Usrc Rome Dialysis

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 49512 Based on document review and interview, the dialysis unit did not comply with New York State Codes, Rules and Regulations, Title 10 § 400.1: Health provider network access and reporting requirements, as they did not maintain a current Health Commerce System (HCS) account and did not ensure that current staff were assigned to various HCS roles as required. These lapses could cause the dialysis unit to be unaware of important information provided through HCS. Findings include: -- Per review of the dialysis unit’s current HCS directory on 9/10/2024 with Staff A, Regional Director, they confirmed that no roles have been assigned in HCS since the facility’s transition to US Renal Care. -- During interview of Staff A, Regional Director, on 9/10/2024 at 12:15 pm, they confirmed the above findings.”

“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: 48296 Based on document review, observation, and interview, in 3 of 3 observations, dialysis unit staff did not ensure a patient performed hand hygiene post treatment before exiting the unit and dialysis unit staff did not perform hand hygiene and use gloves as required. Additionally, the dialysis unit’s policy and procedure lacked instruction to staff to have patients perform hand hygiene post treatment. This places patients and staff at risk for potential infection. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Hand Hygiene,” revised 8/2020, indicated hand hygiene consists of either: handwashing with soap and water or use of an alcohol-based formulation. Hand hygiene will be performed before and after touching a patient, prior to entering and on exiting station to provide care to patient, prior to contact with vascular access site, prior to adjusting or removing cannulation needles, before medication preparation, before clean/aseptic procedure (e.g., vascular access cannulation/decannulation, catheter care or administration of parenteral medications), after body fluid exposure risk (e.g., contact with contaminated fluids, handling used extracorporeal circuits or prime buckets), after touching patient surroundings (e.g., dialysis machine, any items in the dialysis area or chairside computers), after gloves are removed, before and after touching PPE (personal protective equipment), after contact with inanimate objects, including medical equipment or environmental surfaces at the patient station, before entering and on exiting the patient treatment areas, when moving from a contaminated body site to a clean body site of the same patient, and after handling biohazardous waste. The policy and procedure lacked instruction to staff to have patients perform hand hygiene post treatment and/or before exiting the dialysis unit. -- Per observation on 9/10/2024 at 10:00 am, a patient at Station #7 held their access sites post treatment while wearing a glove. The patient did not perform hand hygiene after doffing their glove and exiting the dialysis unit. Staff B, Licensed Practical Nurse (LPN) acknowledged the finding at the time of observation. -- Per observation on 9/10/2024 at 10:08 am, Staff C, Registered Nurse (RN) was adjusting the blood pressure cuff and machine settings in Station #8. Staff C then left the dialysis station to retrieve a bag of normal saline from the common cart. Staff C did not remove their gloves and perform hand hygiene prior to exiting and entering the dialysis station. Staff C confirmed this finding at the time of observation. -- Per observation on 9/10/2024 at 10:35 am, a patient at Station #5, held their access sites post treatment while wearing a glove. The patient covered the needle sites with a band-aid without waiting for the RN to ensure that bleeding had stopped and that the site was clean and dry prior to discharge. The patient did not perform hand hygiene after doffing their glove and exiting the dialysis unit. Staff C, RN, acknowledged the finding at the time of observation.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 32908 Based on observation, document review, and interview, supply carts in the nursing stations (Nursing Station #1 and Nursing Station #2) housing supplies were stored on the treatment floor and not in a designated clean area. This could lead to potential contamination of dialysis supplies and equipment. Findings include: -- Per observation during the flash tour on 9/10/2024 at 9:00 am of Nursing Station #1, one supply cart containing stock items (i.e., dialyzers, intravenous solution, and dialysis tubing) was next to a portable biohazardous waste container, which was next another supply cart containing stock items (i.e., boxes of clean gloves, off packs, 2 X 2 nonsterile dressings, tape, band-aids, additional saline syringe flushes and chux, etc.) These carts were stationed between patients, approximately 3-4 feet from patients. In Nursing Station #2, two supply carts were again next to each other in the patient treatment area. These carts were located approximately 2-3 feet from the “clean” and “dirty” sinks, and computer charting desk and approximately 2-3 feet from patients. The supply carts were not kept 6 feet from patients and biohazardous waste, and the supplies and stock items were not stored in a designated clean area. -- Review of the dialysis unit’s policy and procedure titled “Infection Control Guidelines Dialysis Precautions,” revised 1/2023 indicated “clean areas should be clearly identified and separated from contaminated (dirty) areas where used supplies and equipment are handled ... If a clean cart is used to store supplies, do not take it from station to station. Keep it in a designated area at a distance from patient stations, biohazard trash, and regular trash to avoid contamination. Clean areas will be clearly designated and separated from contaminated areas and unused supplies and equipment.” -- Per interview of Staff D, Registered Nurse (RN) on 9/10/2024 at 9:15 am, they try to keep a safe distance between the supply carts and patients receiving treatment but it is difficult due to the size and available room in the clinic. Staff D acknowledged the above findings at the time of the observation.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 32908 Based on document review, observation, and interview, in 1 of 1 observations, dialysis unit staff did not properly dispose of potentially infectious waste. This places staff and patients at risk for exposure to infection. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Guidelines for the Handling and Disposal of Infectious Medical Waste,” revised 4/2023, indicated “to properly handle and discard trash and infectious waste to prevent the transmission of disease through exposure to bloodborne and airborne pathogens. The following are to be considered and treated as infectious and/or special waste materials ... contaminated sharps including blades, needles, vacutainers and syringes ... All biological waste and potentially hazardous non-biological waste including all disposable medical products will be discarded into color-coded containers per state and other regulatory guidelines before being secured and transported.” -- Per observation on 9/10/2024 at 12:25 pm, Staff B, Licensed Practical Nurse (LPN), discarded 2 - 10 milliliter (ml) needleless syringes into a non-red bag waste receptacle (regular trash bin). The syringes had been used to flush central venous catheter lines. Staff B confirmed the finding at the time of observation.”

