Davita Marshall Dialysis Center

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48653 Based on record review and staff interview, the facility’s staff failed to: A. ensure post-treatment nursing assessments were completed and documented before the patient was discharged from the facility in 3 (Patient # 1, # 3, and # 8) of 8 patient medical records reviewed. (Cross Refer to Tag V0502) B. ensure that direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 1 (# 3) of 7 patient medical records reviewed. The facility staff failed to follow the facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. (Cross Refer to Tag V0504) C. recognize when 2 (Patient # 8 and # 9) of 2 patients’ serum potassium levels were critically elevated above 6.0mEq/L (milliequivalents per liter). The facility staff failed to promptly notify the physician, provide patient education, and redraw serum potassium levels to ensure the values returned to normal limits. The facility staff failed to follow the “Use of Low Potassium Dialysate” policy. (Cross Refer to Tag V0505)”

“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: 29191 Based on observation, record review, and staff interview, the facility staff failed to maintain and provide a sanitary environment in the medication and laboratory area. The staff did not follow the ‘Infection Control for Dialysis Facilities’ policy. Findings include: During a tour of the facility’s in-center treatment area with Staff #4 on 08/04/2025 at 11:15 AM, the surveyor observed that the medication and laboratory refrigerator had a buildup of dust particles and dirt on the bottom shelf. A review of the facility’s policy, ‘Infection Control for Dialysis Facilities,’ dated April 2023, revealed the following: “PURPOSE: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. POLICY: The Centers for Disease Control (CDC) Recommendations for preventing the transmission of infections among chronic hemodialysis patients (Dialysis Precautions) will be followed when caring for all patients. Additional precautions recommended by the CDC are to be observed for patients with infectious hepatitis B ... DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to the clean/designated area or removal from the treatment area.” An interview with Staff #4 on 08/04/2025 at 11:15 AM confirmed the presence of dust particles and dirt at the bottom of the medication and laboratory refrigerator.”

“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: 29191 Based on observation, record review, and staff interviews, the facility’s direct care staff failed to ensure that multiple vial medications were not beyond the 28-day expiration date. The facility staff failed to follow the facility’s “Medication Policy”. These deficient practices had the likelihood to cause harm to all patients who receive care at the facility by using vaccines that were not within current date usage according to CDC guidelines. Findings include: During a tour of the facility on 08/04/2025 at 11:30 PM, the surveyor observed the following: * There was an open multi-dose vial of Tuberculin in the refrigerator. The vial was labeled with an open date of 06/24/2025. The vial should have been disposed of by July 22, 2025. A review of the facility’s policy titled “Medication Policy” dated October 2023 revealed the following: “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. 11. All refrigerated medications, for example, erythropoietin-stimulating agents (ESA) and vaccines, are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. 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. 18. All syringes prepared from single-use vials/ampules (without preservatives) or multidose vials should be prepared and administered within a four (4) hour period [within one (1) hour for States of New Jersey and South Carolina] period, unless there is specific testing and documents on file, which extends dating.” Review of the CDC guidelines “Safe Injection Practices to Prevent Transmission of Infections to Patients” CDC: Injection Safety revealed the following: “Expiration Dating of Multi-dose Vials The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use date refers to the date after which an opened multi-dose vial should not be used. The beyond-use date should never exceed the manufacturer’s original expiration date. Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. For example: * If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated with the last date that the product should be used (expiration date) and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. Labeling the vial with the ‘date opened’ does not meet the intent of this requirement * If a multi-dose vial has not been opened or accessed (e.g., tab removed, needle-punctured), it should be discarded according to the manufacturer’s expiration date which is generally printed on the label by the manufacturer. * For expiration dates that only include the month/year, the unopened product is considered usable until the end of the month unless otherwise stated by the manufacturer.” An interview was conducted with Staff #4 on 08/04/2025 at 11:00 AM. Staff #4 acknowledged the Surveyor’s findings that the Tuberculosis vaccine was beyond the 28-day expiration.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to check and maintain the salt pellets above the water halfway mark in the brine tank. This deficient practice had the likelihood to cause the water to become hard; failure to ensure adequate salt levels in the brine tank can lead to water hardness in the system at levels unacceptable for dialysis being performed on patients. Findings include: During a tour of the facility’s water room on 08/04/2025 at 10:04 AM observed that the salt pellets were below the water level in the brine tank. An interview with Staff # 5 on 08/04/2025 at 10:30 AM confirmed Staff # 5 visualized the salt pellets in the brine tank below the water line.