Davita English Village Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47976 Based on observation, record review, and interview, the facility failed to 1) regularly monitor for a sanitary environment to minimize the transmission of infectious agents (see V0111); 2) ensure staff performed hand hygiene between each glove change (see V0113); 3) ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient (see V0116); 4) ensure staff disposed of infectious waste in a safe manner (see V0121); 5) ensure staff followed appropriate procedures according to facility policy for the cleaning and disinfection of dialysis stations (see V0122); 6) ensure staff maintained aseptic technique per facility policy when providing care to patients with intravascular catheters (see V0147), resulting in an increased risk for infection for all 71 patients receiving in-center hemodialysis at that facility. The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care in a safe environment for the condition of participation at 494.30 Condition: Infection control.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 39083 Based on interview and record review, the facility failed to conduct the annual tabletop and community-based emergency preparedness training, resulting in the potential for inadequate facility response during an emergency event, and the potential for endangering the health and safety of all patients and staff. Findings include: On 12/13/23 at 12:55 PM, the Group Facility Administrator (GFA) “V” was queried on emergency preparedness drills and stated that they haven’t done any community drills this year and that the emergency plan “needs to be updated.” According to GFA “V” the last training drill was in 2019 or 2020. On 12/13/23 at 1:18 PM, GFA “V” stated that they had talked to Facility Administrator (FA) “B” and confirmed that their emergency preparedness training drills were not completed. During a review of the “Facility Emergency Management Plan,” revised April 2023, it notes under “Training and Education,” ... “1. The FA, or designee, is responsible to provide training of EMP: a. Teammates: i. ANNUALLY 1. Policy Facility Emergency Management Plan 2. Appropriate hazard policies, per HVA 3. Clinical emergency policies 4. Facility specific emergency response procedures””

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 38304 Based on observation, interview, and policy review, the facility failed to regularly monitor for a sanitary environment to minimize the transmission of infectious agents by storing dirty/contaminated items in designated “clean areas” used for patient care and maintain chemical disinfectnants labeled and not expired, potentially effecting all 71 in-center hemodialysis patients, resulting in an increased potential for infections. Findings include: On 12/12/23 at 0948 through 0955, it was observed that 4 of 7 “clean sink” areas on the dialysis treatment floor had medical waste and trash/garbage containers stored within 12 inches or less from the designated clean areas. The Group Facility Administrator (Staff V) acknowledged the findings on 12/12/23 at 1510. Staff V was noted the above findings did not meet facility expectations or the facility policy referenced below. Facility Policy: “Physical Environment”, No. 8-04-01, Revised April 2018 stated, “The dialysis facility will be designed... and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. The dialysis facility will implement and maintain a program to verify all equipment... are maintained and operated in accordance with manufacturer’s recommendations.” 39083 On 12/13/23 at 10:45 AM, during an observation of the treatment floor, a wall mounted bleach dispenser was observed to have two jugs of bleach that expired on 12/5/23. Additionally, two working spray containers, stored on the shelf with the bleach containers, were observed to not have a label of the common name of the chemical to identify the contents. At this time, Biomedical Technician “U” consulted with another staff member and confirmed that the bleach dispenser is operable and used daily. According to the facility’s policy, “Infection Control for Dialysis Facilities,” revised April 2023, it notes, “...Supplies 8. Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. b. Expiration date and package integrity will be verified prior to use. c. Supplies will not be opened until time of use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used.” According to the facility’s policy, “Labeling of Containers,” revised 10/2023, it notes, “All containers of chemicals/materials released of use in the facility will be properly labeled and the chemical/material information verified prior to use... 3. Chemicals/materials will be kept in their original containers whenever possible. If removed from the original container, a label must be affixed to the secondary container with the chemical/material name and appropriate warnings or pictures, symbols, or combination thereof. 4. Chemicals being stored in an enclosed cabinet must also have labeling applied to the exterior of the cabinet. A label with the appropriate warnings, pictures, symbols or combination must be applied.””

“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: 46476 Based on observation, interview, and record review the facility failed to ensure staff perform hand hygiene between each glove change and failed to ensure staff removed gloves between each patient, resulting in the potential for spread of infectious agents to all 17 incenter patients being served by the facility at the time of observation. Findings include: Facility policy titled “Infection Control for Dialysis Facilities”, Policy: 1-05-01, last revised April 2023 was reviewed on 12/14/23. On page 1 under “Hand Hygiene”, it stated: 1. All teammates... will perform hand hygiene... a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves ... d. after patient and dialysis delivery system contact ... f. between patients even if the contact is casual ... g. before touching clean areas such as supplies ...” On page 2 under “PPE”, it stated: “5. PPE is to be ... Removed prior to leaving the treatment area ... 7 ... iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” On 12/12/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1050, Staff L, a Certified Clinical Hemodialysis Technician (CCHT), was observed while performing a conductivity and pH test (test to check acidity or alkalinity level of fluid) at station #12. After the procedure, Staff L removed dirty gloves and did not perform hand hygiene prior to donning a new pair for another task. At 1100, Staff E, a registered nurse (RN), was observed while preparing and injecting an intravenous (IV) medication at station #3. Staff E did not perform hand hygiene prior to preparing the medication; prior to entering the treatment area and donning gloves for medication administration; or, after removal of gloves and leaving the treatment area. At 1108, Staff E was observed while preparing and injecting an intravenous (IV) medication at station #2. Staff E did not perform hand hygiene prior to preparing the medication or after removal of gloves when leaving the treatment area (after medication administration). At 1120, Staff R, a patient care technician, was observed while cannulating a patient’s arteriovenous fistula and connecting blood lines to begin dialysis at station #8. During the multiple step procedure, Staff R removed dirty gloves 5 times and donned a new pair without performing hand hygiene between glove changes. At 1510, Staff L was observed while changing a central venous catheter (CVC) dressing and preparing the CVC for connection of blood lines to begin dialysis treatment at station #9. During the procedure, Staff L was wearing a pair of gloves used in the process of blood line connection. Staff L was observed leaving station #9 treatment area to retrieve a wheeled stool that was at station #7 treatment area and bringing it back to the patient at station #9 while wearing the same gloves. