Bridgewater Center for 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: 21072 Based on document review, observation, and interview, in 6 of 13 observations, dialysis unit staff did not perform hand hygiene and/or use gloves as required. Also, dialysis unit staff did not ensure patients performed hand hygiene post treatment before, exiting the unit. Additionally, the dialysis unit’s policy and procedure (P&P) lacked instruction for staff to perform hand hygiene prior to donning gloves. This places patients and staff at risk for potential infection. Findings include: -- Review of the dialysis unit’s P&P titled “Hand Hygiene,” reviewed 3/2025, stated to do hand hygiene “before and after direct contact with the patients, after contact with inanimate objects, including, but not limited to medical equipment or environmental services at the patient station, after touching blood, body fluids, secretions, excretions, and potentially contaminated items, and after handling any source that is likely to be contaminated. ... Patients should also be encouraged to perform hand hygiene prior to leaving the facility to prevent any spread of infection.” The P&P lacked instruction for staff to perform hand hygiene prior to donning gloves. -- Per observation on 6/2/2025 at 10:30 am, Staff A, Clinical Staff, did not change gloves and perform hand hygiene after the location/palpitation of an arteriovenous (AV) fistula cannulation site and prior to the insertion of the cannulation needle. Staff A confirmed this finding at the time of the observation. -- Per observation on 6/2/2025 at 10:55 am, Staff B, Clinical Staff, did not change gloves and perform hand hygiene after the location/palpation of the cannulation site of an AV fistula and prior to the insertion of the cannulation needle. Staff B confirmed this finding at the time of the observation. -- Per observation on 6/2/2025 at 2:40 pm, Staff A, with visibly blood soiled gloves, walked over to a clean area and removed a timer and clean supplies from the supply cart. Staff A then changed gloves without performing hand hygiene. Staff A confirmed this finding at the time of observation. -- Per observation on 6/2/2025 at 2:50 pm, Staff A, decanulated a fistula. While gloves were visibly soiled with blood, Staff A recorded a blood pressure in the patient’s notebook and handed the notebook back. Staff A then placed the pen used to write in the patient’s notebook into their own pocket without removing soiled gloves or performing hand hygiene. Staff A removed their gloves but did not perform hand hygiene before donning new gloves. Staff A escorted the patient to scale, and removed their gloves, without performing hand hygiene. After the patient’s weight was recorded Staff A picked up the patient’s belongings and held them close to their body while cleaning the scale with their other hand. Staff A walked the patient’s belongings over to a locker and placed them inside. Staff A confirmed this finding at the time of observation. -- Per observation on 6/2/2025 at 3:30 pm, Staff A, did not perform hand hygiene prior to donning gloves for discontinuation of dialysis from a central venous catheter (CVC). Staff A silenced an alarm on the dialysis machine and then disconnected the patient from the machine using the same gloves. Gloves were not changed and hand hygiene was not performed prior to de-accessing the patient’s CVC. Staff A escorted the patient out of the treatment area to the scale with the same gloves used to disconnect the patient from the dialysis machine. Staff A confirmed this finding at the time of observation. -- Per observation on 6/2/2025 at 3:40 pm, Staff A, did not offer hand hygiene to a patient leaving the dialysis unit after treatment. Staff A confirmed this finding at the time of 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: 36617 Based on document review, observation and interview, in 2 of 2 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 (P&P) titled “Removal of Fistula Needles and Post Care of Fistula and Graft,” reviewed 2/2025, indicated staff nurses should dispose of the whole assembly in an appropriate sharps container. -- Per observation on 6/2/2025 at 2:50 pm, Staff A, Clinical Staff, decannulated a patient’s fistula. Staff A then walked with the contaminated cannulation needle across two dialysis stations and disposed of it in a sharps container in a station where a patient was seated in a chair. Staff A confirmed this finding at the time of observation. Staff A reported being unaware that there was a sharps container available in the current station. -- Per observation on 6/2/2025 at 3:15 pm, Staff A, decannulated a patient’s fistula. Staff A then walked with the contaminated cannulation needle across two dialysis stations before disposing of it in a station that was clean and being prepared for the next patient. Staff A confirmed this finding at the time of the observation. Staff A reported being unaware that there was a sharps container available in the current station.”

