Davita Paulding Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of two of two Patient Care Technicians (PCT AA and PCT BB) observed, to independently verify the hemodialysis machine’s dialysate pH (acidity), according to the manufacturer’s DFU and facility P&P. This failure had the potential to negatively affect the health and safety of 14 of 14 patients (P), (P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21 and P#22), who were undergoing hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 72. Findings were: Cross Reference: V 250 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT AA and PCT BB) observed, independently verified the machine’s dialysate pH, according to the manufacturer’s Directions For Use (DFU) and facility P&P.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, a review of records, staff interviews, review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 72 patients who dialyzed at this facility. Findings were: Cross Reference: V 250 - Failure of the Governing Body to ensure that two of two Patient Care Technicians (PCT AA and PCT BB) observed, followed the Manufacturer’s DFU and the facility P&P regarding independently testing the machines’ dialysate pH (acidity) prior to each hemodialysis treatment.”

“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: 50523 Based on observation, staff interview, a review of the Food and Drug Administration (FDA) recommendations and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that expired medications in two of two Medication Drawers were removed and not made available for use and expired laboratory (lab) supplies found in the Crash Cart (Emergency Cart) and lab supply cabinet were not made available for use. This deficient practice had the potential to negatively affect the health and safety of 72 in-center hemodialysis patients who were under the care of this facility. During a tour in the Patient Treatment Room on 11/5/24 from 10:38 a.m. though 12:18 p.m., the following medications and supplies had expired, thus these were not suitable for use. Findings were: In the In-Center Medication Drawer: - Four packets of Liquacel Liquid (Protein supplement) expired 8/2024. - One bottle of Cinacalcet Tablets (controls the amount of calcium in the blood) 30 milligrams (mg) expired 2/2024. -10 vials of Vancomycin Hydrochloride Injection (antibiotic) 1 gram (g) each for injection expired 9/1/24. In the Crash Cart: -Two gold top lab tubes expired 8/16/24. In the lab cabinet: -84 clear top lab tubes expired 10/31/24 On 11/5/24, Registered Nurse/ Nurse Manager (RN/NM) acknowledged these findings at 11:15 a.m. According to FDA recommendations dated 2/8/21, drug and supplies’ expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective. A review of facility Policy: 1-06-01, titled, “Medication Policy” with latest revision date of November 2023, stated: 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.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 49321 Based on observation, staff interview, and a review of facility policy and procedures (P&P), it was determined that the facility failed to ensure that three of four clean sinks for handwashing which had motion detections to initiate the water flow, in one of one In-Center Hemodialysis (ICHD) Treatment Room, had warm water to encourage patients and staff to wash their hands. This deficient practice had the potential to discourage 13 of 13 patients, (P), (P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, and P#21), who were undergoing hemodialysis at the time of this observation and five of five Direct Patient Care (DPC) staff, (Registered Nurse - RN AA, Licensed Practical Nurse - LPN AA, and Patient Care Technicians- PCTs AA, BB, and CC), to wash their hands, which would increase the risk of infection transmission. The facility’s patient census was 72. Findings were: During observation in the Patient Treatment Room on 11/5/24, between 10:45 a.m. to 12:00 p.m., the following was revealed: - Three of four handwashing sinks, which were designated as “clean sinks”, with motion detections to initiate the water flow at the following locations, did not have warm running water, after two minutes: 1. facing station (S)10, 2. facing the isolation room 3. facing the business office - RN AA stated on 11/5/24 at 12:15 p.m., that the water temperatures at the above-mentioned sinks were always cold. The Facility Administrator was made aware of this finding on 11/7/24 at 12:40 p.m., and he stated that he would look into it. A review of Policy :1-05-01 titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES”, last revised April 2023 stated: FACILITY HYGIENE 19. a. Sinks must be plumbed with both hot and cold water.”