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the Registered Nurse failed to ensure post-treatment nursing assessments were completed and documented before the patient was discharged from the facility in 3 (Patient # 1, # 3, and # 8) of 8 patient medical records reviewed. Findings include: Patient # 1 A review of the hemodialysis treatment sheet dated 07/22/2025 revealed the patient’s treatment was terminated at 10:15 AM. The patient’s post-treatment nursing assessment was not documented by Staff # 24 (Registered Nurse) until 2:48 PM, 4 hours and 33 minutes after the patient’s treatment was terminated. Patient # 3 A review of the hemodialysis treatment sheet dated 07/16/2025 revealed the patient’s treatment was terminated at 3:01 PM. The patient’s post-treatment nursing assessment was not documented by Staff # 25 (Registered Nurse) until 5:17 PM, 2 hours and 16 minutes after the patient’s treatment was terminated. A review of the hemodialysis treatment sheet dated 07/21/2025 revealed the patient’s treatment was terminated at 2:39 PM. The patient’s post-treatment nursing assessment was not documented by Staff # 25 (Registered Nurse) until 5:02 PM, 2 hours and 23 minutes after the patient’s treatment was terminated. Patient # 8 A review of the hemodialysis treatment sheet dated 08/02/2025 revealed the patient’s treatment was terminated at 8:40 AM. The patient’s post-treatment nursing assessment was not documented by Staff # 10 (Registered Nurse) until 4:41 PM, 8 hours and 1 minute after the patient’s treatment was terminated. An interview was conducted with Staff # 18 on 08/05/2025 at 10:30 AM which confirmed the facility’s registered nurses were not documenting the post-treatment nursing assessment before the patient discharged from the facility.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility failed to ensure that direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 1 (# 3) of 7 patient medical records reviewed. The facility staff failed to follow the facility policy, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment”. Findings include: Patient # 3 A review of 1 of 6 hemodialysis treatment sheets revealed that Staff # 16 (Patient Care Technician) did not report out-of-parameter vital signs to the charge nurse for further assessment and intervention. A review of the hemodialysis treatment sheet dated 07/18/2025 revealed the following, “11:32 AM: Blood pressure (BP): 201/94 1:32 PM: BP: 206/92 2:02 PM: 212/96 2:32 PM: 214/95 2:46 PM: 203/87” There was no documentation by Staff # 16 to support the charge nurse being made aware of the abnormal blood pressures. A review of facility policy “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with a date of October 2023 revealed, “NOTE: The scope of practice and other statutes, rules and regulations that impact the practice of the RN, LPN/LVN and PCT may vary among states. Refer to state regulations. PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: i. Measurement of patient temperature ii. Measurement of Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet) 2. Intradialytic BP in the sitting/reclined or supine position iii. Heart or pulse rate, noting also if the beat is regular or irregular iv. Patient weight v. Patient’s report of well-being, level of pain or discomfort, complaints, hospitalization vi. Vascular access status 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters iv. Verification that the patient access is visible and face is not covered v. Review of documentation for accuracy, completion and patient data vi. A physical assessment of the patient which includes 1. Apical heart rate and rhythm 2. Auscultation of the lungs 3. Evaluation of volume status including edema 4. Bruising or bleeding 5. Patient statement of well-being, level of pain or discomfort 6. And other components which if observed/informed will be documented, including but not necessarily limited to the following: Change in normal level of consciousness, mobility or mental status, Complaint of nausea, vomiting, diarrhea, constipation, skin changes, headache, respiratory distress, angina, weakness, fever, cramping, dizziness, Reports of illness and/or injuries, falls, conditions/complications or other problem patient has experienced since the last dialysis treatment 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting) PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. 6. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. 7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated. INTRADIALYTIC DATA COLLECTION/ASSESSMENT 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring i. Nocturnal Programs: Treatment checks should be completed at least every 30 minutes prior to the established “lights out” time for the nocturnal program. ii. After the established “lights out” time, treatment checks will remain every 30 minutes with the exception of blood pressure and heart rate. After “lights out” time, blood pressure and heart rate checks will be performed every 60 minutes while the patient is awake and then every three (3) hours once the patient is noted to be sleeping. iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. b. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate iii. Blood and dialysate flows, arterial and venous pressures iv. Fluid removal and/or replacement v. Vascular access visible and line connections intact vi. Patient subjective statement(s) i.e., patient report on overall health, any complaints c. The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment. d. Hourly heparin infusion ordered by the physician/NPP should be monitored every 60 minutes. e. The arterial and venous drip chamber levels should be observed and adjusted as needed ....10. If the dialysis prescription is not being met (including dialysis flow rate or change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record ...ABNORMAL FINDINGS Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ...Blood pressure: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg, Signs/symptoms of hypotension may include: o Nausea and vomiting Cold and clammy skin, Restlessness, Rapid, shallow respirations, Excessive yawning, Diaphoretic ...” An interview was conducted with Staff # 18 on 08/05/2025 at 10:30 AM, which confirmed the facility’s direct care staff did not escalate out-of-parameter vital signs to the charge nurse for further evaluation and treatment.”

