Ara-Holyoke Dialysis LLC

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 10249 Based on review of the Emergency Preparedness Binder and staff interview, the facility failed to maintain an emergency preparedness communication plan that complies with Federal, State and local laws. The communication plan must include, but not limit to, a current list of names and contact information for staff, physician’s and volunteers. Findings include: Review of the ARA Holyoke Dialysis Center Emergency Disaster Staff Contact Information Sheet, located in the Emergency Preparedness binder, listed 21 staff members with contact information, in case of an emergency. Twelve of the 21 staff members listed were not currently employed at the facility. Review of the facility personnel list, provided to the survey team, indicated nine (9) staff members who currently worked at the facility, but were not listed on the emergency disaster contact list. In addition, the Medical Director/physician was missing from the emergency contact sheet. During an interview on 1/24/24 at 2:00 P.M., the Clinical Manager said there have been many staff changes, and the emergency contact list has not been updated to reflect the current staff members working at the facility.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 2 staff members (Licensed Practical Nurse [LPN] #1 and Patient Care Technician [PCT] #3) observed, performed adequate infection control practices related to proper glove use; 1.) while touching patient dialysis tubing contaminated with blood and 2.) during a discontinuation of a dialysis treatment for an arterio-venous graft (AVG) for 1 of 2 patients, in a total sample of 13 patients. Findings Include: Review of the facility policy entitled, Infection Control, last revised 11/29/22, indicated the following: * Gloves are required whenever caring for a patient or touching the patient’s equipment or supplies. * Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items. 1. During an observation of the treatment area (station #7) on 1/23/24 at 9:10 A.M., the surveyor observed LPN #1 return to the station after discharging a patient. Upon LPN #1’s return to station #7, LPN #1 proceeded to pick up the contaminated dialysis tubing, that had fallen on the floor, with her ungloved hands. The dialysis tubing was observed to have blood in the lines, and she did not put on a pair of gloves prior to picking up the dialysis tubing. LPN #1 was then observed applying a pair of gloves without performing hand hygiene. LPN #1 continued to remove the contaminated dialysis tubing and supplies from station #7. During an interview on 1/23/24 at 9:55 A.M., LPN #1 said she should have put on gloves before touching the contaminated dialysis tubing. She also said she should have performed hand hygiene after touching the tubing. 37700 2. For Patient #9, PCT #3 failed to don clean gloves prior to the discontinuation of dialysis through an AVG. During an observation of the treatment area on 1/23/24 at 9:50 A.M., the surveyor observed PCT #3 in station #12 don gloves and tear numerous strips of white tape and place them on the tray table attached to the chair in preparation for a discontinuation of dialysis for Patient #9. PCT #3 then unwrapped a clean glove that was on the tray table that contained a stack of gauze. PCT #3 proceeded to discontinue the AVG dialysis treatment without changing his gloves or performing hand hygiene. During an interview on 1/23/24 at 2:00 P.M., the Clinic Manager said PCT #3 should have donned new gloves prior to discontinuing the dialysis treatment, as required.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 1.) staff stored Personal Protective Equipment (PPE) appropriately within the isolation room while treating a patient with a diagnosis of COVID-19; 2.) the isolation room door remained closed during treatment for a patient with a diagnosis of COVID -19, and 3.) 1 of 1 Patient (#13) diagnosed with COVID-19, wore a surgical mask appropriately to prevent the spread of infection. Findings include: Review of the facility policy entitled, Seasonal Influenza, COVID -19, and Other Respiratory Illnesses, last revised 12/20/23, indicated the following: *Patients with suspected or confirmed infection are dialyzed in a separate room (if available) with the door closed. *Routine COVID Pandemic-related masking practice for patients are recommended and well-fitting surgical mask should be provided if requested. *Patients with any other undiagnosed respiratory symptoms or a recent exposure to COVID-19 should wear a surgical mask over their nose and mouth for the entire time they are in the center. On 1/23/24 at 11:00 A.M., the surveyor observed Patient #13 at station #20 (isolation room). Patient #13 was observed to be receiving his/her dialysis treatment. He/she was observed wearing a mask that was below his/her nose and only covering his/her mouth. Patient #13 has a diagnosis of COVID -19. The isolation room (station #20) door was observed open and there was PPE (gown and N95 mask) hanging on a hook located outside the isolation room. On 1/23/24 at 1:45 P.M., the surveyor observed Patient #13 receiving his/her dialysis treatment at station #20 (isolation room). He/she was observed wearing a mask that was below his/her nose and only covering his/her mouth. The isolation room door was observed open and there was PPE (gown and N95 mask) hanging on a hook located outside the isolation room. During an interview on 1/23/24 at 1:50 P.M., Registered Nurse (RN) #3 said that usually they keep the door closed when the patient is at the beginning of their infection, but because he/she is at the end of his/her infection they can leave the door open. RN #3 said they just hang the PPE on the outside of the door. During an interview on 1/23/24 at 1:55 P.M., the Clinical Manager said the door to the isolation room should always remain closed when a patient with COVID -19 is being treated and that the PPE should be hung up inside the room not outside the door. She said the patient should have had the mask above his/her nose.”