“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: 50523 Based on observation, a review of facility Policy and Procedures (P&P), and staff interviews, it was determined that the Infection Control Committee failed to ensure that three of three Patient Care Technicians (PCTs AA, BB, and CC) observed during preparation of access sites (needle insertion sites) and cannulation (insertion of fistula needles), utilized appropriate infection control techniques to prevent cross contamination during the initiation of hemodialysis treatment of two of two patients (P), (P#1 and P#3). Failure to practice aseptic techniques increased the risks of cross contamination which could negatively affect the health and safety of P#1and P#3. The facility census was 72. Findings were: During observation in the Patient Treatment Room on 11/5/24 from 10:38 a.m. though 12:18 p.m., the following was observed: - PCT AA was observed during initiation of hemodialysis treatment to P#1 at Station (S), (S10). After disinfecting P#1’s access sites, PCT AA palpated (examined by touch) P#1’s access sites again (after the sites had been disinfected), wearing the same contaminated gloves, thus re-contaminating the access sites. - PCT BB was observed at S12 while disinfecting P#3’s access sites using Betadine (a topical antiseptic) pads and then alcohol pads in an up and down motion. PCT BB touched both disinfected access sites, wearing the same contaminated gloves, right before attempting to insert the fistula needles, thus re-contaminating the access sites. PCT BB was unsuccessful in cannulating P#3’s access sites, so PCT CC came to assist PCT BB with cannulation. Without disinfecting the re-contaminated access sites, PCT CC pulled the skin taut to anchor the vessels but in the process, PCT CC touched the access sites before cannulation. This breach in infection techniques had the potential for cross contamination. A review of the facility’s Procedure: 1-04-01E titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SNF) and Administration of Heparin Loading Dose” with latest revision date of October 2022, stated: 13. Do no palpate insertion site once area has been prepped. RATIONALE: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. 19. Without contaminating the fistula needle, pull skin taut with non-dominant thumb below anticipated insertion site in opposite direction of needle insertion. RATIONALE: Pulling the skin taut anchors the vessels and ease the cannulation process. - At 11:23 a.m. on 11/5/24, PCT AA stated that she was still new and she usually palpated the access site right before cannulating a patient to assure needle placement was successful. PCT AA also stated that she wiped her gloves with alcohol before palpating any patients’ access (including P#1’s access) before cannulation. However, this surveyor did not observe PCT AA “wiping her gloves with alcohol” before palpating P#1’s access. - At 12:11 p.m. on 11/5/24, PCT CC stated that she normally must grip the access to cannulate due to the position of P#3’s access.”

“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: 49321 Based on observation, staff interviews, a review of policy and procedures (P&P), and a review of the recommendations of the Centers for Disease Control and Prevention (CDC), it was determined that the infection control committee failed to ensure that one of one Patient Care Technician (PCT BB) observed, practiced infection control techniques to prevent transmission of infection among chronic hemodialysis patients by first making sure that the hemodialysis chair was vacated by the patient before beginning disinfection. This deficient practice had the potential to negatively affect the health and safety of 13 of 13 patients (P), P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, and P#21), who were dialyzing at the time of this observation, and the next patient, (P#22), who will be occupying this station, (S12). The facility census was 72. Findings were: During an observation on 11/5/24 between 11:00 a.m. and 11:30 a.m., the following was revealed: - PCT BB was observed disinfecting the hemodialysis machine at S12, then started setting up a new treatment by connecting new bloodlines and a new dialyzer, while P#9 was still sitting at his hemodialysis chair (at S12), holding his vascular access site to achieve hemostasis (cessation of bleeding). This breach in infection control technique had the potential for cross contamination. - During an interview on 11/5/24 at 11:30 a.m., LPN AA was asked if staff were permitted to set up the dialysis machine while the previous dialysis patient was still sitting at the station. LPN AA said the patient must leave the station before the dialysis machine was set up for the next patient. - During an interview on 11/5/24 at 11:45 a.m., PCT BB was asked if they had always set up the dialysis machine while the previous dialysis patient was sitting in the treatment chair. PCT BB said yes, everyone did it, not just me. - During an interview on 11/5/24 at 3:45 p.m., PCT AA was asked if staff cleaned and set up the dialysis machine for the next patient while the previous patient was still at the station. PCT AA stated yes, we do set up our machines while the patients were still holding their access sites to prevent us from falling behind in our schedule. - A review of Policy 1-05-01, “INFECTION CONTROL FOR DIALYSIS FACILITIES,” last revised April 2023, stated: DISINFECTION: b. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station, and set up for the next patient. - The CDC has recommended that a dialysis station, in order to prevent cross contamination, be completely vacated by the previous patient before the ESRD (End Stage Renal Disease) staff may begin cleaning and disinfection of the station and set up for the next patient.