West Orange Winter Garden Dialysis Center LLC

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 13640 Based on interview and a review of facility documentation, the facility failed to ensure the implementation of a system to track the location of sheltered patients for 4 of 64 total in-center hemodialysis patients. (#8, #9, #10, & #11). Findings: During an interview of the Social Worker on 5/21/24 at approximately 11:45 AM, she stated that newly admitted patients complete the document “Acknowledgement of Personal Disaster Plan” upon admission and annually. Examination of this form reveals that it includes information on sheltering status. She was able to produce a notebook which included these forms. However there was no documentation which indicated that the shelter status had been explored with four of 64 of the in-center hemodialysis patients. During an interview with the Administrator on 5/21/24 at approximately 4:10 PM she confirmed the preceding.”

“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: 39943 Based on observation, interview, and record review the dialysis center failed to ensure all medications and equipment stored in the Emergency Cart and Emergency Evacuation Box were not expired in 2 of 2 crash carts and 1 of 2 Emergency Evacuation Boxes. Findings: On 5/20/24 at 3:45 PM, observation revealed one Emergency [crash] cart and one Emergency Evacuation box on the hemodialysis treatment floor. The Emergency Cart contained emergency mediations for allergic reactions, and other emergencies. The cart also had emergency equipment on top of it. There was a suction machine, an automated external defibrillator (AED), airways, and an artificial resuscitator (Ambu bag). Emergency oxygen tanks were noted to the right side of the crash cart. Review of the inventory sheet listed all the medications and equipment stored in the Emergency Cart. The Emergency Cart was opened and all items inside were checked for expiration dates. The following items were found to be expired in the Emergency Cart: 10- 17 Gx1” BE w/clamp expired on 5/12/24 12- 14 Gx1” BE w/clamp expired on 5/15/24 1- nasal cannula expired on 5/15/24 27- ZD Island dressings expired on 10/17/23 5- 1-liter bags of Normal Saline fluids expired on 4/24 Review of the sign off sheet in the computer revealed the cart was checked and signed off on 5/13/24 by a Registered Nurse (RN). RN A verified that all the above items were expired and could not explain how the cart was checked and the expired items were not removed. The Emergency Cart for the Peritoneal Dialysis treatment floor was checked on 5/20/24 at 4:30 PM. The following items were found to be expired in the cart: 2- 10 milliliter (ml) 10% Calcium Chloride injection bottles expired on 2/24 1-50 ml 50% Dextrose injection bottle expired on 5/01/22. 1 package of Zoll Pads expired on 3/26/24. 5- 10 cc syringes expired on 12/31/23 3- towel/drapes expired 2/13/24 1-nasal cannula expired on 4/13/24 5- transparent dressings expired on 7/31/23 3- chlora prep swabs expired on 7/2022 4- 4x4 sterile sponge pads expired on 1/24 4- safety fistula needles expired on 4/30/24 1-safety fistula needle expired on 1/03/24 The following items were found expired in the Emergency Evacuation Box: 1-Pocket resuscitator expired on 2/15/22 1-Hand sanitizer that expired on 9/2021 2- Safety Fistula Needles 16 G expired on 4/30/24 2- Safety Fistula Needles 17 G expired on 1//31/24 2-IV administration sets expired on 7/31/22 1-box of alcohol prep pads expired on 7/2022 2-1-liter bags of Sodium Chloride fluids expired in October 2021 On 5/20/24 at 4:45 PM RN E acknowledged all the above items removed from the Emergency Cart and Emergency Evacuation Cart were expired. She was not able to explain how the carts could have been checked on 4/08/24 and the expired items remained in the carts. Review of the “Emergency Medications, Equipment and Supplies” policy dated 5/01/23 read: An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date. The above statement was indicated for both the Emergency Cart and the Emergency Evacuation Box.”

“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: 13640 Based on interview and a review of facility documentation, the facility failed to ensure the performance of a community-based exercise at least every two years. Findings: A review of facility Emergency Preparedness documentation did not reveal anything reflecting the performance of a community-based exercise within the preceding two years. Documentation showed that the last one was performed on 5/5/21. During an interview of the Administrator on 5/21/24 at approximately 12:15 PM, she confirmed that they had not performed a community based exercise or an equivalent within the past two years.”

