Davita Brazil Dialysis

“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: 48387 Based on record review and interview, the agency failed to conduct and document the annual exercise for the emergency preparedness plan affecting 1 of 1 facility. Findings include: A policy titled “Facility Emergency Management Plan” indicated the facility will conduct and/or participate in one exercise to test the facility emergency management plan at least annually, conducted on opposite years: one year a full-scale exercise and the next year a facility-based exercise. During an interview on 08/13/2024 at 9:00 AM, the Facility Administrator (FA) indicated she could not locate information provided to staff or sign-in sheets for the 2024 full-scale community-based exercise that FA participated in. She could also not locate 2023 documentation of actual power outage emergency or other documents to confirm that 2023 or 2024 annual emergency preparedness testing was completed.”

“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: 48387 Based on observation, record review, and interview, the facility staff failed to remove gloves and perform hand hygiene, affecting 4 of 5 Patient Care Technicians (PCT) observed. (PCT 1, PCT 2, PCT 4, PCT 5) Findings include: 1. An April 2023 revised policy titled “Infection Control for Dialysis Facilities” indicates all team members are to perform hand hygiene before and immediately after removal of gloves, after patient and dialysis delivery system contact, and before touching clean areas, such as supplies, chairside, and keyboard. Gloves should be changed when going from a dirty area or task to a clean area or task, after touching one patient or their dialysis delivery system, and before arriving to care for another patient or touch another patient’s dialysis delivery system. 2. A policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps” indicates that after removing and discarding old dressing from the CVC, gloves are to be removed and discarded, and hand hygiene is performed and re-glove before cleaning the CVC exit site. 3. During an observation on 08/07/2024 at 12:15 AM, PCT 1 touched the computer and then gloved without performing hand hygiene. 4. During an observation on 08/07/2024 at 1:40 PM, PCT 2 touched the computer and then gloved without performing hand hygiene. PCT 2 picked up a syringe off the floor with a gloved hand and then returned to patient #6’s CVC to place sterile caps, PCT 2 failed to perform hand hygiene and perform a glove change. 5. During an observation on 08/08/2024 at 10:50, PCT 4 removed the old dressing from the CVC site and then cleaned the CVC site on Patient #12. PCT 4 failed to perform a glove change and hand hygiene after removing old dressing and before cleaning CVC site. 6 During an observation on 08/12/2024 at 9:15 AM, PCT 5 touched the computer with gloved hands and then gathered Patient #16’s dirty supplies. PCT 5 failed to perform hand hygiene and glove change after touching computer and before gathering supplies. 7. During an interview on 08/07/2024 at 1:55 PM, PCT 3 indicated the dialysis machine, patient, and chair is considered one area and the computer in another; staff should change gloves and hand hygiene when changing between areas. 8. During an interview on 08/13/2024 at 12:45 PM, PCT 5 indicated that after removing the old dressing from CVC, gloves should be changed, and hand hygiene should be performed.”