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 50523 Based on a review of personnel health records, staff interview, and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that three of three newly hired Patient Care Technicians, (PCTs CC, DD and EE) had current health records, to ensure health, safety, and prevention of transmission of communicable diseases for all patients and staff. This failure had the potential to negatively affect the health and safety of all staff employed, and all 72 hemodialysis patients who received care at this facility. Findings were: During a review of personnel records on 11/7/24, there were no health status of personnel’s Mantoux Test or PPD (a tool for Tuberculosis-TB screening and diagnosis), and Hepatitis B Virus (HBV) status. PCT CC was hired on 1/8/24. There was no documentation of TB or HBV status/evaluation. PCT DD was hired on 5/11/24. There was no documentation of TB or HBV status/evaluation. PCT EE was hired on 6/24/24. There was no documentation of TB or HBV status/evaluation. At 10:35 a.m. on 11/7/24, the Facility Administrator stated that there were no laboratory orders nor results for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B surface Antibody (HBsAb or anti-HBs) for PCTs CC, DD, and EE upon their hire, during their orientation, and currently. There was no documentary evidence that a TB Risk Assessment Questionnaire (TB RAQ) was completed by PCTs CC, DD, and EE, and there was no documentary evidence that a PPD (Purified Protein Derivative) was administered to diagnose silent (latent) TB infection. An order for both HBsAg and HBsAb and PPD was later presented to this surveyor that was dated 11/6/24, however, the lab draw (for HBV status) and the administration of PPD had not been initiated nor completed, as of 11/7/24. A review of facility Policy: 4-06-05, titled, “Tuberculosis Monitoring and Follow-Up” with latest revision date of October 2024, stated: Baseline new hire requirements for all new teammates including volunteers, per diem teammates, non-DaVita agency personnel and teammates will complete the following: 1. TB- Risk Assessment and Symptom Evaluation Questionnaire. 2. Successful completion of Tuberculosis Education for New Teammates Course. 3. Testing options (any one of the following): c. If exemption criteria for TST (Tuberculin Skin Test) is not met, the following testing options are available: i. Baseline TST using a two-step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated one to three weeks after the first, if the initial test is negative). Test results will be recorded on the Teammate Health Monitoring Record ... iv. Baseline TST results must be documented and recorded in millimeters within 10 days of employment... A review of facility Policy: 4-06-03, titled, “Teammate Hepatitis B Monitoring and Follow-Up Guidance “ with latest revision date of April 2024, stated: 1. New teammates who are not able to provide documentation of hepatitis B surface antibodies of 10mIU/ml or greater from any time in the past, regardless of documentation indicating completion of the hepatitis B vaccine series, will be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results.”

“IC-HBV-ISOLATION (EXISTING FACILITY) CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, designate a separate room for their treatment. For existing units in which a separate room is not possible, HBsAg positive patients should be separated from HBsAg susceptible patients in an area removed from the mainstream of activity. This Standard is not met as evidenced by: 49321 Based on observation, a review of facility records, and staff interview, it was determined that the facility failed to maintain one of one room that was designated as an Isolation Room, (a room used for the purpose of dializing any patients that tested positive for the Hepatitis B surface Antigen (HBsAg), a contagious protein found in the blood of a person that tested positive for the Hepatitis B Virus- HBV), as evidenced by stored miscellaneous items in large boxes, a large mechanical lift equipment, and four treatment chairs, all stored in this room. This failure to maintain the Isolation Room had the potential that it will not be readily available when needed. The facility census was 72. Findings were: During a tour of the facility with the Facility Administrator on 11/7/24 at 12:36 p.m., the following was revealed: - The designated Isolation Room with one station (S), (S17), was used as a storage room, with stored miscellaneous items in large boxes, a large mechanical lift equipment, and four treatment chairs, all crammed up in the Isolation Room. - On 11/7/24 at 12:36 p.m., the Facility Administrator was asked by this surveyor how the facility would accommodate patients found to be positive for HBsAg during testing. The Facility Administrator stated that the facility currently had no patients who tested positive for HBsAg, but if a patient were to test positive, the patient would be transferred to a sister facility, which agreed to take patients from the facility who tested positive or sero-convert (changing from negative to positive HBsAg). However, the Facility Administrator could not provide a documentary evidence that there was an agreement with another sister facility who will accept patients from this facility who tested positive for HBsAg. - A review of the CMS (Centers for Medicare & Medicaid Services) 3427 form, (an End Stage Renal Disease Application and Survey and Certification Report Form and Supporting Regulations) submitted to CMS in 2018 by this facility, showed that this facility had one designated room used as an Isolation Room with one station.”

