Davita South Norwalk Dialysis

“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: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to provide a clean and sanitary environment. The findings include: Flash tour observations conducted of the facility treatment floor on 7/22/24 at 8:20 AM identified the following: 1. A coffee cup on the clean medication preparation counter. 2. Two IDPN pumps (used to administer IV nutrition) and one IV pump in the clean hallway ready for use with brown dried splatter throughout the pump and cords. Review of the infection control for dialysis facilities policy directed that the policy’s purpose is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. It directed food and drinks in the treatment area will be limited to patients. Sharing and storage in the treatment area is not allowed. It further directed non-disposable items are to be disinfected after each patient use, prior to removal from the treatment area/station and if contaminated between uses.”

“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 observation, interview and review of facility policy, the facility failed to ensure staff and patients followed appropriate hand hygiene techniques in accordance with facility policy. The finding included: 1. Constant observation on 7/22/24 starting at 11:25 AM identified the following: a. At 11:25 AM Staff Person #1, with a gloved hand, reset the alarm of Machine #5 Station #21. Staff Person #1 then went to Machine #30 Station #20 and reset the alarm without the benefit of removing the gloves used for Machine #5 and performing hand hygiene. Staff Person #1 removed her gloves, did not perform hand hygiene and then went to the computer by Station #6 and began typing without performing hand hygiene. b. At 11:28 AM Staff Person #1, with a gloved hand, reset the alarm of Machine #3 Station #3, removed her gloves and failed to perform hand hygiene. c. At 11:33 AM Staff Person #1 administered medications to the patient at Station #21 with gloved hands, removed her gloves, and failed to perform hand hygiene. Staff Person #1 went to the computer by Station #6 and began typing without performing hand hygiene. d. At 11:35 AM Staff Person #1, with a gloved hand, reset the alarm of Machine #5 Station #21 and touched different parts of hemodialysis machine bicarb system and lines, removed her gloves and failed to perform hand hygiene. Machine #5 alarmed again, Staff Person #1 donned gloves, reset the alarm, and removed her gloves without performing hand hygiene. She then went to the computer by Station #21 and began typing with her dirty gloves in her left hand without the benefit of hand hygiene and disinfecting the computer keyboard. e. At 11:53 AM Staff Person #1, with a gloved hand, reset the alarm of Machine #5 Station #21 and touched different parts of hemodialysis machine bicarb system and lines, removed her gloves and failed to perform hand hygiene. 2. Observation on 7/22/24 at 2:48 PM identified a patient held pressure to his/her access following hemodialysis treatment. The PCT did not offer hand hygiene to the patient and the patient did not perform hand hygiene prior to leaving the treatment floor. Interview with the Director of Clinical Services on 7/23/24 at 3:03 PM identified there will be immediate education on hand hygiene for Staff Person #1 before returning to the treatment floor. Review of the infection control policy directed all teammates will perform hand hygiene prior to gloving and immediately after removal of gloves, after patient and dialysis delivery system contacted and between patients even if the contact is casual. It directed patients and caregivers will be encouraged to perform hand hygiene after treatment before leaving the treatment area.”

“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: 47491 Based on review of clinical records, interviews, and review of facility documentation for one of two patients (Patient #1) for immunization, the facility failed to ensure a susceptible patient was tested monthly for hepatitis B antigen. The finding included: Patient #1 had end stage renal disease, required daily peritoneal dialysis treatments, and had a peritoneal dialysis catheter in his/her lower abdomen. Review of Patient #1’s immunity status identified Patient #1 as susceptible to Hepatitis B as his/her antibody level was less than 10. Review of Patient #1 lab results dated 6/4/24 failed to identify monthly hepatitis B antigen testing was done. Interview with Staff Person #5 on 8/22/24 at 2:22 PM identified facility practice was to test susceptible patients for Hepatitis B antigens monthly and that he/she was unsure as to why Patient #1 was not tested in June 2024. Review of the CMAB Recommended Evaluation and Immunization Against Hepatitis B Infection policy directs patients have be tested monthly for Hepatitis B antigen while susceptible to the virus.”