“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: 10249 Based on observations, interview, and policy review, the facility failed to ensure 1 of 2 staff members observed (Patient Care Technician [PCT] #3, for 1 of 2 observations, adequately cleaned and disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk for cross contamination of blood borne pathogens. Findings include: Review of the facility’s policy entitled, Cleaning and Disinfection of Equipment, Supplies and Treatment Area, revised 11/15/23, included the following: *Unless equipment manufacturers specify use of another agent, equipment, treatment area and work surfaces will be disinfected using 1:100 bleach/water solution using 5.25%-6% bleach. *All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but is not limited to: *Dialysis machine, chair, including the top and bottom of the chair-side table(s), bedside tables television, phone, counters and wall boxes. *Dialysis chairs will be reclined, and all areas inspected and disinfected where blood could accumulate and not readily noticed. *Reusable supplies contaminated with visible blood must be cleaned per this policy and then disinfected, using the bleach/water solution specified in this policy. *Containers used to discard saline prime from dialyzers will be disinfected after each treatment and when visible contaminated with blood. The external and internal surfaces of the container will be wiped with a disposable cloth soaked with the bleach/water mixture used to disinfect the rest of the machines. The cloth is discarded after use. 1. The facility failed to ensure that PCT #3 adequately disinfected station 19 and station 6 for the next patients. The surveyor first observed PCT #3 on 1/23/24 at 9:32 A.M., cleaning and disinfecting station 19 for the next patient. He was observed to disinfect using 1:100 bleached soaked pads. PCT #3 failed to disinfect the area behind the prime waste bucket on the left side of the machine, the right side of the machine, including the attached sharps container, and the lower half of the back of the machine. PCT #3 failed to disinfect the counter, behind the dialysis machine, as well as the clipboard that was resting on the counter. On 1/23/24 at 9:45 A.M., the surveyor again observed PCT #3 clean and disinfect station 6 for the next patient. PCT #3 was observed disinfecting the dialysis machine with 1:100 bleach soaked pads. PCT #3 failed to clean the back of the dialysis machine, the basket (located on the right side of the machine) that holds the blood pressure (BP) cuff, the intravenous (IV) pole and arms, and the stethoscope that was hanging from the IV pole. PCT #3 was observed disinfecting the BP cuff then placing it on the IV arms, which had not been disinfected. PCT #3 was then observed disinfecting the dialysis chair. He failed to clean the outsides of the chair, under the tray tables, and the footrest. PCT #3 also failed to disinfect the back counter, wall, and wall box. During an interview on 1/23/24 at 2:00 P.M., the Clinic Manager said PCT #3 had left for the day and he should have disinfected the area behind the prime waste basket on the left side of the dialysis machine, the entire right side of the machine including the sharps container, the lower half of the back of the machine, and the clipboard and counter behind the dialysis machine and chair, as required. 37700”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 37700 Based on observation, policy review, and interview, the facility failed to ensure 1 of 2 staff (Patient Care Technician [PCT] #3) observed, provided adequate infection control measures regarding an arterio-venous fistula (AVF) cannulation and failed to ensure 1.) the AVF access site was washed with antibacterial soap and water or skin antiseptic wipe prior to cannulation and 2.) the access site was not touched after disinfection and prior to needle insertion for 1 of 2 patients (#10), out of a total sample of 13 patients. Findings include: Review of the facility policy entitled, AVF-AVG Cannulation, Treatment Initiation and Termination, revised 11/15/23, included the following: *The access site will be washed with antibacterial soap and water or skin antiseptic wipe prior to preparing the site for cannulation. *Care givers will perform hand hygiene and don clean gloves before touching the patient’s access. *The patient caregiver will perform hand hygiene and don clean gloves, full face protection and a fluid-resistant gown. *A clean underpad is placed under the access extremity. The first needle insertion is identified and the area is cleaned using Aseptic Non-Touch Technique (ANTT) with an approved antiseptic product per manufacturer’s guidelines. The second needle insertion site is prepared as described. * Each needle insertion site is then disinfected according to the manufacturer’s instructions with one of the following products: 2% Chlorhexidine with alcohol =/> 70% Alcohol =/> 10% Povidone-iodine *If the access is touched after being disinfected, it must be disinfected again before needle insertion. For Patient #10, PCT #3 failed to ensure the AVF access site was washed with antibacterial soap and water or skin antiseptic wipe prior to cannulation and that the access site was not touched after disinfection and prior to needle insertion. On 1/23/24 at 10:45 A.M., during an observation of the treatment area, the surveyor observed PCT #3 in station 19 initiate treatment for Patient #10, who receives dialysis treatment via an AVF. The surveyor did not observe that the access site was washed prior to preparing the site for cannulation. PCT #3 visually assessed the AVF, applied the tourniquet to the left upper arm, and then disinfected the sites using 4 alcohol pads for a total of 20 seconds. He then palpated the sites with his gloved finger and inserted the needles into each site, contaminating each access site. PCT #3 failed to disinfect the access sites after he contaminated both access sites. During an interview on 1/23/24 at 2:00 P.M., the Clinic Manager said PCT #3 had left for the day and he did not ensure Patient #10 had washed the access site at the facility prior to cannulation, as required. She further said PCT #3 should not have palpated the access site once he disinfected the site, as required.”

