Davita Charlottesville Dialysis

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 45736 Based on observations and facility document review, the facility failed to remove expired medications and supplies from the emergency cart. The findings include: During the flash tour on April 21, 2025, the surveyor inspected the contents in the facility’s emergency cart and evacuation kit. The following expired medications and supplies were found in the emergency cart: One (1) - Nasal cannula tubing - expired July 7, 2023 Six (6) - Yankauer catheters - Five (5) expired July 31, 2024 and One (1) expired February 15, 2025 Two (2)- Epinephrine single dose injectors 0.3 mg (milligrams) expired March 31, 2025 The checklist/logs documented that checks of the evacuation kit and emergency cart contents have been performed by nursing staff weekly, with the last documented date as April 21, 2025. The surveyor notified Staff Member #1 of the expired supplies the afternoon of April 21, 2025. A facility policy, Emergency Equipment Checks, last revision, October 2024, was reviewed and revealed, in part, “...6. A list of all dated supplies will be posted, with the expiration dates, on the cart and is to be checked weekly by licensed nurse teammate assigned to check the emergency cart...””

“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: 45736 Based on facility policy review and personnel file review, the facility failed to provide initial and/or annual training in emergency preparedness (EP) for three (3) of twelve (12) staff members. The findings include: The surveyour reviewed personnel files of current staff. Three (3) of twelve (12) staff members personnel files did not have documentation of current EP training. Staff Member #1 (hire date April 25, 2016), #13 (hire date August 13, 2018) and #15 (hire date June 27, 2023). A review of the facility’s Digital Teammate Files Document Guidance Checklist, last revision January 2023, indicated in part: “...Annual StarLearning Courses SL-1 Emergency Procedure Training (SAF4000) Direct Patient Care...””

“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: 45736 Based on observation and facility policy review, the facility failed to ensure infection protocols were followed for hand hygiene to prevent the transmission of infections. The findings include: On April 21, 2025, at 11:30 AM during observations of care on the treatment unit, the surveyor observed Staff Member #3 leave Station #16 to get supplies, returned to Station #16, did not sanitize their hands, donned clean gloves and connected the patient’s central venous catheter (CVC) lines. Staff Member #3 proceeded to another station to get a thermometer, returned to Station #16, did not sanitize their hands, utilized the computer keyboard, donned clean gloves, touched the machine and took the patient’s temperature. On April 21, 2025, at 12:30 PM during observations of care on the treatment unit, the surveyor observed Staff Member #3 at Station #13. Staff Member #3 did not sanitize their hands, donned clean gloves, left Station #13, returned to Station #13, did not sanitize their hands, donned clean gloves. Staff Member #3 removed gloves, touched the computer keyboard, did not sanitize their hands, donned clean gloves and touched the patient’s arteriovenous (AV) access site. The facility policy, Infection Control for Dialysis Facilities, last revision April 2023, was reviewed and revealed, in part: “Hand Hygiene: 1. All teammates, Physicians, and non-Physician (NPP) will perform hand hygiene...b. prior to gloving and immediately after the removal of gloves...d. after patient and dialysis delivery system contact...g before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse...””

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 19883 Based on observation, and facility document review, the facility staff failed to ensure that soap and paper towels were available at a clean sink in the treatment area. The findings include: Upon entry into the dialysis treatment area on April 21, 2025 at approximately 12:08 PM, the clean sink was observed to be void of soap and paper towels. Review of the facility’s policy titled: “Infection Control for Dialysis Facilities” with a revision date of April, 2023, reads in part as follows: “...Soap and a supply of paper towels protected from contamination must be available at each clean sink.””

“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: 19883 Based on observation and facility policy review, the facility failed to ensure that staff’s fingernails were natural nails, not extending more than 1/4 inch. The findings included: On April 21, 2024 at approximately 11:00 AM, Staff Member #1 was observed providing dialysis treatments. Staff Member #1’s nails were artificial, painted and adorned with a non-traditional nail polish and accessories, and extended to a length more than 1/4 inch beyond their fingertips. Review of the facility’s policy titled: “Infection Control for Dialysis Facilities” with a revision date of April 2023, reads in part as follows: “...It is a requirement for all (name of facility) teammates whose primary location is working in a facility to have only natural nails and fingernail length should not extend more than 1/4 inch. Traditional nail polish that is not chipped may be worn.””