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). 47976 During dialysis floor observation on 12/12/23 and 12/13/23, the following observations were made: On 12/12/23 at 1015, Certified Clinical Hemodialysis Technician (Staff L) was observed disconnecting the patient at station #12 from dialysis. Staff L was observed starting the process of disconnecting the patient with gloves on then leaving the treatment area to get clean supplies from the cart needed to complete the task. Upon returning to station #12, Staff L was observed to continue the procedure on the patient without changing gloves and performing hand hygiene. On 12/12/23 at 1100, Staff L was observed cleaning station #12. Upon completion of wiping the station off with bleach wipes, Staff L was observed discarding the dirty wipes into the trash can and going directly to the clean supply cart for new supplies to set up the station for the next patient without taking her gloves off. She continued to set up station #12 with the same gloves she had used with the dirty wipes. After she was done setting up the machine, Staff L was observed removing her gloves and putting on new gloves to assist the patient at station #9 without performing hand hygiene in between. On 12/12/23 at 1145, another Certified Clinical Hemodialysis Technician (Staff R) was observed walking across the treatment floor, discarding his dirty gloves in a trash bin, then donning clean gloves at station #5 without performing hand hygiene in between. On 12/12/23 at 1510, Staff R was observed wearing gloves from station #4 to the clean supply cart to get more supplies. Staff R was observed returning to the patient at station #4 and disconnecting and bandaging the patient. After Staff R was done with the procedure, he was observed discarding his gloves and putting on new gloves to assist the next patient without performing hand hygiene in between. On 12/13/23 at 1030, another Certified Clinical Hemodialysis Technician (Staff K) was observed removing the bloodlines form the dialysis machine at station #16. After discarding the materials in the biohazard bin, Staff K was observed going directly to station #17 and touching the dialysis machine with the same gloves he had on while assisting the patient coming off of dialysis at station #16. After leaving station #17, Staff K was observed going to station #16 again and touching the mouse in the “clean” area with the same gloves. He then removed the gloves he was wearing and donned new gloves again without performing hand hygiene. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100.”

“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: 47976 Based on observation, interview, and record review, the facility failed to ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient, resulting in the potential to spread infectious diseases to all 17 patients receiving in-center dialysis at this facility at the time of observations. Findings include: **Policy 1-05-01 titled “Infection Control for Dialysis Facilities” (revised April 2023) stated on page 3, “Measures will be taken to prevent cross contamination between patients ...b. Electronic thermometers and/or blood glucose meters should not be placed on potentially contaminated equipment such as the dialysis delivery system.” It stated on page 4, “Non-disposable items are to be disinfected after each patient use prior to the removal from the treatment area/station and if contaminated between uses” **Policy 2-08-01B titled, “Operation of Portable Myron L Conductivity Meter (D-1)” stated on page 3, “10. When you are finished with the D1 meter, RINSE thoroughly with dialysis quality water. Clean the exterior of the meter with 1:100 bleach solution and place meter in the clean storage location.” During dialysis floor observation on 12/12/23 at 1041, the staff was observed using the Hoyer lift (a device used to mechanically lift patients who cannot stand) with the patient at station # 14. Upon completion of the transfer, it was noted the staff returned the Hoyer lift to its storage spot without disinfecting it first. During an interview on 12/13/23 at 1028, registered nurse (Staff C) was queried regarding how the staff knows the Hoyer lift is clean and ready for use with the next patient. Staff C stated it should be disinfected immediately after use with the patient and before returning it to where it is stored. She reported if it is in its storage area, it should be clean. At 1050 on 12/12/23, the staff was observed testing the conductivity at station #12 with the Myron L Conductivity Meter (machine used to test the conductivity of the dialysate). Certified Clinical Hemodialysis Technician (Staff L) was observed placing the Myron L Conductivity Meter on top of the dialysis machine at station #12. Upon completion of testing the dialysate at this station, Staff L was observed taking the Myron L Conductivity Meter from station #12 directly to station #8 without disinfecting it first. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100. 46476 On 12/12/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1510, Staff L, Certified Clinical Hemodialysis Technician ( (CCHT) was observed while changing a central venous catheter (CVC) dressing and preparing the CVC for connection of blood lines to begin dialysis treatment at station #9. During the procedure, Staff L was observed leaving station #9 treatment area to retrieve a wheeled stool that was at station #7 treatment area (station was vacant but had not yet been disinfected) and brought it directly back to station #9 without disinfecting it first. On 12/14/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1055, a patient was observed walking across the treatment floor to the weight scale. While walking, staff noted the patient’s access site had been bleeding and drops of blood were on the path the patient had walked. There was also a small amount of pooled blood on the floor where the patient had stopped once staff noted the bleed. Staff O and Staff J (both CCHT’s) responded immediately. Staff O grabbed a wheeled stool that was nearby and rolled it through the blood on the floor before placing it behind the standing patient. Staff C, a registered nurse, immediately retrieved a chair without wheels, rolled the stool with bloody wheels out of the way to place the non-wheeled chair behind the patient. Staff O then rolled the stool with bloody wheels even further away from the area where all 3 staff were working. After the patient was stabilized, the wheeled stool was not disinfected. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B).”

“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: 47976 Based on observation and record review, the facility failed to dispose of infectious waste in 6 of 18 containers, resulting in the risk for exposure to bloodborne pathogens from over full sharps containers for all patients and staff. Findings include: **Policy 4-03-07 titled, “Segregation of Medical Waste” (revised October 2023) stated, “Sharps containers are to be sealed when ¾ full and placed in designated area for medical waste pick up.” During a tour of the dialysis treatment area on 12/12/23 at 1020, it was observed 6 of 18 Sharps containers were filled beyond the line labeled “Do Not Fill Above This Line”, indicating it was ¾ full and needed to be disposed of. Two of these containers were so full that parts of plastic syringes could be seen protruding from the top of the container. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100.”