“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: 31240 Based on record review and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed relative to Blood Flow Rate (BFR-measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer during the process of dialysis, for 4 of 7 applicable patients (#2, #4, #7, #3), out of a total sample of 13 patients. Findings include: 1. For Patient #2, facility staff failed to ensure the dialysis prescription was delivered as prescribed relative to BFR. Patient #2 was admitted to the facility in December 2023 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Review of the Physician’s order, dated 12/12/23, indicated the BFR was to be delivered at a rate of 400. Review of 9 hemodialysis flowsheets, dated 12/12/23 through 1/18/24, indicated the BFR was not delivered as prescribed on 4 of 9 hemodialysis flowsheets as follows: *12/12/23-The BFR was delivered at the rate of 450, not 400 as ordered and there was no documentation to indicate why the physician’s order was not followed. *12/23/23-The BFR was delivered at the rate of 450, not 400 as ordered and there was no documentation to indicate why the physician’s order was not followed. *12/26/23-The BFR was delivered at the rate of 450 from 8:34 A.M. through 9:49 A.M., not 400 as ordered and there was no documentation to indicate why the physician’s order was not followed. *1/9/24-The BFR was delivered at the rate of 350-450, not 400 as ordered. The flowsheet had no documentation to indicate why the physician’s order was not followed. During an interview on 1/24/24 at 2:35 P.M., the Clinical Manager said that if the BFR is set at a different rate than the physician’s order, staff must document the reason on the hemodialysis flowsheet. She said, after reviewing the 4 hemodialysis flowsheets, the BFR was not delivered as ordered, and there was no documentation to indicate why it was not. 44223 2. For Patient #4, the facility failed to ensure that the dialysis prescription was delivered as prescribed relative to BFR. Patient #4 was admitted to the facility in March 2023 with a diagnosis of ESRD, requiring dialysis. Review of the physician orders, dated 1/2/24, indicated the BFR was to be delivered at a rate of 450. Review of 9 treatment records, dated 1/2/24 through 1/20/24, indicated the BFR was not delivered as prescribed for 4 of 9 treatments including the following: *1/2/24- the BFR was delivered at a rate of 375-425, not the 450 as prescribed, with no documented reason as to why. *1/9/24- the BFR was delivered at a rate of 350-500, not the 450 as prescribed, with no documented reason as to why. *1/13/24- the BFR was delivered at a rate of 300-400, not the 450 as prescribed, with no documented reason as to why. *1/20/24- the BFR was delivered at a rate of 300-385, not the 450 as prescribed, with no documented reason as to why. During an interview on 1/24/24 at 2:20 P.M., the Clinical Manager said there should be documentation on the treatment record as to why the BFR did not run at the prescribed rate. 10249 3. For Patient #7, the facility failed to ensure that the dialysis prescription was delivered as prescribed relative to BFR. Patient #7 was admitted to the facility in November 2020 with a diagnosis of ESRD, requiring dialysis. Review of the physician orders, dated 1/11/24, indicated the BFR was to be delivered at a rate of 450. Review of 9 treatment records, dated 12/22/23 through 1/22/24, indicated the BFR was not delivered as prescribed for 2 of 9 treatments including the following: *1/12/24-the BFR was delivered at a rate of 400, not the 450 as prescribed, with no documented reason as to why the order was not followed. *1/22/24-the BFR was delivered at a rate of 400, not the 450 as prescribed, with no documented reason as to why the order was not followed. During an interview on 1/24/24 at 2:15 P.M., the Clinic Manager said the expectation is staff should document on the flowsheets if there is a reason to change the blood flow rate during treatment. She also said that if a pattern develops, the physician should be contacted. 37700 4. For Patient #3, the facility failed to ensure the dialysis prescription was delivered as prescribed relative to BFR. Patient #3 was admitted to the facility in June 2023 with a diagnosis of ESRD, requiring dialysis. Review of the physician orders, dated 1/4/24, indicated the BFR was to be delivered at a rate of 450. Review of 9 treatment records, dated 1/4/24 through 1/23/24, indicated the BFR was not delivered as prescribed for 5 of 9 treatments, including the following: *1/6/24-the BFR was delivered at a rate of 400, not the prescribed 450, with no documentation as to why the order was not followed. *1/9/24-the BFR was delivered at a rate of 500, not the prescribed 450, with no documentation as to why the order was not followed. *1/11/24-the BFR was delivered at a rate of 400, not the prescribed 450, with no documentation as to why the order was not followed. *1/13/24-the BFR was delivered at a rate of 400, not the prescribed 450, with no documentation as to why the order was not followed. *1/20/24-the BFR was delivered at a rate of 400, not the prescribed 450, with no documentation as to why the order was not followed. During an interview on 1/24/24 at 10:35 A.M., the Clinical Manager, after reviewing the 5 treatment sheets, said that she could not find any documentation why the BFR was not delivered as prescribed during the identified treatments.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 1.) 