reassessment. ...Existing experienced dialysis patients (not new to dialysis) must have a comprehensive assessment and Plan of Care completed ...and then annually thereafter if stable. 1. PI # 6 was admitted to the facility on 8/6/18 with a diagnosis of End Stage Renal Disease. Review of the MR revealed the Comprehensive Interdisciplinary Assessment (CIA) for PI # 5 had not been completed for 2024. The last CIA completed for this patient was on 10/12/23. Documentation on the Customized Forms List revealed the CIA was completed by the RD and SW on 11/5/24, and by the RN and Medical Director on 11/6/24, which is 26 days past the due date, and not annually. An interview was conducted on 11/7/24 at 2:10 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the CIA was not completed annually by the IDT. 39098 2. PI # 2 was admitted to the facility on 8/15/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the MR revealed the POC was dated 9/16/24. There were no dates on the POC to indicate when the comprehensive assessments were completed. A Customized Forms List was provided which revealed the following: The Social Worker completed the assessment on 9/29/24, which was 13 days after the POC. The Registered Dietician completed the assessment on 9/18/24, which was 2 days after the POC. The Medical Doctor completed the assessment on 9/17/24, which was 1 day after the POC. An interview was conducted on 11/7/24 at 1:42 PM with EI # 1, Facility Administrator, who confirmed the assessments were completed after the POC, and not prior, per policy. 3. PI # 4 was admitted to the facility on 3/22/22 with a diagnosis of ESRD. Review of the current POC revealed a date of 10/7/24. There were no dates by the team’s electronic signatures on the POC to indicate when the comprehensive assessments were completed. A Customized Forms List was provided which revealed the following: The Social Worker completed the assessment on 10/17/24, which was 10 days after the POC. The Registered Dietician completed the assessment on 11/5/24, which was 29 days later. An interview was conducted on 11/7/24 at 1:30 PM with EI # 1, who confirmed staff failed to complete the assessments prior to the POC.”

“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: 49894 Based on review of facility policy, facility Quality Assessment and Performance Improvement (QAPI) data, and staff interview, it was determined the facility failed to ensure the QAPI program tracked and trended complete patient data used for mortality. This deficient practice had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings Include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date: Not Listed Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’s Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality... QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by. A. Improvement will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitilization/Mortality, Patient Safety... A review of the facility QAPI data was conducted on 11/7/24 at 3:00 PM with Employee Identifier (EI) # 1, Facility Administrator. Review of the facility’s mortality data revealed the facility was tracking cause of death as follows: August: 3 Cardiac Events September: 2 Cardiac Events October: 0 deaths A focused review of aspects of care related to cardiac deaths, such as, Hemodialysis ultrafiltration rates, length of treatment, the use of low potassium dialysate, serum bicarbonate levels, KT/V < 1.2 (adequacy of treatment with the current dialysis prescription), type of access, etc., were not being identified, tracked, trended, and analyzed to identify potential areas for improved patienr outcomes. The facility did not have an action plan in place for their mortality tracking and trending. EI # 1 confirmed during the QAPI review that he/she was not collecting, tracking, or trending and reporting the specific data related to patient death to the QAPI Committee, and the facility did not have an action plan currently in place.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 49894 Based on review of the facility’s Quality Assessment Performance Improvement (QAPI) data, patient lab values, physician’s orders, facility policy, observation, and staff interviews, it was determined the facility failed to ensure the QAPI Committee developed and implemented an action plan to obtain and administer Venofer (Intravenous (IV) iron) to patients for the managemrnt of anemia per facility policy. This deficient practive had the potential to negatively affect all thirty-one patients dialyzing at the facility. Findings include: Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not Listed Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services.... Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. The MD is the Chairperson of the QAPI Committee and is responsible for the overall effectiveness of the facility QAPI Program and communication with the Governing Body (GB)... The CCO is the facilitator of the QAPI meeting and shares responsibilities with the FA for the day-to-day oversight and implementation of the QAPI Program activities. These activities include: Identification of improvement opportunities, ...development, implementation, and monitoring of improvement plans, ...Documentation of QAPI activities, including meeting minutes and improvement/action plans. Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality... QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress... A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... A Flash Tour on 11/5/24 at 11:45 AM revealed there was no Venofer (intravenous (IV) iron) available for administration to the patients. Employee Identifier (EI) # 3, Registered Nurse (RN), stated the medication had been out of stock since the end of July. Review of the lab values for all 31 in-center hemodialysis patients revealed 21 patients had Transferrin Saturation (T-Sat) and Ferritin values out of range and requiring IV iron, and five more patients with lab values trending down. Further investigation revealed the facility had failed to obtain and stock venofer for the management of anemia. Patients with out-of-range or decreasing lab values had not received Venofer as ordered since 8/1/24l. An unsampled patient required a preventable hospitalization for a blood transfusion due to the lack of anemia management by this clinic and is currently receiving iron transfusions outside of the clinic. Review of the QAPI data revealed an action plan for the intravenous iron dating back to July, 2024 that included informing the patients of the out of stock medication and offering patients transfer to another facility where they could get the medication. An interview with a Patient Identifier # 4, who had been ordered Venofer 100 mg on 8/27/24, 9/24/24, and 10/29/24 and did not receive any of the ordered doses, revealed that he/she was not aware of the medication shortage and had not been offered a transfer. No action plan had been developed and implemented to obtain and administer the Venofer to patients as ordered to improve anemia management. An interview was conducted on 11/7/24 at 9:20 AM with EI # 1, Facility Administrator, who confirmed the Venofer had not been stocked due to lack of financial resources. EI # 1 also confirmed EI # 2, Chief Clinical Officer, and EI # 7, Medical Director, were aware of the patients not receiving the prescribed IV iron. An interview was conducted on 11/7/24 at 10:05 AM with EI # 7, who confirmed he/she was aware the patients had not received Venofer since July, 2024 due to lack of finacial resources at the facility. EI # 7 stated there was an improvement plan in place to notify the patients of the lack of medication, patients would be offered a transfer to a facility currently administering the medication, patients’ hemoglobin weekly, and prescribe oral iron medications.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 49894 Based on review of facility policy, facility (Quality Assessment Performance Improvement Program) QAPI data, and staff interview, it was determined the facility failed to ensure the QAPI Committee implemented a performance improvement plan to obtain and administer Influenza (FLU) Vaccines per facility policy. This deficient practice had the potential to negatively affect all thirty-one patients dialyzing at the facility. Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not Listed Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’s Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The Medical Director (MD), Chief Clinical Officer (CCO), Director of Operations (DO), and Facility Administrator (FA) are responsible for monitoring and evaluating effectiveness of the QAPI Program...The facility QAPI Committee establishes priorities, develops and implements improvement projects based on established priorities and monitors these projects for effectiveness. QAPI Committee members include, but are not limited to, MD, CCO, DO, FA, Registered Dietician, Social Worker, Home Therapies representative, and Technical Services Representative. The MD is the Chairperson of the QAPI Committee and is responsible for the overall effectiveness of the facility QAPI Program and communication with the Governing Body (GB)... The CCO is the facilitator of the QAPI meeting and shares responsibilities with the FA for the day-to-day oversight and implementation of the QAPI Program activities. These activities include: Identification of improvement opportunities, ...development, implementation, and monitoring of improvement plans, ...Documentation of QAPI activities, including meeting minutes and improvement/action plans. Required QAPI Documents: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... QAPI Meeting Requirements: QAPI Program activities for each facility include: ...Completion and analysis of the QAPI trending tools, ...Review aggregate data by modality to identify opportunity for improvement for clinical outcomes, and track progress by: 1. Evaluating clinical outcomes monthly using Graphs, Outcome Trending Reports, and any CMS or Network generated facility report... 2. Identify commonalities among patients who do not reach the minimum expected patient targets. 3. Develop a plan to address those causes. 4. Implement the plan. 5. Monitor the effectiveness of the plan. 6. Adjust portions of the plan that are not successful. A. Improvement plans will be prioritized by the QAPI committee... B. An improvement plan (or action plan) will be developed as needed for QAPI projects implemented by the QAPI Committee to facilitate tracking of action items, monitoring and follow-up. Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality... Medical Director Follow Through: The MD will communicate with the GB regarding QAPI activities. The GB will review information related to significant problems identified and their causes, and provide guidance and support for proposed needed corrections. Facility Policy: Hemodialysis Standing Orders Policy Number: None listed Date Revised: 1/24 ...Influenza Vaccine: Effective during influenza season. Obtain patient consent... If patient declines vaccination, obtain signature of declination form. Provide patient with vaccine information sheet... Verify patient has not received vaccination from another facility... Verify dosage...Administer appropriate dosage for current year influenza vaccination... A review of the facility’s QAPI Program was conducted on 11/7/24 at 3:00 PM with EI # 1. Review of the QAPI data for Influenza (FLU) Vaccines revealed only four of the facility’s thirty-one patients had received the FLU vaccine for the 2024-2025 season. The four patients who had received the vaccine, had received it at an outside facility (doctor’s office). EI # 1 confirmed during the QAPI review the vaccine had not been obtained by the facility to be administered to the patients due to lack of financial resources.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 49894 Based on review of the facility’s Quality Assessment Performance Improvement (QAPI) documentation, QAPI policy, medical record reviews, and staff interviews, it was determined the facility failed to demonstrate Medical Director operational oversight of the QAPI program and ensure quality indicators were tracked, trended, and analyzed by the QAPI Committee with appropriate action plans implemented. This deficient practice had the potential to negatively affect all thirty-one patients dialyzing at the facility. Facility Policy: Quality Assessment and Performance Improvement Program Policy Number: Hemodialysis: Policy 216 Date Published: Not Listed Program Scope: The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate and improve the quality and appropriateness of patient care and services by identifying opportunities and resolving identified problems through the use of QAPI methodology to achieve measurable improvement of health outcomes, optimize the number of patients who achieve individual patient targets as outlined on the Physicians’s Choice Dialysis trending tool and prevent and reduce medical errors. Responsibility: The MD is the Chairperson of the QAPI Committee and is responsible for the overall effectiveness of the facility QAPI Program and communication with the Governing Body (GB)... Elements of QAPI: Patient Care Outcomes, Infection Surveillance/Hospitalization/Mortality, Patient Safety... Medical Director Follow Through: The MD will communicate with the GB regarding QAPI activities. The GB will review information related to significant problems identified and their causes, and provide guidance and support for proposed needed corrections. A review of the facility’s QAPI Program data was conducted on 11/7/24 at 3:00 PM with Employee Identifier (EI) # 1, Facility Administrator. Review of the facility’s mortality data revealed the facility was only tracking cause of death as follows: August: 3 Cardiac Events September: 2 Cardiac Events October: 0 deaths A focused review of aspects of care related to cardiac deaths, such as, Hemodialysis ultrafiltration rates, length of treatment, the use of low potassium dialysate, serum bicarbonate levels, KT/V < 1.2 (adequacy of treatment with the current dialysis prescription), type of access, etc., were not being tracked and trended. The facility did not have an action plan in place for their mortality tracking and trending. EI # 1 confirmed during the QAPI review that she was not collecting, tracking, or trending the specific data related to patient death and the facility did not have an action plan currently in place. Review of the QAPI data for Influenza (FLU) Vaccines revealed only four of the facility’s thirty-one patients had received the FLU vaccine for the 2024-2025 season. The four patients that had received the vaccine, had received it at an outside facility (doctor’s office). EI # 1 confirmed during the QAPI review the vaccine had not been ordered by the facility to be administered to the patient’s due to lack of financial resources. A Flash Tour conducted on 11/5/24 revealed there was no Venofer (intravenous (IV) iron) available for administration to the patients. EI # 3, Registered Nurse (RN), stated the medication had been out of stock since the end of July. Review of the lab values for all 31 in-center hemodialysis patients revealed 21 patients had Transferrin Saturation (T-Sat) and Ferritin values out of range and requiring IV iron, and five more patients with lab values trending down. Further investigation revealed the facility had failed to obtain and stock Venofer for the management of anemia. Patients with out-of-range or decreasing lab values had not received Venofer since 8/1/24 as ordered per protocol. An unsampled patient required a preventable hospitalization for a blood transfusion due to the lack of anemia management by this clinic and is currently receiving iron transfusions outside of the clinic. Review of the QAPI data revealed an action plan for the intravenous iron dating back to July, 2024 that included informing the patients of the out of stock medication and offering patients transfer to another facility where they could get the medication. It was revealed through patient interview that patients were not aware of the medication shortage and had not been offered a transfer.