“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: 46476 Based on observation, record review, and interview, the facility failed to ensure staff followed appropriate procedures according to facility policy for the cleaning and disinfection of dialysis stations in 1 of 2 observations resulting in the potential for the transmission of bloodborne pathogens and other infections for the 17 patients receiving incenter dialysis services at the facility at the time of observation. Findings include: Facility policy titled “Infection Control for Dialysis Facilities”, Policy: 1-05-01, last revised April 2023 was reviewed on 12/14/23. On page 4., it stated: “b. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient.” On 12/13/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1035, Staff J, a Certified Clinical Hemodialysis Technician, was observed while removing a patient from dialysis blood lines and decannulating one of two needles from the arteriovenous (AV) fistula at station #4. While waiting for the patient to hold pressure after the first needle was removed (for clotting), Staff J went and got wipes containing a bleach solution and brought them to station #4 and began to disinfect the dialysis machine. The patient was still in the dialysis chair and holding a bloody gauze and was still waiting to be decannulated from the second needle. When Staff J was done wiping the dialysis machine, Staff J removed the second needle from the patient’s AV fistula and waited for clotting to occur. After the patient was able to vacate the dialysis treatment station, Staff J disinfected the dialysis chair but did not go back and disinfect the dialysis machine. This finding was reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Staff B stated that patients should not be in the dialysis chair when disinfection of the station begins.”

“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: 46476 Based on observation, interview, and record review, the facility failed to ensure staff maintained aseptic technique when providing care to patients with intravascular catheters during 4 (Station #’ 8 on two separate occations, 9 and 12) of 4 observations resulting in an increased risk for infection and potential for poor patient outcomes. Findings include: Facility policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure”; Procedure: 1-04-02B; Last revised October 2023 was reviewed on 12/14/23. On page 2., it stated: “ ... Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason ... Device Disinfectant and Skin Antiseptic, 70% Alcohol pad, Effective for CVC Hubs”. On page 5., it stated: “16. ... Hold limbs until the antiseptic has dried ...Verify open lumen is not placed on a nonsterile surface and minimize the time it is open.” On 12/12/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1510, Staff L, a Certified Clinical Hemodialysis Technician ( (CCHT) was observed while changing a central venous catheter (CVC) dressing and preparing the CVC for connection of blood lines to begin dialysis treatment at station #9. During the procedure, Staff L removed both CVC catheter end caps exposing the open ends (hubs) and scrubbed each hub separately for 7 seconds each. On 12/13/23 during incenter hemodialysis treatment floor observation of staff, the following was observed: At 1150, Staff M, a CCHT was observed while changing a CVC dressing and preparing the CVC for connection of blood lines to begin dialysis treatment at station #8. During the procedure, Staff M removed both CVC catheter end caps exposing the hubs and began to scrub each hub separately. After scrubbing the arterial line hub with an alcohol prep pad for 12 seconds, and while preparing to scrub the venous line hub, the arterial line hub (open and exposed) fell off a sterile pad and onto the patient’s skin. Staff M gathered up the arterial line hub and placed it back onto the sterile pad (contaminating the sterile pad) and continued with scrubbing the venous line hub with an alcohol prep pad for 12 seconds. Staff M laid both open hubs on the contaminated pad while preparing syringes on the chair-arm table and then attached the syringes to each of the hub ends (no additional scrubbing prior to that connection). These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Staff B stated the hub ends should have been scrubbed for 15 seconds each for both observations and the PCT should have changed the sterile pad and rescrubbed the arterial line hub for the observation on 12/13/23. 47976 During dialysis floor observation on 12/12/23 at 1015, Certified Clinical Hemodialysis Technician (Staff L) was observed disconnecting the central venous catheter (CVC) line on the patient at station #12 after the completion of dialysis. Staff L was observed disconnecting the blood lines and connecting a syringe of saline to each side. Upon removing each saline syringe, Staff L was observed scrubbing each catheter hub for 6 seconds before placing the cap on the end. At 1445, another Certified Clinical Hemodialysis Technician (Staff O) was observed disconnecting the central venous catheter (CVC) line on the patient at station #8 after the completion of dialysis. Staff O was observed disconnecting the first blood line and scrubbing it for 2 seconds before attaching a syringe of saline. She did not perform any disinfection before attaching the syringe on the other side. After removing the first syringe, Staff O was observed scrubbing it for 2 seconds before placing the cap on the end. She scrubbed the other side for 6 seconds before placing the cap. During an interview on 12/14/23 at 1100, the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) were queried on the procedure for scrubbing the hubs after disconnecting a patient with a CVC from dialysis. Staff V reported they are taught to scrub for 15 seconds immediately after disconnecting the blood lines and prior to connecting the syringe of saline. Staff B and Staff V acknowledged the findings.