Davita Sandy Shores Dialysis

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 29151 Based on observation, policy review and staff interview, the facility staff failed to adhere to current aseptic techniques policies and procedures for intravenous medications, as evidenced by the staff failure to appropriately label medication syringes and medication vials. The findings included: Facility policy titled “Medication Policy” last revised October 2023 documents “If medications are prepared and administered immediately, by the same licensed nurse teammate, the medications do not need to be labeled. if the medication is not immediately administered or to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initial of the teammate preparing the medication. Medications containing a preservative must be discarded 28 days after opening...each vial is labeled with initials of the person opening the vial and the expiration date.” Facility policy titled “Anticoagulation” last revised September 2024 documents “The Heparin concentration used to administer the patient loading dose, hourly infusion or intradialytic bolus doses is 1000 units per milliliter. Each vial is labeled with the initials of the person opening the vial and the expiration date. An observation conducted on the treatment floor on 06/23/25 beginning at 9:14 AM revealed the medication area had six syringes filled with a dark substance, labeled as Venofer. Closer observation failed to provide evidence of the time the medication was prepared and who prepared them. In addition there was a multidose vial of Heparin opened, half full and not labeled with initials, date opened or expiration date. Interview with Staff A, the Registered Nurse conducted on 06/23/25 at approximately 9:36 AM revealed she is the person that prepared the syringes for the next shift and verified she did not document the time the medication was prepared or her initials on the medication label. The staff also verify the Heparin vial was not dated.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 29151 Based on observation, policy review and interview, it was determined, the clinical staff failed to ensure catheter care was performed following aseptic technique. This failure affected 1 of 2 patients observed for catheter care at Station #9. The findings included: The facility’s policy regarding Central Venous Catheter (CVC) with Clearguard HD Antimicrobial ends caps procedure, Procedure: 1-04-02 B, last revised April 2025 documents the following steps to include: “Perform hand hygiene and put on personal protective equipment. Remove old dressing and discard. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. Holding catheter with non-dominate hand and using aseptic technique. Clean exit site with 2% Chlorehexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds. Using aseptic technique, remove each cap. One at a time, disconnect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood.” An observation of the catheter care with the patient at Station 9 was conducted on 06/23/25 beginning at 11:12 AM with Staff C, a Patient Care Technician. Staff C performed hand hygiene and donned clean gloves, then removed the dirty dressing from the CVC site and removed the cover from the catheter limbs. Staff C then cleansed the exit site with the same gloves. Staff C continued by performing hand hygiene, donning clean gloves and applying the clean dressing. The staff failed to perform hand hygiene after removing the dirty dressing to minimize risk of cross contamination. Interview with Staff C conducted on 06/25/25 at 12:04 PM revealed the staff acknowledged the proper procedure is to remove the dirty dressing and then do hand hygiene.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 22517 Based on staff interview, review of the facility’s administrative records and policies and procedures, the Water Treatment staff failed to ensure the monthly samples are collected before the weekly disinfection cycle of the water system for 4 of 6 months reviewed and failed to provide evidence that the Medical Director reviewed the results monthly for 2 of 5 months. The findings included: The facility’s policy for Water Culture, Revision Date: April 2025, “ The Medical Director documents a review of all water culture results monthly. Routine Water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. Monthly is defined as within a calendar month. The facility utilizes a CWP (automated) disinfection system in which the system performs a heat disinfection each night and a weekly chemical disinfection. Review of the monthly cultures and the weekly disinfection cycle revealed