Davita Annandale Dialysis

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility failed to conduct emergency preparedness training for fifteen (15) of fifteen (15) staff members who work at the facility. The findings include: On September 3, 2024, Staff Member #1 advised the surveyors that the facility administrator (FA) left on long-term leave started Friday August 30, 2024. Due to the FA leaving, it may be difficult to find required items in staff member personnel files. On September 4, 2024, Staff Member #7 provided the surveyors with the Personnel File Worksheet for all staff members who work at the facility. The worksheet was empty for all staff members in the area of emergency procedures and infection control training. The facility policy titled “TEAMMATE QUALIFICATIONS, LICENSURE AND ADEQUATE TEAMMATE STAFFING” states in part: “The dialysis facility’s teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to service collectively the comprehensive needs of the patient.””

“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: 40084 Based on interview and document review, it was determined the facility failed to participate in full scale exercise every 2 years or conduct a facility-based functional exercise every 2 years for the past 3 years. The findings include: On September 4, 2024, the surveyors reviewed the facility’s emergency preparedness program binder containing policies, procedures and all related documentation. The binder contained documentation of staff training on June 13, 2024 that included in-service on mock codes for active shooter, shelter in place, fire drill, machine disinfection and infection control. The documentation also included a tabletop exercise that occured in this facility on May 9, 2023. The binder included information for a full scale exersice that was scheduled for February 3, 2022 but no further documentation of participation was provided. Staff Member #1 advised the surveyors that the facility administrator (FA) left on long-term leave that started Friday August 30, 2024. Due to the FA leaving, it is challenging to find specific documentation for the above noted events and it’s possible other testing exercises occured but they can’t locate the documenatation.”

“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: 40084 Based on four (4) infection control observations, interview and document review, it was determined the facility staff failed to conduct hand hygiene to prevent the spread of infectious diseases. The findings include: On September 3, 2024 at 3:02 p.m., the surveyor conducted an observation of Staff Member #9 discontinuing dialysis for a patient with an AV fistula/graft at dialysis station #6. Staff Member #9 used the same gloves, and did not conduct hand hygiene, during the preparation and reinfusion phase as well as disconnection of blood lines, removal of the first dialysis needle and placement of a clamp. Staff Member #9 removed gloves and then conducted hand hygiene. Staff Member #9 donned new gloves and performed a similar process for the second dialysis needle. Staff member #9 typed on the computer, removed the second needle, and placed a second clamp. Staff Member #9 removed gloves but did not conduct hand hygiene and then donned a single glove to remove the patient’s blood pressure cuff. On September 3, 2024 at 3:22 p.m., the surveyor conducted an observation of Staff Member #9 discontinuing dialysis for a patient with an AV fistula/graft at dialysis station #7. Staff Member #9 conducted a similar process regarding glove use and hand hygiene, except on this occasion, the staff member did not change gloves or conduct hand hygiene for the entire process of preparation and reinfusion and removing both needles. On September 3, 2024 at 3:27 p.m., the surveyor conducted an observation of Staff Member #8 discontinuing dialysis for a patient with an AV fistula/graft at dialysis station #13. Staff Member #8 used the same gloves, and did not conduct hand hygiene, during the preparation and reinfusion phase as well as disconnection of blood lines, removal of the first dialysis needle and instructed patient to hold pressure on their access site. Staff Member #8 removed gloves and then conducted hand hygiene. Staff Member #8 donned new gloves and performed a similar process for the second dialysis needle. On September 4, 2024 at 12:39 p.m., the surveyor conducted an observation of Staff Member #19 initiating dialysis for a patient with an AV fistula/graft at dialysis station #2. Staff Member #19 disinfected access site with alcohol wipe, palpated fistula and inserted first cannulation needle and secured it in place. Without disinfecting the access site again inserted the second cannulation needle. On September 4, 2024 during the exit conference, Staff Member #6 advised that a glove change should be conducted prior to disconnecting the patient from the dialysis machine. The facility policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” states in part: “Hand Hygiene 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene... b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material,... g. before touching clean areas such as supplies, supply care and chairside keyboard/mouse...””