“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: 32908 Based on document review, observation, and interview, (1) in 1 of 1 observations, dialysis unit staff did not clean and disinfect the hand held thermometer used to scan patient’s temperatures post treatment and the Hoyer lift post treatment. (2) In 1 of 1 observations, dialysis unit staff did not clean and disinfect their stethoscope used to auscultate patient’s heart and lungs between patients. (3) In 2 of 2 observations, dialysis unit staff did not clean and disinfect the dialysis machine post treatment per the dialysis unit’s policy and procedure. This places patients and staff at risk for potential exposure to infections. Findings related to (1) include: -- Review of the dialysis unit’s policy and procedure titled “Disinfection and Cleaning of Dialysis Machine Equipment,” revised 7/2023, indicated “the purpose is to provide guidance on proper disinfection of the dialysis station, machine, equipment, and surrounding surfaces with the appropriate method prevents the transmission of disease/infection to the dialysis population. Clean ancillary equipment ... “ -- Review of the dialysis unit’s policy and procedure titled “Infection Control Guidelines Dialysis Precautions,” revised 1/2023, indicated to “disinfect ... electronic thermometers ... between patients ...” -- Per observation on 9/10/2024 at 10:05 am, Staff C, Registered Nurse (RN), did not clean and disinfect the thermometer used to scan a patient’s temperature post-treatment and the Hoyer lift post treatment. Staff C confirmed the above findings at the time of observation. Findings related to (2) include: -- Review of the dialysis unit’s policy and procedure titled “Infection Control Guidelines Dialysis Precautions,” revised 1/2023, indicated to disinfect ... stethoscopes ... between patients ...” -- Per observation on 9/10/2024 at 10:05 am, Staff C, RN, did not clean and disinfect their stethoscope after it was used to auscultate patient’s heart and lungs. Staff C confirmed the above finding at the time of observation. Findings related to (3) include: -- Review of the dialysis unit’s policy and procedure titled “Disinfection and Cleaning of Dialysis Machine Equipment,” revised 7/2023, indicated to clean and disinfect all external surfaces of the dialysis machine to include top, sides, front and back, blood pressure cuffs and basket; dialysate connectors and lines ... . -- Per observation on 9/10/2024 at 10:25 am, Staff C, RN, did not empty the prime waste receptacle on the dialysis machine. Staff C did not clean and disinfect the internal and external surfaces of the prime waste container before the machine was used to prepare for another patient’s treatment. Staff C confirmed this finding at the time of observation. -- Per observation on 9/11/2024 at 9:25 am, Staff E, RN, did not clean and disinfect the internal blood pump of the dialysis machine before the machine was used to prepare for another patient’s treatment. Staff E confirmed the finding at the time of observation.”