“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: 45736 Based on interview, facility policy review and personnel file review, the facility failed to verify hepatitis B immunity in one (1) of twelve (12) staff according to personnel files review. The findings include: On April 22, 2025 at 1:00 PM, a surveyor reviewed the personnel files for twelve (12) facility staff members. A review of Staff Member #11’s personnel file, hired on March 21, 2025, revealed they did not have documentation of screening for hepatitis B surface antigen or evidence of immunity to hepatitis B. There was no evidence that the facility offered Staff Member #11 the hepatitis B vaccine. During an interview on April 22, 2025 at 1:15 PM with Staff Member #4 confirmed that the facility did not have Staff Member #11’s documentation of Hepatitis B status and that this should be completed within ten (10) days. A facility policy titled “Teammate Hepatitis B Monitoring and Follow-Up Guidance”, last revision April, 2024, revealed, in part: “...1. New teammates who are not able to provide documentation of hepatitis B surface antibodies..from any time in the past...will be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results...”. Note: During the last recertification survey of this clinic, conducted between July 30, 2024 and July 31, 2024, the facility was cited for the same deficient practice. Their plan of correction submitted on August 16, 2024, revealed, in part, “...Ongoing compliance will be monitored with quarterly teammate file audits...””

“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: 45736 Based on facility policy review and personnel file review, the facility failed to provide documentation for four (4) of twelve (12) staff member’s infection control training. The findings include: Review of personnel records on April 22, 2025 at 1:00 PM revealed that four (4) of twelve (12) staff members did not have documentation of current infection control training - Staff Member #1 (hire date April 25, 2016), #13 (hire date August 13, 2018), #15 (hire date June 27, 2023) and Staff Member #16 (hire date August 21, 2023). During an interview on April 22, 2025 at 1:30 PM, Staff Member #4 indicated that infection control training is under the facility’s safety training. A review of the facility’s Digital Teammate Files Document Guidance Checklist, last revision January 2023, indicated in part: “...Annual StarLearning Courses SL-1 Safety Training...Direct Patient Care...””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 45736 Based on observations, facility policy review and interview, the facility failed to label opened glucose monitoring control solutions and test strips. The findings include: During the flash tour on April 21, 2025, the surveyor observed the facility’s glucose test kit that contained the glucose monitor, control solutions and test strips. The control solutions and test strips did not have a date on them of when they were opened, discard date or staff initials. A facility policy titled, “Embracepro (TM) Blood Glucose Monitor: Quality Control (QC)”, last revision September 2020, revealed, in part, “...Procedure 3...Check high and low control solutions expiration date. Do not use control solutions past expiration date. Discard control solutions 90 days after opening...When opening a new control solution, write the open and discard dates on the side of the bottle along with teammate initials. 4. Do not use test strips past expiration date. Discard test strips four (4) months after opening...When opening new test strips, write the open and discard dates on the side of the bottle along with teammate initials...” During an interview with Staff Member #4, the afternoon of April 21, 2025, Staff Member #4 explained that , “absolutely yes,” open and discard date along with staff’s initials should be written on the control solution and test strips bottles when first used.”