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1 and Patient Care Technician [PCT] #3) observed evaluated a vascular access to ensure functionality by listening for the bruit the length of the access (swooshing sound heard with the stethoscope placed over the access) for 2 of 2 patients (#8, #10) with arteriovenous fistula/graft (AVF/G) access sites, out of a total sample of 13 patients; and 2.) a pressure clamp was monitored and removed within 20 minutes per the facility policy to prevent access failure and/or stenosis for patient (#9), out of a total sample of 13 patients. Review of the facility policy titled, “AVF-AVG Cannulation, Treatment, Initiation, and Termination”, last revised 11/15/23, indicated the following: * The access is palpated for thrill and auscultated for bruit. Access is assessed for signs of infection, open sores, edema, and any potential problems for needle cannulation. Once the assessment is complete and patency is confirmed, cannulation sites are identified. * The thrill and bruit must be present to verify patency of the access. * If a fistula clamp is used, it must be closely monitored while in use to verify that the access site does not bleed and that a thrill or bruit is present on both ends of the access. The clamp should be checked every 10 minutes to verify access patency and determine if bleeding has stopped. The clamp should not be left on the access for more than 20 minutes total. 1. The facility failed to ensure 2 of 2 staff members observed (CCHT #1, PCT #3) evaluated the AVF access to ensure functionality by way of listening for a bruit the length of the access prior to initiation of dialysis treatment. A. For Patient #8, CCHT #1 failed to evaluate the vascular access site to ensure functionality by way of auscultation (listening) for a bruit prior to initiation of dialysis treatment. On 1/23/24 at 11:10 A.M., the surveyor observed CCHT #1 as he was preparing Patient #8 for his/her dialysis treatment via AVF. CCHT #1 palpated the arteriovenous access with his fingertips for the presence of a thrill (pulsation felt with fingertips as blood is forced through the vasculature), he applied a tourniquet, and then proceeded to disinfect the sites. He inserted the needle into the lower access, and then the upper access. CCHT #1 did not auscultate the site to assess for the presence of a bruit. During an interview on 1/23/24 at 11:20 A.M., CCHT #1 said that he should have listened for a bruit with the stethoscope, but he didn’t because he knows Patient #8’s arm well enough. 37700 B. For Patient #10, PCT #3 failed to evaluate the vascular access site to ensure functionality by way of auscultation (listening) for a bruit prior to initiation of dialysis treatment. On 1/23/24 at 10:45 A.M., the surveyor observed PCT #3 as he was preparing Patient #10 for his/her dialysis treatment via AVF. PCT #3 disinfected the sites, applied a tourniquet and palpated the arteriovenous access with his fingertips for the presence of a thrill, then inserted the needle to the lower access. He palpated the upper access with his fingertips, and inserted a needle. PCT #3 did not auscultate the site to assess for the presence of a bruit. During an interview on 1/23/24 at 2:00 P.M., the Clinic Manager said PCT #3 had left for the day and he should have auscultated for the presence of a bruit prior to accessing the AVF, as required. 2. For Patient #9, the facility failed to ensure a pressure clamp was monitored every 10 minutes, and removed within 20 minutes, per the facility policy to prevent access failure and/or stenosis of AVG. On 1/23/24 at 9:50 A.M., the surveyor observed PCT #3 as he discontinued a dialysis treatment via AVG for Patient #9. PCT #3 removed the needle, applied a gauze dressing and clamp to the site at 9:52 A.M. PCT #3 exited the station and went into the next station to provide patient care. PCT #3 did not have complete view of Patient #9 due to the location of the next station. He returned to the Patient #9 at 10:13 A.M., 21 minutes after the clamp was first applied, and removed the clamp. The clamped AVG site was not checked every 10 minutes to verify access patency and determine if bleeding had stopped. The clamp was left on for more than 20 minutes total. During an interview on 1/23/24 at 2:00 P.M., the Clinic Manager said PCT #3 had left for the day. She said PCT #3 should have checked the clamp every 10 minutes and not left it on for more than 20 minutes, as required.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 10249 Based on record review, interview, and policy review, the facility failed to ensure 1.) the care plan was signed by the patient or the patient’s designee, or if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided, to ensure the patient had involvement with his/her plan of care for 2 of 7 applicable patients (#1, #3); and 2.) the physician signed the care plan, as part of the interdisciplinary team, for 2 of 7 applicable patients (#1, #2), from a total of 13 patients. Findings Include: Review of the facility policy entitled, Treatment Plans, last revision date 5/2022, indicated the following, but not limited to: *The treatment plan is developed by the centers interdisciplinary team (IDT) which included, but not limited to the: Physician, Registered Nurse with knowledge of the patient, Dietitian, Social Worker, Patient and/or patient representative if desired by the patient. *The patient will be an integral part of the planning process and will be part of the interdisciplinary meeting whenever possible. If the patient is not able or chooses not to attend the meeting, the treatment plan will be discussed with him/her by a member of the healthcare team and the patient’s signature obtained on the treatment plan. *The IDT must make efforts to involve the patient and/or patient representative in the treatment plan process. The team must document efforts to include the patient in the process and the patient’s response to those efforts in the patient’s electronic medical record. *If the patient chooses not to sign the treatment plan, this choice must be documented on the treatment plan along with the reason the signature was not provided. 