“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: 44675 Based on a review of clinical records, interview, and policy review for three (3) of six (6) hemodialysis patients reviewed for prescription, (Patient #3, #5 and #12), the facility failed to ensure the patient’s hemodialysis treatment was delivered in accordance with the physician orders. The findings include the following: 1. Patient #3 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours thirty (30) minutes with a left arteriovenous fistula (AVF), fifteen (15) -gauge needs, a dialysate flow rate (DFR) of 500 and blood flow rate (BFR) of 450. A sample review of Patient #3’s treatment flowsheets identified the following: a. On 6/18/24 Patient #3 began treatment at 11:10 AM with a BFR of 450. At 1:32 PM Patient #3’s BFR decreased to 400 and decreased again at 2:03 PM to 350 BFR with no rationale as to why the prescribed BFR of 450 was not met. Patient #3’s arterial pressures were above -220 for the entire treatment. b. On 6/20/24 Patient #3 began treatment at 10:45 AM with a BFR of 450. At 11:31 AM Patient #3’s BFR decreased to 400 (arterial pressure -240) and decreased again at 12:31 PM to 350 BFR (arterial pressure -324) with no rationale as to why the prescribed BFR of 450 was not met. c. On 6/22/24 Patient #3 began treatment at 10:58 AM with a BFR of 450. At 12:01 PM Patient #3’s BFR decreased to 400 with no rationale as to why the prescribed BFR of 450 was not met. d. On 6/29/24 Patient #3 began treatment at 11:22 AM with a BFR of 400 (arterial pressure -233). At 12:33 PM Patient #3’s BFR decreased to 380 (arterial pressure -234) and decreased again at 1:33 PM to 350 BFR (arterial pressure -227) with no rationale as to why the prescribed BFR of 450 was not met. e. On 7/6/24 Patient #3 began treatment at 11:08 AM with a BFR of 450. At 11:31 AM Patient #3’s BFR decreased to 390 with no rationale as to why the prescribed BFR of 450 was not met. f. On 7/11/24 Patient #3 began treatment at 11:16 AM with a BFR of 350 (arterial pressure -272). At 12:07 PM Patient #3’s BFR decreased to 235 with no rationale as to why the prescribed BFR of 450 was not met. g. On 7/13/24 Patient #3 began treatment at 11:18 AM with a BFR of 450. At 1:02 PM Patient #3’s BFR decreased to 350 (arterial pressure -239) with no rationale as to why the prescribed BFR of 450 was not met. Review of the nursing notes failed to identify documentation of issues with Patient #3’s hemodialysis access and why the prescribed BFR was not being achieved. Interview with the Director of Clinical Services on 7/23/24 at 3:00 PM identified everything the prescription is not being achieved, it should be documented on the treatment sheet. Review of the AVF and AVG vascular access care policy directed that for fifteen gauge needles, the anticipated pre-pump arterial pressure limit is no more negative than -220. 2. Patient #5 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times weekly for four hours and fifteen minutes with a left arteriovenous fistula (AVF), fifteen (15) -gauge needs, a dialysate flow rate (DFR) of 800 and blood flow rate (BFR) of 450. Review of Patient #5’s kt/v lab (efficacy of dialysis) dated 7/2/24 identified the result of 1.11 (under the goal of 1.2). Patient #5’s stable care plan dated 7/11/24 identified for Patient #5’s adequacy care area, the goal was to maintain adequacy goal. A sample review of Patient #5’s treatment flowsheets identified on 6/29/24, 7/2/24, 7/4/24, 7/6/24, 7/11/24, 7/13/24, 7/16/24 and 7/18/24 Patient #5’s DFR was 500 with no rational as to why the prescribed DFR of 800 was not met. Review of the nursing notes failed to identify documentation of issues with Patient #5’s hemodialysis access and why the prescribed DFR was not being achieved. 