“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: 39943 Based on observation and interview the facility failed to ensure patients were educated on emergency procedures such as how to emergency clamp and disconnect from the dialysis machine in case of an emergency for one of three patients, (#12). Findings: On 5/21/24 at 11:45 AM, during an interview with patient #12 she stated that she was not instructed how to disconnect from the dialysis machine during an emergency. She said she has been a patient at the facility since 2022. She said she did not recall getting instructions from anyone on the procedure. On 5/21/24 at approximately 12:00 PM, PCT D stated the patient should be instructed on their first visit and throughout the year it is refreshed with the patient. The PCT stated, usually the nurse or PCT will provide the education. She said she was not aware that the patient did not receive the education. On 5/21/24 at approximately 2:00 PM the Nurse Manager stated that all the patients are instructed on how to disconnect from the dialysis machine in case of an emergency. She stated it is part of the facility QA process to review the Emergency and Disaster Preparedness with all the residents quarterly. She stated this included the patient should be able to verbalize emergency disconnect procedures. She stated that the form is signed by the nurse or PCT who reviewed the procedures with the patient and placed in the patents medical record. The Nurse Manager was not able to produce any documentation regarding Emergency and Disaster Preparedness from resident #12’s record. Review of the “In-center HD Patient Participation in Emergency and Disaster Preparedness,” dated 9/06/22 included: The patient should be able to : Correctly perform/verbalize emergency clamp and disconnect procedure. Correctly perform/verbalize emergency rinse back (hand crank) procedure. Complete this form for each quarterly review and place in patient’s medical record. Review of the “Guidelines for Emergency Preparedness,” policy dated 7/03/23 included: Quarterly, all Fresenius Kidney Care patients must receive fire drill and emergency evacuation training. Training must be documented in QAI and the fire drill attendance form. All drills: Fire, emergency evacuation , tabletop and community-based drill must be reviewed and documented in QAI.”

“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: 39943 Based on observation and interview the facility failed to have a clean sink in the isolation room available for patients and staff to wash their hands. Findings: On 5/20/24 at approximately 11:30 AM, an observation of the facility’s isolation room it was noted that the room only contained one sink and it was labeled a dirty sink. Patient Care Technician (PCT) C stated she believes the water in the sink has been turned off for a few months because of a leak, and confirmed the sink was labeled “Dirty Sink.” On 5/21/24 at approximately 12:40 PM, an interview with the Regional Quality Assurance Nurse regarding the isolation room not having a clean sink. She stated she would check the room and return with an answer. She was also told the surveyors were informed that the water had been turned off for several months due to a leak. She returned and stated the bio med technician was not aware that the water was off and went to turn it on. Upon doing so discovered the sink was leaking and turned off the cold water. He informed her the sink does have hot water. Regarding the sink being a clean or dirty sink, the Regional Quality Assurance Nurse said the sink should be a clean sink for handwashing.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 13640 Based on observation, interview and a review of facility documentation, the facility failed to ensure the storage of supplies and equipment in the form of gowns was in a clean area. Findings: During an observation on the treatment floor on 5/20/24 at approximately 11:05 AM, the cabinet area beneath a sink was examined. Five folded blue disposable gowns that were not enclosed in a plastic bag or other protective material were observed on the floor of the cabinet area. Storage of patient care items in this manner exposes them to the risk of getting wet from any leaks in the sink drain, thus increasing the risk of the growth of microbes on them. During an interview of the Administrator on 5/21/24 at approximately 9:20 AM, she confirmed that the gowns should not have been stored in that manner. A review of facility policy Storage of Supplies revealed the following: “All supplies must be stored in a clean . . . environment.” Thus, the facility failed to follow its established policy.”

“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: 13640 Based on observation, interview and a review of facility documentation, the facility failed to provide a safe treatment area for patients due the presence of expired medications. Findings: During an observation of the medication cabinet on the treatment floor on 5/21/24 at approximately 10:51 AM the following was observed: three unopened boxes of 100 capsules each and one opened box with 62 capsules of Diphenhydramine 25 MG, all with expiration dates of 3/2024. Also, five vials of Adrenalin 1 MG (Milligrams)/ML (milliliters) with expiration dates of 7/2023 and one with an expiration date of 9/2023. A review of facility policy Sequestering Medications revealed the following: “Medications that are expired . . . may pose a significant health and safety risk to patients and needs to be sequestered.” During an interview of the Administrator on 5/21/24 at approximately 11:15 AM, she confirmed that the medications should have been discarded.”

“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: 39943 Based on observation and interview the facility failed to ensure the access site remained uncovered and in visible during the entire dialysis treatment for 1 of 10 patients (#4). Findings: During an observations of the patient treatment area on 5/20/24 from 1:00 PM through 1:15 PM, patient #4’s dialysis access, a left leg catheter, was covered by a blanket. The staff present in the treatment area failed to identify and correct the issue. Registered Nurse, RN A was informed of the covered dialysis access and said the the site should had not been covered. On 5/20/24 from 3:45 PM to 3:55 PM, patient #4’s dialysis access site was observed covered by a blanket. The staff, in the treatment area, made no attempts to ensure the patient’s dialysis access remained uncovered. On 5/20/24 at approximately 3:56 PM, Registered Nurse, RN A, confirmed that patient #4’s dialysis access should not be covered by a blanket. RN A said that the patient’s dialysis access should be visible at all times during the treatment. A review of facility policy “Patient Assessment and Monitoring.” Dated 5/01/2023, revealed the following: “ Observe connections are secure and visible. Ensure access remains uncovered throughout the treatment. Observe and ensure tape is intact, needles are intact. No bleeding or infiltration is noted.””

