Davita Danbury 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 3/25/24 at 9:30 AM identified the following: 1. Treatment floor utility sink contained one scissor with rust throughout the device. 2. The wall next to the treatment floor utility sink had a hole with drywall exposed. 3. The countertops in Pod A and Pod B had sticker residue throughout. Interview with the FA on 3/26/24 at 10:00 AM identified the scissors may have been used to cut open used saline bags for draining into the sink and were subsequently discarded. 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.”

“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: 47491 Based on observations and review of facility policy, the facility failed to perform hand hygiene between tasks which created the potential of exposing patients and staff to contaminated medical equipment, infectious substances, and the transmission of infectious diseases. The findings included: a) Observation on 3/25/24 at 1:00 PM identified Staff Person #5 failed to perform hand hygiene following glove removal after removing needles from Patient #12’s dialysis access at the end of treatment. b) Observation on 3/25/24 at 1:24 PM identified Staff Person #5 failed to offer Patient #12 at Station # 8 hand sanitizer following the removal of his/her glove after holding his/her access site. Patient #12 was further observed leaving his/her dialysis station, proceeding to the weigh station to obtain his/her weight with Staff Person #1 and was not offered hand sanitizer at the weigh station or prior to exiting the clinic. The infection control policy identified hand hygiene is required after glove removal and prior to exiting the treatment floor.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44675 Based on observations, clinical record review, interview and review of facility policy the facility failed to ensure the hemodialysis station was disinfected thoroughly per facility policy. The finding included: Observations conducted on 3/19/24 at 10:00 AM identified Staff Person #3 disinfecting the dialysis station after a hemodialysis treatment. Staff Person #3 failed to disinfect the top of the IV pole attached to the dialysis machine and the stethoscope hanging from the IV pole. Further, Staff Person #3 failed to clean the drain lines from the hemodialysis machine to the wallbox. Additionally, Staff Person #3 proceeded to clean the wall box and then the back of the dialysis machine with the same bleach cloth. Review of the infection control for dialysis facilities policy directed the wall box, drain, and water supply lines are considered part of the dialysis delivery system and should be clean with 1:100 bleach as part of the routine station disinfection between each patient treatment. It further identified non-disposable items (i.e. stethoscopes) are to be disinfected after each patient use.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 44675 Based on facility tour and interview with facility staff, the facility failed to ensure that the water mixing room was secured and accessible only to authorized users. The finding includes: Observation conducted on 3/25/24 at 11:30 AM identified the mixing room door (the room where dialysis treatment solutions are performed and stored), which contained a pin code lock, was held open with a rolling cart. At 2:18 PM, the mixing room door remained accessible to unauthorized personal and this observation was confirmed by the Biomedical Technician. At 2:23 PM the mixing room door was closed was closed by the Biomedical Technician. Interview with the Biomedical Technician on 3/25/24 at 2:18 PM identified the mixing room door should remain closed and locked and was unsure why the door was opened. He identified subsequent to speaking with the dialysis technician, she had left the door open for another teammate who would later need access to the room. He subsequently informed her that the mixing room door had to remain closed and locked.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47640 Observations on 03/26/24 at 10:00 AM, during document review, the surveyor was not provided documentation from the facility or the building owner that the facilities sprinkler system has been maintained and tested as required. i.e., There was no paperwork provided to indicate that a 2nd quarter inspection for 2023 or a 5th year obstruction inspection had been completed.”

“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 clinical record review, interview and review of facility policy for two (2) of three (3) Patients (Patient #1 and #9), reviewed for target weight, the facility failed to address and implement interventions for patients who post weight was 1 kg or more above or below the prescribed EDW and for one patient (Patient #2) reviewed for a cardiac event, the facility failed to maintain the ultrafiltration rate in accordance with physician’s orders resulting in a cardiac episode. The finding included: 1. Patient #1 was admitted to the facility with diagnoses that included end stage renal disease. Patient #1’s physician orders included hemodialysis treatment three times a week for four hours, 2.0 K 2.5 Ca dialysate,with an estimated dry weight (EDW) of 105 kg and blood flow rate of 400. Review of the annual stable care plan dated 9/26/23 identified to maintain Patient #1’s post weight compared to target weight. Review of Patient #1’s treatment flowsheets identified the following: a. On 12/2/23 Patient #1’s post weight was 112.2 kg (4.2 kg above prescribed EDW). b. On 12/5/23 Patient #1’s post weight was 113.2 kg (5.2 kg above prescribed EDW). c. On 12/7/23 Patient #1’s post weight was 112.4 kg (4.4 kg above prescribed EDW). d. On 12/9/23 Patient #1’s post weight was 112.2 kg (4.2 kg above prescribed EDW). e. On 12/14/23 Patient #1’s post weight was 115.2 kg (6.2 kg above prescribed EDW). Review of the treatment flowsheets and progress notes for the aforementioned