“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: 48296 Based on document review, observation and interview, in 3 of 3 observations, dialysis unit staff did not clean and disinfect the dialysis machine post treatment per the dialysis unit’s policy and procedure (P&P). This places patients and staff at risk for potential exposure to infections. Findings include: -- Review of the dialysis unit’s P&P titled “Cleaning and Disinfection of Surfaces and Equipment,” dated 2/19/2025, stated “at the end of each patient treatment, the staff will clean and disinfect the dialysis station. Special attention should be given to cleaning control panels on the dialysis machines, the treatment chairs, and other surfaces that are frequently touched. ... The staff will discard all fluids and clean and disinfect all surfaces of the containers associated with the prime waste (including containers attached to the machines) after each treatment. ... Staff will clean and disinfect the internal circuit of the dialysis machine.” -- Per observation on 6/2/2025 at 10:20 am, Staff B, Clinical Staff, did not clean the footrest of a treatment chair after a patient had completed their dialysis treatment and exited the dialysis station. Staff B confirmed this finding at the time of observation. -- Per observation on 6/2/2025 at 10:30 am, Staff C, Clinical Staff, did not clean the internal wheel of the dialysis machine. Staff C did not discard the fluid in the prime waste bucket and clean the bucket after patient use. Staff C stated they clean the prime waste bucket in the morning and they should clean it after each patient use. Staff C confirmed these findings at the time of observation. -- Per observation on 6/2/2025 at 2:55 pm, Staff D, Clinical Staff, did not discard the fluid in the prime waste bucket and clean the bucket after patient use. Staff D confirmed this finding at the time of observation”

“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: 36617 Based on document review, observation, and interview, 1) in 1 of 3 observations dialysis unit nursing staff did not implement appropriate infection control measures regarding medication preparation. 2) Dialysis unit staff did not ensure pre-drawn medications were appropriately labeled and administered per the dialysis unit’s policy and procedure (P&P). This could compromise patient/staff safety. Findings regarding (1) include: -- Review of the dialysis unit’s P&P titled “Administration of Medications,” revised 2/2025, indicated staff nurses should prepare medications as ordered. -- Review of the dialysis unit’s P&P titled “Administration of Heparin,” reviewed 8/2024, indicated the procedure as follows: clean vial with alcohol swab, draw appropriate dose from vial, label syringe with appropriate patient information, date, time, and initials of person preparing heparin. -- Per observation on 6/2/2025 at 11:35 am, Staff A, Clinical Staff, did not cleanse the septum (rubber stopper of a medication vial) of a vial of medication with alcohol prior to insertion of a sterile needle and syringe to withdraw the medication. Staff A confirmed this finding at the time of observation. Findings regarding (2) include: -- Review of the dialysis unit’s P&P titled “Administration of Medications,” revised 2/2025, indicated intravenous medications should be appropriately labeled with a medication label indicating dose, time of preparation, and initial of person preparing. All medications will be prepared/drawn up immediately prior to administration. All medications will be administered by the person preparing, mixing, or drawing the medication from the vial. -- Per observation on 6/2/2025 at 9:25 am, the medication cabinet contained multiple pre-drawn heparin syringes for all patients scheduled for dialysis on that day. The syringes did not have the date, time, and initials of the person who had prepared the medication on the label. -- Per interview of Staff D, Clinical Staff on 6/2/2025 at 9:25 am, they prepared all intravenous heparin syringes around 5:30 am for all patients scheduled that day. Staff D does not date, time or initial the syringes when the medication is drawn up. Staff D indicated the medication was stable in the syringes for 24 hours. -- Per observation of Staff A, Clinical Staff on 6/2/2025 at 3:00 pm, they obtained a syringe of heparin from the medication cabinet for a patient, the medication had been drawn up earlier in the day by another clinical staff member. -- During interview of Staff E, Director of Dialysis on 6/3/2025 at 12:15 pm, they acknowledged the above finding and were unable to provide verification of the medication (heparin) stability once drawn up into a syringe.”