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47976 Based on observation, interview and record review, the facility failed to ensure the pH (acidity or basicity level) of the dialysate was properly tested prior to initiation of dialysis in 2 of 2 observations on the dialysis floor; and failed to ensure conductivity of the dialysate was properly tested prior to initiation of dialysis treatment per facility policy in 2 of 2 observations on the dialysis floor, resulting in the potential for unsafe treatment conditions and poor patient outcomes. Findings include: During dialysis floor observation on 12/12/23 at 1055, Certified Clinical Hemodialysis Technician (Staff L) was observed testing the pH level at station #12. Upon completion of conductivity testing, Staff L took a pH test strip from the bottle and swirled it around in the residual dialysate left in the conductivity machine for 8 seconds. She then immediately compared the results to the colors located on the bottle. Staff L was asked how long she is supposed to dip the test strip per policy, and she stated 10 to 15 seconds. During dialysis floor observation on 12/13/23 at 1020, another Certified Clinical Hemodialysis Technician (Staff O) was observed testing the pH level at station #6. Upon completion of conductivity testing, Staff O used the cup portion of the plunger for the conductivity machine to collect more dialysate for pH testing. Staff O poured the water into the conductivity machine and used a pH strip to swirl it around for 15 seconds. She then immediately compared the results to the colors on the test bottle. Staff O was asked how long she is supposed to dip the test strip per policy, and she stated 15 seconds. Staff O was also asked how soon after dipping the strip should she read the results. Staff O stated, “I honestly don’t know that answer. I usually read it right away, but I can find out.” Interviews were also conducted with 2 additional Certified Clinical Hemodialysis Technicians regarding their understating of the procedure to test pH. Certified Clinical Hemodialysis Technician (Staff K) was interviewed on 12/13/23 at 1015. Staff K stated you are supposed to collect the dialysate in a small plastic cup and are supposed to dip the strip in for 5 seconds. Another Certified Clinical Hemodialysis Technician (Staff M) was interviewed on 12/13/23 at 1017. Staff M stated you are supposed to collect 10 cc (cubic centimeters) into a cup, dip the test strip for 15 to 30 seconds and read the results immediately. The Group Facility Administrator (Staff V) was asked on 12/13/23 at 0940 to provide the facility policy for how to properly test pH. Staff V was unable to find a policy that described the steps, but reported the staff is to follow the manufacturer’s instructions on the test strip bottle. Test strip bottle labeled “K100-0117CT E-Z Chek Test Strips” was examined and instructions were as follows: “Directions for Use: 1) Dip into test solution and shake off excess liquid. 2) Compare color reaction on strip to color chart on bottle to determine closest match for a. Citric acid/bicarbonate dialysate immediately after 10 seconds b. Bicarbonate concentrate immediately after 15 seconds 3) Read pH value for the closest match” Staff V stated this clinic uses the Citric acid/bicarbonate dialysate so should follow step “a”. He also reported that the staff should “dip” per above instructions and not hold the strip under the solution. Findings were further reviewed with and acknowledged by the Facility Administrator (Staff B) during an interview on 12/14/23 at 1100. 46476 On 12/12/23 during hemodialysis floor observation of staff, the following was observed: At 1050, Staff L, a Certified Clinical Hemodialysis Technician (CCHT), was observed while performing the procedure for checking the quality (conductivity) of the dialysis fluid (dialysate) using a Myron L Conductivity Meter at station #12. Staff L filled the meter cell cup with the dialysate fluid and agitated the sample. Staff L did not repeat any steps (per facility procedure guidelines) before reading the results. On 12/13/23 during hemodialysis floor observation of staff, the following was observed: At 1017, Staff O, a CCHT, was observed while performing the procedure for checking conductivity of the dialysate fluid using a Myron L Conductivity Meter at station #6. Staff O filled the meter cell cup with the dialysate fluid and agitated the sample. Staff O did not repeat any steps before reading the results. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Facility procedure titled “Operation of Portable Myron L Conductivity Meter (D-1)”; Procedure: 2-08-01B; Last revised April 2020, was reviewed on 12/14/23. On page 2., it stated: “3. Fill meter cell cup with sample ... 4. Agitate sample ... 5. Repeat steps # 3 and # 4 - at least 3 times ... 6. Obtain another proportioned dialysate sample ... immediately read and release the button. 7. Repeat set # 6 twice and press Read/Check button and record conductivity reading.””

“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: 47976 Based on observation, record review and interview, the facility failed to ensure patient access sites were in view of staff during dialysis treatment at 4 (Station #8 on 2 separate occasions, 16, 17) of 17 stations, resulting in the potential for needle dislodgement or line disconnection to go undetected and for significant unrecognized blood loss to occur. Findings include: **Policy 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection and Nursing Assessment” (revised October 2023) stated on page 3, “c. The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment.” During dialysis floor observation on 12/12/23 at 1433, the access site for the patient at station #8 was noted to be completely covered. At 1448, patient care technician (Staff R) was observed going to station #8 to check on the patient. When Staff R left the station, the access site for the patient was still completely covered. Staff R was quired whether he was able to see the access site for this patient. Without looking, Staff R stated he was able to see it. Staff R was asked to look at the patient again to show where he could see the access site. Upon returning to station #8, Staff R reported he has to keep an eye on this patient because he likes to cover himself back up but acknowledged that he should do a better job. On 12/13/23 at 0953, the access sites for the patients at stations #8, 16 and 17 were all completely covered. At 1008, Certified Clinical Hemodialysis Technician (Staff O) was observed walking by station #8 and checking the machine before going to work with a patient at station #6. Staff O was asked whether she was able to see the access site of the patient at station #8. Staff O returned to station #8 and noted she was unable to see the access site and asked the patient to uncover it. Staff O stated she always has to tell the patients to stay uncovered. From 0953 to 1010, another Certified Clinical Hemodialysis Technician (Staff K) was observed working in the pod with stations #16 and #17. During this time, he was observed checking on the patients in this area multiple times. At 1010, Staff K was asked if he was able to see the access sites on the patients at station #16 and #17. Staff K looked at both patients and acknowledged that he could not see their access sites. Staff K stated the patients know they are supposed to keep themselves uncovered, but they don’t always listen. He acknowledged he should watch better. