Fresenius Medical Care of Lowell

“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: 27189 Based on observation, interview, and policy review, the facility failed to ensure infection control practices related to wearing gloves in an Isolation room (designated room utilized by patients with a positive Hepatitis B surface Antigen, indicating a Hepatitis B infection) for 1 of 1 applicable staff members(Registered Nurse (RN) #10). Findings include: Review of the facility policy, titled Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+), dated 11/6/23, indicated but was not limited to the following: *Caring for HBsAg positive patients requires adherence to strict guidelines. The hepatitis B virus is highly infectious because of 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 (seven) days. During an observation on 6/3/25 at 11:23 A.M., RN #10 entered the isolation room (Patient #6, who was Hepatitis B positive, was receiving dialysis treatment), washed her hands, donned the required PPE, but did not don a pair of clean gloves. RN #10 was then observed touching the plastic supply bin located within the isolation room with bare hands. Before retrieving the supplies out of the plastic bin, RN #10 closed the draw of the bin and went to the hand sink in the room and washed her hands. She then donned a pair of clean gloves and resumed retrieving supplies from the plastic bin. During an interview on 6/4/25 at 9:20 A.M., RN #10 said she should have donned gloves before touching the plastic supply bin but did not and had touched the plastic supply bin with her bare hands.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 37349 Based on observation, interview and policy review, the facility failed to ensure that 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #4 and Registered Nurse [RN] #18 ) wore protective eyewear during procedures which spurting or spattering of blood or bleach may occur. Findings include: Review of the facility policy, titled, Personal Protective Equipment, published 11/6/23, included the following: * Personal protective equipment (PPE) including a full-face shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or spattering of blood might occur (e.g. during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). * Protective eyewear is provided by the facility and must be eye protection designed under normal conditions of use to prevent blood and OPIM from reaching the eyes. Prescription corrective eyewear is not considered appropriate eye protection. 1. On 6/3/25 at 10:15 A.M., the surveyor observed CCHT #4 clean and disinfect station 25 for the next patient. During the disinfection of the station CCHT #4 was not wearing eye protection. During an interview on 6/3/25 at 10:25 A.M., CCHT #4 said she should wear eye protection when disinfecting the station. During an interview on 6/5/25 at 1:30 P.M., the Director of Operations said that staff should wear eye protection when disinfecting the station. 44223 2. On 6/3/25 at 10:25 A.M., the surveyor observed RN #18 enter dialysis station 10 while Patient Care Technician (PCT) #5 was initiating treatment for a Central Venous Catheter. RN #18 proceeded to assess the patient without wearing eye protection. During an interview on 6/5/25 at 11:20 A.M., the Clinic Manager said that RN #18 should have been wearing eye protection while assessing the patient.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 27189 Based on observation, interview and policy review, the facility failed to ensure that 1 of 4 staff (Patient Care Technician [PCT] #1), followed proper infection control practices during the initiation of dialysis for 1 of 4 patients (Patient #16) with an Arteriovenous Fistula/Graft (AVF/G), from a total sample of 17 patients. Findings include: Review of the facility policy titled, Assessment and Cannulation, dated 5/5/2025, included but was not limited to the following: *Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection. For Patient #16, PCT #1 failed to disinfect the cannulation site of the patient’s AVF/G, after she and the patient contaminated the site by touching the site with their fingers, causing concern for the potential risk for infection. Patient #16 was admitted to the facility in September 2013 with the diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis three times a week. During an observation on the treatment floor on 6/3/25 at 9:30 A.M., the surveyor observed PCT #1 initiate dialysis treatment for Patient #16 with an AVF. PCT #1 disinfected the lower access site of the AVF, the patient then touched the site to show PCT #1 where she wanted the cannulation needle to be inserted. PCT #1 then touched the site with her finger to indicate to the patient where she was going to insert the needle and did not disinfect the site again before cannulation after she and Patient #16 contaminated the site. During an interview on 6/3/25 at 11:00 A.M., PCT #1 said she should have disinfected the AVF access site after she and Patient #16 contaminated the area, just prior to cannulation, but did not.”