“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: 40084 Based on four (4) infection control observations, interview and document review, it was determined the facility staff failed to disinfect items (thermometer) taken into the patient station and then returned to a common clean area. The finding include: On September 3, 2024 at 3:19 p.m. while conducting an observation of Staff Member #9 discontinuing dialysis for a patient at dialysis station #6, the surveyor observed Staff Member #9 obtain a thermometer from a nearby computer cart, use the thermometer on the patient at station #6, and then without cleaning the item, place it on a computer cart at the next station over. On September 3, 2024 at 3:25 p.m. while conducting an observation of Staff Member #9 discontinuing dialysis for a patient at dialysis station #8, the surveyor observed Staff Member #9 obtain a thermometer from a nearby computer cart, use the thermometer on the patient at station #6, and then without cleaning the item, return it to the same computer cart. On September 4, 2024 at 11:09 a.m. while conducting an observation of Staff Member #19 initiating dialysis for a patient at dialysis station #4, the surveyor observed Staff Member #19 obtain a thermometer from a computer cart in station #5, use the thermometer on the patient at station #4, and then without cleaning the item, return it to the same computer cart. On September 4, 2024 at 12:39 a.m. while conducting an observation of Staff Member #19 initiating dialysis for a patient at dialysis station #2, the surveyor observed Staff Member #19 obtain a thermometer from a nearby computer cart, use the thermometer on the patient at station #3, and then without cleaning the item, return it to the same computer cart. On September 4, 2024 during the exit conference, Staff Member #6 advised the thermometer should be cleaned prior to be placed back on the computer cart. The facility policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” states in part: “Non-disposable items are to be disinfected after each patient use, prior removal from treatment/station...””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 40084 Based on three (3) infection control observations and facility document review, it was determined the facility staff failed to clean and disinfect contaminated surfaces to prevent the risk of transmission of infectious diseases. Findings: The facility’s policy titled “Infection Control for Dialysis Facilities” revised April 2023, states in part: “...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient.... “ On September 3, 2024, at 3:01 p.m. Staff Member #10 placed the “dirty” blood pressure cuff on the “dirty” dialysis chair and wiped one side of the cuff with the bleach wipe, then flipped the blood pressure cuff over and placed the side that was disinfected on the “dirty” chair so the staff member could wipe the other side of the cuff. On September 4, 2024, at 10:58 a.m. Staff Member #19 placed the “dirty” blood pressure cuff on the “dirty” dialysis chair and wiped one side of the cuff with the bleach wipe, then flipped the blood pressure cuff over and placed the side that was disinfected on the “dirty” chair so the staff member could wipe the other side of the cuff. Staff Member #19 failed to fold the treatment chair’s side tables down and disinfect the side of the chair where table touches the side. On September 4, 2024, at 11:07 a.m. Staff Member #19 placed the “dirty” blood pressure cuff on the “dirty” dialysis chair and wiped one side of the cuff with the bleach wipe, then flipped the blood pressure cuff over and placed the side that was disinfected on the “dirty” chair so the staff member could wipe the other side of the cuff.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility failed to vaccinate for Hepatitis B or obtain a declination for twelve (11) out of fifteen (15) staff members who work at the facility. The findings include: On September 3, 2024, Staff Member #1 advised the surveyors that the facility administrator (FA) left on long-term leave started Friday August 30, 2024. Due to the FA leaving, it may be difficult to find required items in staff member personnel files. On September 4, 2024, the surveyor reviewed the personnel files for staff members #8, 9, 10. During that review, Hepatitis B vaccination or a declination could not be found for Staff Members #8, and 9. Additionally, later that day, when presented the Personnel File Worksheet by Staff Member #7 for all staff members who work at the facility, the form indicted that Hepatitis B vaccination or declination documentation could not be found for Staff Members #8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility failed to conduct infection control training for fifteen (15) of fifteen (15) staff members who work at the facility. The findings include: On September 3, 2024, Staff Member #1 advised the surveyors that the facility administrator (FA) left on long-term leave started Friday August 30, 2024. Due to the FA leaving, it may be difficult to find required items in staff member personnel files. On September 4, 2024, Staff Member #7 provided the surveyors with the Personnel File Worksheet for all staff members who work at the facility. The worksheet was empty for all staff members in the area of emergency procedures and infection control training. The facility policy titled “TEAMMATE QUALIFICATIONS, LICENSURE AND ADEQUATE TEAMMATE STAFFING” states in part: “The dialysis facility’s teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to service collectively the comprehensive needs of the patient.””