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to have Against Medical Advice (AMA) documentation per their policy concerning early termination of dialysis treatment for 3 (P #’s 2, 4, and 5) of 6 in-center records reviewed, out of a total sample of 7 records reviewed, resulting in the potential for 71 in-center patients currently receiving services not understand their right to refuse or the possible consequences of early termination. Findings include: P-2: This 68-year-old patient was admitted to the dialysis facility on 5/13/2020, with diagnosis which included end stage renal disease, anemia, and hypertension. P-2 was receiving treatments 3 times per week (Mon-Wed-Fri) for an ordered duration of 195 minutes each treatment. On 12/13/23, record review of P-2’s six most recent dialysis treatment sheets found 5 of 6 treatments were terminated early according to the following documentation: 12/11/23: 178 minutes of dialysis (shortened by 17 minutes) with no AMA form evidenced in the medical record. 12/08/23: 157 minutes of dialysis (shortened by 38 minutes) with no AMA form evidenced in the medical record. 12/06/23: 181 minutes of dialysis (shortened by 14 minutes) with no AMA form evidenced in the medical record. 12/04/23: 160 minutes of dialysis (shortened by 35 minutes) with no AMA form evidenced in the medical record. 11/29/23: 187 minutes of dialysis (shortened by 08 minutes) with no AMA form evidenced in the medical record. In addition, no physician notification was found in the medical record, which is stipulated by facility policy referenced below whenever a treatment is shortened by 30 minutes or more (12/4/23 and 12/8/23). The Group Facility Administrator (Staff V) reviewed and acknowledged the above findings during an interview on 12/13/23 at 1335. Later that day at 1520, Staff V confirmed no documentation was found in the medical record concerning any of the needed AMA forms or physician notification. Facility Policy: “Prescribed Treatment Time Not Met” No. 1-01-09 (Revised October 2023) stated, “The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient request to terminate their treatment earlier than the prescribed run time... If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention.” 47976 P-7: This 63-year-old patient was admitted to this dialysis facility on 2/2/23 with the diagnosis of end stage renal disease and was receiving dialysis treatments 3 times per week. During record review on 12/13/23, it was determined the patient’s visits were shortened on the following dates as follows: On 11/14/23 by 30 minutes On 11/28/23 by 30 minutes On 12/7/23 by 64 minutes The Facility Administrator (Staff B) was queried regarding the location of Against Medical Advice (AMA) forms filled out and signed by the patient during an interview on 12/14/23 at 1100. Staff B was not able to find evidence of an Against Medical Advice (AMA) form being filled out and signed by the patient for 11/14/23. She was able to provide AMA forms for the dates of 11/28/23 and 12/7/23, but these were not signed by the patient. Staff B acknowledged the findings. 46476 P-4: This 31-year-old was admitted to the facility on 11/29/22 with end stage kidney disease; high blood pressure; and Lupus (an autoimmune disease). The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 10/13/23 and 12/9/23. The active physician orders in the plan of care for the period reviewed included a hemodialysis treatment duration of 210 minutes each treatment. On the treatment sheet dated 10/18/23, the total treatment duration was 147 minutes (63 minutes less than prescribed). On the treatment sheet dated 10/27/23, the total treatment duration was 176 minutes (34 minutes less than prescribed). There were no signed AMA forms found for the dates above which would have indicated that P-4 was informed of the health consequences associated with early termination or that doing so was against medical advice. P-5: This 61-year-old was admitted to the facility on 11/6/23 with end stage kidney disease; high blood pressure; and type 2 Diabetes. The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 11/24/23 and 12/9/23. The active physician orders in the plan of care for the period reviewed included a hemodialysis treatment duration of 210 minutes each treatment. On the treatment sheet dated 11/24/23, the total treatment duration was 101 minutes (109 minutes less than prescribed). There was no signed AMA form found for the date above which would have indicated that P-5 was informed of the health consequences associated with early termination or that doing so was against medical advice. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B).”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to provide medication services as outlined in the patients Plan of Care in 2 (P-2 and 4) of 6 in-center records reviewed, from a total sample of 7 records reviewed, resulting in medication(s) being administered outside of what was prescribed, and potentially leading to poor patient outcomes. Findings include: P-2: This 68-year-old patient was admitted to the dialysis facility on 5/13/2020, with diagnosis which included end stage renal disease, anemia, and hypertension. P-2 was receiving treatments 3 times per week (Mon-Wed-Fri) for an ordered duration of 195 minutes each treatment. On 12/13/23, record review of P-2’s treatment orders noted Heparin (a medication used for blood thinning) was to be administered at 500 Units/Hour and stopped 60 minutes before the end of treatment. Further record review of P-2’s six most recent dialysis treatment sheets found 6 of 6 treatments documented P-2 was administered 1,100 units of Heparin (blood thinning medication) for each treatment. However, additional review noted the following: On the treatment dated 12/11/23, dialysis treatment duration was 178 minutes - 60 minutes (time Heparin was to be stopped prior to completion), equals 118 minutes of 500 Units/Hour of Heparin administration. This equates to a total delivered dosage of 983 Units of Heparin, not the documented 1,100 Units noted above. On the treatment dated 12/08/23, dialysis treatment duration was 157 minutes - 60 minutes, equals 97 minutes of 500 Units/Hour of Heparin administration. This equates to a total delivered dosage of 808 Units of Heparin. On the treatment dated 12/06/23, dialysis treatment duration was 181 minutes - 60 minutes, equals 121 minutes of 500 Units/Hour of Heparin administration. This equates to a total delivered dosage of 1,008 Units of Heparin. On the treatment dated 12/04/23, dialysis treatment duration was 160 minutes - 60 minutes, equals 100 minutes of 500 Units/Hour of Heparin administration. This equates to a total delivered dosage of 833 Units of Heparin. On the treatment dated 12/01/23, dialysis treatment duration was 197 minutes - 60 minutes, equals 137 minutes of 500 Units/Hour of Heparin administration. This equates to a total delivered dosage of 1,142 Units of Heparin. On the treatment dated 11/29/23, dialysis treatment duration was 187 minutes - 60 minutes, equals 127 minutes of 500 Units/Hour of Heparin administration. This equates to a total delivered dosage of 1,058 Units of Heparin. The above findings were reviewed and acknowledged during interview on 12/14/23 at 1015 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Staff V noted the clinicians likely documented the total dose from the prescription (1,100 Units) if P-2 would have stayed for the entire prescribed treatment duration (195 minutes) but due to this type of documentation, the dose given was understood to be a medication error. Facility Policy: “Medication Policy” No. 1-06-01, (Revised October 2023) stated, “9. Medications are administered as prescribed and then documented in the patient’s medical record ...” 