the facility staff completed the monthly cultures after disinfecting the system for 4 of 6 months reviewed as follows: In April 2025, the facility staff performed the weekly disinfection on 04/30, 04/23, 04/16, 04/09, and 04/02/25. The facility obtained the monthly cultures on 04/24/2025, one day after disinfecting the system on 04/23/25. In March 2025, the facility staff performed the weekly disinfection on 03/26, 03/19, 03/12, and 03/05/25. The facility obtained the monthly cultures on 03/28/25, two day (48 hours) after disinfecting the system on 03/26/25. In February 2025, the facility staff performed the weekly disinfection on 02/26, 02/19, 02/12, and 02/05/25. The facility obtained the monthly cultures on 02/27/25, one day after disinfecting the system on 02/26/25. In January 2025, the facility staff performed the weekly disinfection on 01/29, 01/22, 01/15, 01/08, and 01/02/25. The facility obtained the monthly cultures on 01/23/25, one day after disinfecting the system on 01/22/25. An interview was conducted on 06/24/25 beginning at 12:58 PM with the Biomedical Technician, who confirmed that he missed and took his cultures after disinfecting the system. Another interview was conducted on 06/24/25 at 1:15 PM, he presented the surveyor with signed lab results for October and November but he said he was unable to locate any further signed lab to ensure that the Medical Director had reviewed the lab results.`He later provided the surveyor additional months but after further review of the monthly culture results, revealed that the facility failed to provide evidence that the physician reviewed the culture results for February and March.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22517 Based on administrative record review and interviews, the facility failed to provide evidence the facility followed the manufacturer’s recommendation for the acid mixer. This is evidenced by the facility failure to provide documentation that the micron filter for the acid mixer was changed monthly. The findings included: Review of the facility’s policy and procedure for Preparation of Rockwell Dri-Sate utilizing DAMX45 Dry Acid Concentrate Mixer, Revision Date: October 2024 documented, “Verify 5 micron filter is within manufacturers recommendations.” Review of the Rockwell Medical Dry Acid Concentrate Mix System Operation and Installation Instruction Manual, Revision Date: August 2019 documented “To be performed after each 1500 gallons (15 batches) mixed or once a month whichever occurs first: Replace the 5 micron filter (if equipped). Please ensure that you use a 5 (five) micron filter and not a .5 (point five) micron filter. Use of the incorrect filter type can damage and shorten the lifespan of your pump. Associated component: GE Hytex GX05-9 3/4 (or similar). These filters are available through Customer Service.” Review of the Acid Mixing, Citric Complete Batch Production Record revealed the following months when the facility failed to provide evidence that the filter was changed monthly as follows: Mixing sheets for 2 K (potassium) 2.5 Ca (Calcium) “5-micron Hytex filter present/Date of Replacement: ___ (Replace after disinfection of mixer, monthly or after transfer of 1500 gallons)” 1. Acid Mixed on 05/12/25 - Date of Replacement: 05/06/25 2. Acid Mixed on 05/19/25 - Date of Replacement: 05/06/25 3. Acid Mixed on 05/30/25 - Date of Replacement: 05/06/25 4. Acid Mixed on 04/28/25 - Date of Replacement: 02/10/25 5. Acid Mixed on 04/16/25 - Date of Replacement: 02/10/25 6. Acid Mixed on 03/21/25 - Date of Replacement: 02/10/25 7. Acid Mixed on 03/14/25 - Date of Replacement: 02/10/25 8. Acid Mixed on 02/10/25 - Date of Replacement: 12/24/24 9. Acid Mixed on 01/31/25 - Date of Replacement: 12/24/24 An interview was conducted on 06/24/25 in the morning with the Biomedical Technician. The surveyor reviewed with him changing the micron filter. He confirmed that he did not keep a record of when he changed the filter. He also confirmed being provided conflicting information on when the filter was to be changed. The surveyor then requested the facility’s policy and the manufacturer’s recommendations. He later confirmed that the filter is to be changed monthly. An interview was conducted on 06/25/25 at approximately 11:30 AM with the Patient Care Technician, Staff B. The staff confirmed he is the Technician who mixes the acid. He stated that when he completes the paperwork noting the acid mixing. He gets the date regarding the filter on the sticker the BioMed Technician puts on the filter and he will document the date on the sticker on his paperwork when the filter is to be replaced.”