3. Patient #12 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and forty five (45) minutes. Patient #12’s hemodialysis orders dated 6/8/24 - 7/10/24 directed a dialysate flow rate (DFR) of 800, sixteen (16)-gauge needles and a blood flow rate (BFR) of 350. Review of Patient #12’s kt/v lab (efficacy of dialysis) dated 6/28/24 identified the result of 1.15 (under the goal of 1.2). A sample review of Patient #12’s treatment flowsheets identified on 6/28/24, 7/1/24, 7/3/24, 7/5/24, 7/8/24 and 7/10/24 Patient #12’s DFR was 500 with no rational as to why the prescribed DFR of 800 was not met. Patient #12’s hemodialysis orders dated 7/10/24 - current directed a dialysate flow rate (DFR) of 0, fifteen-gauge needles and a blood flow rate (BFR) of 450. The physician’s orders failed to identify an accurate prescribed DFR. A further review of Patient #12’s treatment flowsheets identified on 7/12/24, 7/15/24, 7/17/24, 7/19/24, and 7/22/24 Patient #12’s DFR was 500. Interview with the Medical Director, Patient #12’s physician, on 7/23/24 at 2:05 PM identified Patient #12’s DFR should have been what the previous order had it at, 800 DFR. He identified Patient #12 had a newer access that was taking longer to mature. He identified the increase in DFR was an intervention due to Patient #12’s low kt/v (along with increasing Patient #12’s treatment time). Review of the pre-intra-post treatment data collection, monitoring and nursing assessment identified if the dialysis prescription is not being met (including dialysis flow rate) the reason will be documented and the licensed nurse informed. 47491”

“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 four (4) of eleven (11) hemodialysis patients reviewed for fluid management, (Patient #1, 6, 8, and 9), the facility failed to address the patient not meeting the prescribed target weight in the medical record, failed to obtain stading blood pressures and failed to report an abnormal blood pressure in accrodance to facility policy.The findings include the following: 1) Patient #1 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for ( 3)three hours and forty five (45) minutes with a left arteriovenous fistula (AVF) and an estimated dry weight (EDW) of 72 kg. The annual stable care plan dated 1/29/24 identified Patient #1’s blood pressure and fluid management goal was to maintain post weight compared to target weight. Review of Patient #6’s hemodialysis treatment sheets identified the following: a. On 7/16/24 Patient #1’s post weight was 79.0 kg (5.5 kg above prescribed EDW). Review of the nursing assessments and progress notes failed to identify Patient #1’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. b. On 7/18/24 Patient #1’s post weight was 77.1 kg (5.1 kg above prescribed EDW). The nursing assessment identified Patient #1 had generalized edema. Review of the nursing assessment and progress notes failed to identify Patient #1’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. c. On 7/20/24 Patient #1’s post weight was 74.6 kg (2.6 kg above prescribed EDW). Review of the nursing assessments and progress notes failed to identify Patient #1’s EDW not being achieved, interventions and education provided (if any), and if the physician was notified. 2. Patient #6 had diagnoses that included end stage renal disease. Patient #6’s physician orders included hemodialysis treatment three (3) times a week for four (4) hours, 2.0 K 2.5 Ca dialysate and an estimated dry weight (EDW) of 94 kg. Review of Patient #6’s hemodialysis flowsheets identified the following: On 5/29/24, 6/5/24, and 6/19/24, Patient #6 ambulated with a cane to treatment and did not have a post treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. 3. Patient #8 had diagnoses that included end stage renal disease. Patient #8’s physician orders included hemodialysis treatment three (3) times a week for three (3) hours, 2.0 K 2.5 Ca dialysate and an estimated dry weight (EDW) of 77 kg. On 6/4/24, 6/15/24, 7/2/24, and 7/6/24, Patient #8 ambulated without assistance to treatment and did not have a post treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. 4. Patient #9 had diagnoses that included end stage renal disease. Patient #9’s physician orders included hemodialysis treatment three (3) times a week for three (3) hours, 2.0 K 2.0 Ca dialysate and an estimated dry weight (EDW) of 72.5 kg. Patient #9 had abnormal blood pressures on 7/15/24 of 158/142, 184/146, and 171/151 while receiving treatment and failed to notify the physician. Interview with the Director of Clinical Services on 7/22/24 at 2:30 PM identified if abnormal blood pressures are rechecked and/or continue to occur, the medical director or attending physician should be notified. Interview with the Medical Director on 7/23/24 at 1:58 PM identified the attending physician should be notified of any abnormal findings and does not recall being contacted regarding Patient #9’s abnormal blood pressures on 7/15/24. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed staff to document the required pre and post treatment blood pressure measurement (and if the patient was unable to stand, to document the reason why), and the licensed nurse to notify the physician of changes in the patient’s status. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed if an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions or notification of the physician is necessary. Abnormal findings for fluid status post treatment is if a patient is above 1 kg from the target weight. 47491”