46476 P-4: This 31-year-old was admitted to the facility on 11/29/22 with end stage kidney disease; high blood pressure; and Lupus (an autoimmune disease). The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 10/13/23 and 12/9/23. There was an active physician orders in the plan of care for Heparin (blood thinning agent) 500 Units per hour intravenously to be given every dialysis treatment. There was also an active physician order in the plan of care for Clonidine 0.1 milligram (mg) that could be given every 4 hours as needed for high blood pressure. During record review, the following medication discrepancies were noted: On the treatment dated 10/18/23, the dialysis treatment ended in 147 minutes (2 hour and 27 minutes). It was documented that 1700 Units of Heparin was given during this treatment (475 Units more than prescribed). On the treatment dated 10/27/23, the dialysis treatment ended in 176 minutes (2 hours and 56 minutes). It was documented that 1700 Units of Heparin was given during this treatment (approximately 233 Units more than prescribed). On the treatment dated 11/24/23, the dialysis treatment ended in 156 minutes (2 hours and 36 minutes). It was documented that 1700 Units of Heparin was giving during this treatment (400 Units more than prescribed). On the treatment sheet dated 11/29/23, it was noted that the nurse documented Clonidine 0.2 mg was given during the treatment for high blood pressure (0.1 mg more than prescribed). There was no documentation with an explanation to why a larger dose was given than prescribed. There was no documentation indicating that the nurse contacted the physician regarding the dose given or received verbal orders to give a larger dose. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B).”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure each patient new to dialysis had a comprehensive assessment completed within 30 days or 13 treatments of admission in 2 (Patient #6, 7) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-6: This 72-year-old patient was admitted to this dialysis facility on 8/30/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/13/23, it was determined the initial comprehensive assessment was due by 9/29/22 and was not completed until 11/10/22. There was no documentation regarding the reason for the delay. P-7: This 63-year-old patient was admitted to this dialysis facility on 2/2/23 with the diagnosis of end stage renal disease and was receiving dialysis treatments 3 times per week. During record review on 12/13/23, it was determined the initial comprehensive assessment was due 3/4/23 and the only comprehensive assessment done was completed on 8/8/23 and was labeled as a 90-day assessment. The Facility Administrator (Staff B) was queried whether there was a 30-day comprehensive assessment in the computer. Staff B reported the only comprehensive assessment she could find was the one mentioned above that was dated 8/8/23. Staff B reported she thinks this patient had stopped dialysis treatments for a while due to regaining kidney function, but she was unable to provide evidence of this being the reason for missing assessments. There was no evidence of a 30-day initial comprehensive assessment being completed. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 47976 Based on record review and interview, the facility failed to ensure a follow up comprehensive reassessment occurred within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care in 2 (Patient #6, 7) of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-6: This 72-year-old patient was admitted to this dialysis facility on 8/30/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/13/23, it was determined the 90-day comprehensive assessment was due by 11/28/22 and was not completed until 2/2/23. There was no documentation regarding the reason for the delay. P-7: This 63-year-old patient was admitted to this dialysis facility on 2/2/23 with the diagnosis of end stage renal disease and was receiving dialysis treatments 3 times per week. During record review on 12/13/23, it was determined the 90-day comprehensive assessment was due by 5/3/23 and was not completed until 8/8/23. There was no documentation regarding the reason for the delay. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to ensure patient blood pressure (BP) monitoring and assessment was performed per facility policy in 2 (P-2 and 4) of 6 in-center records reviewed, and failed to notify the registered nurse (RN) of elevated BP readings per facility policy in 4 (P-2, 4, 6, 7) of 6 in-center records reviewed, out of a total sample of 7 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-2: This 68-year-old patient was admitted to the dialysis facility on 5/13/2020, with diagnosis which included end stage renal disease, anemia, and hypertension. P-2 was receiving treatments 3 times per week (Mon-Wed-Fri) for an ordered duration of 195 minutes each treatment. On 12/13/23, record review of P-2’s six most recent dialysis treatment sheets found 4 of 6 treatments failed to notify the registered nurse (RN) of multiple runs with BP readings greater than 180 mm/Hg. (systolic) and/or BP greater than 100 mm/Hg. (diastolic) per facility expectations and policy noted below. The four treatment sheets are as follow: 1) On 12/11/2023, dialysis treatment started at 0637 with a BP reading of 189/106, 183/94 at 0703, and 201/105 at 0733 with no documentation the RN was notified of the elevated BP readings in 3 of 3 opportunities. 2) On 12/4/2023, dialysis treatment started at 0651 with a BP reading of 204/106; 213/103 at 0703; 206/114 at 0733; 188/112 at 0805; 187/104 at 0833; and 171/107 at 0903. No RN notification was found in 6 of 6 opportunities concerning P-2’s elevated BP readings. 3) On 12/1/2023, dialysis treatment started at 0559 with a BP reading of 189/93; 199/91 at 0603; 207/183 at 0633; 202/102 at 0636 (RN was first notified at this time). 4) On 11/29/2023, dialysis treatment started at 0628 with a BP reading of 195/92; 181/97/103 at 0636; 194/83 at 0703; 176/98 at 0733; 190/94 at 0833; 192/101 at 0903; 184/113 at 0933, and 176/118 at 0939. No RN notification regarding P-2’s elevated BP readings was found in 7 of 8 opportunities. The above findings were reviewed and acknowledged during interview on 12/14/23 at 1025 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Both noted this did not meet facility expectations to report to the RN when patients have runs of systolic BP readings of greater than 180 mm Hg. and/or diastolic BP readings of greater than 100 mm Hg. at any time during treatment. Facility Policy: “Pre-Intra-Post Treatment Data collection, Monitoring and Nursing Assessment” No. 1-03-08 (Revised October 2023) stated, “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately.” 