“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: 50523 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of two of two Patient Care Technicians (PCT AA and PCT BB) observed, to independently verify the hemodialysis machine’s dialysate pH (acidity), according to the manufacturer’s DFU and facility P&P before each patient treatment. This failure had the potential to negatively affect the health and safety of 14 of 14 patients (P), (P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21 and P#22), who were undergoing hemodialysis treatment at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 72. Findings were: During observation in the Patient Treatment Room on 11/5/2015 between 10:38 a.m. and 12:18 p.m., the following was revealed: - PCT AA did not test the dialysate pH of the hemodialysis machine at Station (S10) before initiating P#10’s hemodialysis treatment. PCT AA stated on 11/5/24 at 11:15 a.m., that she was running behind schedule and did not check the pH at station S10 before initiating treatment. - The Registered Nurse stated at 11:47 a.m. on 11/5/24 that the pH is to be checked right after the machine is tested. - PCT BB did not independently test the dialysate’s pH at stations (S12 and S14) before intiating patient treatment for P#11 and P#12. PCT BB stated on 11/5/24 at 12:12 p.m. that the facility’s hemodialysis machines self-checked/self-tested the dialysate’s pH therefore she did not independently check the pH levels of the machine’s dialysate at stations S12 and S14 before initiating patient treatment. - On 11/5/24 at 12:45 p.m., the Biomedical Technician (BMT) revealed that the facility’s hemodialysis machines only self-test for conductivity (ability of the dialysate to conduct electricity) not pH, therefore the pH must be tested/verified independently before initiating patient treatment. A review of “Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Operator’s Troubleshooting Guide” showed the following: Page 9 - Miscellaneous - On the Test and Options screen, Independent Conductivity does not show pH (the pH is not available). - Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If they are not, do not initiate dialysis. - A review of the facility’s Policy: 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” with latest revision date of April 2020 stated: 6. Independent pH is required to be performed prior to each treatment.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 33921 Based on a telephonic interview with complainant, a review of facility records and staff interviews, it was determined that the Interdisciplinary Team (IDT) failed to develop and implement a written, individualized comprehensive plan of care that addressed the specific safety needs of one of one patient (P#9) who had a history of multiple drug allergies and Systemic Mastocytosis (caused by an overproduction of abnormal mast cells) or Mast Cell Activation Syndrome (unexplained episodes of severe symptoms such as swelling, diarrhea, vomiting, flushing and itching without a clear trigger). This deficient practice could negatively affect the health and safety of P#9. The facility census was 72. Findings were: - During a telephonic interview with the complainant on 11/6/24 at 11:15 a.m., the complainant stated that P#9 had always required six bags (1 Liter per bag) of Normal Saline (NS) for P#9’s dialysis set up (priming) and NS flushes per treatment for the past 20 years and continued upon admission to this facility since 2018. The complainant added that P#9 was sent to the hospital’s Emergency Department (ED) for her hemodialysis (HD) treatment for the last 4 weeks due to the shortage of NS supplies. A review of facility records revealed the following: - P#9 was admitted to this facility on 7/20/2018. P#9’s First Day of Dialysis Ever (FDoDE) was on 7/6/2004 at another facility. - On 10/9/24, Registered Nurse/Nurse Manager (RN-NM), in her Late Entry Note, for event date 10/3/24 at 12:30 p.m., stated: Patient (P#9) called to state that she was not coming to her treatment that was scheduled for today. Later in the day we were informed of the saline shortage. This nurse contacted the patient to inform her that we are being allotted one single bag of saline per patient. Patient had previously stated she medically requires that her dialyzer be primed with 2 bags of saline, 100 mL (milliLiter), NS flushes every 30 minutes, her treatment time is 180 minutes but she also requires a complete new set up after 90 minutes and that dialyzer will need to also be primed with 2 bags of saline. The patient states that this is what works for her to prevent anaphylactic shock. That if she had a reaction she will require Solu-Medrol (used to treat many different inflammatory conditions) and 100% 02 (oxygen) at max (maximum) flow. She was informed to proceed to the ED for treatment as we are unable to accomodate what she states she requires for treatment related to safety concerns for her. (sic) - A review of the initial doctor’s treatment prescription orders and subsequent orders, Registered Nurse’s Pre-treatment evaluation, initial Comprehensive IDT Assessment and Plan of Care (POC), as well as subsequent IDT Assessments and POCs, did not address P#9’s specific HD treatment set up as mentioned above. And that this was in relation to P#9’s multiple drug allergies including an allergy to Heparin (anticoagulant), and a diagnosis of Mast Cell Activation Syndrome. - A review of P#9’s History and Physical (H &P) dated 6/22/22, included