“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: 37349 Based on observation, interview and policy review, the facility failed to ensure that staff followed aseptic technique when drawing saline flushes during a pre-filled syringe shortage. Findings include: Review of the facility policy, titled, Medication Preparation and Administration Procedure Addendum: Drawing Saline Flushes during a Pre-filled Syringe Shortage, published 1/11/22, included the following: * Flushes in the clinic setting must be drawn at the medication station and not at the patient station. * The saline bag should not be entered more than 4 times to draw flushes (does not include spiking the saline bag). * A saline bag may ONLY be used for ONE patient. Saline flushes drawn from a saline bag, and the saline bag itself, must be used for only one patient’s dialysis treatment. * A ‘community’ saline bag at the medication station where multiple staff draw saline flushes is not allowed. * Follow the procedure below to draw saline flushes: 1. Gather supplies. 2. Take saline bag to medication area to prepare saline flushes. 3. Wipe the rubber stopper of the saline bag with an alcohol prep pad. 4. Withdraw 10 milliliters (ml) of normal saline into the syringe. 5. Continue to follow steps 3-4 with up to 4 needles and syringes as needed. On 6/3/25 at 10:00 A.M., the surveyor observed Registered Nurse #5 at the medication station. She wiped the rubber stopper of a saline bag and filled a syringe with 10 ml of saline. She repeated the process and filled a second syringe with 10 ml of normal saline. She then proceeded to label the bag 10 A.M. On 6/3/25 at 11:18 A.M., the surveyor observed Patient Care Technician (PCT) #2 at the medication station. She wiped the rubber stopper of the saline bag labeled 10 A.M. and withdrew 10 ml of saline (3rd needle in 10 A.M. saline bag). Without wiping the rubber stopper again she entered the saline bag with another needle and withdrew 10 ml of saline. (4th needle in 10 A.M. saline bag) On 6/3/25 at 12:10 P.M., the surveyor observed PCT #2 at the medication station. She wiped the rubber stopper of the saline bag labeled 10 A.M. and withdrew 10 ml of saline. (5th needle in 10 A.M. saline bag) Without wiping the rubber stopper again she entered the saline bag with another needle and withdrew 10 ml of saline. (6th needle in 10 A.M. saline bag) During an interview on 6/4/25 at 8:30 A.M., the Clinic Manager said that staff should not have used a ‘community’ saline bag, staff should not have entered the saline bag more than 4 times and they should have disinfected the septum every time they entered the bag with a new needle.”

“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: 27189 Based on observation, interview, document review and policy review the facility failed to ensure equipment solutions were maintained according to Manufacturer’s stability timeframe’s and/or expiration dates and not used when outdated or expired. Findings include: Review of the facility policy titled Myron L-D6 meter maintenance procedure (dated 9/1/2022) indicated but was not limited to the following: *At the beginning of the day check conductivity, TDS (442) and pH solution expiration dates. Discard expired solutions or solutions that are found without a cap. Use unexpired solutions for meter verification. Review of the facility document titled Test Strips and Solutions (revised 5/21/2025) indicated but was not limited to the following: *All test strips and solutions must be dated and initialed when first opened. The reason for this is the products stability starts to deteriorate once opened. *Stability varies by manufacturer. Product must be discarded once the timeframe or the manufacturer’s expiration date has been reached. *Mesa Medical 4-7-10 pH Standard Buffer Solution. Stability Timeframe = 90 days. On 6/3/25 at 8:30 A.M., during the flash tour of the dialysis water treatment area the surveyor observed the following bottles of solutions required for testing of the the pH and conductivity had exceeded the 90 day stability timeframe and/or the manufacturer’s expiration date: Standard pH buffer 10 pH solution-dated as opened on 1/26/25, exceeded the 90 day stability timeframe and the manufacturer’s expiration date was 3/1/25. Standard pH buffer 7 pH solution-dated as opened on 2/26/25, exceeded the 90 day stability timeframe. Standard pH buffer 4 pH solution-dated as opened on 2/26/25, exceeded the 90 day stability timeframe. During an interview on 6/4/25 at 2:00 P.M., the Bio-med Technician and the Regional Bio-med Technician said the above solutions exceeded the 90 day stability timeframe and the Standard pH buffer 10 pH solution was also expired. During an interview on 6/5/25 at 9:20 A.M., the Clinic Manager said that she had been made aware of the solutions that had exceeded the stability time frame/expired and that the solutions should have been discarded and 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: 27189 Based on observation, record review and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min to draw toxins from the patient’s blood) for 1 of 4 patient prescriptions (#17) observed and for 1 patient (#2) record reviewed out of 15 applicable patients, out of total sample of 17 patients. 1. For Patient #17, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to the DFR. Patient #17 was admitted to the facility in October 2021, with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. During an observation on the treatment floor on 6/3/25 at 1:20 P.M., the surveyor observed Patient #17 receiving dialysis treatment, and the machine was set at a DFR rate of 500. Review of the treatment flow sheet indicated that the DFR was to be run at 700 according to the physician’s order dated 4/18/25. During an interview on 6/3/25 at 1:20 P.M., Registered Nurse (RN) #10 and the surveyor verified the patient’s prescription and she said the rate the machine had been set at was incorrect. She said Patient #17’s dialysis prescription indicated that Patient #17’s DFR should be running at 700 and not at 500. 44223 2. Patient #2 was admitted to the facility in April 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 5/10/25 indicated the dialysis order included a BFR to be delivered at a rate of 450 ml/min and a DFR to be delivered at a rate of 800 ml/min. Review of 9 hemodialysis flow sheets, dated 5/17/25 through 5/31/25, indicated the BFR and DFR had not been delivered as prescribed for 6 of 9 treatments, including the following: *5/13/25 - The BFR was delivered at a rate of 300-425 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/15/25 - The BFR was delivered at a rate of 350-400 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/20/25 - There was no documentation of the BFR/DFR rates on the treatment sheets. *5/22/25 - The BFR was delivered at a rate of 370 ml/min, not the 450 ml/min as ordered, and the DFR was delivered at a rate of 500-600 ml/min, and there was no documentation to indicate why the physician’s order was not followed. *5/27/25- The DFR was delivered at a rate of 700 ml/min, not the 800 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *5/29/25- The BFR was delivered at a rate of 425 ml/min, not the 450 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 6/4/25 at 2:00 P.M., the Clinic Manager said she did not have any documented evidence or information on why the BFR/DFR was changed.”