47976 **Policy 1-03-08 titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (revised October 2023) on page 5, “Members of the patient care team should report ANY changes in patient conditions ... immediately to the licensed nurse ...”, and abnormal findings were stated as: “Blood pressure: Intradialytic: Difference of 20 mm Hg increase or decrease from patient’s last intradialytic treatment BP reading ...” P-6: This 72-year-old patient was admitted to this dialysis facility on 8/30/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/13/23, the last 6 treatment sheets were reviewed. It was noted the blood pressure (BP) readings recorded by the patient care technician (PCT) were as follows: On 11/28/23- From 0804 to 0835, BP from 155/63 to 179/89 = 24 millimeters of mercury (mm Hg) increase in the systolic (top number) and 26 mm Hg increase in diastolic (bottom number) From 0835 to 0904, BP from 179/89 to 108/53 = 71 mm Hg decrease in systolic and 36 mm Hg decrease in diastolic From 0935 to 1004, BP from 110/51 to 145/63 = 35 mm Hg increase in systolic On 12/7/23- From 0704 to 0734, BP from 144/71 to 114/63 = 30 mm Hg decrease in systolic From 0835 to 0905, BP from 126/34 to 95/46 = 31 mm Hg decrease in systolic From 0905 to 0935, BP from 95/46 to 123/51 = 28 mm Hg increase in systolic There was no evidence these values were reported to the registered nurse on duty. P-7: This 63-year-old patient was admitted to this dialysis facility on 2/2/23 with the diagnosis of end stage renal disease and was receiving dialysis treatments 3 times per week. During record review on 12/13/23, the last 6 treatment sheets were reviewed. It was noted the blood pressure (BP) readings recorded by the patient care technician (PCT) were as follows: On 11/21/23- From 1046 to 1119, BP from 99/62 to 121/69 = 22 mm Hg increase in systolic From 1119 to 1205, BP from 121/69 to 94/87 = 27 mm Hg decrease in diastolic On 11/25/23 - From 1003 to 1032, BP from 129/73 to 101/76 = 28 mm Hg decrease in systolic From 1101 to 1131, BP from 121/70 to 90/56 = 31 mm Hg decrease in systolic On 11/28/23- From 1116 to 1146, BP from 149/80 to 113/61 = 36 mm Hg decrease in systolic From 1146 to 1216, BP from 113/61 to 143/117 = 30 mm Hg increase in systolic and 56 mm Hg increase in diastolic From 1244 to 1246, BP from 154/131 to 112/64 = 42 mm Hg decrease in systolic and 67 mm Hg decrease in diastolic From 1316 to 1346, BP from 107/67 to 42/28 = 65 mm Hg decrease in systolic and 39 mm Hg decrease in systolic From 1346 to 1412, BP from 42/28 to 69/53 = 27 mm Hg increase in systolic and 25 mm Hg increase in diastolic From 1412 to 1416, BP from 69/53 to 161/122 = 92 mm Hg increase in systolic and 69 mm Hg increase in systolic From 1416 to 1436, BP from 161/122 to 87/47 = 74 mm Hg decrease in systolic and 75 mm Hg decrease in diastolic On 11/30/23- From 1058 to 1113, BP from 102/67 to 168/58 = 66 mm Hg increase in systolic From 1113 to 1137, BP from 168/58 to 144/123 = 24 mm Hg decrease in systolic and 65 mm Hg increase in diastolic From 1137 to 1203, BP from 144/123 to 128/45 = 78 mm Hg increase in diastolic On 12/7/23 - From 1059 to 1126, BP from 102/63 to 71/62 = 31 mm Hg decrease in systolic From 1126 to 1138, BP from 71/62 to 110/65 = 39 mm Hg increase in systolic From 1138 to 1156, BP from 110/65 to 53/28 = 57 mm Hg decrease in systolic and 37 mm Hg decrease in diastolic From 1156 to 1227, BP from 53/28 to 93/78 = 40 mm Hg increase is systolic and 50 mm Hg increase in diastolic From 1227 to 1256, BP 93/78 to 117/78 = 24 mm Hg increase in systolic There was no evidence these values were reported to the registered nurse on duty. The Facility Administrator (Staff B) was asked if she could find documentation of the registered nurse being notified of the above values during an interview on 12/14/23 at 1110. Staff B stated if it was reported, it would be on the treatment sheets, therefore there was no evidence. Findings were also acknowledged by the Group Facility Administrator (Staff V) at that time. 46476 Facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, Policy: 1-03-08; Last revised October 2023 was reviewed on 12/14/23. On page 5., it stated: “the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record ... Blood Pressure- Intradialytic: Difference of 20 mm Hg increase or decrease from patient’s last intradialytic treatment BP reading ...” P-4: This 31-year-old was admitted to the facility on 11/29/22 with end stage kidney disease; high blood pressure; and Lupus (an autoimmune disease). The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 10/13/23 and 12/9/23. During review of the treatment sheet dated 10/13/23, the following was noted: At 1336, the blood pressure (BP) was recorded as 132/82 millimeters of mercury (mm/Hg). At 1436 (the next consecutive reading), a patient care technician (PCT) recorded the BP as 191/82 mm/Hg (an increase in systolic BP of 59 mm/Hg). At 1518, a PCT recorded the BP as 144/79 mm/Hg (a decrease of 47/3 mm/Hg). At 1530 (the post treatment reading), a PCT recorded the BP as 139/38 mm/Hg (a decrease of 5/41 mm/Hg). There was no documentation that the above changes in BP readings were reported to the nurse. During review of the treatment sheet dated 12/9/23, the patient had the following BP readings: At 1249, the registered nurse (RN) recorded the BP as 144/114. At 1304, the PCT recorded the BP as 162/105. At 1434, the PCT recorded the BP as 159/105. At 1504, the PCT recorded the BP as 148/106. At 1534, the PCT recorded the BP as 122/105 There was no documentation that the RN was aware of BP readings between 1304 and 1534. There was no documentation that the physician became aware of the elevated BP readings. Of note, P-4 had an active physician order in the plan of care for Clonidine 0.1 mg to be given every 4 hours as needed for high blood pressure. This medication was not documented as given during this treatment. It is unclear if the RN assessed the patient after 1249. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Staff B was queried as to whether the PCT should ignore elevated readings (above 180/100) because it is not a change of 20 mm/Hg during the treatment. Staff B stated that although the changes in BP readings on the 12/9/23 treatment record may not have changed by 20 mm/Hg between recorded BP’s, the PCT should be reporting elevations in BP above 180 systolic or 100 diastolic to the RN for evaluation, and the RN should consider available interventions or call the physician to report, and should have provided documentation of all actions.”