“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: 36617 Based on document review, observation, and interview, in 3 of 3 observations, dialysis unit staff did not clean the cannulation site of an arterial venous (AV) fistula in accordance with the dialysis unit’s policy and procedure (P&P). This places patients at risk for potential exposure to infections. Findings include: -- Review of the dialysis unit’s P&P titled “Cannulation of Arterial Venous Fistula and Arterial Venous Graft,” reviewed 1/2025, stated “using aseptic technique, cleanse cannulation sites with alcohol pad. ... Always cleanse from center of area to periphery of area, scrub for 30 seconds.” -- During observation on 6/2/2025 at 10:30 am, Staff A, Clinical Staff, cleansed the patient’s AV fistula cannulation site with alcohol for 15 seconds. Staff A acknowledged this finding at the time of observation. -- During observation on 6/2/2025 at 10:35 am, Staff B, Clinical Staff, cleansed the patient’s AV fistula cannulation site with alcohol for 10 seconds. Staff B acknowledged this finding at the time of observation. -- During observation on 6/2/2025 at 10:55 am, Staff D, Clinical Staff, cleansed the patient’s AV fistula cannulation site with alcohol for 10 seconds. Staff D acknowledged this finding at the time of observation.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 36617 Based on document review, medical record (MR) review, and interview, in 4 of 5 MRs (Patient #1, #2, #3, and #4) reviewed, dialysis unit staff did not ensure the hemodialysis prescriptions were implemented per the physician’s orders. Specifically, the blood flow rate (BFR - the rate blood is being processed through the artificial dialyzer) was consistently lower than the prescribed rate and there was no documentation regarding the lowering of the BFR or notification of the physician. This could cause patients to not receive adequate treatment. Findings include: -- Review of the dialysis unit’s policy and procedure (P&P) titled, “Patient Care/Monitoring: During Treatment,” reviewed 3/2025, stated “to assess access function ... ability to achieve ordered blood flow ... note blood flow rate. ... Notify physician if unable to achieve prescribed blood flow rate/range for 3 or more consecutive treatments. ... Document results and any unusual condition or change of the patient on the flowsheet.” -- Review of Patient #1’s MR revealed the prescribed BFR was 400 milliliters (ml)/hour (hr). Review of the dialysis treatment sheets from 5/16/2025 - 6/2/2025 (7 visits) revealed on 5/16/2025, 5/19/2025, 5/21/2025, 5/23/2025, 5/26/2025, 5/30/2025, and 6/2/2025 the BFR rate ranged between 200 ml/hr - 355 ml/hour. There was no documentation in the MR indicating the reason for the decrease of rate or any notification to the provider. -- Review of Patient #2’s MR revealed the prescribed BFR was 400 ml/hr. Review of the dialysis treatment sheets from 5/16/2025 - 5/30/2025 (6 visits) revealed on 5/16/2025, 5/19/2025, 5/23/2025, and 5/26/2025 the BFR rate ranged between 200 ml/hr - 375 ml/hour. There was no documentation in the MR indicating the reason for the decrease of rate or any notification to the provider. -- Review of Patient #3’s MR revealed the prescribed BFR was 400 ml/hr. Review of the dialysis treatment sheets from 5/16/2025 - 5/30/2025 (7 visits) revealed on 5/16/2025, 5/21/2025, 5/23/2025, 5/26/2025, 5/28/2025, and 5/30/2025 the BFR rate ranged between 200 ml/hr - 390 ml/hour. There was no documentation in the MR indicating the reason for the decrease of rate or any notification to the provider. -- Review of Patient #4’s MR revealed the prescribed BFR was 450 ml/hr. Review of the dialysis treatment sheets from 5/16/2025 - 5/30/2025 (7 visits) revealed on 5/16/2025, 5/21/2025, 5/23/2025, 5/26/2025, 5/28/2025, and 5/30/2025 the BFR rate ranged between 200 ml/hr - 400 ml/hour. There was no documentation in the MR indicating the reason for the decrease of rate or any notification to the provider. -- During interview of Staff E, Director of Dialysis on 6/3/2025 at 11:00 am, they acknowledged the above findings.”

