Wallingford Dialysis Care LLC

“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: 44675 Based on observations, facility documentation, facility policy the facility failed to ensure that patients who removed their gloves after holding their hemodialysis access sites were offered hand hygiene, and failed to ensure a staff member performed hand hygiene after glove removal in accordance with facility policy. The findings included: 1. Patient #6 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left forearm Arteriovenous Fistula (AVF), Blood Flow Rate (BFR) of 400 and Dialysate Flow Rate (DFR) of 600. Observations conducted 4/22/25 at 2:16 PM identified Patient #6 was observed with a glove on his/her right hand, holding his/her left hemodialysis access after hemodialysis treatment. At 2:25 PM Staff Member #5 taped up Patient #6’s access and the patient removed his/her glove. Patient #6 proceeded to the scale without being offered hand hygiene. 2. Patient #9 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and forty-five (45) minutes with a right upper AVG, a BFR of 400 and DFR of 600. Observations conducted 4/23/25 at 10:05 AM identified Patient #9 was observed with a glove on his/her left hand from holding his/her right hemodialysis access after hemodialysis treatment. At 10:13 AM Charge Nurse #1 taped up Patient #9’s access and the patient removed his/her glove. Patient #9 proceeded to the scale without being offered hand hygiene. 3. Observation conducted on 4/24/25 at 12:33 PM identified Staff Member #2 applying gloves to attend to a machine alarm, re-setting the machine, removing his/her gloves and then reviewing a patient’s vitals (at Station #7) on the mobile computer without first performing hand hygiene. Review of the infection control policy identified hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, bloodily fluids, secretions, excretions and contaminated items.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (1) out of four (4) hemodialysis patients reviewed for vaccinations (Patient #7), the facility failed to monitor a patient’s hepatitis B antigen monthly in accordance with facility policy. The findings include the following: Patient #7 was admitted to the facility on 6/4/24 with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left forearm arteriovenous fistula (AVF). Review of Patient #7’s hepatitis B antibodies dated 6/6/24 identified Patient #7’s hepatitis B antibodies were less than four (4) (less than 10 indicates susceptible of the hepatitis B virus) and the hepatitis B antigen was negative (identifies if infected with the hepatitis B virus). Review of Patient #7’s medical record failed to identify a hepatitis B antigen was drawn from the period of 6/7/24 - 11/6/24 (four (4) months). Interview with the FA on 4/24/25 at 12:30 PM identified a patient who is susceptible to the hepatitis B virus should have hepatitis antigens drawn monthly. Review of the hepatitis B policy directed If a patient is susceptible to the hepatitis B virus, hepatitis B antigen should be checked monthly.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 38422 Based on facility documentation and interviews the facility failed to ensure that the sprinkler system was tested and fire drills were conducted in accordance with facility policy. The findings include: 1. On 04/22/25 during document review the surveyor was not provided with documentation from the Bio Med Tech or the Facility Administrator to indicate that the Pitch Investigation of the sprinkler system was completed as required by section # 5.2.4.1 of NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems” and as part of the facilities’ preventative maintenance program, i.e. Documentation from the 12/17/24 Inspection Report indicated that the test was due. Test was not done nor was it scheduled to be done at the time of this survey. 2. On 04/22/25 during document review, the surveyor was not provided with documentation from the BioMed Technician or the Facility Administrator (FA) to indicate that the fire drills are being conducted at varying times and under various conditions, as required by section # 21.7.1.4 of the “Life Safety Code”; i.e. There were no 1st or 3rd shift drills completed in the 3rd or 4th quarter of 2024.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47491 Based on review of clinical records, interviews, and review of facility documentation for three (3) of eight (8) patients (Patient #3, #4, and #11) reviewed for hemodialysis prescription, the facility failed to administer patients hemodialysis treatments in accordance with physician’s orders. The findings included: 1. Patient #3 had diagnoses that included end stage renal disease. Physician’s orders directed to hemodialysis three (3) times weekly for four (4) hours with a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 400, dialysate flow rate (DFR) of 500, using an Arteriovenous Fistula (AVF). Review of Patient #3’s treatments identified the following: a. On 4/3/25 hemodialysis treatment was administered at a BFR of 450 and dialysate flow rate of 700 for the entire treatment without documentation identifying the reason for the increased BFR and DFR for the entire treatment. b. On 4/8/25 hemodialysis treatment was administered at a BFR of 450 and DFR of 800 without documentation identifying the reason for the increased BFR and DFR for a total of (2) hours and twenty-nine (29) minutes. 2. Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed to hemodialysis treatments three (3) times weekly for three (3) hours and thirty (30) minutes per treatment, with a 3.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 350, dialysate flow rate (DFR) of 600, using a central venous catheter (CVC). Review of Patient #4’s treatments identified the following: a. On 4/9/25 hemodialysis treatment was administered at a BFR of 400 and DFR of 800 without identifying the reason for the increased BFR and DFR for three (3) hours and nineteen (19) minutes of treatment. b. On 4/22/25 hemodialysis treatment was administered at a BFR of 400 through the treatment without documentation identifying the reason for the increased BFR. Interview with Charge Nurse #2 on 4/24/25 at 9:15 AM identified staff was to document the reason the patient’s BFR and/or DFR was not attained in accordance with physician’s orders during treatment on the vitals line of the electronic medical record. 3. Patient #11 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper arteriovenous fistula (AVF), blood flow rate (BFR) of 400 and dialysate flow rate (DFR) of 700. a. Observation on 4/23/25 at 1:37 PM identified Patient #11 receiving hemodialysis treatment at Station #2. Patient #11’s DFR was set to 500 (not the prescribed rate of 700). Review of Patient #11’s hemodialysis flowsheet dated 4/23/25 identified Patient #11’s hemodialysis treatment was initiated at 12:05 PM by Staff Member #3 with a DFR of 500. Patient #11’s DFR remained at 500 until surveyor inquiry at 1:45 PM. Interview with Staff Member #3 on 4/23/25 at 1:45 PM identified she initiated Patient #11’s hemodialysis treatment and put Patient #11 on at 700 DFR but sometimes the machine would reset the DFR after treatment initiation. She identified she should have gone back and checked Patient #11’s machine settings after initiation. Review of the Monitoring and Documentation of Patient Care During Treatment policy directed proper documentation of all patient care activities before, during, and after each hemodialysis treatment. The policy further directs if a patient’s policy was not met for any reason, a detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.”

“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: 44675 Based on a review of clinical records, interview, and policy review for two (2) of four (4) patients (Patient #3 and #4) reviewed for fluid balance, the facility failed to follow physician’s orders related to blood pressure parameters for a patient with hypotensive episodes and failed to follow standing orders for a hypotensive patient, and for one (1) of four (4) residents (Patient #4) reviewed for hemodialysis prescription, the facility failed to identify fluid removal parameters for a new patient receiving hemodialysis. The findings included: 1. Patient #3 had diagnoses that included end stage renal disease. Physician’s orders directed to hemodialysis three (3) times weekly for four (4) hours with a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 400, dialysate flow rate (DFR) of 500, using an Arteriovenous Fistula (AVF). The physician’s orders further identified blood pressure parameters directing to pause treatment (hold ultrafiltration and normal saline solution bolus) for systolic blood pressure of less than 85. Review of Patient #3’s treatment sheets identified the following: a. On 4/1/25 a blood pressure of 75/49 was identified at 6:30 AM and a blood pressure of 83/54 was identified at 7:30 AM without treatment being paused to stop ultrafiltration (UF) (removal of additional fluid during treatment). Although Patient #3’s blood pressure improved to 90/59 at 7:00 AM, his/her blood pressure continued to decline to 79/44 and 78/45 at 8:00 AM and 8:01 AM. UF was then held until 8:30 AM where a blood pressure of 93/57 was obtained. b. On 4/15/25 blood pressures of 77/44, 76/43, 80/44, and 77/44 were identified between 6:31 AM and 7:31 AM without treatment being paused to stop ultrafiltration (UF). The vitals taken at 7:31 AM identified ultrafiltration was turned off and remained off until 8:01 AM when Patient #3’s blood pressure increased to 86/41. c. On 4/19/25 a blood pressure of 83/46 was identified at 6:31 AM without treatment being paused to stop ultrafiltration, the next vitals check at 7:01 AM where Patient #3’s blood pressure improved to 86/51. Interview with Charge Nurse #2 on 4/24/25 at 9:15 AM identified the standard of practice was for staff to follow the physician’s orders which directed to hold ultrafiltration when Patient #3’s systolic blood pressures dropped below 85. 2. Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed to hemodialysis treatments three (3) times weekly for three (3) hours and thirty (30) minutes per treatment, with a 3.