Fmc Pioneer Valley Dialysis Center

“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: 31240 Based on observation, staff interview, and policy review, the facility failed to ensure 2 of 2 staff members observed (Patient Care Technician [PCT] #8 and PCT #1) adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens. Findings include: Review of the facility’s policy entitled, Cleaning and Disinfecting the Dialysis Station, dated 9/5/23, indicated the following: * All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make surface glisteningly wet and let air dry unless otherwise specified by the manufacture. * Equipment in the dialysis station many include (but is not limited to) the following: Dialysis machine and attachments such as intravenous (IV) pole, blood pressure (BP) cuff and hand sanitizer/ holder, organizer. 1. During an observation on 3/26/25 at 9:50 A.M., the surveyor observed PCT #8 disinfect station E using 1:100 bleach soaked wipes. She was observed disinfecting the hemodialysis machine and the BP cuff., which she placed in the wire basket on the left side of the dialysis machine. She failed to disinfect the wire basket used to hold the BP cuff. During an interview on 3/26/25 at 9:55 A.M., PCT #8 said she should have cleaned the wire basket on the dialysis machine, but missed doing it. 38141 2. On 3/26/25 at 10:45 A.M., during observation of the treatment area, the surveyor observed PCT #1 disinfecting the dialysis machine at station B for the next patient. He was observed disinfecting the dialysis machine using the 1:100 bleach-soaked pads. PCT #1 failed to disinfect the basket on the right side of the dialysis machine. PCT #1 was observed disinfecting the blood pressure cuff, then placed it on the dirty basket that had not been disinfected. During an interview of 3/26/25 at 10:55 A.M., PCT #1 said that he did not realize that he missed the basket during the disinfection process.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 31240 Based on observation, staff interview and policy review, the facility failed to provide evidence that the isolation room had dedicated equipment for use only for Hepatitis B positive patients. Findings include: Review of the facility’s policy, entitled Dialyzing Patients with Positive Hepatitis Antigen, dated 11/6/23, indicated the following: * Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because the concentration of virus particles in the blood is very high and the hepatitis B virus can live outside the body on surfaces for at least 7 days. Outbreaks of hepatitis B have been linked directly to poor infection control practices. Outbreaks tend to occur in patients who are antibody negative and who have not been vaccinated for hepatitis B. * All supplies used in the isolation room/area, such as clamps, blood pressure cuffs, testing reagents, etc., should be labeled “isolation” and not routinely removed. On 3/27/25 at 7:45 A.M. during an observation of the isolation room with Registered Nurse (RN) #3, the surveyor observed an unlabeled centrifuge and stethoscope on the counter. RN #3 said the facility did not have any Hepatitis B patients currently on the census. She said she is unsure why the equipment was unlabeled. On 3/28/25 at 10:00 A.M., during an observation of the isolation room with the Interim Clinic Manager and Director of Operations, the surveyor observed the unlabeled centrifuge machine and stethoscope. In addition, the surveyor observed an unlabeled bag of items stored on the back shelf of the room and 3 unlabeled stools. The Interim Clinic Manager said the bag of items on the shelf appeared to for a patient and should not have been left inside the room. During an interview at 10:05 A.M., the Director of Operations said all items in the isolation room should be labeled as required by the policy. He said the facility has not used the isolation room for some time as they have no hepatitis B positive patients on the census.”