“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: 45736 Based on personnel file review, interview, and facility policy review, the facility failed to ensure that color blindness testing was performed on two (2) of twelve (12) facility staff members. The findings include: Review of twelve (12) personnel records on April 22, 2025 at 1:00 PM, revealed no documentation of color blindness testing being completed on Staff Members #11 (hire date March 21, 2025) and #12 (hire date September 3, 2024). During an interview on April 22, 2025, Staff Member #1 and #4 confirmed that the personnel records for the above staff members did not contain evidence that a color blindness test was performed. A review of the facility’s policy “Color Vision Evaluation”, last revision October 2017, revealed, in part, “...1...Color blindness testing is performed at time of hire...3. The Facility Administrator/Program Manager/designee is responsible for assuring that the appropriate teammates are evaluated for ability to see color...”. Note: During the last recertification survey of this clinic, conducted between July 30, 2024 and July 31, 2024, the facility was cited for the same deficient practice. Their plan of correction submitted on August 16, 2024, revealed, in part, “...Ongoing compliance will be monitored with quarterly teammate file audits...””

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 45736 Based on medical record review and facility policy review, the facility failed to ensure an initial comprehensive assessment was completed within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session for one (1) of seven (7) patients included in the survey sample, Patient #4. The findings include: One (1) of seven (7) medical records that were reviewed, indicated the lack of a Plan of Care (POC) for Patient #4. Patient #4’s medical record indicated an initial dialysis start date of October 20, 2023 at this facility. There was no POC found for Patient #4. Staff Member #4 spent a length of time looking for the POC and the time of exit conference informed the surveyors that they can’t locate the POC and it can not be provided for review. A facility policy, titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, Policy 1-14-01,” last revision July 2023, revealed, in part, “...Plan of Care:...10. 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 (or 13 outpatient dialysis sessions for hemodialysis) beginning with first outpatient dialysis treatment or per state guidelines.””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 19883 Based on medical record review and facility document review, the facility staff failed to verify the dialysis prescription and perform a blood pressure check per facility policy for one (1) of seven (7) patients included in the survey sample, (Patient #1). The findings include: On March 20, 2025, Patient #1’s dialysis treatment started at 11:24 AM. Patient #1’s treatment prescription was not verified by the nurse until 12:59 PM and on one occasion during this treatment one hour elapsed between blood pressure measurements. The facility’s policy titled: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” with a revision date of April 2024 reads in part: “...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.””

“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: 19883 Based on medical record and facility document review, the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) and/or DFR (dialysis flow rate) for two (2) of seven (7) in-center dialysis patients included in the survey sample, (Patient #1 and Patient #5). The findings include: Patient #1: The treatment records evidenced a dialysis prescription for a BFR of 450 ML/Min, and a DFR of 500 ML/Min. The treatment records evidenced the following: On March 20, 2025, Patient #1’s DFR was documented as 800. There was no documentation explaining why the DFR was not administered as prescribed. Patient #5: The treatment records evidenced a dialysis prescription for a BFR of 400 ML/min, and a DFR of 500 ML/Min. The treatment records evidenced the following: On April 2, 2025 Patient #5’s DFR was documented as 600. There was no documentation explaining why the DFR was not administered as prescribed. Review of Patient #5’s treatment record for April 7, 2025 revealed a BFR of 0 ML/Min; and 350 ML/Min; and a DFR of 800 ML/Min. There was no documentation explaining why the BFR or DFR was not administered as prescribed. The facility’s policy titled: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” with a revision date of April 2024 reads in part: “...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.””

“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: 45736 Based on interview, facility policy review and personnel file review, the facility failed to: A, Perform initial Tuberculosis (TB) testing on one (1) of twelve (12) staff members. B, provide evidence that four (4) of twelve (12) staff member’s annual competencies were maintained according to facility policy. The findings include: On April 22, 2025 at 1:00 PM, a surveyor reviewed the personnel files for twelve (12) facility staff members. A, Review of Staff Member #11’s personnel file, hired on March 21, 2025, did not reveal documentation of TB testing. A facility policy, titled “Teammate Health Monitoring Program”, last revision April 2019, revealed, in part: “...7. New teammates will be: Screened for Hepatitis B, Hepatitis C and Tuberculosis...” A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, last revision January 2023, revealed, in part “...Onboarding Documents TB Skin Test (TST or refusal form). Teammates who are in contact with patients...” The facility policy did not outline a time frame for the TB testing. During an interview on April 22, 2025 at 1:15 PM, Staff Member #4 indicated that the facility did not have Staff Member #11’s TB testing documentation and that this should be completed during staff onboarding. When the surveyor asked if it was reasonable that the TB testing would be completed within the ten (10) days like Hepatitis B testing, Staff Member #4 confirmed that it should. B, Staff Members #1 (hire date April 25, 2016), #9 (hire date August 27, 2007), #13 (hire date August 13, 2018), and #14’s (hire date February 10, 2025) personnel files did not include evidence that their competencies were verified prior to performing direct patient care or did not include an annual competency exam. A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, last updated January 2023, indicated in part: “Onboarding Documents...Verification of Competency...Annual StarLearning Courses..Annual Competency Exam..””