“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: 40084 Based on observation, interview and document review, it was determined the facility staff failed to aseptically conduct exit site care, initiate dialysis, and discontinue dialysis for a patient with a central venous catheter (CVC) for three (3) out of three (3) observations. The findings include: On September 3, 2024 at 3:08 p.m., the surveyor conducted an observation of Staff Member #10 discontinuing dialysis for a patient at dialysis station #11 with a CVC. Prior to disconnection, Staff Member #10 failed to place a clean field under the CVC ports. Additionally, the staff member scrubbed the hub of each CVC connection for approximately 3 seconds on venous port and 5 seconds on arterious port. On September 3, 2024 at 3:54 p.m., the surveyor conducted an observation of Staff Member #10 discontinuing dialysis for a patient at dialysis station #12 with a CVC. Prior to disconnection, Staff Member #10 failed to place a clean field under the CVC ports. Additionally, the staff member scrubbed the hub of each CVC connection for approximately 5 seconds. On September 3, 2024 at 3:59 p.m., the surveyor conducted an observation of Staff Member #10 discontinuing dialysis for a patient at dialysis station #13 with a CVC. Prior to disconnection, Staff Member #10 failed to place a clean field under the CVC ports. Additionally, the staff member scrubbed the hub of each CVC connection for approximately 5 seconds. A review of the policy titled “CENTRAL VENOUS CATHETER (CVC) WITH CLEARGUARD HD ANTIMICROBIAL END CAPS PROCEDURE” states in part: “Upon completion of dialysis... Discard used barrier that was used during treatment and place a new clean, moisture proof barrier under catheter to prevent contamination... Aseptically disconnect arterial blood line... Aseptically disconnect venous blood line... Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds...””

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 40084 Based on observation, interview and document review, it was determined the facility failed to properly conduct water chlorine testing during one (1) of one (1) chlorine test. The findings include: On September 4, 2024 at 10:00 a.m., the surveyor conducted an observation of Staff Member #20 performing chlorine testing with the E-Z Chek Sensitive Total Chlorine Test Strips. The surveyor observed Staff Member #20 place the test strip into the water for testing and perform no other action. After approximately 20 seconds, Staff Member #20 removed the test strip from the water and interpreted the results. During the exit conference in the afternoon of September 4, 2024, Staff Member #6 advised the test strip should be “swished” in the water prior to removing and interpreting the results. A review of the facility policy titled “E-Z CHEK SENSITIVE TOTAL CHLORINE TESTING” states in part: “Immerse the reagent area of test strip into 20 ml of test water. Vigorously move test strip back and forth in the test water for 10 second.””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 40084 Based on observation, interview and document review, it was determined the facility failed to maintain a safe environment by not fixing a water leak that created a flowing stream of water across the floor of the water room. The findings include: During a flash tour of the facility on September 3, 2024, the surveyor observed a steam of water flowing across the water room floor that appeared to be originating from an outlet port of the RO machine. The water on the floor made the area slippery and hazardous to staff members. While reviewing the water room with Staff Member #21 later that day, the surveyor pointed out the still visible stream of water on the floor. Staff Member #21 advised that the source of the water may be an outlet for the RO that dispenses water at high pressure. When this is occurs, some of the water is not contained and leaks out onto the floor. During an observation of the water room on September 4, 2024, the surveyor noticed that the water continued to stream across the water treatment room floor. A review of the facility policy titled “PHYSICAL ENVIRONMENT” states in part: “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility failed to conduct competency training for water/dialysate for eleven (11) of thirteen (13) staff members (nurses and PCTs) who work at the facility. The findings include: On September 3, 2024, Staff Member #1 advised the surveyors that the facility administrator (FA) left on long-term leave started Friday August 30, 2024. Due to the FA leaving, it may be difficult to find required items in staff member personnel files. On September 4, 2024, the surveyor reviewed the personnel files for staff members #8, 9, 10. During that review the annual competency training for water/dialysate for Staff Member #8 and 9 could not be located. Later that day, Staff Member #7 provided surveyors with the Personnel File Worksheet for all staff members who work at the facility. A review of the worksheet revealed the space for annual competencies for water/dialysate was left blank or more than a year old for Staff Members #11, 12, 14, 15, 17, 18, 19, 22, 23. The facility policy titled “AUDITING OF CLINICAL PRACTICE REQUIREMENTS FOR WATER AND DIALYSATE CONCENTRATE” states in part: “The ESRD Conditions for Coverage require the operators of the water/dialysate system equipment to be training by the manufacturer of the equipment or the training must be done from material provide by the manufacturer. Initial training will be completed after new hire and annually thereafter””

“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: 40084 Based on observation and document review, it was determined the facility staff failed to follow the facility’s policy ensuring that patient access sites are visible during the dialysis treatment. The findings include: On September 3, 2024, at 1:15 p.m. the surveyor observed that patient at station #5 was asleep with support person at their side and patient’s access site was completely covered up by a blanket. Staff Member #10 came to the station at 2:07 p.m. used the computer station and didn’t asked the patient or support person to uncover access site. Staff Member #7 came to station #5 at 2:20 p.m., talked to support person and uncovered patient’s access site. Policy 1-03-08, last revised April 2024, titled “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” read in part: “...Intradyalitic treatment monitoring and data collection/assessment... b. at minimum, obtain and document the following:.....v. vascular access visible and line connections intact... c. The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment....””