“BACT OF H20-MAXIMUM & ACTION LEVELS CFR(s): 494.40(a) 4.1.2 Bacteriology of water: max & action levels Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall contain a total viable microbial count lower than 200 CFU/mL and an endotoxin concentration lower than 2 EU/mL The action level for the total viable microbial count in the product water shall be 50 CFU/mL, and the action level for the endotoxin concentration shall be 1 EU/mL. If those action levels are observed in the product water, corrective measures shall promptly be taken to reduce the levels. This Standard is not met as evidenced by: 46869 Based on document review and interview, the dialysis unit did not ensure that corrective measures were promptly taken to reduce the total viable microbial count in the unit’s dialysis product water, after being notified that the total viable microbial count had exceeded Association for the Advancement of Medical Instrumentation (AAMI) maximum allowable levels. This places patients at risk for potential exposure to infections. Findings include: -- Review of the dialysis unit’s total viable microbial count testing from 7/31/2023 to 8/31/2024 revealed the following conditions: - On 7/31/2023, the product water from the first test outlet on the dialysis product water loop and the reverse osmosis test outlet were tested and verified as having >300 colony-forming units per milliliter (CFU/mL), which is three times the maximum allowable level of 100 CFU/mL. - On 8/31/2023, the product water from the reverse osmosis test outlet was tested and verified as having >300 CFU/mL, which is three times the maximum allowable level of 100 CFU/mL - On 10/1/2023, the product water from the reverse osmosis test outlet was tested and verified as having 166 CFU/mL, which is above the maximum allowable level of 100 CFU/mL. - On 8/2/2024, the product water from the first test outlet on the dialysis product water loop was tested and verified as having 120 CFU/mL, which is above the maximum allowable level of 100 CFU/mL. -- Review of the dialysis unit’s Quality Assessment Performance Improvement (QAPI) meeting minutes for the months of 8/2023, 9/2023, 10/2023, and 8/2024 revealed the following information: - The dialysis unit’s biomedical technician’s report for the 8/2023 QAPI meeting stated that the above test results for 7/31/2023 were over action level and that the biomedical technician or area biomedical technician must retest by 9/30/2023, approximately two months from the initial test. - The dialysis unit’s biomedical technician’s report for the 9/2023 QAPI meeting stated that the above test results for 8/31/2023 were over action level and that the biomedical technician or area biomedical technician must retest by 9/30/2023, approximately one month from the initial test. - The facility’s biomedical technician’s report for the 10/2023 QAPI meeting stated that the above test results for 10/1/2023 were over action level and that the sample was redrawn for the reverse osmosis test outlet and was documented at 24 CFU/mL. - The dialysis unit’s biomedical technician’s report for the 8/2024 QAPI meeting stated that the above test results for 8/2/2024 were over action level and that the biomedical technician or area biomedical technician must retest by 8/31/2024, approximately one month from the initial test. -- Per review of the facility’s policy and procedure titled, “Microbiology - Water and Dialysate,” last revised 4/2023, the corrective action to be taken when product water results of 50-199 or 200 CFU/mL would be to “notify the medical director, facility administrator, and biomedical technician ... disinfect the [dialysis] equipment as soon as possible ... redraw the sample within 3-5 days from the date results are known.” Every time a result is outside of acceptable range, a plan of action must be implemented and a ‘Microbiology Plan of Action’ form must be completed.” -- Per interview of Staff G, Regional Technical Manager, on 9/11/2024 at 10:55 am, they acknowledged the above findings and confirmed that the water samples from 7/31/2023, 8/31/2023, and 8/2/2024 were not promptly retested per the facility’s policy and procedure.”