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 350, dialysate flow rate (DFR) of 600, using a central venous catheter (CVC). Physician orders dated 4/2/25 to 4/17/25 failed to identify and estimated dry weight for Patient #4. Review of treatment records indicated Patient #4 was administered dialysis treatment on 4/2/25, 4/4/25, 4/7/25, 4/9/25, 4/11/25, 4/15/25, 4/17/25, and 4/19/25 without an identified estimated dry weight (which was used when calculating the amount of fluid to be removed during each dialysis treatment). Interview with Charge Nurse #1 on 4/23/25 at 9:12 AM identified the amount of fluid removal during the patient’s treatment was determined by subtracting the patient’s estimated dry weight from their current weight, however because Patient #4 was new to dialysis, it was determined that treatments would be set to gently remove fluid from the patient due the patient’s history of hypotensive episodes while hospitalized. Charge Nurse #1 further indentified that he/she had discussed the amount of fluid removal with the physician prior to administering each treatment, however failed to document the amount of fluid the physician directed him/her to remove. Review of the Orders for Patient Care policy directed all verbal/telephone orders must be entered into the appropriate electronic order pathway by an appropriate licensed and trained nurse and shall be countersigned by the physician within the timeframe required by IRC Medical Bylaws, federal and state regulations.”

“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: 44675 Based on a review of clinical records, interview, and policy review for one (1) of four (4) hemodialysis patients reviewed for monthly laboratory results (Patient #9), the facility failed to monitor a patient’s potassium levels monthly in accordance with facility protocol. The findings include the following: Patient #9 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and forty-five (45) minutes with a right upper arteriovenous graft (AVG), 3K (potassium) dialysate, blood flow rate (BFR) of 400 and dialysate flow rate (DFR) of 600. An unstable care plan dated 4/15/24 identified the dietitian was to monitor labs monthly per protocol or as needed. Patient #9’s potassium on 4/10/24 was 3.5 with the goal met. A laboratory result dated 5/1/24 identified Patient #9’s potassium was 4.2 (normal range is 3.5 - 5). Review of Patient #9’s laboratory results identified there has been no potassium drawn since 5/1/24 (approximately eleven months). Interview with the Charge Nurse on 4/24/25 at 11:30 AM identified potassium labs are drawn monthly. Interview with the FA on 4/24/25 at 2:00 PM identified she was not aware that Patient #9 did not have any potassium labs since 5/1/24. She identified patients on 3K dialysate do not require more frequent potassium monitoring other than monthly. Review of the annual/standing orders identified monthly lab works includes potassium.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (1) out of four (4) hemodialysis patients reviewed for physician visits, (Patient #5), the facility failed to ensure the patient was seen at a minimum of monthly by the physician. The findings include the following: Patient #5 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly on Tuesday, Thursday and Saturday for three (3) hours and fifteen (15) minutes with a right upper arteriovenous fistula (AVF), blood flow rate (BFR) of 450 and dialysate flow rate (DFR) of 800. A ninety-day care plan dated 9/11/24 identified Patient #5 regularly missed dialysis sessions particularly on Thursdays. Patient #5 insisted that two sessions per week of dialysis were sufficient. Education about need and benefit of dialysis provided multiple times. A physician’s (MD #1) note dated 11/30/24 (the last physician visit documented in the clinical record) identified Patient #5 regularly missed dialysis sessions particularly on Thursdays. Patient #5 insisted that two sessions per week of dialysis were sufficient. Education about need and benefit of dialysis provided multiple times. Review of physician notes identified that on 12/5/24, 1/16/25, and 3/27/25 identified Patient #5 was a no call/no show. The patient had not been seen by the physician since 11/30/24 (4 months). Interview with the FA on 4/23/25 at 11:57 AM identified there is no policy on physician visits, however, the expectation is to follow CMS regulations where the physician is expected to see the patients at a minimum of monthly. She identified the team has tried to get the patient to go to the office for a physician visit. She identified the Medical Director rounds on Thursdays and Fridays. Interview with the Medical Director on 4/24/25 at 12:35 PM identified Patient #5 refuses to come to treatments on Thursdays. He identified he would try to come on Tuesdays to see the patient. He further identified he had not reached out to Patient #5 via the phone but would consult with the nursing staff on how his/her treatments were going.”