“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: 36617 Based on document review, medical record (MR) review, and interview, dialysis unit nursing staff did not assess and monitor patients in accordance with generally accepted standards of chronic dialysis care. Specifically, in 1 of 5 MRs reviewed (Patient #4), dialysis treatment sheet dated 5/21/2025 and 5/23/2025 indicated the patient reported a change in status, however, there was no documentation that the patient was evaluated by the nursing staff. This lack of appropriate monitoring poses a potential risk for adverse patient outcomes. Findings include: -- Review of the dialysis unit’s policy and procedure (P&P) titled “Patient Care/Monitoring: During Treatment,” reviewed 3/2025, indicated to document results and any unusual condition or change of the patient on the flow sheet. -- Review of Patient #4’s dialysis treatment sheet dated 5/21/2025, at 6:01 pm, revealed the patient complained about pain at the catheter site. Staff F, Clinical Staff, notified a registered nurse (RN) of the incident. There was no documentation by an RN related to this incident. -- Review of Patient #4’s dialysis treatment sheet dated 5/23/2025, at 3:00 pm, revealed the patient complained of shortness of breath. Staff G, Clinical Staff, documented they placed patient on oxygen. There was no documentation that the RN was notified. -- Review of Patient #4’s dialysis treatment sheet dated 5/23/2025, at 4:34 pm, revealed the patient experienced hypotension for a duration of 30 minutes. Staff H, Clinical Staff, notified a RN of the incident. There was no documentation by an RN related to this incident. -- During interview of Staff E, Director of Dialysis on 6/3/2025 at 11:00 am, they acknowledged the above findings.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 46869 Based on document review and interview, the facility did not ensure annual contact was made with the facility’s local emergency preparedness agency as specified in the Centers for Medicare and Medicaid Services Appendix Z for End Stage Renal Dialysis providers. Lack of a comprehensive emergency preparedness plan places patients and staff at risk to be unable to safely respond to emergencies at the facility. Findings include: -- Review of the facility’s emergency preparedness plan, last approved 3/2023, revealed that the plan did not have an up-to-date contact list with local, state, and federal emergency officials. There was also no documentation of annual correspondence with the facility’s local emergency preparedness agency to ensure that the agency is aware of the dialysis facility’s needs in the event of an emergency. -- During interview of Staff A, Director of Dialysis, on 2/7/2024 at 11:10 am, he/she/they acknowledged the above findings.”

“Policies/Procedures-Volunteers and Staffing CFR(s): §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: 46869 Based on document review and interview, the facility did not ensure that it’s emergency preparedness policies and procedures addressed the use of volunteers in an emergency, or other emergency staffing strategies, as specified in the Centers for Medicare and Medicaid Services Appendix Z for End Stage Renal Dialysis providers. Lack of a comprehensive emergency preparedness plan places patients and staff at risk to be unable to safely respond to emergencies at the facility. Findings include: -- Review of the facility’s emergency preparedness plan, last approved 3/2023, revealed that the plan did not address the use of volunteers in an emergency or other emergency staffing strategies. -- During interview of Staff A, Director of Dialysis, on 2/7/2024 at 11:10 am, he/she/they acknowledged the above findings.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 32908 Based on document review, observation and interview, in 1 of 2 observations dialysis unit staff did not follow generally accepted infection control practices when accessing patient’s dialysis access sites prior to cannulation. Additionally, the dialysis unit’s policy and procedure lacked instruction to staff to not touch cannulation sites after antisepsis without repeating skin antisepsis. This lapse in infection control technique may place patients at increased risk for healthcare acquired infections. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Cannulation of Arterial Venous Fistula and Arterial Venous Graft,” revised 3/2023, indicated to use aseptic technique, cleanse cannulation sites with Chloraprep. Be mindful not to touch the area once Chloraprep has ben applied to ensure that it does not become contaminated. The dialysis unit’s policy and procedure lacked instruction to staff to repeat skin antisepsis if the cannulation sites are re-palpated. -- Per observation on 2/6/2024 at 10:55 am at Station #5 Staff B, Certified Clinical Hemodialysis Technician, cleansed the patient’s access sites and re-palpated the sites with a gloved hand but did not repeat skin antisepsis. He/she/they confirmed the finding at the time of observation.”