“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: 38141 Based on observation, interview, and record review, the facility failed to ensure the dialysis treatment was delivered as prescribed, relative to Blood Flow Rate (BFR) (measured in milliliters per minute (ml/min) in which the patient’s blood is pushed through dialyzer and back to the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysis solution flows in ml/min to draw toxins from the patient’s blood) during the process of dialysis, for 1 of 4 prescriptions (Patient #9) reconciled, and 1 of 7 applicable patients (Patient #1) reviewed, out of a total sample of 10 patients. Findings include: 1. For Patient #9, the facility failed to ensure the dialysis prescription was delivered as prescribed, relative to the BFR and DFR. Patient #9 was admitted to the facility in April 2024, with diagnoses which included End Stage Renal Disease, requiring dialysis. Review of the physician’s order, dated 3/12/25, indicated the BFR should run at 450 ml/min and dialysis flow rate should run at 800 ml/min. On 3/26/25 at 1:32 P.M., a verification of dialysis treatment was conducted with Registered Nurse (RN) #5 for Patient #9 in station J. The surveyor observed Patient #9 receiving dialysis treatment and the dialysis machine was set to a BFR of 350 ml/min, not 450 ml/min as ordered, and DFR of 500 ml/min, not 800 ml/min as ordered. During an interview on 3/26/25 at 1:35 P.M., RN #5 adjusted the patient #9’s BFR to 450 ml/min, and DFR to 800 ml/min as ordered and said that she will notify the physician. 31240 2. For Patient #1, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the DFR. Patient #1 was admitted to the facility in January 2018 with diagnosis of End Stage Renal Disease requiring hemodialysis treatments 3 times a week. Review of physician’s orders, dated 2/19/25 and 3/14/25, indicated the DFR was to be delivered at a rate of 800 ml/min. Review of 9 Hemodialysis Flowsheets, dated 3/3/25 through 3/24/25, indicated the DFR had not been delivered as prescribed for 3 of 9 hemodialysis treatments as follows: *3/3/25 - The DFR was delivered at a rate between 500 ml/min during part of the treatment, not 800 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/14/25 - The DFR was delivered at a rate of 500 ml/min, not 800 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/24/25 - The DFR was delivered at a rate of 500 ml/min, not 800 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 3/27/25 at 9:15 A.M., the Interim Clinic Manager said that if the DFR is not delivered as ordered, then staff should document the reason the prescription ordered by the physician was not followed. She said staff did not document why the DFR was not delivered as ordered, as required, for the 3 treatment sessions noted above.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 38141 Based on observation, interview, and policy review, the facility failed to ensure staff (Patient Care Technician [PCT] #7) evaluated a vascular access to ensure functionality by the way of listening for a bruit the length of the access (swooshing sound heard with a stethoscope place over the access) for 1 of 2 applicable In Center patients (#10) with an arteriovenous fistula/graft (AVF/G) access, out a total sample of 10 patients. Findings include: Review of the facility policy titled, “Access Assessment and Cannulation”, published May 6, 2024, included the following: “Assessment of Vascular Access” *Listen: -Bruit high pitch/whistle -Staff who had been trained to auscultate vascular access should listen to the entire length for changes in the sound of bruit. A normal low-pitched bruit should be present. -If no sounds present, assume the access is thrombosed and do not attempt cannulation. During an observation of the In Center treatment floor, on 3/26/25 at 9:30 A.M., the surveyor observed PCT #7 as he was preparing Patient #10 for his/her dialysis treatment via an AVF. PCT #7 palpated the vascular access with his fingertips for the presence of thrill, disinfected the fistula sites, and inserted the needle into the lower access, and then the upper access. PCT #7 did not assess Patient #10’s AVF access for the presence of bruit. During an interview on 3/26/25 at 9:40 A.M., PCT #7 said he knew the patient well, but he should have still listened for bruit during assessment.”

“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: 31240 Based on record review, staff interview, and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration of heparin (blood thinning medication) bolus to initiate dialysis treatment for 1 of 7 applicable patients (#5), out of a total sample of 10 patients. Findings Include: Review of the facility’s policy titled, Heparinization, published 8/3/2020, indicated the following: * The physician must order the heparin dose and method of administration. * A heparin bolus loading dose is administered 3-5 minutes pretreatment. For Patient #5, the Medical Director failed to ensure staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after heparin bolus to initiate dialysis treatments. Patient #5 had a physician’s order to administer heparin bolus 4000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 3/7/25 through 3/26/25, indicated for 5 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 3/10//25 treatment started at 7:17 A.M., heparin was documented as administered at 7:30 A.M., 13 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 3/12/25 treatment started at 7:40 A.M., heparin was documented as administered at 7:38 A.M., 2 minutes before the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 3/14//25 treatment started at 7:21 A.M., heparin was documented as administered at 7:20 A.M., 1 minutes before the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 3/17//25 treatment started at 7:37 A.M., heparin was documented as administered at 7:39 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 3/19//25 treatment started at 7:45 A.M., heparin was documented as administered at 7:45 A.M., 0 minutes after the initiation of treatment, not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. During an interview on 3/28/25 at 9:15 A.M., the Interim Clinic Manager said staff did not follow the facility’s policy for heparin bolus administration, as required, for the 5 treatment days noted above.”