“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: 46869 Based on observation and interview, (1) the dialysis unit did not maintain their soiled utility room and clean utility room doors to self-close and latch, in order to isolate potential fire hazards and maintain air pressure relationships with the adjacent rooms per American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 170, (2) the dialysis unit did not ensure that paper towels or other hand-drying provisions was available at both patient restrooms to complete handwashing, and (3) the dialysis unit did not ensure that their plumbing fixtures were maintained and free of leaks. This could impact patient and staff safety. Findings related to (1) include: -- Per observation of the dialysis unit’s soiled utility room and clean utility room on 9/10/2024 at 9:50 am: The door to the soiled utility room did not latch. A soiled utility room must have a negative air pressure relationship with adjacent areas per American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 170, which necessitates the door to the room being maintained closed and latched to ensure the pressure relationship. The door to the clean utility room did not have a self-closing device installed and the door was left open. Inside the room were 8 size-E tanks of oxygen, a 4 foot by 4 foot electrical box suspended from the ceiling, and two shelves containing clean supplies. A clean utility room must have a positive air pressure relationship with adjacent areas per American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 170, which necessitates the door to the room being maintained closed and latched to ensure the pressure relationship. Also, the presence of higher hazard materials in the room would necessitate the door being maintained closed. -- During interview of Staff F, Biomedical Technician, on 9/10/2024 at 10:10 am, they confirmed the above findings. Findings related to (2) include: -- Per observation of the dialysis unit’s 2 patient-accessible restrooms on 9/10/2024 at 9:55 am, neither room had paper towels or another hand-drying provision to ensure that patients or staff could turn off the sink faucet without recontamination of their hands. -- During interview of Staff H, Facility Administrator, on 9/10/2024 at 10:30 am, they confirmed the above findings. Findings related to (3) include: -- Per observation of the dialysis unit’s soiled utility room and environmental services room on 9/10/2024 at 10:00 am: The soiled utility room’s flush-rim sink used to dispose bodily fluid waste and blood had a major leak at the faucet, which had resulted in a 1 foot diameter puddle of water to pool in the corner of the room. The environmental services room’s mop sink had a minor leak at the faucet, which was contained to the inside of the mop sink but kept the sink constantly moist. -- During interview of Staff F, Biomedical Technician, on 9/10/2024 at 10:15 am, they confirmed the above findings.”

“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: 46869 Based on document review, observation, and interview, the dialysis unit did not ensure that all equipment was maintained and operated in accordance with manufacturer’s recommendations. Specifically, the testing controls for the blood glucose meter in the facility were expired. This could lead to adverse outcomes for patients. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Blood Glucose Testing,” last revised 2/2023, revealed “do not use control solution or test strips past manufacturer expiration date ...” -- Per observation of the point-of-care testing area in the dialysis unit on 9/10/2024 at 10:00 am, 2 containers of EvenCare G2 Blood Glucose Test Strips (to provide blood glucose measurement) expired on 9/7/2024. -- During interview of Staff H, Facility Administrator, on 9/10/2024 at 10:30 am, they confirmed the above findings.”

“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: 32908 Based on document review, observation, and interview, in 2 of 3 observations, dialysis unit staff did not follow acceptable medication administration practices when patient identity was not confirmed prior to the administration of a medication. This could lead to patients receiving incorrect medication. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Guidelines for Administration of Medication,” revised 4/2024, indicated “when administering a medication, the following steps will be followed: ... follow the “5 Rights” to ensure proper administration fo the medication; the right: patient, medication, dose, route of administration, time ...” -- Per observation on 9/10/2024 at 1:20 pm, Staff C, Registered Nurse, (RN), did not confirm the identity of the patient at Station #10 prior to administration of intravenous (IV) medication. Staff C acknowledged this finding at the time of observation. -- Per observation on 9/11/2024 at 9:10 am, Staff E, RN, did not confirm the identity of the patient at Station #3 prior to administration of IV medication. Staff E acknowledged this finding at the time of observation.”