“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: 32908 Based on document review, observation and interview, in 6 of 12 observations, dialysis unit staff and patients 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 before leaving the dialysis unit. This places patients and staff at risk for potential infection. Findings include: -- Per review of the dialysis unit’s policy and procedure titled “Hand Hygiene,” revised 3/2023, “staff should perform hand hygiene before and after direct contact with patients, after touching blood, body fluids, secretions, excretions, and potentially contaminated objects, immediately after gloves are removed even if it is with the same patient and/or changing gloves and after contact with inanimate objects including, but not limited to medical equipment or environmental surfaces at the patient station”. -- Per observation on 2/6/2024 at 9:50 am, Staff C, Registered Nurse used equipment (vital signs machine and dialysis machine) after care of an access site. Staff C used the same gloves to give care to an access site. Staff C did not remove gloves and perform hand hygiene after contact with equipment. He/she/they acknowledge this finding at the time of observation. -- Per observation on 2/6/2024 at 10:00 am, Staff C did not instruct a patient to perform hand hygiene following a treatment and prior to leaving the dialysis unit. Staff C confirmed this finding at the time of observation. -- Per observation on 2/6/2024 at 11:05 am, Staff D, Licensed Practical Nurse, used the covered keyboard of the computer on wheels without wearing gloves in the patient care area and then went to the medication cabinet to unlock it without performing hand hygiene. He/she/they confirmed the finding at the time of observation. -- Per observation on 2/6/2024 at 11:40 am, Staff E, Registered Nurse, left the patient care area to retrieve supplies without removing gloves and performing hand hygiene. Staff E confirmed the finding at the time of observation. -- Per observation on 2/7/2024 at 10:00 am, Staff F, Patient Care Technician, removed gloves after giving the patient at Station #3 a glove to wear to hold his access sites post dialysis and reapplied gloves without performing hand hygiene. He/she/they confirmed the finding at the time of observation. -- Per observation on 2/7/2024 at 10:20 am, the patient at Station #3 held his access sites post treatment with a gloved hand. After hemostasis was achieved he removed his glove but did not perform hand hygiene. Staff G, Registered Nurse, acknowledged this finding at the time of observation.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 32908 Based on document review, observation and interview, dialysis unit staff stored clean supplies in the patient hemodialysis treatment area. Also, a sterile wound dressing was unwrapped and stored in a clean drawer. This places staff and patients at risk for infections. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Storage of Equipment /Supplies,” revised 3/2023, indicated to ensure equipment is cleaned, disinfected, and stored properly in the appropriate area. -- Per observations on 2/6/2024 at 10:50 am at Stations #2, #5, #7 and #8, various blood pressure cuffs were stored on the ledges in the dialysis stations. -- Per observation on 2/7/2024 at 12:05 pm an unwrapped (open) sheet of Opticell Chitosan Based Gelling Fiber Sterile Wound dressing (used to promote healing while protecting wounds) was stored in a clean drawer and available for patient use. -- During interview on 2/6/2024 at 11:15 am of Staff A, Director of Dialysis, he/she/they acknowledged the above 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: 46869 Based on document review, observation and interview, the facility did not ensure that clean supplies were stored in clean spaces. Failure to maintain the clear separation of clean and dirty areas can result in potential infection risks. Findings include: -- Per observation on 2/6/2024 at 10:00 am, a cardboard box containing clean towels intended for patient use were stored underneath the clean linen room’s sink. This finding was acknowledged by Staff A, Director of Dialysis, at time of observation. -- Per observation on 2/6/2024 at 10:45 am, a box of Nipro syringes and Foamtec medical wipes were stored underneath a sink in the patient-care area. These findings were acknowledged by Staff C, Registered Nurse, at time of observation. -- Per observation on 2/6/2024 at 11:00 am, a bundle of 8 rapid COVID tests were stored underneath the clean supply room’s sink. These findings were acknowledged by Staff C at time of observation. -- Per review of facility policy and procedure titled “Storage of Equipment/Supplies Policy,” last revised 3/2023, “facility staff must ensure equipment is clean, disinfected, and stored properly in the appropriate storage area”.”