“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: 40084 Based on medical record review, facility policy review, and staff interview, it was determined the facility staff failed to document the reason for, and notification to the registered nurse, of the change in blood flow rate (BFR) and/or (DFR) for four (4) of four (4) medical records of in-center hemodialysis patients records reviewed in the survey sample (Patient #’s 4, 5, 6 and 7). In addition, facility staff failed to administer bolus and infusion of heparin per Patient #1’s dialysis prescription on two (2) occasions and complete nursing assessment for Patient #1 as per facility policy. The findings include: The surveyor conducted a review of flowsheets for Patient #4 on September 4, 2024. That record review revealed that for two thirds of treatment on August 30, 2024, dialysis was administered at a different dialysate flow rate (DFR) then that prescribed by the physician. The flow sheets contained no documentation of why the dialysis was not administered as ordered. The surveyor conducted a review of flowsheets for Patient #5 on September 4, 2024. That record review revealed that for the entire treatment on August 28, 2024, dialysis was administered at a different blood flow rate (BFR) then that prescribed by the physician. The flow sheets contained no documentation of why the dialysis was not administered as ordered. The surveyor conducted a review of flowsheets for Patient #6 on September 4, 2024. That record review revealed that for approximately 1 hour and 20 minutes during treatment on August 28, 2024, dialysis was administered at a different blood flow rate (BFR) then that prescribed by the physician. The flow sheets contained no documentation of why the dialysis was not administered as ordered. The surveyor conducted a review of flowsheets for Patient #7 on September 4, 2024. That record review revealed that during treatments on August 20, 2024, August 22, 2024, August 29, 2024 and August 31, 2024, the patient experienced bradycardia with a heartbeat of less than 60. The flow sheet contained no documentation that the PCT reported the abnormal findings to the licensed nurse. The surveyor conducted a review of flowsheets for Patient #1 on September 4, 2024. That record review revealed that on August 20, 2024 and August 28, 2024, Staff Member #2 failed to administer Heparin Pork 2,000 units intravenous push and 600 units per hour intravenous infusion. The dialysis prescription ordered to administer the medication as a loading dose and infusion every dialysis treatment. The flow sheets contained only documentation “Not given. Reason: Missed Administration” but failed to include why the dialysis treatment was not administered as ordered and/or who was notified of the change. The record further revealed that on August 20, 2024 and August 31, 2024, Staff #2 didn’t complete nursing assessment within one hour of treatment initiation. On August 20, 2024 Patient #1 started treatment at 7:49 am and was assessed by Staff Member #2 at 10:02 am and on August 31, 2024, Patient 31 started treatment at 7:39 am and was assessed by Staff Member #2 at 8:55 am. A review of the facility’s policy 1-03-08, last revised April 2024, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” states in part: “...Policy: ...3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: ...f. Blood flow rate g. Dialysate flow rate ...j. Heparinization (intradialytic infusion setting) ...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. 11. Abnormal findings or findings outside of any patient specific physician ordered parameter will be reported to the licensed nurse immediately (refer to Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician or (NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record... Post Treatment Data Collection/Assessment 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge...””

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 40084 Based on observation, interviews and document review, it was determined the facility staff failed to encourage fifteen (15) of fifteen (15) patients to wash access extremity before starting treatment in their dialysis station. The findings include: On September 3, 2024 at 11:07 a.m., the surveyor started observation of Staff Member #9 who was bringing a patient to the treatment floor. Before patient arrived to dialysis station #5, Staff Member #9, weighted patient, walked with them passing a hand washing station and two large posters “Stop, don’t forget to wash your access.” displayed on columns, proceeding directly to the treatment station and started preparation for dialysis treatment. At no point has the staff asked patient to wash their access site. Staff Member #9 disinfected patient’s access site before initiation of dialysis treatment. The surveyor observed on September 3, 2024 between the hours of 11:15 am and 12:56 pm the same sequence of events unfold for six (6) additional patients- entering treatment floor, being weighed, passing by washing station and signs reminding them to wash access site but never doing so. The Staff Members #8, 9 and 10 were providing dialysis treatment initiation during that time. The surveyor interviewed patients receiving treatment in stations 5, 10, 13 and 15 inquiring if they have been asked to wash access site before treatment today or in the recent past. All patients answered “No.” The surveyor asked the above noted staff members what their usual practice was regarding access site cleaning before starting treatment. Staff members explained that they always disinfect patient’s access site before starting cannulation. When asked if patients would usually wash their own access with soap and water prior to treatment initiation, Staff Member #8 explained, “that’s not the norm here.” On September 4, 2024 between the hours of 11:55 am and 12:55 pm , the surveyor conducted additional eight (8) observation of patients arriving to the treatment floor and starting dialysis treatment without stopping to wash their access site at the wash station located in the close proximity to the scale. Staff Members # 18 and 19 initiated majority of the dialysis treatments. Patient interviews confirmed the same findings as the day prior, staff doesn’t remind them to wash their access site prior to dialysis treatment start and admitted they haven’t paid much attention to the four posters hanging in the treatment floor reminding them to wash their access. The facility policy 1-04-01, last revision October 2023, titled “ARTERIOVENOUS FISTULA (AVF) AND ARTERIOVENOUS GRAFT (AVG) VASCULAR ACCESS CARE” states in part: “4. patients are encouraged to wash access extremity with soap and water upon arrival for dialysis, if able. If patient unable to wash access site, patient care teammate will clean access extremity with skin cleansing agent and pat dry.””

