Usrc Amherst Dialysis

“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: 40430 Based on policy review, observation, and interview, nursing staff do not follow standard infection control practices regarding the use of gloves and hand hygiene. Specifically, staff do not change gloves and/or perform hand hygiene when performing access care and initiating the dialysis treatment, when entering/exiting the dialysis station, and while preparing the dialysis machine for the next patient use. Findings include: Review of the policy “Infection Control and Precautions for All Patients,” revised July 2023, indicated staff will perform hand hygiene using soap and water or antibacterial hand sanitizer before/after all patient contact and before applying and after removing gloves. Hand hygiene must be performed after contact with the machine and keyboard, regardless of whether contact occurred through gloved or ungloved hands. Staff must remove gloves and perform hand hygiene between each patient or station. Review of the policy “Hand Hygiene,” revised August 2020, indicated hand hygiene will be performed: before and after touching a patient; prior to entering and on exiting dialysis station; prior to contact with vascular access site; before clean/aseptic procedure (the practice of preventing contamination); after touching patient surroundings or dialysis machine; after gloves are removed; and after contact with inanimate objects, including medical equipment or environmental surfaces in the patient station. Review of the policy “Dialysis Catheter Dressing Change Procedure,” revised February 2023, indicated staff are to remove the old exit site/central venous catheter (CVC-tube inserted into a large vein in the body to provide access for dialysis) dressing and discard. Staff are to remove gloves, perform hand hygiene, and apply clean gloves prior to cleansing the skin surrounding the CVC exit site (site where the catheter enters the body). Observation on 03/31/25 at 10:50 AM at Station #10 for Patient #4 revealed Staff (K), Licensed Practical Nurse (LPN) removed the old dressing from the CVC ports (external tubing portion of CVC that provides access to the bloodstream) and discarded. Staff (K) removed their gloves, but did not perform hand hygiene before applying a new pair of gloves. Staff (K) cleansed the CVC ports, removed the end caps, and removed their gloves. Staff (K) did not perform hand hygiene before applying a new pair of gloves to attach a syringe and aspirate solution/blood from the ports. Staff (K) removed their gloves, but did not perform hand hygiene before applying a new pair of gloves to flush the CVC ports with normal saline (intravenous (IV) solution used during dialysis). Staff (K) removed their gloves, but did not perform hand hygiene before applying a new pair of gloves to connect Patient #4 to the dialysis machine, touched the machine screen and/or keyboard, and initiated treatment. Staff (K) removed their gloves, did not perform hand hygiene and exited Station #10. At 10:57 AM, Staff (K) entered Station #11 but did not perform hand hygiene before applying a new pair of gloves and proceeded to touch the clean dialysis machine/blood lines that was set up for the next patient appointment. Staff (K) removed their gloves, exited Station #11 and washed their hands. Observation on 04/02/25 at 10:25 AM at Station #1 for Patient #1 revealed Staff (O), Registered Nurse (RN), removed the old CVC dressing but they did not remove their gloves and perform hand hygiene prior to cleansing the skin surrounding the CVC exit site. Interview on 04/02/25 at 11:30 AM with Staff (A), Facility Administrator, Staff (F), Covering Facility Administrator, and Staff (G), Clinical Specialist, verified these findings.”

“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: 34528 Based on policy review, observation, and interview, staff do not wear personal protective equipment (PPE- face shields, goggles with side shields, gloves, and gowns) appropriately while performing procedures during which the spurting or spattering of blood might occur. Findings include: Review of policy “Personal Protective Equipment (PPE),” last revised July 2023 revealed face shields and goggles with side shields are worn when potential exposure to blood, body fluids, and other substances is possible. Goggles with side shields are used with a face mask to provide full face protection. Regular eyeglasses are not worn in place of safety goggles. Observation on 03/31/25 at 10:00 AM at Station #4 revealed Staff (L), Patient Care Technician (PCT), was wearing “regular” glasses without side shields and had a face shield setting on top of their head not covering the face while removing used bloodlines from the dialysis machine. At 01:55 PM at Station #10, Staff (L) was wearing regular glasses without side shields and had a face shield setting on top of their head not covering the face while removing used bloodlines from the dialysis machine. Interview on 04/02/24 at 01:30 PM with Staff (G), Clinical Specialist, verified findings.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 34528 Based on policy review, observation, and interview, staff do not secure medication filled syringes. Findings include: Review of the policy “Guidelines for Administration of Medication,” last revised February 2025, revealed medications will not be left unattended/unsecured at any time in the patient treatment area (patient station, counters, desks). Observation on 03/31/25 at 10:07 AM revealed two Heparin (medication used to prevent blood clotting during dialysis) filled syringes for Patient #4 and two Heparin filled syringes for Patient #17 were unsecured and unattended located on the island counter in the center of the clinic. Interview on 04/02/25 at 01:30 PM with Staff (G), Clinical Specialist, verified findings.”