“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, in 3 of 6 observations, dialysis unit staff did not clean and disinfect the patient scale between uses and in 2 of 2 observations dialysis unit staff did not clean and disinfect environmental surfaces (countertops) after patient’s placed personal items on while using the scale. 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 “Cleaning and Disinfection of Surfaces and Equipment,” revised 3/2023, indicated at the end of each dialysis treatment, all surfaces without visible blood will be cleaned following the low level disinfection protocol using soap detergent or detergent germicide. Recommendations for low level disinfection includes environmental surfaces. -- Per observation on 2/6/2024 at 10:00 am, Staff C, Registered Nurse, did not clean and disinfect the handrails of the scale after obtaining a patient’s post treatment weight. Staff C confirmed this finding at the time of observation. -- Per observation on 2/6/2024 at 3:05 pm, Staff D, Licensed Practical Nurse, did not clean and disinfect the handrails of the scale after obtaining a patient’s post treatment weight. Staff D confirmed this finding at the time of observation. -- Per observation on 2/6/2024 at 3:40 pm, Staff E, Registered Nurse, did not clean and disinfect the handrails of the scale after obtaining a patient’s post treatment weight. Staff E confirmed this finding at the time of observation. -- Per observation on 2/7/2024 at 3:45 pm, the patient from Station #6 post dialysis treatment, placed a personal item on the countertop at the nurse’s station while using the scale. Dialysis staff did not clean and disinfect the countertop after the patient removed his personal item. Staff D confirmed this finding at the time of observation. -- Per observation on 2/7/2024 at 3:50 pm, the patient from Station #3 post dialysis treatment, placed a personal item on countertop while using the scale. Dialysis staff did not clean and disinfect countertop after patient removed his personal item. Staff D confirmed this finding at the time of observation.”