dates failed to identify the physician was notified of Patient #1 not achieving the prescribed EDW and/or if any interventions were put into place. Interview with the Clinical Coordinator on 3/26/24 at 2:00 PM identified if a patient is greater than 1 kg over their prescribed target weight, an extra treatment should be offered. Although the Clinical Coordinator identified Patient #1 would not come for an extra treatment if offered, the care plan and/or progress notes failed to reflect this. 2. Patient #9 was admitted to the facility with diagnoses that included end stage renal disease. Patient #9’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 51 kg and blood flow rate of 400. Review of the annual stable care plan dated 5/11/23 identified to maintain Patient #9’s post weight compared to target weight. Review of Patient #9’s hospitalization record identified Patient #9 was hospitalized from 2/23/24 - 3/8/24 for hypoxia. Review of Patient #9’s treatment flowsheets identified the following: a. On 3/11/24 Patient #9’s post weight was 45.2 kg (5.8 kg below prescribed EDW). b. On 3/15/24 Patient #9’s post weight was 45 kg (6 kg below prescribed EDW). c. On 3/22/24 Patient #9’s post weight was 46.7 kg (4.3 kg below prescribed EDW). Review of the treatment flowsheets and progress notes for the aforementioned dates fail to identify the physician was notified of Patient #9 not achieving the prescribed EDW. Interview with the Clinical Coordinator on 3/26/24 at 2:10 PM identified the first treatment back from a hospitalization the target weight should be assessed. She identified the target weight assessment was not done for Patient #9 since returning from the hospital and did not know why it was not done. Subsequent to surveyor inquiry she identified Patient #9’s target weight would be addressed. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed the PCT or licensed nurse will obtain and document basic data on each patient post dialysis and if an abnormal finding is identified post treatment, this needs to be reported to the licensed nurse and the licensed nurse will assess the patient prior to discharge. The licensed nurse will use their clinical judgment based on individual patient needs to determine notification of the physician. It further identified if a patient is above or below 1 kg from their target weight, it would be an abnormal finding. 3. Patient #2 had end stage renal dialysis, required hemodialysis three times weekly, had an arteriovenous fistula in his/her upper left arm and a central venous catheter in her upper right chest. Physician’s orders dated 1/15/24 directed hemodialysis for a three-hour treatment with a maximum ultrafiltration rate (the rate of fluid removal) of 13milliliters (ml) per kilogram (kg) per hour. Review of Patient #2’s treatment sheet dated 1/15/24 identified that Patient #2’s pre-treatment weight was 71.2 kg, making her maximum ultrafiltration rate 925 ml/hr. The patient’s treatment was initiated at 9:23 AM with a fluid removal goal of 2.4 liters, which calculates to an ultrafiltration rate of 800 milliliters per hour. At 11:52AM, two hours and twenty-nine minutes after starting his/her dialysis treatment, Patient #2’s treatment was terminated early due to a slight blood leak from the tubing located below the blood pump and his/her total volume already removed was 2.10 liters. Review of Patient #2’s treatment flow sheet at 11:52 AM identified Staff Person #3 documented that the treatment was resumed at 12:21 PM for the remaining thirty-one minutes on a new dialysis machine and his/her fluid goal was increased to 2.8 liters to account for the additional normal saline given to the patient (200 ml during treatment initiation and 200 ml during the rinse back at the end of treatment, on the second machine). At 12:51 PM (thirty minutes after treatment resumed on the second machine) 700 ml of fluid was removed within 30 minutes, when a maximum of only 463 ml’s should have been removed in that time frame according to the physician order of an ultrafiltration rate 13 ml/kg/hour fluid). Review of the Cardiopulmonary Arrest Sheet dated 1/15/24 identified that at 12:48 PM CPR was in progress, saline was given, the patient responded after an additional 400 ml’s of normal saline was given and cardiac compressions were given for 10-15 seconds. Patient #2 had return of spontaneous circulation. The patient refused to be hospitalized and was discharged home in stable condition. Once home the daughter took the patient to the hospital. Interview with Staff Person #3 on 3/27/24 at 10:50 AM identified between thirty and sixty minutes of being on the new dialysis machine, Patient #2 was greeted by Staff Person #5 and did not respond. Patient #2 was immediately given 600ml of normal saline by Staff Person #5, the charge nurse came to Patient #2’s station to assist, and was unable to palpate a carotid pulse and the patient did not react to a sternal rub, cardiopulmonary resuscitation was initiated and Emergency Medical Services was called. After performing compressions for less than one minute, Patient #2 became responsive and refused to go to the hospital. Interview with the Medical Director on 3/27/24 at 12:42 PM identified he was not aware of exactly what happened on 1/15/24 as he wasn’t in the clinic that day. The Medical Director further indicated Patient #2 was seen in the hospital later that day, the hospital physicians were unable to diagnose exactly what occurred, but that he suspected it was an episode of intradialytic hypotension due to too much fluid being removed during treatment.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 44675 Based on clinical record review, interview and review of facility policy for two (2) of three (3) Patients (Patient #7 and #10), reviewed for anemia, the facility failed draw hemoglobin per physician’s orders and for one (1) of two (2) patients (Patient #3) reviewed for Erythropoietin Stimulating Agent (ESA) therapy the facility failed to manage iron supplementation while receiving ESA. The finding included: 1. Patient #7 had a diagnoses that included end stage renal disease. Patient #7’s physician orders included hemodialysis treatment three times a week for three hours, 2.