“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: 40430 Based on policy review, observation, and interview, staff do not ensure expired medication is not available for use. Findings include: Review of the policy “Preparation and Administration of IV/SubQ/IM Medications,” last revised February 2023, indicated staff are to label multi-dose vials with the date and initial when first opened. Epogen (medication used to treat anemia or low red blood cells) must be discarded 21 days after opening. Review of the policy “Preparation and Administration Erythropoietin-Stimulating Agents (medications used to treat anemia that stimulate the bone marrow to produce more red blood cells),” revised April 2021, indicated staff are to check both the expiration date and the date of first puncture (opened on date) of the Epogen vial to ensure the medication has not expired. Multi-dose vials of Epogen must be discarded 21 days after initial entry. Observation on 03/31/25 at 10:20 AM and 04/01/25 at 11:45 AM, in the medication refrigerator, revealed one multi-dose vial of Epogen 20,000 units/two milliliters (ml) had no “opened on” date or staff initials written on the vial. Interview on 04/02/25 at 11:30 AM with Staff (A), Facility Administrator, Staff (F), Covering Facility Administrator, and Staff (G), Clinical Specialist, verified this finding.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, in two of six medical records reviewed, the facility does not ensure pre-treatment central venous catheter (CVC- tube inserted into a large vein in the body to provide access for dialysis) assessments are completed and/or documented timely by a registered nurse when treatment was initiated by a licensed practical nurse (Patient #4 and Patient #8). Findings include: Review of the policy “Dialysis Catheter Dressing Change Procedure,” last revised February 2023, revealed the care of catheters will include an accurate assessment of the insertion site for signs and symptoms of infection. Review of the policy “Pre-treatment Assessment Policy,” last revised January 2020, revealed pre-dialysis nursing assessments will occur within the first hour of patient contact or per stricter state regulations (In New York State, assessments must be performed within the first 45 minutes for a CVC access and within one hour for all other patients). Review of the medical record treatment flowsheets for Patient #4, dated 03/07/25 through 03/28/25, revealed on 03/28/25 at 10:22 AM, treatment was started by a licensed practical nurse, but the CVC site assessment was not completed by the registered nurse until 01:40 PM. Review of the medical record treatment flowsheets dated for Patient #8, dated 03/07/25 through 03/28/25, revealed on 03/26/25 at 02:25 PM, treatment was started by a licensed practical nurse, but the CVC site assessment was not completed by the registered nurse until 05:30 PM. On 03/28/25 at 02:16 PM, treatment was started by a licensed practical nurse, but the CVC site assessment was not completed by the registered nurse until 05:24 PM. Interview on 04/02/25 at 12:00 PM with Staff (G), Clinical Specialist, verified these findings.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 42572 Based on policy review, observation, and interview, the facility does not ensure acid (a fluid that makes up dialysate or fluid to maintain the body’s eletrolyte or chemical balance) jugs used on machines for patient treatments are labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. Findings include: Review of the policy “Concentrate Labeling and Storage”, last revised January 2020, revealed concentrate jugs should be, at a minimum, labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. Observation on 03/31/25 at 01:15 PM on a black cart behind the nurse’s station, revealed ten 5-gallon jugs filled with clear liquid. Six of the ten jugs had laminated labels attached to the handles identifying the contents as “2.0 K 2.0 CA” acid concentrate. Four of the ten jugs did not have a label identifying the contents. Interview on 03/31/25 at 01:20 PM with Staff (L), Patient Care Technician, revealed all ten jugs on the cart were 2.0 K 2.0 CA acid concentrate. Staff (L) stated that the laminated labels had torn off the handles of the four unlabeled jugs and they have not been able to replace them due to their laminating machine being missing. Interview on 04/01/25 at 02:00 PM with Staff (E), Biomedical Technician, verified these findings.”