“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 facility did not ensure that equipment was maintained and operated in accordance with manufacturer’s recommendations. Specifically, (1) the refrigerator used for the storage of intradialytic parenteral nutrition was not maintained at 36 degrees Fahrenheit - 46 degrees Fahrenheit. (2) Three of 3 refrigerator temperatures were not recorded on Sundays. (3) Hemodialysis machines had missing documentation of weekly chemical system disinfections per manufacturer’s instructions for use. Failure to maintain and operate facility equipment in accordance with manufacturer’s recommendations may result in patient harm. Findings related to (1) include: -- Per observation of the facility’s intradialytic parenteral nutrition refrigerator thermometer on 2/6/2024 at 10:20 am, the temperature was 50 degrees Fahrenheit. A single intradialytic parenteral nutrition bag was stored in the refrigerator at the time. -- Review of temperature logs for the facility’s intradialytic parenteral nutrition refrigerator showed that between 10/2023 and 2/2024 the intradialytic parenteral nutrition fridge had exceeded the temperature limit of 46 degrees Fahrenheit 30 times without documented action to address the elevated temperatures -- Review of facility’s policy and procedure titled “Intradialytic Parenteral Nutrition,” revised 3/2023, states “maintain refrigerator temperature between 36-46 degrees Fahrenheit.” -- During interview of Staff H, Biomed Technician, on 2/6/2024 at 10:30 am, he/she/they acknowledged these findings and he/she/they disposed of the intradialytic parenteral nutrition bag stored in the refrigerator. Findings related to (2) include: -- Review of temperature logs, dated 7/2023 through 2/2024, for the facility’s medication refrigerator, specimen refrigerator and intradialytic parenteral nutrition refrigerator showed that refrigerator temperatures were not recorded on Sundays. -- During interview of Staff C, Registered Nurse, on 2/6/2024 at 11:10 am, he/she/they confirmed the above findings and stated that there is no function for the refrigerator thermometers to read-back the temperatures on Sundays. Findings related to (3) include: -- Review of hemodialysis machine weekly chemical disinfection logs, dated 6/2023 through 2/2024, showed that the following Fresenius 2008k hemodialysis machines did not have documented weekly chemical disinfections on the following dates: - 1/27/2024, hemodialysis machines #11 - #18 - 10/6/2023, hemodialysis machine #16 - 6/24/2023, hemodialysis machine #15 -- Review of “Fresenius Medical Care - 2008k Hemodialysis Machine Operator’s Manual” states that chemical rinse of the hemodialysis machine is recommended weekly. -- During interview of Staff H on 2/6/2024 at 2:10 pm, he/she/they acknowledged the above 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: 32908 Based on document review, observation and interview, in 1 of 10 observations, dialysis unit staff did not ensure patients’ access sites were visible during hemodialysis treatment. This could lead to undetected needle dislodgement or line disconnection. Findings include: -- Review of the dialysis unit’s policy and procedure titled “Patient Care/Monitoring: During Treatment,” revised 3/2023, indicated the access site used in the delivery of treatment will remain visible and monitored throughout the treatment. -- Per observation on 2/7/2024 at 9:45 am, the patient receiving dialysis at Station #5 had their vascular access site covered with a blue disposable towel. Staff I, Certified Clinical Hemodialysis Technician, confirmed the findings at the time of observation.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 46619 Based on document review and interview, the dialysis unit did not ensure that the Quality Assurance Performance Improvement team maintained an infection log that included all types of infections. This could prevent trends from being recognized and strategies for improvement from being developed, which could lead to adverse patient outcomes. Findings include: -- Review of the dialysis unit’s Infection Log, undated, included only one entry for one patient who had an infection in his hemodialysis catheter on 11/6/2023. -- Review of the dialysis unit’s hospitalization and rehospitalization log, dated 8/15/2023 to 2/1/2024, indicated one patient had been admitted with an infected dialysis catheter on 11/8/2023. Other dialysis patients had been hospitalized on six occasions with possible infections (i.e., complicated urinary tract infection, wounds, sepsis, pneumonia, osteomyelitis, abdominal infection, and endocarditis) between 8/15/2023 and 2/1/2024. -- Review of the dialysis unit’s policy and procedure titled “Quality Assurance Performance Improvement,” revised 3/2023, indicated data on required indicators, which includes infection control, will be reviewed and trended by the interdisciplinary team. -- Review of the dialysis unit’s December Quality Assurance Performance Improvement Meeting minutes, undated, indicated that there were no hemodialysis related infections for the month of December 2023. Data regarding hospitalizations for the month of December 2023 indicated there were seven hospitalizations. Of these seven hospitalizations, three were listed as relating to infection/sepsis. -- Per interview of Staff A, Director of Dialysis on 2/7/2024 at 1:30 pm, the Infection Log has been used to track only line infections. -- During interview of Staff J, Facility Administrator, on 2/7/2024 at 1:30 pm, he/she/they acknowledged the above findings.”