“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: 13640 Based on interview, record review and a review of facility documentation, the facility failed to provide the necessary care and services including a corrective plan to manage the patient’s volume status concerning a failure to meet target weights (estimated dry weights) and obtain treatment for a prescribed duration in hours in three of seven sampled patients. (#1, #6, #7) Findings: 1. A review of the medical record of patient #6 was performed. A review of the Treatment Sheets revealed the following. Physician orders of 1/22/24 indicated a target weight of 109.50 KG and a treatment duration of 4 hours. On 5/3/24, the patient had a pre-treatment weight of 120.50 KG and a post-treatment weight of 115.50 KG. On 5/6/24, the patient had a pre-treatment weight of 119.70 KG and a post-treatment weight of 114.50 KG. On 5/8/24, the patient had a pre-treatment weight of 118.20 KG and a post-treatment weight of 116.00 KG. On 5/10/24, the patient had a pre-treatment weight of 118.00 KG and a post-treatment weight of 113.60 KG. On 5/13/24, the patient had a pre-treatment weight of 118.40 KG and a post-treatment weight of 113.50 KG. On 5/15/24, the patient had a pre-treatment weight of 116.60 KG and a post-treatment weight of 112.80 KG. The treatment had started at 6:03 AM and ended at 9:16 AM. This was approximately one hour less than what had been ordered and could have skewed the weight findings as stated. A nurse’s note in the treatment sheet read: “Pt came 1 hour after his regular treatment time. Pt was educated about compliance with his treatment time.” As to whether or not the patient was offered another treatment time to make up for the lost time, there was no evidence of such in the medical record. On 5/17/24, the patient had a pre-treatment weight of 116.20 KG and a post-treatment weight of 111.20 KG. On 5/20/24, the patient had a pre-treatment weight of 116.80 KG and a post-treatment weight of 111.70 KG. There was nothing n the medical record which indicated any physician notification regarding the patient’s consistent failure to meet target weights from 5/3/24 through 5/20/24, or his awareness of this failing. There were no entries on the dates mentioned in prior text which explained why the target weight was not achieved on each occasion. A review of facility policy Nursing Supervision and Delegation revealed the following: “Prior to discharge, the RN must review the treatment record for . . . whether patient is achieving dry weight and identifying reason for patient not achieving dry weight.” Excess weight beyond the target weight can represent excess fluids in body tissues. This can put a strain on the heart and circulation. During an interview of the Quality Manager on 5/21/24 at approximately 6:10 PM, she confirmed the preceding. 39943 2. On 5/09/24, while completing a review of patient #3’s medical record, it was noted that the physician prescribed EDW was 74 kilograms (kg).. The patient was prescribed three treatments a week and the prescribed treatment time was three hours and forty-five minutes. Review of the treatment flow sheets from 5/01/24 to 5/20/24 revealed that patient #3 did not achieve the prescribed EDW on eight of nine treatments. Pt. #3 did not achieve the prescribed EDW goal on the following dates: 5/01/24-post wt. 75.1 kg., 5/06/24-post wt. 74.7 kg., 5/08/24-post wt. 74.6 kg., 5/10/24-post wt. 75.3kg., 5/13 24-post wt. 76.2 kg., 5/17/24-post wt. 74.9 kg., and on 5/20/24-post wt. 76.4kg. 3. On 5/09/24 while completing a review of patient #4’s medical record, it was noted that the physician prescribed EDW was 105.5 kg. The patient was prescribed three treatments a week and the prescribed treatment time was three hours and thirty minutes. The staff failed to identify that patient #1 had not achieved the prescribed EDW on seven of ten treatments and failed to give a reason why the EDW was not attained. Patient #4 did not reach their EDW goal on, the following dates: 4/29/24- post wt.107.8 kg., 5/01/24-post wt. 106.6 kg., 5/06/24-post wt. 107.0 kg., 5/10/24- post wt. 106.6 kg., 5/15/23- post wt. 110.3 kg., 5/17/24- post wt. 111.0 kg., and on 5/20/24-post wt. 111.0 kg. Review of resident #4’s Dietician and Social Work notes revealed no evidence of discussion regarding patient not meeting his EDW. Further record review for patients #3 and #4 revealed that there was no evidence, after each treatment, that the staff identified that the patients had not achieved their respective EDWs. Or notified the physician that the EDW was not being met. There was no evidence on the treatment flow sheets that the staff had offered an extra treatment so patients #3 and #4 could achieve the doctor prescribed dry weight.