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility’s staff failed to recognize when 2 (Patient # 8 and # 9) of 2 patients’ serum potassium levels were critically elevated above 6.0mEq/L (milliequivalents per liter). The facility staff failed to promptly notify the physician, provide patient education, and redraw serum potassium levels to ensure the values returned to normal limits. The facility staff failed to follow the “Use of Low Potassium Dialysate” policy. Elevated serum potassium levels can cause serious, life-threatening complications, including cardiac arrhythmias, which can lead to sudden cardiac death. Failure to closely monitor these electrolyte levels in hemodialysis patients can result in serious harm, injury, and death to all patients receiving hemodialysis at the facility. A normal serum potassium level is between 3.5 and 5.5 mEq/L. Findings include: During a review of the facility’s “IDT Rounding Report” printed on 08/05/2025, the surveyor observed the following: Patient # 8 A review of Patient # 8’s medical record revealed the patient was prescribed a 1 K2+ (Potassium) dialysate bath and required weekly serum potassium levels to be drawn. The patient had the following serum potassium results documented: “07/08/2025: 6.1 mEq/L 07/15/2025: Redrawn 07/18/2025: Cancelled 07/22/2025: Cancelled 07/29/2025: Cancelled 07/31/2025: Undrawn” The patient had a critically elevated serum potassium level on 07/08/2025. The patient did not have another potassium result as of 08/05/2025. The facility staff failed to recognize an elevated serum potassium level and failed to obtain weekly potassium levels on the patient. Patient # 9 A review of Patient # 9’s medical record revealed the patient was prescribed a 1 K2+ (Potassium) dialysate bath and required weekly serum potassium levels to be drawn. The patient had the following serum potassium results documented: “07/08/2025: 7.0 mEq/L 07/15/2025: Redraw 07/18/2025: Error 07/22/2025: 6.1 mEq/L 07/29/2025: Cancelled” The patient had a critically elevated serum potassium level on 07/08/2025 and 07/22/2025. The patient did not have another potassium result as of 08/05/2025. The facility staff failed to recognize an elevated serum potassium level and failed to obtain weekly potassium levels on the patient. A review of the facility’s policy, “Use of Low Potassium Dialysate” with a date of October 2023 revealed, “PURPOSE: To restrict use of low potassium dialysate and to provide guidance for monitoring serum potassium levels in patients prescribed low potassium dialysate. POLICY: 1. Initiation of low potassium dialysate less than 2K+ (,2K+) is restricted to patients with a pre-dialysis potassium level greater than 6 mEq/L (>6) and management and follow-up consistent with this policy. 2. Orders for dialysate <2K+ require approval in Pharos through the Formulary Management Process. 3. No order for <2K+ dialysate will exceed one (1) month duration. 4. Dialysate requests in Pharos are approved for up to 90 days. A renewal task will trigger for the facility 28 days prior to the expiration. A submission is required for clinical review by Clinical Pharmacy Management for continued use of low potassium dialysate. 5. Patients with orders for <2K+ dialysate will have follow-up pre-dialysis serum potassium levels checked weekly and referred to the dietitian for additional dietary counseling. A. If follow-up pre-dialysis serum potassium is <6 mEq/L, RN will contact the nephrologist or non-physician practitioner (NPP) for review, who will decide subsequent changes to dialysate potassium level prior to next treatment. B. If pre-dialysis serum potassium level remains >6.5 mEq/L, RN will contact the nephrologist or NPP for additional considerations. 6. Facility Health Meetings (FHM) will review all patients on <2K+ dialysate, their weekly pre-dialysis serum potassium results, dialysate order start date, if the patient’s nephrologist/NPP was contacted, and any dialysate order changes ...” An interview with Staff # 18 (Clinical Specialist) on 08/05/2025 at 8:45 AM confirmed that the facility’s direct care staff were not following appropriate guidelines for the safe collection of laboratory specimens. Staff # 18 explained that the direct care staff were pre-labeling laboratory collection tubes more than 24 hours before the laboratory specimen was collected from the patient. The deficient practice resulted in an ‘expired’ sticker on the laboratory collection tubes, and therefore, the lab could not process the specimens.”