“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: 44675 Based on review of clinical records, interview, and review of facility documentation the facility failed to ensure that expired medical supplies and medications were discarded. The findings included: During a flash tour of the facility on 4/22/25 at 9:30 AM, observations included: a. A bottle Glucose Tablets, 50 count, with no expiration date on the bottle. b. A bottle of Calcium Carbonate, 500 milligrams, 150 count with an expiration date of January 2025 (3 months expired). c. Fifteen (15) three (3) milliliter syringes in the medication room with an expiration date of 2/28/25 (approximately 1 month expired). Interview with the Charge Nurse #1 on 4/22/25 at 9:40 AM identified the standard of practice was to discard both medications and supplies prior to their expiration date. The Charge Nurse further indicated the reason the items were still in circulation was due to them getting missed or overlooked. Review of the Medication Handling, Administration, Storage, and Disposal policy directed expired medications, including over the counter medications and nutritional product samples as applicable, are immediately removed from the treatment and inventory areas and disposed as per state/local regulations.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 32738 Based on clinical record review, facility policy and interviews, for one (1) of four (4) patients reviewed for fluid balance (Patient #4), the facility failed to ensure that the clinical record was complete and accurate to include physician communication regarding a patients hypotension (low blood pressure) during treatments. The findings include: 1. Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed to hemodialysis treatments three (3) times weekly for three (3) hours and thirty (30) minutes per treatment, with a 3.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 350, dialysate flow rate (DFR) of 600, using a central venous catheter (CVC). Review of Patient #4’s treatment sheets identified the following: a. On 4/15/25 blood pressures of 78/54, 83/49, 76/53, 73/48, 74/37, 74/30, and 81/55 were recorded between 11:01 AM and 11:34 AM with ultrafiltration held at 11:04 AM and 150 milliliters of saline administered at 11:34 AM. Blood pressures of 77/50, 88/53, and 88/55 were recorded between 12:01 PM and 1:01 PM, ultrafiltration continued to be held until the end of treatment with no further interventions were taken. b. On 4/17/25 blood pressures of 75/48, 73/40, 80/33, 67/47, 67/45 and 84/46 were recorded between 10:47 AM and 11:03 AM with ultrafiltration held at 11:03 AM and 100 milliliters of normal saline administered. Patient #4’s blood pressure improved steadily to 90/55, 94/55, 113/65, 105/63, 126/70. 129/70, and 143/86 from 11:31 AM to the end of treatment at 2:16 PM with ultrafiltration remaining off. Interview with Charge Nurse #2 on 4/24/25 at 12:20 PM identified Patient #4’s hemodialysis order failed to identify blood pressure parameters, and that the facility’s standard of practice was to assess the patient and notify the physician regarding the patient’s low blood pressures. Charge Nurse #2 indicated he/she had sent the list of Patient #4’s medications per the physician’s request when he/she informed the physician of the patient’s low blood pressures, however failed to document the physician was contacted and/or informed of Patient #4’s blood pressure issue/concerns in the clinical record.”