1. For Patient #1, the facility failed to ensure the patient’s involvement in his/her plan of care occurred by signing the plan of care or if the patient chose not to sign, there was no documentation as to why he/she did not provide a signature. The facility also failed to ensure that the physician signed the care plan, as required. Patient #1 was admitted to the facility in October 2021 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis. Review of the clinical record indicated an annual care plan was initiated on 5/4/23, and the care plan meeting was held on 5/18/23. Review of the IDT signature section of the care plan, dated 5/18/23, included the electronic signatures of the nurse, dietitian and social worker. There was no signature from the physician or Patient #1. There was no documented evidence as to why Patient #1 did not provide a signature. During an interview on 1/24/24 at 2:15 P.M., the Clinic Manager said she could not find the signature page for Patient #1 and was unable to find documentation as to why there was no patient signature. The Clinic Manager also said the physician wrote a progress note on 5/24/23, however did not signed the Patient’s plan of care as required. 31240 2. For Patient #2, who was admitted to the facility in December 2023 with ESRD requiring hemodialysis, the facility failed to ensure the physician signed the care plan. Review of the clinical record indicated an admission care plan was initiated on 12/12/23, and the care plan meeting was held on 12/21/23. Review of the interdisciplinary team signature section of the care plan, included the nurse, dietitian and social worker signatures. The signature section did not include the nephrologist’s (kidney physician) signature. During an interview on 1/24/24 at 12:40 P.M., the Clinic Manager said the physician had completed Patient #2’s assessment, but had not signed the care plan, as required. 37700 3. For Patient #3, the facility failed to ensure the patient involvement in his/her plan of care occurred by signing the plan of care or if the patient chose not to sign, there was no documentation as to why he/she did not provide a signature. Patient #3 was admitted to the facility in June 2023 with a diagnosis of ESRD, requiring hemodialysis. Review of the clinical record indicated the plan of care, dated 10/9/23, included a signature section which included the electronic signatures of the IDT. The signature section did not include Patient #3’s signature and there was no documented evidence that the patient refused to sign, or that the plan of care was reviewed with the patient. During an interview on 1/24/24 at 11:58 A.M., the Clinic Manager said she could not locate any signed documentation that indicated the plan of care had been reviewed with Patient #3.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 10249 Based on staff interviews, review of the 2024 Quarterly Dialysis Facility Report (QDFR), and Facility Quality Assessment and Performance (QAPI)/Total Quality Management (TQM committee meeting minutes, the facility failed to revise an action plans for in-center hemodialysis patients (ICHD) when the anemia tracking showed an increase in patients with a hemoglobin (Hgb) less than 10 g/dl. Findings include: Review of the facility policy entitled, Quality Assessment and Performance Improvement (QAPI), dated 1/2021, included the following, but not limited to: *The QAPI program must: *Continually look at indicators for patients and associates as they are available. *Trend outcomes. *Identify any commonalities among patients who do not reach minimum expected targets. *Develop an improvement plan when indicated by the data. *Implement an action plan. *Monitor the effectiveness of the plan. *Adjust portions of the plan to achieve success. *At a minimum, the QAPI program must include: *Anemia Management *When protocols are used to address problems such as anemia and mineral metabolism, the efficacy of the protocol must be evaluated if the center QAPI goals in that area are not achieved over consecutive evaluation periods. Review of the 2024 QDFR, prior to survey, indicated the facility had a higher than average percentage of hemodialysis patients (36.3%) with a serum hemoglobin (Hgb) less than 10 g/dl. The National Average was 23.4%. The QDFR indicated the serum hemoglobin data showed a steady increase from 2021-2023 (trending upwards) from 32.6 to 36.3%. Review of the facility TQM data for ICHD patients for Anemia Management indicated: *7/2023-27.03% of ICHD patients had a Hgb level less than 10. *8/2023-27.63% of ICHD patients had a Hgb level less than 10. *9/2023-28.95% of ICHD patients had a Hgb level less than 10. *10/2023-33.33% of ICHD patients had a Hgb level less than 10. *11/2023-37.66% of ICHD patients had a Hgb level less than 10. *12/2023-43.42% of ICHD patients had a Hgb level less than 10. Review of the TQM meeting minutes indicated in May 2023 an action plan was developed and implemented. The plan specified the charge nurse was to review hemoglobin levels weekly for all patients. Notify MD if anemia protocol is not showing positive outcome. Dose off protocol with MD order when necessary (obtaining a new physician’s order vs following the anemia protocol). Further review of the TQM indicated that as of December 2023 there was no change in the action plan for anemia, despite the increasing trend of patients having a hemoglobin of less than 10 g/dl. During an interview on 1/24/24 at 1:30 P.M., the Clinic Manager said they had developed an action plan several months back, but said due to the increase in patients having a Hgb less than 10, the action plan should have been revised. During an interview on 1/24/24 at 2:00 P.M., the Medical Director said he noted the increased number of patients with low hemoglobin was trending up, but would have to investigate further to drill down the issue.”