“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: 42572 Based on observation and interview, the facility does not maintain two of two emergency eyewash stations (used to flush the eyes for potential contamination) to ensure nothing is blocking the water flow and to eliminate any chance of contamination from stagnant water. Findings include: Observation on 03/31/25 at 01:05 PM of the inspection tags attached to two of two emergency eyewash stations located on the treatment floor and in the water room revealed both eyewashes were not activated/tested one time per week as required by the American National Standard Institute Z358.1 2014: Emergency Eyewash & Shower Standard. Both inspection tags were dated 11/17/24, 12/02/24, 01/07/25, 02/03/25, 03/20/25 and 03/28/25. Interview on 04/01/25 at 02:00 PM with Staff (E), Biomedical Technician, verified these findings.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 40430 Based on policy review, observation, and interview, the facility does not ensure patients are in view of staff during their hemodialysis treatment to ensure safety. Specifically, staff left the chairside during the treatment termination procedure. Findings include: Review of the policy “Termination of Dialysis Treatment,” revised April 2023, indicated staff will not leave the patient’s chairside while re-infusing extracorporeal (blood and/or fluid flowing through tubing and dialyzer or artificial kidney-filter used to clean blood on the dialysis machine) blood. Observation on 03/31/25 at 10:35 AM at Station #9, revealed Staff (I), Registered Nurse was terminating treatment, rinsing Patient #3’s blood back through the machine/dialyzer with the blood pump running/set at 200 milliliters per minute (ml/min). Staff (I) walked away from the chairside to the common island/supply/sink area for supplies, then returned to Station #9 to complete the treatment and disconnect Patient #3 from the machine. At 01:45 PM at Station #10, Staff (I) was terminating treatment, rinsing Patient #4’s blood back through the machine/dialyzer with the blood pump running and set at 200 ml/min. Staff (I) walked away from the chairside to the common island to check the schedule for the next patient, then returned to Station #10 to complete the treatment and disconnect Patient #4 from the machine. Interview on 04/02/25 at 11:30 AM with Staff (A), Facility Administrator, Staff (F), Covering Facility Administrator and Staff (G), Clinical Specialist, verified these findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, in three of seven medical records reviewed, post treatment assessments were not completed timely by a registered nurse (Patient #4, Patient #6, and Patient #9). Findings Include: Review of the policy “Post Dialysis Assessment of Patient,” last reviewed January 2020, revealed post-dialysis assessments are performed by qualified nursing staff based on state specific end stage renal disease regulations (a registered nurse is required in New York State). The post-dialysis assessment will be completed to address any identified issues prior to discharging the patient. Review on 04/02/25 of the hemodialysis treatment flowsheets for Patient #4, dated 03/07/25 to 03/28/25, revealed on 03/07/25, treatment was terminated at 02:23 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 04:04 PM. On 03/10/25, treatment was terminated at 02:02 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 04:17 PM. On 03/12/25, treatment was terminated at 02:00 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 03:29 PM. On 03/19/25, treatment was terminated at 01:40 PM by licensed practical nurse, but the registered nurse post treatment assessment was not completed until 03:34 PM. On 03/21/25 treatment was terminated at 01:43 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 04:51 PM. On 03/24/25, treatment was terminated at 01:44 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 03:22 PM. On 03/26/25, treatment was terminated at 01:50 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was signed off as completed at 03:36 PM. Review on 04/02/25 of the hemodialysis treatment flowsheets for Patient #6, dated 03/05/25 to 03/28/25, revealed on 03/07/25, treatment was terminated at 04:30 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 05:31 PM. Review on 04/02/25 of the hemodialysis treatment flowsheets for Patient #9, dated 03/05/25 to 03/28/25, revealed that on 03/07/25, treatment was terminated at 05:59 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 07:16 PM. On 03/17/25, treatment was terminated at 05:28 PM by a licensed practical nurse, but the registered nurse post-treatment assessment was not completed until 06:48 PM. Interview on 04/02/25 at 12:00 PM with Staff (G), Clinical Specialist, verified these findings.”