a hemodialysis order of treatment prescription stating: HD treatment three times a week for 180 minutes (3 hours)... There was no mention of this special hemodialysis set up (using a total of six liters of NS per treatment, including 100 mL of NS flushes every 30 minutes). - A review of P#9’s Dialysis Treatment Flowsheets (Treatment Details Report) between 9/16/24 and 9/29/24, also did not mention a special HD treatment set-up (as mentioned above), although the Direct Patient Care (DPC) Staff (RNs, License Practical Nurses - LPNs, and Patient Care Technicians - PCTs) had followed this same routine since P#9’s admission. - A review of hospital records (where P#9 had undergone HD treatment), included the following, but not limited to: A review of the hospital’s admitting doctor’s H & P dated 10/4/24 showed that P#9 stated that the facility sent her to the hospital because the facility did not have enough saline flushes and she had a mast cell disorder and was allergic to Heparin (anticoagulant) so she needed a certain amount of saline flushes to not clot. - During a discussion with the Manager of Clinical Services (MCS) on 11/6/24 at approximately 2:00 p.m., with the Facility Administrator on 11/6/24 at approximately 3:00 p.m., and with the Director of Clinical Services on 11/7/24 at approximately 2:30 p.m., all three confirmed that P#9 had required six bags of NS per treatment but couldn’t find any specific orders by the doctor nor any documentation by the facility’s DPC Staff regarding this special HD treatment set up process, although the staff had been doing this routine for a long time. They couldn’t find any documentation from previous facilities where P#9 had HD treatment because some facilities had closed or the previous staff were no longer available for inquiry and the electronic record system had been switched. - The first mention of this special set up and NS flushes was only documented by RN/NM on 10/9/24.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 50523 Based on a review of medical records, staff interviews and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that an individualized plan of care (POC) was developed and implemented within 30 days of admission, for two of two patients (P), (P#2 and P#7) sampled, who were recently admitted to this facility. This deficient practice had the potential to negatively affect the health and safety of P#2 and P#7. The facility census was 72. Findings were: - During a review of medical records of patients sampled, the following was revealed: - P#2 was admitted to this facility on 7/29/24, who was new to ESRD (End Stage Renal Disease). There was no documentary evidence that an initial POC was completed for this patient. - P#7 was admitted to this facility on 8/1/24, who was also new to ESRD. There was no documentary evidence that an initial POC was completed for this patient. The Facility Administrator was notified of this finding on 11/7/24 at 1:30 p.m. and he confirmed that it was greater than 30 days since P#2’s and P#7’s admission and both patients had 13 hemodialysis treatments, yet there were no care plans developed and implemented for these two patients sampled. A review of facility Policy: 1-14-01, titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” with latest revision date of October 2024, stated: 4. A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. - 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...”

“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: 50523 Based on a review of facility records and staff interview, it was determined that the facility failed to effectively manage anemia (low red blood cell counts), and to evaluate the effectiveness of the facility’s anemia protocol in six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (April 2024 - September 2024). This deficient practice had the potential to negatively affect the health and safety of all 72 hemodialysis patients who were under the care of this facility. Findings were: A review of the facility’s QAPI meeting minutes from April 2024 - September 2024, revealed no documentary evidence that the QAPI team conducted a comprehensive review of the facility’s anemia management [measured by Hemoglobin (Hgb: protein in red blood cells that carries oxygen) and transferrin (iron) saturation]. For example: A review of Fiscal Year 2024 Quarterly Dialysis Facility Report (QDFR: A report prepared by Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), revealed that 28.9 % of hemodialysis (HD) patients at this facility had Hgb levels of less than (<) 10 g/dL (grams per deciLiter). The U.S. average was 16.0%. However, the average Hgb less than 10 g/dL for the past six months reviewed, (April 2024 - September 2024), was 37.3%. A review of this facility’s Hgb report for the last six months, revealed the following: - In April 2024, 35.9% of patients had Hgb levels of <10.0 g/dL. - In May 2024, 30.3% of patients had Hgb levels of <10.0 g/dL. - In June 2024, 35.9% of patients had Hgb levels of <10.0 g/dL. - In July 2024, 35.7% of patients had Hgb levels of <10.0 g/dL. - In August 2024, 37.1% of patients had Hgb levels of <10.0 g/dL; and - In September 2024, 37.3% of patients had Hgb levels of <10.0 g/dL. There was no documented evidence that this facility analyzed root cause(s) of the upward trend in patients that did not meet the goal for Hgb, and to identify opportunities for improving care. The Director of Clinical Services acknowledged the findings on 11/7/24 at 12:49 p.m.”