“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: 10249 Based on review of the facility Quality Assessment and Performance Improvement (QAPI)/Total Quality Management (TQM) committee meeting minutes, Infection Control Audits, and staff interviews, the facility failed to ensure monthly Infection Control Audits were completed to ensure they could be consistently measured, analyzed, and a plan developed based on the results of monthly infection control audits. Findings include: Review of the facility policy entitled, Quality Assessment and Performance Improvement (QAPI), dated 1/2021, included the following, but not limited to: *The QAPI program must: *Continually look at indicators for patients and associates as they are available. *Trend outcomes. *Identify any commonalities among patients who do not reach minimum expected targets. *Develop an improvement plan when indicated by the data. *Implement an action plan. *Monitor the effectiveness of the plan. *Adjust portions of the plan to achieve success. *At a minimum, the QAPI program must include: *Infection control. Review of the Monthly Infection Control Audits from June 2023 through December 2023 indicated audits were not completed for 6 of 7 months (June, July, August, September, October, November 2023), therefore not able to track, trend or analyze by the TQM/QAPI committee. During the survey, the surveyors observed several infection control breaches including: *Staff failed to perform hand hygiene. *Staff failed to don appropriate personal protective equipment (gloves). *Staff failed to practice adequate infection control practices during initiation and termination of an arteriovenous (AV) Fistula/graft. *Staff failed to properly clean and disinfect the hemodialysis station after patient use. *Staff failed to follow infection control practices while caring for a patient who tested positive for COVID, including to ensure the door to the isolation room was closed during treatment and properly storing PPE used during treatment. During an interview on 1/24/24 at 1:00 P.M., during the TQM/QAPI review, the Clinic Manager said the prior Clinic Manager was responsible for the infection control audits, however it was not discovered that they were not completed until after he/she left the position in November 2023. The Clinic Manager said she started doing infection control audits in December 2023. During an interview on 1/24/24 at 2:00 P.M., after sharing surveyor infection control observations, the Medical Director said there has been a high turnover in staff, and the prior Clinic Manager was not doing infection control audits, although it was his/her responsibility.”

“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: 10249 Based on observation, interview, record review, and policy review, the Medical Director failed to ensure that 1.) 1 of 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #3) observed, administering heparin (a blood thinner used to minimize blood loss due to clotting of the dialysis system during treatment) and adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment; and 2.) staff administered a heparin intravenous (IV) infusion as ordered by the physician for 2 of 2 applicable patients (#1 and #3) reviewed, from a total sample of 13; and 3.) staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment for 4 of 6 applicable patient records reviewed (#7, #3, #2, #4), out of a total sample of 13 patients. Findings include: Review of the facility policy entitled, CVC: Initiation and Discontinuation of Treatment, last revision date 9/1/2023, indicated the following, but not limited to: *After the patency of both lumens is verified, administer the patient’s heparin bolus as prescribed via the lumen. Allow the heparin to circulate systemically for 3-5 minutes before initiating the hemodialysis treatment. 1. For Patient #12, the Medical Director failed to ensure CCHT #3 adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated that Patient #12 had a physician’s order to administer heparin bolus 3000 units, every dialysis treatment. On 1/23/24 at 10:45 A.M., the surveyor observed CCHT #3 initiate treatment to Patient #12 through a central venous catheter (CVC). CCHT #3 was observed administering the heparin bolus at 11:04 A.M., then initiated treatment at 11:06 A.M., and did not wait the 3-5 minutes per facility policy. During an interview on 1/23/24 at 11:15 A.M., CCHT #3 said she thought she waited 3 minutes before initiating the dialysis treatment. She said she the policy says to wait 3-5 minutes. During an interview on 1/23/24 at 2:00 P.M., the Clinic Manager said staff should wait 3 minutes before starting treatment. Refer to V726 2. For 2 of 2 applicable patients (#1 and #3) reviewed, the Medical Director failed to ensure that staff administer a heparin intravenous (IV) infusion as ordered. A. For Patient #1, the Medical Director failed to ensure that staff followed the heparin IV infusion order during dialysis treatments. Review of a Physician’s order, dated 12/27/23, indicated to administer heparin 1000 units for two hours, for a total of 2000 units per treatment. Review of 9 treatment sheets, dated 12/27/23 through 1/19/24, indicated for 7 of 9 treatments the heparin IV infusion was not administered as ordered, including the following: *Review of a treatment sheet, dated 12/27/23, indicated the patient’s dialysis treatment began at 4:44 P.M. and ended at 8:03 P.M. The staff documented that Patient #1 received a total of 300 units of IV heparin, not the 2000 units of