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined that three (3) of eight (8) patients sampled failed to have an initial plan of care implemented within 30 days or 13 treatments. The findings include: The surveyor conducted a review of the medical records for Patients #1-8 on September 4, 2024. That review revealed the following initial plans of care that were not implemented within the required timeframe. Patient #1 was admitted to the facility on April 4, 2024. The initial plan of care was not completed and implemented until 126 days later on August 10, 2024. Patient #4 was admitted to the facility on July 10, 2023. The initial plan of care was not completed and implemented until 73 days later on September 21, 2023. Patient #5 was admitted to the facility on June 26, 2024. As of September 4, 2024, 70 days after admission, an initial plan of care was not completed and implemented. During the exit conference on September 4, 2024, Staff Member #4 and 7 advised they were not aware of the current staffing challenges at the facility, but were able and willing to help if they had known. A review of the facility policy titled “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” states in part: “An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days...””

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined that two (2) of eight (8) patients sampled failed to have a care plan conducted annually. The findings include: The surveyor conducted a review of the medical records for Patients #1-8 on September 4, 2024. That review revealed the following initial plans of care that were not implemented within the required timeframe. Patient #6 had an annual plan of care completed on March 6, 2023. The next plan of care was not completed and implemented until 393 days later on April 2, 2024 Patient #7 had an annual plan of care completed on February 14, 2023. The next plan of care was not completed and implemented until 413 days later on April 10, 2024. During the exit conference on September 4, 2024, Staff Member #4 and 7 advised they were not aware of the current staffing challenges at the facility, but were able and willing to help if they had known. A review of the facility policy titled “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” states in part: “A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted:... At least annually for stable patients...””

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility’s bio-medical representative failed to attend and contribute to the facility’s monthly quality assessment and performance improvement (QAPI) program for six (6) out of eight (8) months reviewed. The findings include: The surveyor conducted a review of the facility’s QAPI program on September 4, 2024. That review included an examination of the monthly meeting notes and record of attendance. That review revealed that the facility’s bio-medical representative failed to attend six (6) out of the eight (8) meetings for 2024. During the exit conference later that afternoon, Staff Member #4 advised that a bio-med representative is supposed to attend the monthly QAPI meeting and present data relative to their assigned area.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility failed to conduct annual competency testing for three (3) of ten (10) staff members (nurses and PCTs) who work at the facility. Additionally, the facility failed to conduct tuberculosis (TB) screening for six (6) out of fifteen (15) staff members who work at the facility. The findings include: On September 3, 2024, Staff Member #1 advised the surveyors that the facility administrator (FA) left on long-term leave started Friday August 30, 2024. Due to the FA leaving, it may be difficult to find required items in staff member personnel files. On September 4, 2024, the surveyor reviewed the personnel files for staff members #8, 9, 10. During that review the annual competency for Staff Member #9 could not be located. Also, during that review, the annual TB screening for Staff Member #9 and 10 could not be located. Additionally, later that day, when presented the Personnel File Worksheet by Staff Member #7 for all staff members who work at the facility, Staff Member #7 advised that a TB screening is an annual requirement. A review of the worksheet revealed the space for annual competencies was left blank or more than a year old for Staff Members #11 and 12. Also, the space for TB evaluation date was blank or indicated the action was incomplete for Staff Member #11, 13, 17, 22. On September 4, 2024 during the exit conference, Staff Member #6 advised surveyors that competencies are to be conducted annually. The facility policy titled “TEAMMATE QUALIFICATIONS, LICENSURE AND ADEQUATE TEAMMATE STAFFING” states in part: “The dialysis facility’s teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to service collectively the comprehensive needs of the patient.””