“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: 27189 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 4 staff members (Patient Care Technician [PCT] #1) observed, 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 placed over the access) and palpating for a thrill ( (palpable vibration/buzzing sensation on the skin over the area of turbulent blood flow) for 1 of 4 applicable patients (#16) with arteriovenous fistula/graft (AVF/AVG) access sites, out of a total sample of 17. Findings include: Review of the facility’s policy titled Access Assessment and Cannulation, dated 5/5/2025, indicated but was not limited to the following: LISTEN: *Bruit High pitch/whistle. *Bruit not present throughout access. *Document in treatment record. *Staff are trained to auscultate the vascular access with a stethoscope the entire length of the access for changes in the sound of the bruit. FEEL: *Pulse not soft/not easily compressible. *Thrill not strong at anatomists. *Thrill not present throughout access. *Document in treatment record. *Thrill should have of two sensations-a purring like a cat, or a vibration like a cell phone. It should not pulsate. Strong pulsation suggests there is a flow issue due to stenosis. For Patient #16, PCT #1 failed to listen (auscultate) and feel (palpate) the AVF prior to cannulation. Patient #16 has a diagnosis of End Stage Renal Disease (ESRD) and requires hemodialysis three times a week. During an observation on the treatment floor on 6/3/25 at 10:37 A.M., the surveyor observed PCT #1 initiate dialysis treatment for Patient #16, via an AVF. PCT #1 disinfected the fistula sites, applied the tourniquet, and inserted the needles into the lower access, and then upper access. PCT #1 failed to assess for the presence of a bruit with the use of a stethoscope and palpate for the presence of a thrill prior to cannulation. During an interview on 6/3/25 at 11:00 A.M., PCT #1 said she didn’t listen for the bruit or palpate for a thrill prior to cannulation, but should have.”

“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: 27189 Based on observation, interview and policy review the Medical Director failed to ensure that staff adhered to the heparin administration policy and wait 3-5 minutes after administration of heparin (blood thinning medication) to initiate dialysis treatment for 1 patient (#16 ) out of a total sample of 17 patients. Findings Include: Review of the facility’s policy titled, Factorial; Initiation of Treatment Using an Arteriovenous Graft (AVG) or fistula (AVF), dated 5/5/25, indicated but was not limited to the following: * Wait at least 3-5 minutes prior to initiation of dialysis to allow time for the protein-binding to occur, prevent loss of heparin through the dialyzer, and provide full anticoagulation as soon as treatment starts. For Patient #16, the Medical Director failed to ensure that staff adhered to the heparin administration policy and wait 3-5 minutes after administration to initiate dialysis treatment. Review of the treatment flow sheet indicated that Patient #16 had a physician’s order dated 1/4/25 for heparin sodium 1,000 units-bolus. On 6/3/25 at 10:37 A.M., during an observation on the treatment floor, the surveyor observed PCT #1 as she prepared Patient #17 for dialysis. At 10:57 A.M. PCT #1 administered a bolus of heparin 1,000 units via Patient #17’s AVF. At 10:59 A.M. PCT #1 started the dialysis treatment for Patient #17. PCT #1 did not wait the required 3-5 minutes after the administration of the heparin bolus to initiate dialysis treatment. During an interview on 6/3/25 at 11:14 A.M., PCT #1 said that she did not wait the 3-5 minutes after the heparin bolus to initiate dialysis treatment. She said that she probably only waited about 2 minutes before the initiation of dialysis after the bolus, but should have waited the required amount of time which is 3-5 minutes.”