heparin as prescribed. *Review of a treatment sheet, dated 12/31/23, indicated the patient’s dialysis treatment began at 1:28 P.M. and ended at 4:40 P.M. The staff documented that Patient #1 received a total of 2500 units of IV heparin, not the 2000 units of heparin as prescribed. *Review of a treatment sheet, dated 1/3/24, indicated the patient’s dialysis treatment began at 4:09 P.M. and ended at 8:06 P.M. The staff documented that Patient #1 received a total of 2900 units of IV heparin, not the 2000 units of heparin as prescribed. *Review of a treatment sheet, dated 1/5/24, indicated the patient’s dialysis treatment began at 4:03 P.M. and ended at 6:43 P.M. The staff documented that Patient #1 received a total of 2600 units of IV heparin, not the 2000 units of heparin as prescribed. *Review of a treatment sheet, dated 1/8/24, indicated the patient’s dialysis treatment began at 4:51 P.M. and ended at 8:25 P.M. The staff documented that Patient #1 received a total of 3000 units of IV heparin, not the 2000 units of heparin as prescribed. *Review of a treatment sheet, dated 1/15/24, indicated the patient’s dialysis treatment began at 4:16 P.M. and ended at 8:15 P.M. The staff documented that Patient #1 received a total of 3000 units of IV heparin, not the 2000 units of heparin as prescribed. *Review of a treatment sheet, dated 1/19/24, indicated the patient’s dialysis treatment began at 4:46 P.M. and ended at 8:22 P.M. The staff documented that Patient #1 received a total of 3000 units of IV heparin, not the 2000 units of heparin as prescribed. During an interview on 1/24/24 at 2:15 P.M., the Clinic Manager said after reviewing the treatment sheets she could not find any documentation as to why the patient may have received the wrong dose of IV heparin during the seven treatments identified. B. For Patient #3, the Medical Director failed to ensure that staff followed the heparin IV infusion order during dialysis treatments. Review of a Physician’s order, dated 1/4/24, indicated to administer heparin 1000 units per hour for a total of 4000 units per treatment. Review of 9 treatment sheets dated 1/4/24 through 1/23/24 indicated that for 7 of 9 treatments, the heparin IV infusion was not administered as ordered, including the following: *Review of a treatment sheet dated 1/4/24, indicated the patient’s dialysis treatment began at 11:04 A.M. and ended at 3:44 P.M. The staff documented that Patient #3 received a total of 3000 units of IV heparin, not the 4000 units of heparin as prescribed. *Review of a treatment sheet dated 1/6/24, indicated the patient’s dialysis treatment began at 10:54 A.M. and ended at 3:42 P.M. The staff documented that Patient #3 received a total of 3700 units of IV heparin, not the 4000 units of heparin as prescribed. *Review of a treatment sheet dated 1/9/24, indicated the patient’s dialysis treatment began at 10:48 A.M. and ended at 3:33 P.M. The staff documented that Patient #3 received a total of 3800 units of IV heparin, not the 4000 units of heparin as prescribed. *Review of a treatment sheet dated 1/11/24, indicated the patient’s dialysis treatment began at 11:07 A.M. and ended at 3:45 P.M. The staff documented that Patient #3 received a total of 3300 units of IV heparin, not the 4000 units of heparin as prescribed. *Review of a treatment sheet dated 1/13/24, indicated the patient’s dialysis treatment began at 11:03 A.M. and ended at 3:49 P.M. The staff documented that Patient #3 received a total of 3700 units of IV heparin, not the 4000 units of heparin as prescribed. *Review of a treatment sheet dated 1/16/24, indicated the patient’s dialysis treatment began at 11:01 A.M. and ended at 3:48 P.M. The staff documented that Patient #3 received a total of 4300 units of IV heparin, not the 4000 units of heparin as prescribed. *Review of a treatment sheet dated 1/18/24, indicated the patient’s dialysis treatment began at 10:36 A.M. and ended at 3:26 P.M. The staff documented that Patient #3 received a total of 3700 units of IV heparin, not the 4000 units of heparin as prescribed. During an interview on 1/24/24 at 1:20 P.M., the Clinical Manager said, after reviewing the 7 treatments sheets, that she could not find any documentation why Patient #3 received the incorrect dose of IV heparin during the identified treatments. 3. The Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment for 4 of 6 applicable patient records reviewed (#7, #3, #2, #4). A. For Patient #7, admitted to the facility in November 2020 with a diagnosis of End Stage Renal Disease (ESRD) requiring hemodialysis, the Medical Director Failed to ensure that staff waited 3-5 minutes after administration of a heparin bolus to initiate treatment. Review of a Physician’s order, dated 12/14/23, indicated heparin bolus 3000 units every dialysis treatment, three times a week. Review of 9 hemodialysis flowsheets, dated 12/22/23 through 1/22/24, indicated for 2 of 9 treatments staff failed to wait 3-5 minutes after the administration of heparin to initiate treatment, including the following: *12/29/23, treatment began at 11:16 A.M., and a bolus dose of heparin, 3000 units, was documented as administered at 11:28 A.M. (not 3 to 5 minutes prior to the initiation of treatment). *1/15/24, treatment began at 10:57 A.M., and a bolus dose of heparin, 3000 units, was documented as administered at 11:00 A.M. (not 3 to 5 minutes prior to the initiation of treatment). During an interview on 1/24/24 at 2:15 P.M., the Clinic Manager said the expectation is staff should administered the bolus heparin 3-5 minutes prior dialysis being initiated. 