“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: 46466 Based on interview and facility documentation review, the facility failed to conduct annual exercises to test the facility’s emergency management plan. The findings include: On July 30, 2024, a review of the facility’s red Emergency Preparedness binder was conducted. The binder did not include evidence that either a facility-based or community-based functional exercise was performed to test the facility’s emergency plan in 2023. On July 30 2024 at approximately 2:30 PM, the surveyor requested evidence of the facility’s annual emergency testing from Staff Member #2. Staff Member #2 was unable to provide any documentation to support that the facility conducted facility-based or community-based testing in 2023. A review of the facility’s policy “Facility Emergency Management Plan (ICHD, Home)”, revised April 2024, revealed in part: “...Emergency Drills..2...e...Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP at least ANNUALLY, conducted on the OPPOSITE years (one year full-scale exercise, next year facility-based/exercise of choice)...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 46466 Based on interview, medical record and facility documentation review, the facility failed to perform quarterly patient fire safety training for six (6) of eight (8) patient records sampled. The findings include: On July 30, 2024 and July 31, 2024 a review of seven (7) in-center hemodialysis and one (1) peritoneal dialysis patient medical records was conducted. Patient’s #2, #3, #4, #5, #6 and #7 medical records did not contain documented evidence that any of these patients received quarterly Fire Safety Training for the second quarter of 2024. On July 31, 2024 at 2:20 PM, Staff Member #2 confirmed that there was no documented evidence related to Patients #2, #3, #4, #5, #6 or #7 receiving Fire Safety Training in the second quarter of 2024. A review of the facility’s policy “Facility Emergency Management Plan (ICHD, Home)”, revised April 2024 indicated in part: “...Training and Education. Emergency Management Plan 1. The FA, or designee, is responsible to provide training of EMP:...b. Patients...ii. Quarterly: 1. Fire Safety Preparedness...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“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: 46466 Based on interview and facility document review, facility staff failed to verify hepatitis B immunity in two (2) of seven (7) staff as evidenced in personnel files sampled. The findings include: On 7/31/24 at 1:30 PM, the surveyor reviewed the personnel files for seven (7) facility staff members. The personnel file for Staff Member #12 did not contain documentation of screening for hepatitis B surface antigen or evidence of immunity to hepatitis B. There was no documented evidence that the facility offered Staff Member #12 hepatitis B vaccine. The personnel file for Staff Member #13 did not contain documentation of screening for hepatitis B surface antigen or evidence of immunity to hepatitis B. There was no documented evidence that the facility offered Staff Member #13 the hepatitis B vaccine. Staff Member #13 was hired on 7/8/24. On 7/31/24 at 1:50 PM, Staff Member #1 confirmed that the facility did not have Staff Member #12 and #13’s documentation of Hepatitis B status. A review of the facility’s policy “Teammate Hepatitis B Monitoring and Follow-Up Guidance”, revised April, 2024, indicated in part: “...1. New teammates who are not able to provide documentation of hepatitis B surface antibodies..from any time in the past...will be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 46466 Based on observations and facility document review, it was determined that the facility staff failed to maintain a safe environment for dialysis patients by not properly labeling two (2) medication syringes according to facility policy. The findings include: On July 30, 2024 at 11:05 AM, two (2) pre-drawn syringes of heparin were observed on a counter on the treatment floor. The syringes were labeled, but did not include the time and the initials of the staff member who prepared the medication. A review of the facility’s policy “Medication Policy”, revised October 2023, indicated in part “...20...If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“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: 46466 Based on interviews and facility document review, the facility staff failed to ensure that color blind testing was performed on five (5) of seven (7) employees as evidenced in personnel records sampled. The findings include: On July 31, 2024 at 1:30 PM, a review of seven (7) personnel records was conducted. There was no documentation of Staff Members #7, #9, #11, #12 and #13 completing the color blind test. On July 31, 2024 at 1:50 PM, an interview was conducted with Staff Member #1. Staff Member #1 confirmed that personnel records for the above listed staff members and/or any other facility documents did not contain evidence that a color blind test was performed. A review of the facility’s policy “Color Vision Evaluation”, revised October 2017, indicated in part: “...1...Color blindness testing is performed at time of hire...3. The Facility Administrator/Program Manager/designee is responsible for assuring that the appropriate teammates are evaluated for ability to see color...