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 49894 Based on observations of patient care, review of medical records (MR), facility policies and procedures, facility Quality Assessment Performance Improvement (QAPI) data, and staff interviews, it was determined the Medical Director failed to provide oversight of the care provided to patients at this facility. This deficient practice had the potential to negatively affect all thirty-one patients dialyzing at this facility. Findings include: Facility Policy: Governing Body Facility Policy: Hemodialysis: Policy 200 Date Published: Not listed Each Physician’s Choice Dialysis is under control of a GB which has full legal authority and responsibility for the management and operations of the facility. The GB will assure that this policy and the Operational Objectives listed below are met: ...2. The GB will appoint a Chief Executive Officer (CEO), an alternate CEO, and a Medical Director... ...5. Designate a Physician Director (Medical Director) or designee to be responsible for the implementation of patient care policies... A Flash tour conducted on 11/5/24 at 11:45 AM revealed supplies in the Crash Cart were expired and available for patient use, chairs had tears in the vinyl, medications in the medication refrigerator were expired and available for patient use, the water treatment and storage area was not secured, supplies were not dedicated for single patient use, and medications (Venofer (Intravenous Iron) and Influenza (FLU) Vaccines) were not stocked for patient administration. Observations of patient care, MR reviews, and facility policies revealed final dialysate was not tested per facility policy, staff were not qualified to verify chlorine test strips, dialysis stations were not cleaned per policy, supplies were not dedicated for single patient use, patient accesses were not assessed, washed, and prepped for cannulation per facility policy, Comprehensive Assessments and Plans of Care (POC) were not completed per policy, and medications administered and treatment parameters were not administered and/or documented per facility policy. An interview was conducted on 11/7/24 at 2:10 PM with EI # 1, Facility Administrator, who confirmed all evidence revealed on the Flash Tour and during observations of patient care were not per facility policy. A review of the facility’s QAPI program was conducted on 11/7/24 at 3:00 PM revealed EI # 1 was not tracking and trending specific data relative to patient deaths, and the QAPI Committee had not implemented a plan to obtain and administer Venofer or FLU vaccines to patients. An interview was conducted during the QAPI review with EI # 1 who confirmed the QAPI data was not complete and the Venofer and FLU vaccines had not been obtained due to the facility’s financial situation. EI # 1 also confirmed the Medical Director was aware. An interview was conducted on 11/7/24 at 10:05 AM with EI # 7, Medical Director, who confirmed he was responsible for the clinic operations, including Infection Control, patient Plan of Care, the facility’s QAPI program, Water and Dialysate Quality, patient safety, and staff competencies. He also confirmed he was aware of the medication shortages and stated medications had not been ordered due to a lack of financial resources at the facility.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 49894 Based on review of medical records (MR), review of facility policies, and staff interviews, it was determined the Governing Body failed to ensure the facility policies were enforced to promote the health and safety of patients. These deficient practices did affect 26 patients, and had the potential to affect all 31 patients dialyzing at this facility. Findings include: Facility Policy: Hemodialysis: Governing Body Policy Number: 200 Date: None listed Purpose: Each Physicians Choice Dialysis facility is under control of a Governing Body which has full legal authority and responsibility for the management and operations of the facility... Policy: ...3. Approve... all rules, policies, and procedures related to: - The health, safety, personal and property rights of patients. - Personnel practices and training. - Clinical, Water/Technical... policies and procedures. - Comprehensive Plans of Care and Documentation processes. - Provision of dialysis and other ESRD (End Stage Renal Disease) services to patients. Observations of patient care, MR reviews, and review of facility policies revealed ordered medications, including Venofer and Flu vaccines, were not administered, Comprehensive Assessments and Plans of Care were not completed per policy, final dialysate was not tested per facility policy, staff were not qualified to verify chlorine test strips, dialysis stations were not cleaned per policy, supplies were not dedicated for single patient use, and patient accesses were not assessed, washed, and prepped for cannulation per facility policy. An interview was conducted on 11/8/24 at 1:00 PM with Employee Identifier # 2, Chief Clinical Officer, who confirmed the Governing Body had not implemented a plan to obtain and administer ordered medications, and failed to ensure staff followed facility polices and procedures.”