37700 B. For Patient #3, admitted to the facility in June 2023 with a diagnosis of ESRD requiring hemodialysis, the Medical Director failed to ensure that staff waited 3-5 minutes after administration of a heparin bolus to initiate treatment. Review of a Physician’s order, dated 1/4/24, indicated heparin bolus 3000 units every dialysis treatment, three times a week. Review of 9 Hemodialysis Flowsheets, dated 1/4/24 through 1/23/24, indicated for 2 of 9 treatments staff failed to wait 3-5 minutes after the administration of heparin to initiate treatment, including the following: *1/11/24, treatment began at 11:07 A.M., and a bolus dose of heparin, 3000 units, was documented as administered at 11:25 A.M. (not 3 to 5 minutes prior to the initiation of treatment). *1/18/24, treatment began at 10:36 A.M., and a bolus dose of heparin, 3000 units, was documented as administered at 11:02 A.M. (not 3 to 5 minutes prior to the initiation of treatment). During an interview on 1/24/24 at 10:35 A.M., the Clinic Manager said the expectation is staff should administer the bolus heparin 3-5 minutes prior dialysis being initiated. She further said the heparin boluses administered on 1/11/24 and 1/18/24 were not within the required 3-5 minutes before initiation of the dialysis treatment. 31240 C. For Patient #2, admitted to the facility in December 2023 with a diagnosis of ESRD requiring hemodialysis, the Medical Director failed to ensure that staff waited 3-5 minutes after the administration of a heparin bolus to initiate treatment. Review of a Physician’s order, dated 12/12/23, indicated heparin bolus 2000 units every dialysis treatment, three times a week. Review of 9 hemodialysis flowsheets, dated 12/12/23 through 1/18/24, indicated for 4 of 9 treatments staff failed to wait 3-5 minutes after the administration of heparin to initiate treatment, including the following: *12/12/23, treatment began at 6:01 A.M., and a bolus dose of heparin, 2000 units, was documented as administered at 6:15 A.M. (not 3 to 5 minutes prior to the initiation of treatment). *12/21/23, treatment began at 5:55 A.M., and a bolus dose of heparin, 2000 units, was documented as administered at 6:56 A.M. (not 3 to 5 minutes prior to the initiation of treatment). *12/30/23, treatment began at 5:48 A.M., and a bolus dose of heparin, 2000 units, was documented as administered at 9:21 A.M. (not 3 to 5 minutes prior to the initiation of treatment). *1/18/24, treatment began at 5:58 A.M., and a bolus dose of heparin, 2000 units, was documented as administered at 7:36 A.M. (not 3 to 5 minutes prior to the initiation of treatment). During an interview on 1/24/24 at 11:25 A.M., the Clinic Regulatory Manager said a heparin bolus should be administered 3 to 5 minutes prior to initiating the dialysis treatment, regardless of the patient’s access site. During an interview on 1/24/24 at 2:35 P.M., after reviewing the 4 Flowsheets for Patient #2, the Clinic Manager said the heparin bolus were documented as being administered after treatment were initiated, but staff should have administered it 3 to 5 minutes prior dialysis being initiated. 44223 D. For Patient #4, the Medical Director failed to ensure that staff adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate dialysis treatment. Review of the clinical record indicated that Patient #4 had a physician’s order to administer a heparin bolus of 2000 units IV every dialysis treatment. Review of 9 treatments, dated 1/2/24-1/20/24, indicated for 2 of 9 treatments staff failed to wait 3-5 minutes after the administration of heparin to initiate treatment, including the following: *1/11/24- Treatment began at 5:30 A.M., a bolus dose of heparin 2000 units was documented as given at 1:04 P.M., 7 hours after the dialysis treatment started, not 3-5 minutes prior to the start of treatment per facility policy. *1/13/24- Treatment began at 5:48 A.M., a bolus dose of heparin 2000 units was documented as given at 5:47 A.M., 1 minute before the treatment started, not the 3-5 minutes prior to the start of treatment per facility policy. During an interview on 1/24/24 at 2:20 P.M., the Clinical Manager said that heparin should be given 3-5 minutes prior to the initiation of dialysis treatment.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 10249 Based on observation, record review, and interview, the facility failed to maintain complete and accurate medical records for 1 of 1 applicable patients (#12), from a total sample of 13, in regards to intravenous (IV) heparin administration documentation. Findings include: Patient #12 was admitted to the facility in October 2021 with diagnoses which included end stage renal disease, requiring hemodialysis. Review of a Physician’s order, dated 1/16/2024, indicated that Patient #12 was to receive 3,000 units of Heparin as an intravenous loading dose (just prior to the start of hemodialysis). On 1/23/24 at 10:45 A.M., the surveyor observed CCHT #3 initiate treatment to Patient #12, who had a central venous catheter (CVC). CCHT #3 was observed administering the heparin bolus at 11:04 A.M., then initiated treatment at 11:06 A.M. Review of Patient #12’s dialysis flowsheet, dated 1/23/24, indicated that Patient #12 received the IV heparin 3000 unit loading dose at 11:00 A.M., despite the surveyors observations on 1/23/24 at 11:04 A.M., that revealed that CCHT #3 incorrectly documented the administration of the heparin bolus. This was electronically signed as given by CCHT #3.”