“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: 47976 Based on record review and interview, the facility failed to deliver the prescribed blood flow rate (BFR) and dialysate flow rate (DFR) for 3 (Patient #4, 5, 6) of 6 records reviewed of patient receiving in-center hemodialysis, resulting in the potential to impact the adequacy of dialysis for all 71 patients served by the facility. Findings include: **Policy 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection and Nursing Assessment” (revised October 2023) stated on page 4 under the header of “Intradialytic Data Collection/Assessment”, “10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.” P-6: This 72-year-old patient was admitted to this dialysis facility on 8/30/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/13/23, it was determined the BFR was ordered at 400 milliliters per minute (mL/min) and the DFR was ordered at 800 mL/min. Upon review of the last 6 treatment sheets, it was noted the BFR and DFR were run incorrectly as follows: On 12/7/23, the BFR was run at 200 mL/min for just over an hour, including 4 checks by the patient care technician. On 12/9/23, the DFR was run at 500 mL/min for 2 hours and was recorded at 0 mL/min for the remainder of the treatment. There were 9 checks done by the patient care technician during this time. There was no documentation of the reason the BFR and DFR were not met or that the licensed nurse was notified. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100. 46476 P-4: This 31-year-old was admitted to the facility on 11/29/22 with end stage kidney disease; high blood pressure; and Lupus (an autoimmune disease). The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 10/13/23 and 12/9/23. The active physician order in the plan of care for dialysis treatment included a blood flow rate (BFR) of 400 milliliters/minute (mL/min) for each treatment. On the treatment sheet dated 12/9/23, it was noted the BFR was changed from 400 mL/min at 1504, to 330 mL/min at 1534 (70 mL/min less than prescribed). At 1604, it was again changed to 350 mL/min (still 50 mL/min less than prescribed) and continued running at that rate until treatment was terminated at 1611. There was no documented explanation to why the BFR was run at a rate of less than prescribed for 37 minutes during the treatment. P-5: This 61-year-old was admitted to the facility on 11/6/23 with end stage kidney disease; high blood pressure; and type 2 Diabetes. The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 11/24/23 and 12/9/23. The active physician order in the plan of care for dialysis treatment included a BFR rate of 400 mL/min for each treatment. On the treatment sheet dated 11/24/23, the BFR was changed from 400 mL/min at 1301 to 300 mL/min at 1331 (100 mL/min less than prescribed) and remained there until the treatment was terminated at 1401. There was no documented explanation to why the BFR was run at a rate of less than prescribed for 60 minutes during the treatment. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B). Staff B reviewed the treatment sheets dated above for both P-4 and P-5 and agreed that no documented reason could be found for why the BFR had been reduced in both cases.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 38304 Based on record review, and interview, the facility failed to accurately monitor, track, and trend the facility’s performance concerning the Home Program’s peritonitis infection rates, resulting in the potential to negatively impact all 6 home PD (peritoneal dialysis) patients receiving treatment at this facility. Findings include: During an interview on 12/14/23 at 0945, the facility’s QAPI (quality assurance performance improvement) program was reviewed with the Group Facility Administrator (Staff V) and Facility Administrator (Staff B), who is tasked with the oversight of clinical applications generated from QAPI data collected. Review was completed of multiple facility concerns, including but not limited to hospitalizations, infections, water and dialysate quality, complaints and grievances, dialysis treatment adherence to facility policy and procedures, as well as discussion of performance improvement projects (PIP’s). During QAPI review, the statistical details concerning the Home Program’s peritonitis PIP (September through November 2023) was chosen due to severely elevated rates per 100 patients (15.38% for 2022 vs. only 2.59% for State and 2.47% for U.S averages) identified during pre-survey to ascertain the overall insight and application of the data collected. Additional review revealed the following concerns: 1) The desired “Improvement Goal(s)” of the PIP was to have a “Peritonitis rate of > (greater than) 60%” which was fortunately “not met”. 2) The data collected concerning active patient peritonitis rates was 17.45%, 19.06% and 20.27% respectively for the months noted above. When Staff B and V were queried how a sample of just 6 eligible patients in the Home Program generated different percentages down to the hundredths value, both could not offer an explanation. Further, when the infection logs from 06/01/2023 through 12/14/23 were reviewed for peritonitis concerning all patients during that timeframe, the results showed “No Data Available”. Staff B and Staff V were then asked how an improvement goal for an infection rate of 60% of all PD patients was logical when 2.5% was typical per State and National averages, and why did the QAPI program show 17.45% to 20.27% peritonitis rates while the infection logs showed no infections or 0.00% during the same timeframe. Both Staff B and Staff V could offer no explanation at the time. The facility failed to adhere to its policy referenced below concerning the insight and management of QAPI data collected to improve patient care. Facility Policy: “Continuous Quality Improvement Program” No. 1-14-06 (Revised April 2021) stated, “The facility will measure, analyze, and track quality indicators or other aspects of performance. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.””

“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: 47976 Based on record review and interview, the Medical Director failed to ensure the facility followed policy and that the Initial Nursing Assessment was performed by a registered nurse prior to initiation of treatment in 2 (Patient #3, and 6) of 7 records reviewed; and failed to ensure the physician was notified of treatments that were shortened greater than 30 minutes per facility policy in 3 (Patient #7, 4 and 5) of 6 records reviewed of patients receiving in-center hemodialysis, resulting in the potential for poor patient outcomes. Finding included: P-3: This 68-year-old patient was admitted to this dialysis facility on 10/12/23 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/13/23, it was determined the Initial Nursing Assessment was completed on 10/12/23 at 1634. The Facility Administrator (Staff B) was asked when the patient’s first treatment was, and she stated it was at 1510 on 10/12/23 - before the Initial Nursing Assessment was completed. P-6: This 72-year-old patient was admitted to this dialysis facility on 8/30/22 with the diagnosis of end stage renal disease and was receiving dialysis treatment 3 times per week. During record review on 12/13/23, it was determined the Initial Nursing Assessment was dated 8/30/23 on the top of the first page but did not contain a signature of who completed the assessment or a time the assessment was completed. Findings were reviewed with and acknowledged by the Facility Administrator (Staff B) and Group Facility Administrator (Staff V) during an interview on 12/14/23 at 1100. ___ **Policy 1-01-09 title, “Prescribed Treatment Time Not Met” (revised October 2023) stated, “If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient ’ s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient ’ s specific needs.” P-7: This 63-year-old patient was admitted to this dialysis facility on 2/2/23 with the diagnosis of end stage renal disease and was receiving dialysis treatments 3 times per week. During record review on 12/13/23, it was determined the patient’s visits were shortened on the following dates as follows: On 11/14/23 by 30 minutes On 11/28/23 by 30 minutes On 12/7/23 by 64 minutes During an interview on 12/14/23 at 1100, Staff B was queried whether there was evidence in the record to show the physician was contacted on these dates per facility policy. Staff B reported the staff may have contacted the physician, but there was no documentation of this. She acknowledged the findings. 46476 P-4: This 31-year-old was admitted to the facility on 11/29/22 with end stage kidney disease; high blood pressure; and Lupus (an autoimmune disease). The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 10/13/23 and 12/9/23. During review it was noted that the treatment on 10/18/23 was terminated 63 minutes early. It was also noted that the treatment dated 10/27/23 was terminated 34 minutes early. There was no documentation included on the above treatment sheets indicating that the physician was made aware of the early terminations. P-5: This 61-year-old was admitted to the facility on 11/6/23 with end stage kidney disease; high blood pressure; and type 2 Diabetes. The medical record was reviewed on 12/13/23 and included 6 hemodialysis treatment sheets between the dates of 11/24/23 and 12/9/23. During review it was noted that the treatment on 11/24/23 was terminated 109 minutes early. There was no documentation included on the treatment sheet indicating that the physician was made aware of the early termination. These findings were reviewed and acknowledged during an interview on 12/14/23 at 1215 with the Group Facility Administrator (Staff V) and the Facility Administrator (Staff B).”