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 46466 Based on interview and facility document review, the facility staff failed to provide evidence that six (6) staff members knowledge and skills were maintained according to facility policy. The findings include: On 7/31/24 at 1:30 PM, the surveyor reviewed the personnel files for seven (7) facility staff members. Staff Members #7, #8, #9, #10, #11 and #12’s personnel files did not include documentation of annual Water Skills Checks being completed within the last year. An interview was conducted with Staff Member #1 on July 31, 2024 at 1:50 PM. Staff Member #1 confirmed that the documentation of annual Water Skills Testing was not present in the six (6) personnel files sampled or any other facility documents. A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, last updated January 2023, indicated in part: “...Annual Documents...Water Skills Checklist...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 19883 Based on interviews, facility and medical document reviews, the facility staff failed to provide evidence that Plans of Care (POC) for unstable patients were completed on a monthly basis for three (3) of eight (8) patients as evidenced in medical records sampled. (Patient #2, #3 and #6) The findings include: Patient #3 was a new admission to the facility on December 14, 2023. Patient #3 was hospitalized in May 2024. On May 15, 2024, Patient #3 was deemed unstable by the Interdisciplinary Team (IDT) . At the time of the survey, Patient #3’s POC had not been updated for two (2) consecutive months; June 2024, and July 2024. Staff Member #2 indicated in an interview on July 31, 2024, that it is the expectation that the POC for a patient deemed unstable due to hospitalization would be completed within thirty (30) days of having returned to the facility for dialysis. A review of a facility policy, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” dated July 2023, revealed, in part, “...A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted at least monthly for unstable patients including, but not limited to, patients with the following: Extended or frequent hospitalizations; marked deterioration in health status; significant changes in psychosocial needs; concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.” 46466 Based on interviews, facility and medical document reviews, the facility staff failed to provide evidence that Plans of Care (POC) for unstable patients were completed on a monthly basis for three (3) of eight (8) patient records sampled. The findings include: On July 30, 2024 through July 31, 2024, a review of seven (7) in-center hemodialysis (ICHD) patients and one (1) peritoneal dialysis (PD) patient was conducted. A review of Patient #2’s medical chart revealed a POC dated March 20, 2024 and listed Patient #2 as unstable. A request was made of Staff Member #2 on July 31, 2024 to provide signed copies of Patient #2’s POC for April and May of 2024. Staff Member #2 was unable to provide evidence to support that a monthly POC was completed for Patient #2 in April or May of 2024. Staff Member #1 was able to provide evidence in Patient #2’s electronic medical record (EMR) that a POC for Patient #2 was completed on June 26, 2024. A review of Patient #6’s medical chart revealed a POC dated February 5, 2024 and listed Patient #6 as unstable. A request was made of Staff Member #2 on July 31, 2024 to provide signed copies of Patient #6’s POC after February 2024. Staff Member #2 was unable to provide evidence to support that Patient #6’s POC was reviewed and updated on a monthly basis after February 2024. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 46466 Based on interviews, facility and medical document reviews, the facility staff failed to provide evidence that Plans of Care (POC) were developed and implemented for three (3) of eight (8) patients as evidenced in medical records sampled. The findings include: On July 30, 2024 and July 31, 2024 a review of seven (7) in-center hemodialysis (ICHD) and one (1) peritoneal dialysis (PD) patient records was conducted. The review revealed that Patient’s #4, #5 and #6 medical charts, did not contain evidence to support that POC’s were developed and implemented in writing. On 7/31/24 at 2:30 PM, Staff Member #2 was requested to provide the POC’s for these patient’s. Staff Member #2 stated that they could not find the POC’s for Patient’s #4, #5 and #6. A review of the facility’s policy “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, revised July 2023, indicated in part: “...Plan of Care 8. The facility’s interdisciplianary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 19883 Based on clinical record review, and facility document review, the facility staff failed to (A) document standing blood pressures on ambulatory patients for three (3) of eight (8) patient records sampled and (B) ensure the Registered Nurse (RN) assessed patients within an hour of dialysis treatment per facility policy for five (5) of eight (8) patient records sampled. (Patients #2, #3, #4, #6 and #7) The findings include: A review of treatment records for the sampled patients revealed the following: Patient #3’s dialysis treatment began at 10:31 AM on July 27, 2024. A pre-treatment assessment was documented by the RN at 12:57 PM. Review of the facility’s policy titled: “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with a revision date of April 2024 reads in part, “...Intradialytic Data collection/Assessment: The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law.” 46466 A review of treatment records for the sampled patients revealed the following: Patient #2: Six (6) treatment records were reviewed from 6/28/24 through 7/19/24. On 7/1/24, Patient #2’s treatment began at 11:53 AM. The RN assessment was documented at 1:54 PM. On 7/17/24, Patient #2’s treatment began at 11:08 AM. The RN assessment was documented at 12:49 PM. On 7/19/24, Patient #2’s treatment began at 12:04 AM. The RN assessment was documented at 1:31 PM. Patient #4: Six (6) treatment records were reviewed from 7/22/24 through 7/29/24. Six (6) of six (6) treatment records did not document standing blood pressures. Patient #4’s mobility observation was documented as “Ambulates-No Assistance Needed” for each date. On 7/19/24, Patient #4’s treatment began at 7:16 AM, and the RN assessment was documented at 9:14 AM. Patient #6: Six (6) treatment records were reviewed from 7/17/24 through 7/29/24. Six (6) of six (6) treatment records did not document standing blood pressures. Patient #6’s mobility observation was documented as “Ambulates-No Assistance Needed” for each date. Patient #7: Six (6) treatment records were reviewed from 7/16/24 through 7/27/24. Six (6) of six (6) treatment records did not document standing blood pressures. Patient #7’s mobility observation was documented as “Ambulates-No Assistance Needed” for each date. A review of the facility’s policy “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, last revised April 2024, indicated in part: “...1....ii. Measurement of Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“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: 19883 Based on medical record and facility document review, the facility staff failed to (A) follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) and/or DFR (dialysis flow rate) for six (6) of seven (7) in-center dialysis patients included in the sample and (B) follow facility policy regarding patients terminating their treatment times early. (Patients #1, #2, #3, #5, #6 and #7) The findings included: Patient #3: The surveyor reviewed six (6) dialysis treatment records from July 13, 2024 through July 27, 2024 for Patient #3. The treatment sheets evidenced a prescription for a BFR of 400 ML/Min and a DFR of 500 ML/Min. The treatment records evidenced the following: On July 17, 2024, the DFR was documented as 800. On July 25, 2024, the BFR was documented as 350. On July 27, 2024, the DFR was documented as 600. Patient #3’s clinical record failed to contain evidence of documentation explaining why the DFR and BFR was not administered as prescribed. The facility’s policy titled: “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” with a revision date of April 2024 reads in part: “...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.” 46466 The findings included: Patient #1: The surveyor reviewed six (6) dialysis treatment records from 7/16/24 to 7/27/24. On 7/19/24, it was documented that Patient #1 was discharged AMA (against medical advice). On 7/31/24 at 11:05 AM, Staff Member #2 confirmed that there was no documentation that Patient #1 signed an AMA form. Patient #2: The surveyor reviewed six (6) dialysis treatment records from 6/28/24 to 7/19/24. The treatment records evidenced a prescription for BFR of 450 and a DFR of 500. The treatment sheets evidenced the following: On 6/28/24, the BFR was documented as 400. On 7/19/24, the BFR was documented as 400 and the DFR was documented as 800. Patient #2’s clinical record failed to contain evidence of documentation explaining why the BFR and DFR was not being administered as prescribed. Patient #5: The surveyor reviewed six (6) dialysis treatment records from 7/17/24 to 7/29/24. The treatment records evidenced a prescription for BFR of 400. The treatment sheets evidenced the following: On 7/24/24, the BFR was documented as 350. Patient #5’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. Patient #6: The surveyor reviewed six (6) dialysis treatment records from 7/17/24 to 7/29/24. The treatment records evidenced a prescription for BFR of 450 and DFR of 800. The treatment sheets evidenced the following: On 7/19/24, the BFR was 350 and the DFR was 500. On 7/22/24, the DFR was documented as 500. Patient #6’s clinical record failed to contain evidence of documentation explaining why the BFR and DFR were not being administered as prescribed. Patient #7: The surveyor reviewed six (6) dialysis treatment records from 7/16/24 to 7/27/24. The treatment records evidenced a prescription for BFR of 400. The treatment sheets evidenced the following: On 7/18/24, the BFR was documented as 350. Patient #7’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. On 7/16/24, 7/18/24, 7/20/24, 7/22/24, 7/25/24 and 7/27/24 it was documented that Patient #7 was discharged AMA (against medical advice). On 7/31/24 at 11:05 AM, Staff Member #2 confirmed that there was no documentation that Patient #7 signed an AMA forms on any of these treatment dates. A review of the facility’s policy “Prescribed Treatment Time Not Met”, revised April 2024, indicated in part: “...1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time...5. If a patient refuses to sign the Early Termination of Treatment Against Medical Advice form, the RN will document the patient’s refusal with the words “patient refused” in the patient signature box along with the date...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”