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 62 kg and blood flow rate of 350. The annual stable plan of care dated 5/9/23 identified Patient #7’s hemoglobin was in range. A physician’s order dated 12/29/23 directed Mircera 30 mcg every two weeks. A physician’s lab order dated 12/30/23 directed to draw hemoglobin levels two times a month for anemia. Review of Patient #5’s hemoglobin labs identified on 1/4/24 Patient #7’s hemoglobin was 11.7 (expected value goal for chronic kidney patients is 10-12). Patient #7’s lab result from 1/18/24 identified the lab declined the blood sample due to specimen not being received five days past draw date. Patient #5 only had one hemoglobin value for the month of January 2024. Interview with the Clinical Coordinator on 3/27/24 at 2:00 PM identified the hemoglobin lab that was drawn on 1/18/24 and the electronic records identified it was declined by the lab due to the sample being five days post lab draw but was unsure why that lab declined the sample. 2. Patient #10 had diagnoses that included acute renal disease. Patient #10’s physician orders included hemodialysis treatment three times a week for three hours, 3.0 K 2.5 Ca dialysate, estimated dry weight (EDW) of 39.5 kg and blood flow rate of 350. A physician’s order dated 12/29/23 directed Mircera 30 mcg every two weeks. A physician’s lab order dated 12/30/23 directed hemoglobin lab two times a month for anemia. Review of Patient #10’s hemoglobin labs identified on 12/21/23 Patient #10’s hemoglobin was 9.4. On 1/4/24 Patient #10’s hemoglobin lab identified a redraw was needed and on 1/18/24 the lab declined the blood sample due to the specimen not received five days past draw date. Patient #5 did not have any hemoglobin results for the month of January 2024. On 2/6/24 Patient #5’s hemoglobin result was 7.5 (1.9 decrease). Interview with the Clinical Specialist on 3/27/24 at 11:20 AM identified the lab declined the blood draw from 1/18/24. She identified Patient #10 should have had a re-draw prior to 2/6/24. Interview with the FA on 3/27/24 at 11:22 AM identified she is aware of issues of lab results resulting from the lab. She identified she has called the lab before with no resolution. She identified when a lab does not result, the staff should redraw the lab on the next treatment. 3. Patient #3 had end stage renal disease, required daily peritoneal dialysis, and had an abdominal peritoneal dialysis access. Review of Patient #3’s hemoglobin levels identified a drop in hemoglobin from 10.0 on 1/3/24 to 8.8 on 2/2/24 to 7.0 on 3/4/24. A physician’s order for 200 mg of venofer once monthly from 7/21/23 to 12/6/23 subsequently between 12/6/24 and 3/25/24 there was no order for venofer. Review of Patient #3’s lab results dated 1/3/24 identified a ferritin level of 648 and t-sat level of 7. Review of Patient #3’s ESA administration indicated incremental dose increases from 200 mcg given to 400 mcg administered between 1/30/24 and 3/12/24, however the facility failed to administer supplemental iron during this period. Interview with the Medical Director on 3/27/24 at 12:41 PM identified he/she was not aware Patient #3 was not on an iron protocol and that a ferritin result of 648 and t-sat result of 7 would indicate the need for iron supplementation as the patient’s hemoglobin levels were low and Patient #3 was receiving ESA. The Medical Director further indicated he/she was told Patient #3 had vasculitis and was immunosuppressed, but would still have provided iron supplementation to ensure the effectiveness of the ESA treatment. Review of the Micera Shape 5.1 home protocol indicated all patients should have adequate iron stores to maintain erythropoiesis and all patients receiving Micera should receive iron repletion via IV iron administration.”

“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 observation, interview and review of facility policy the facility failed to discard expired medications and failed to obtain follow up cultures after a peritonitis infection (Patient #12). The finding included: 1) During the flash tour of the facility on 3/25/24 at 9:55 AM Patient #10’s intradialytic parental nutrition (IDPN) was identified in the medication room refrigerator with a discard date of 3/22/24. Review of the medication policy directed that the disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations. 2) Patient #12 had end stage renal disease, required daily dialysis treatments, and had an abdominal peritoneal dialysis catheter. Interview with Staff Person #7 on 3/27/24 at 12:00 PM identified Patient #12 had been diagnosed with peritonitis and had provided the peritoneal dialysis fluid, culture and gram stain results, dated 2/20/24, which identified methicillin resistant staphylococcus epidermidis as the causative organism. Review of clinical records identified Patient #12 was started on a twenty-one-day course of vancomycin, every five days starting 2/14/24, upon presentation of the initial signs and symptoms of infection, and completed on 3/6/24. Although requested, Staff Person #7 was unable to provide the post peritonitis infection culture and cell count results, due two weeks following the final administration of antibiotics, as peritoneal fluid samples were not collected and sent for testing. Interview with Staff Person #7 on 3/27/24 at 12:15 PM indicated it was protocol to send peritoneal fluid samples for testing two weeks after administering the final dose of antibiotics to ensure the infection had resolved. Although requested, Staff Person #7 failed to provide a policy for cultures following treatment for peritonitis. .”