“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: 29151 Based on clinical record review, policy review and interview, it was determined, the facility failed to ensure the dialysis prescription was consistently followed for 1 of 4 sampled patients (Patient #1). This is evidenced by the clinical staff failure to follow the dialysis prescription for the prescribed Blood Flow Rate (BFR) and failed to document the clinical rationale for not following the prescribed treatment prescription. In addition, the facility staff failed to ensure the appropriate time elapsed after the administration of heparin and initiating the treatment and the facility. This failure affected 1 of 4 sampled patients (Patient #2) The findings included: 1) Clinical record review revealed Patient #2 was admitted to the facility on 09/16/19 and is prescribed to receive dialysis treatment 3 times a week for 3 hours and 30 minutes. The physician also prescribed for the patient to receive Heparin 1000 units bolus. Treatment record dated 05/19/25 documents the staff failed to administer the Heparin and wait 3-5 minutes before initiating the treatment. The nurse documented the treatment started at 10:05 AM with no complications and the Heparin was administered at 10:14 AM. Treatment record dated 06/18/25 documents the staff failed to administer the Heparin and wait 3-5 minutes before initiating the treatment. The nurse documented the treatment started at 10:38 AM with no complications and the Heparin was administered at 10:44 AM. The record provides no clinical rational for administering the Heparin after the treatment was initiated. Interview with the Facility Administrator conducted on 06/25/25 at approximately 11:52 AM confirmed the documentation validates the heparin was administered after the treatment was initiated with no clinical rationale for the delayed administration. Facility policy titled “”AV (arterial venous) Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose”, last revised April 2025 documents as follows: “The heparin concentration used to administer the patient bolus or continuous heparin doses is 1000 units/milliliters. attach heparin loading dose to the venous fistula needle. Flushing promotes administration systemically. Do not initiate dialysis for a minimum of three to five minutes after administering heparin loading dose. Allow heparin to circulate systemically. clotting is to be avoided because it may decrease the patient’s hematocrit or it may decrease the available surface area of the dialyzer, which can impact the adequacy of the hemodialysis treatment. After a minimum of three to five minutes, initiate dialysis per procedure...waiting a minimum of three to five minutes allows the heparin to interrupt the coagulation cascade.” 2) Clinical record review conducted on 06/24/25 revealed Patient #1 has physician order prescribing for dialysis treatment, 3 hours, three times a week with Blood Flow Rate (BFR) 400 and Dialysis Flow Rate (DFR) of 500. On 05/28/25, the staff documented a BFR of 350 throughout the treatment. On 05/30/25, the staff documented a BFR of 300 throughout the treatment. Interview with the Facility Administrator conducted on 06/25/25 at approximately 12:48 PM, after review of the treatment records, confirmed the staff did not follow the prescription and did not document the reason for the changes.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 22517 Based on clinical record review and interview, the facility failed to ensure that the necessary care and services are provided to 2 of 4 sample patients (Patient # 1 and # 3), who had clinical nutritional needs that were not met. This is evidenced by the patients not receiving timely intervention when the patient’s experienced abnormal nutritional labs and/or the patient’s physician orders are not implemented in a timely manner. The findings included: 1) Review of the clinical record for Patient # 3 revealed that the patient was admitted to the facility on 04/11/25. A 04/23/25 albumin lab result revealed results of 3.6. A 04/11/25 physician order revealed a standing order of supplement ONS, Bar protein, low calorie Protein Drink. Further review of the treatment sheets for Patient # 3 failed to provide evidence that the patient received the supplement despite having a low albumin level. An interview was conducted on 06/25/25 at 10:10 AM with the Dietitian, who stated that that they recognized on Monday that the protocol was not put in the system for Patient # 3, so it was just added. She stated that the admission nurse will usually put in the protocol but it was definitely missed. An interview was conducted on 06/25/25 at 10:50 AM with the Registered Nurse, who confirmed she admitted the patient but there was a glitch in the system and they had to manually do the labs. She stated she was unable to enter the ONS protocol. There was no evidence of further follow-up until June (2 months after the patient’s abnormal albumin level). 29151 2) Clinical record review conducted on 06/23/25 revealed Patient #1 had low Albumin level of 2.6 on 04/09/25 (normal range 3.5-5). The record indicates the Albumin level remained below target on 05/09/23 with reading of 3.3. There are no further tests results as of 06/23/25. Progress Notes dated 05/09/24 documents “Received message from patient Care America informing patient will be able to receive IDPN (Intradialytic Parenteral Nutrition) starting next Wednesday (05/14/25).” Physician’s order dated 05/14/25 documents give nutritional supplement, IDPN three times a week via intravenous infusion. Review of the treatment records dated 05/14/25 and 05/21/25 failed to provide evidence that Patient #6 received the nutritional supplement. Interview with The Facility Administrator conducted on 05/24/25 at 9:32 AM confirmed Patient #1 did not receive the prescribed nutritional therapy, and stated the documentation noted the items were not in stock. There is no documentation of attempts to get the prescribed therapy. Subsequent interview with the Dietician conducted on 06/25/25 at 10:22 AM revealed she received the approval for the nutritional therapy for Patient #1, and she writes the order the date the therapy is to start, after all the logistics have been completed. Generally the company sends a week supply and if any concerns she is made aware and contacts them to resolve the issues. The dietician is not aware why Patient #1 missed two doses of the nutritional therapy, she was not made aware of delivery issues.”