“PA-RD-NUTRITIONAL STATUS CFR(s): 494.80(a)(6) The patient’s comprehensive assessment must include, but is not limited to, the following: (6) Evaluation of nutritional status by a dietitian This Standard is not met as evidenced by: 47491 Based on review of clinical records, interview, and policy review for one (1) of four (4) hemodialysis patients reviewed for albumin, (Patient #7), the facility failed to ensure a patient whose albumin was not in goal range was re-started on Intradialytic Parenteral Nutrition (IDPN) upon return from an extended hospitalization. The findings included the following: Patient #7 had diagnoses which included end stage renal disease. The physician’s order directed to hemodialysis treatments three (3) times weekly for three (3) hours and thirty (30) minutes, using a central venous catheter (CVC) in the left chest, with 2.0 K, 2.5 Ca dialysate, a 400 blood flow rate, and a 500 dialysate flow rate. Review of Patient #7’s albumin (blood protein level) results identified a value of 3.1 on 4/17/24 and 2.7 on 5/31/24. A physician’s order dated 4/25/24 directed infusion of 337 milliliters of IDPN (intravenous protein supplementation) with each dialysis treatment which was inactivated on 5/26/24 due to hospitalization. Review of Patient #7’s hospitalization history identified admission from 4/23/24 to 5/30/24 and from 6/10/24 to 7/2/24. Review of Patient #7’s July 2024 treatments identified he/she had received seven dialysis treatments subsequent to the hospital stay on 7/3/24, 7/5/24, 7/8/24, 7/10/24, 7/12/24, 7/15/24, and 7/17/24 and was not restarted/administered IDPN therapy. Interview with the Dietician on 7/23/24 at 11:28 AM identified he/she was out of the office (6/28/24 to 7/17/24) when Patient #7 had returned from his/her hospitalization and had failed to inform staff and/or the covering dietician to restart Patient #7’s IDPN order for treatment upon his/her discharge from the hospital. Interview with the Medical Director on 7/23/24 at 1:55 PM identified Patient #7 should have been restarted on IDPN upon his/return from his/her July 2024 hospitalization.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 47491 Based on clinical record review, facility documentation, policy review and interview, for two (2) patients reviewed for peritoneal dialysis, (Patient #10 and #11), the facility failed to ensure that peritoneal dialysis treatment sheets were monitored to ensure the dialysate guidelines were followed in accordance with physician’s orders. Patient #10 had end stage renal disease, required daily peritoneal dialysis treatments, and had a peritoneal dialysis catheter in his/her lower abdomen. Patient #11 had end stage renal disease, required daily peritoneal dialysis treatments, and had a peritoneal dialysis catheter in his/her lower abdomen. Review of both Patient #10 and Patient #11’s daily treatment records identified both patients were compliant with their daily treatments, however failed to identify both patients were following their fluid guidelines (which specified the concentration of dialysate solution to use with treatments based on weight and/or blood pressure) as the facility was unable to provide the guidelines prescribed to each patient. Interview with Staff Person #2 on 7/23/24 at 10:05 AM identified copies of the fluid guidelines were not kept on file for Patient #10 or Patient #11 and that treatment flowsheets were not thoroughly reviewed as he/she could not compare what dialysate was used for treatment to what the physician ordered. Review of the Home Dialysis Monitoring and Ongoing Patient Education directs the facility to document in the patient’s medical record that the patient, the caregiver, or both have received and demonstrated an adequate comprehension of the training by reviewing home patient clinical records for evidence of compliance with their training.”