“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: 46466 Based on interview, medical record review and facility document review, it was determined that facility staff failed to ensure that Plans of Care (POC) were signed by the patient in four (4) of eight (8) patient records sampled. Eighteen (18) additional POC’s were also identified that were missing patient signatures. The findings included: On July 30, 2024 and July 31, 2024 a review of seven (7) in-center hemodialysis (ICHD) and one (1) peritoneal dialysis (PD) patient records was conducted. Patient #2’s last POC (dated March 20, 2024) failed to document Patient #2’s signature or Patient #2’s refusal to sign. Staff Member #1 was able to provide evidence that Patient #2 had a POC completed in their electronic medical record (EMR) on June 26, 2024, however, Staff Member #1 was unable to provide evidence of the patient’s signed acknowledgment of this POC. Patient’s #4, #5 and #6 signed POC’s were not provided to survey team for review. On July 30, 2024 at 9:40 AM, the surveyors observed a stack of patient POC’s laying on the desk in the room where the surveyors were working. The stack revealed eighteen (18) POC’s dated from February 21, 2024 through May 22, 2024 that were not signed by the patients or had an indication that the patients refused to sign. On July 31, 2024 at 2:00 PM, Staff Member #1 was asked about the stack of unsigned POC’s. Staff Member #1 replied that these were patients that had either been discharged or had been in and out of the hospital multiple times therefore facility couldn’t obtain their signatures on POC. A review of the facility’s policy “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, revised July 2023, indicated in part: “...14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided...”. The findings were discussed with Staff Members #1, #2, #6, #16 and #17 at the exit conference on July 31, 2024 at 3:15 PM.”