“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: 22517 Based on clinical and administrative record review and interview, the facility failed to provide the necessary care and services to achieve and sustain appropriate anemia management for 1 of 4 sampled patients (Patient # 3). This is evidence by the facility failure to provide the necessary orders and administration of the medication used to treat iron stores in a timely manner. The findings included: Review of the clinical record for Patient # 3 revealed that the patient was admitted to the facility on 04/11/25 and was prescribed to receive in-center hemodialysis treatment three times a week. The patient lab results are as follows: Hgb (Hemoglobin) Tranferrin Saturation (T-Sat) Ferritin (normal 12 to 16g/dl) less than 20% indicate iron deficiency (13 to 150 ng/ml) 04/25 7.3 g/dL 128 ng/mL 04/30 8.1 g/dL 05/09 8.1 g/dL 8.0 % 51 ng/ml 05/28 8.4 g/dL 150 06/09 8.8 g/dL Further review of the physician orders and treatment revealed that the patient received Venofer 100 mg every treatment for 10 treatments from 05/15 through 06/06/25. There is no evidence that the patient was prescribed or received any additional doses of Venofer since 06/06/25 despite having abnormally low T-Sat and Ferritin levels. An interview was conducted on 06/25/25 at 10:50 AM with the Registered Nurse, who confirmed that once the loading doses are completed, a repeat lab is done and then the patient will be prescribed a maintenance dose. She further stated that Patient # 3 received the loading dose but we missed the maintenance doses. She also confirmed that the patient has not received additional Venofer doses after 06/06/25. She stated she will contact the physician to get orders.”

“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: 29151 Based on observation, policy review, and interview, it was determined, the clinical staff failed to ensure vascular access care was provided while utilizing aseptic technique to minimize risk of infection. The failure affected 2 of 3 observations of initiation of treatment. The findings included: Facility policy titled “AV (arterial venous) Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles and Administration of Heparin Loading Dose”, last revised April 2025 documents as follows: “Do not palpate insertion site once the area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. While maintaining aseptic technique, prep each planned needle site by applying a 70 percent alcohol prep pad to each site using a circular rubbing motion, enter out.......If the site has become contaminated, prep insertion site as per steps.” 1) Observation of care conducted on 06/23/25 at approximately 10:04 AM revealed Staff B, a Patient Care Technician, initiating dialysis treatment at Station #6. The staff checked the pH level, then performed hand hygiene, donned clean gloves, and cleansed the access site multiple times. The dialysis machine was alarming, Staff B proceeded to touch the machine to turn off the alarm and with the same gloves inserted the first needle. Staff B continued by disinfecting the second access site, and again touched the machine to turn off the alarm and proceeded with the second cannulation. The staff failed to perform hand hygiene and change gloves after touching the dialysis machine and prior to inserting the needles. Interview with Staff B conducted on 06/24/25 at 10:46 AM verified the observation noted above. 2) Observation of care conducted on 06/23/25 at approximately 10:28 AM revealed Staff C, a Patient Care Technician, initiating dialysis treatment at Station #9. The staff donned clean gloves, disinfected the access site, then palpated the area and inserted the first needle. Staff C proceeded by disinfecting the second site, then again, palpated the area multiple times and inserted the second needle. Staff C failed to cleanse the access sites after palpating and prior to needle insertion. Interview with Staff C conducted on 06/23/25 at 12:04 PM revealed the patient is hard to cannulate and confirmed the observation noted above.”