“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 observations, facility documentation, facility policy and interviews, the facility failed to ensure opened multiuse medications were labeled appropriately, failed to discard expired medications, complete appropriate tuberculosis testing per facility policy, and failed to follow heparin protocols at the initiation of treatment. The findings include: 1. Flash tour observations conducted of the facility treatment floor on 7/22/24 at 8:20 AM identified two lidocaine multi-use vials and two heparin multi-use vials opened without the date opened and initials of who opened the bottles. Review of the medication policy identified each vial is labeled with the initials of the person opening the vial and the expiration date. 2. Twenty recirculators (used when to connect dialysis lines to recirculate saline/fluids) with an expiration date of 3/5/24. 3. Four 2.5 milligrams of Parsabiv (used to treat high levels of blood calcium) with an expiration date of 6/2024. 4. Twenty-seven vials of Pneumococcal Vaccine Polyvalent (pneumonia vaccine) with an expiration date of 5/6/24. 5. Five prefilled syringes of Fluzone Influenza Vaccine 2023-2024 formula with an expiration date of 6/2024. 6. Fifteen 0.5 milliliters prefilled syringes of Flucelvax Quadrivalent Flu Vaccine with an expiration date of 6/23/24. Interview with the Charge Nurse on 7/22/24 at 8:54 AM identified expired supplies and medications were to be taken out of circulation and disposed of on or before the expiration date and were missed when inventory was reviewed/checked. Review of the Medication Policy identified that expiration dates will be checked monthly and directs expired medications to be removed from treatment and inventory areas and disposed of. 2. Patient #12 was admitted to the facility on 4/29/24 with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times weekly for three (3) hours and forty five (45) minutes. Review of Patient #12’s Tuberculin purified protein derivative (PPD test which helps diagnose a tuberculosis infection) results identified Patient #12 had a PPD placed on 4/29/24 and read on 5/1/24 as 0 mm (negative result). The medical record failed to identify a second PPD test was administered and read within twenty-eight (28) days per facility policy. Interview with the Clinical Services Manager on 7/23/24 at 3:00 PM identified a new admission is to have a two step PPD test series completed (a total of two PPD tests). Review of the tuberculosis infection control policy directed for an admission new to dialysis with a chest x-ray prior to the first treatment, upon admission administer one step tuberculin skin test (TST) followed by a second TST one to three weeks after the admission TST. 3)Patient #13 had diagnoses that included end stage renal disease. The physician’s orders directed to hemodialysis treatment three times per week for three (3) hours per treatment, using a right upper arm graft, 2.0 K / 2.5 Ca dialysate at a 450 blood flow rate and 500 dialysate flow rate. Observation of Staff Person #3 on 7/23/24 at 11:50 AM instilling 500 units of heparin (a medication used to prevent the formation of blood clots) into Patient #13’s venous line and initiating Patient #13’s treatment at 11:52 AM. Interview with Staff Person #3 at 11:56 AM identified he/she had failed to wait five (5) minutes following the heparin instillation to initiate treatment as policy directs. Review of the Anticoagulation Policy directs the initial loading dose of heparin was to be administered at least 3 to 5 minutes prior to the initiation of the hemodialysis treatment. 47491”