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 20257 Based on observation, interview, and record review, the facility failed to provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin level for 1 of 3 patients reviewed for anemia management (#2). Findings: Patient #2 started home peritoneal dialysis (PD) at the facility on 4/9/21. Her diagnoses included End Stage Renal Disease (ESRD), anemia related ESRD, polycysitic kidney disease, and diabetes mellitus. The Patient Transfer: Care Transitions Report read that she currently received CCPD (Continuous Cycling Peritoneal Dialysis) at home 7 days a week via a double cuff coiled PD catheter in her left lower quadrant. Review of patient #2’s most recent Plan of Care was dated 7/27/23. It included a plan for anemia management was initiated on 5/10/21. Interventions for anemia management indicated that patient #2’s anemia management was in progress, that her HGB levels were to be monitored, and that the patient was to be educated on iron administration and anemia. (“Hemoglobin is the part of red blood cells that carries oxygen to your tissues. if your number is too low, you have anemia and you will need to take a medicine called on ESA (erythropoiesis-stimulating agent) to treat it. STAT and serum ferritin are measures of the iron stores in your body. iron is important to your body’s ability to make red blood cells. you may need extra iron if you have anemia.”- httpps://www.kidney.org) According to patient #2’s Current Orders Report dated July 2023 through May 2024, Micera was ordered on 8/19/23 for anemia. The order read: “CMAB [Corporate Medical Advisory Board] Recommended Anemia Algorithm [Orders] for Micera - Micera Sub Q [subcutaneous] Administration (PD, HHD) Version 2.0, Daily, Clinic 100969.” On 5/21/24 from 1:10 PM - 1:45 PM, patient #2 was observed and interviewed during her monthly clinic visit assessment which included lab draws. During this time the PD nurse was observed obtaining blood draws from the patient. Both patient #2 and the PD nurse indicated one of the reasons for the lab test was to assess her HGB levels due to anemia diagnosis. The patient said that she comes to the clinic to receive her Micera injections. The last 4 months of Hgb lab results for patient #2 were reviewed. The normal reference range for Hgb levels was listed as 12-16 g/dL (grams per deciliter). The patient’s Hgb levels were noted to be trending down as follows: 4/2/24: Hgb - 10.1 g/dL (low) 3/5/24: Hgb - 10.7 g/dL (low) 2/6/24: Hgb - 11.4 g/dL (low) 1/5/24: Hgb - 11.2 g/dL (low) A review of the facility’s ‘Micera Algorithm HHD, PD 2.0’ included parameters for the dosing of Micera and for the number of required monthly lab draws based on the patient’s Hgb levels. For an established patient, like patient #2, it read: “If patient is on ESA and Hgb is not in target, draw Hgb twice monthly (lab draws should be at least 7 days apart.) There was not any evidence presented to support that patient #2’s labs for Hgb were drawn twice monthly during the above months. The maintenance dosing chart in the Micera Algorithm Order Guide read: For “Rapid Hgb Fall: Increase Dose for rapid Hgb fall of over 1.0 g/dL over past 2 weeks and if Micera is not on hold, use Column 1 of Maintenance Dose Chart”. Column 1 included to increase dose if Hbg was between 8.0-10.0 g/dl or if rapid Hgb fall (trending down) or if Hgb was less than 10.5 and decreasing. Because the facility had not monitored the patient’s Hgb every two weeks per the Algorithm Orders, patient #2’s Hgb was trending down rapidly without appropriate monitoring and/or dosage increase. The patient’s Hgb had dropped to 10.1 g/dL, over 1.4 g/dL. On 5/21/24 at 4 PM, the PD Nurse said that she was using Column 2, not Column 1 of the Micera Algorithm order set, to determine how much Micera to monthly give patient #2. She said that she had not changed the patient’s monthly dosage of Micera 50 mcg (micrograms) in over the 3 months to date. The PD nurse said column 2 indicated that when Hgb lab levels were within the 10.1 -10.7 g/dL range, 50 mcg Micera was to be given. At about 4:15 PM, during a review of the Micera Algorithm with the Regional Home Dialysis Manager, she indicated that Column 1 rather than Column 2 of the Algorithm should have been used to increase patient #2’s Micera dosage from 50 mcg to 75 mcg due to the patient’s Hgb levels trending down and falling below 10.5 g/dL. She acknowledged that most likely the results of the Hgb lab draw from today would be even lower that last month’s results of 10.1 g/dL, possibly into the 9’s g/dL because the correct dosing adjustments were not made.”