“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: 48387 Based on observations, record review, and interviews, the facility staff failed to clean the medication preparation area prior to preparing medications, affecting 3 of 3 staff observed preparing medication (RN 1, PCT 1, PCT 2). Findings include: 1. An October 2023 revised policy titled “Medication Policy” indicates an aseptic environment is used when preparing medications. 2. During the flash tour on 08/07/2024 at 9:28 AM, a clipboard was observed on the medication prep counter. 3. During an observation on 08/07/2024 at 1:40 PM, Patient Care Technician (PCT) 2 prepared Patient #6’s medication on the medication preparation counter. PCT 2 failed to disinfect the medication preparation counter before using. 4. During an observation on 08/07/2024 at 2:20 PM, PCT 1 prepared Patient #9’s medication on the medication preparation counter. PCT 1 failed to disinfect the medication preparation counter before using. 5. During a random observation on 08/08/2024 at 9:10 AM, Registered Nurse (RN) 1 prepared medication on the medication preparation counter. RN 1 failed to disinfect the medication preparation counter before using. 6. During an observation on 08/12/2024 at 8:50 AM, paper documents and writing instruments were seen placed on the counter in the clean area designated for medication preparation. 7. During an interview during the daily conference on 08/08/2024 at 3:30 PM, the Manager of Clinical Services (MCS) indicated the medication counter should be wiped down first thing in the AM with bleach and as needed; she defined as needed as if anything else had come in contact with counter other than medication and medication supplies. The counter would need to be cleaned again. She indicated it should only be used as a medication counter. 8. During an interview on 08/13/2024 at 12:12 PM, RN 1 indicated she cleans the medication preparation counter every morning, between shifts, and at the end of the day, using a 1:100 bleach solution, but not for each patient’s medication 9. During an interview on 08/13/2024 at 12:45 PM, PCT 5 indicated the medication preparation counter was cleaned in the morning and when visibly dirty.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 48387 Based on observations, record reviews, and interviews, the agency failed to clean and disinfect contaminated equipment on 2 of 3 observation of care days. Findings include: 1. An April 2023 revised policy titled “Infection Control for Dialysis Facilities” indicates equipment should be cleaned and/or disinfected before returning to a clean area; items disinfected via submersion will be fully submerged; stethoscopes will be disinfected with an alcohol prep pad before removal from treatment station. 2. An October 2023 revised policy titled “Bleach Policy” indicated bleach solution needs to be covered with a secure lid. 3. During a flash tour on 08/07/2024 at 9:28 AM, the disinfectant container for the hemodialysis tubing clamps was uncovered without bleach solution, and the clamps were exceeding the rim of the container. 4. During an observation on 08/12/2024 at 9:15 AM, Patient Care Technician (PCT) 2 listened to Patient #7’s AV Fistula (a connection made between an artery and a vein for dialysis access), then placed stethoscope on computer keyboard. PCT 2 failed to clean the stethoscope before or after using it on Patient #7 and before placing the stethoscope on the clean computer keyboard. 5. During an interview on 08/07/2024 at 3:55 PM, the Facility Administrator (FA) indicated she had seen clamps in the sink and container upon entering the treatment room. Staff told her they just hadn’t had time to mix bleach for clamps yet. 6. During an interview on 08/12/2024 at 2:15 PM, PCT 2 indicated that clamps are to be rinsed and placed in a bleach solution for 10 minutes, then placed in a colander at a clean sink. PCT 2 also indicated that stethoscopes should be cleaned after use and before being laid elsewhere in the treatment area.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 48387 During observation, record review, and interview, the facility failed to secure the water treatment room, affecting 1 of 2 access points to the water treatment room. Findings include: 1. A policy titled “Water Treatment Systems Minimum Component Requirements” indicates that the water purification and distribution systems should be located in a secure area; access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply orders. 2. During the flash tour on 08/07/2024 at 9:28 AM, the water treatment room door was observed held open with a large bag of salt unattended. 3. During an interview on 08/07/2024 at 9:30 AM, the Chief Technician indicated he was setting up in the Biomed office and did not know the Indiana Department of Health was in the building. He indicated he had gotten tired of unlocking the door to enter the room and propped it open; usually, the door is shut and locked. 4. During an interview on 08/13/2024 at 12:12 PM, Registered Nurse (RN) 1 indicated the water treatment room should be locked and the door should not be propped open.”

“RO-MONITOR/ALARM/PREVENT UNSAFE H20 USE CFR(s): 494.40(a) 5.2.7 Reverse osmosis: alarm/prevent use of unsafe water Refer to RD62:2001, 4.3.7 Reverse osmosis: Reverse osmosis devices shall be equipped with on-line monitors that allow determination of rejection rates and product water conductivity. The product water conductivity monitor should activate audible and visual alarms when the product water conductivity exceeds the preset alarm limit. The audible alarm must be audible in the patient care area when reverse osmosis is the last chemical purification process in the water treatment system. Monitors that measure resistivity or TDS may be used in place of conductivity monitors. 6.2.7 Reverse osmosis: Reverse osmosis systems should be monitored daily using continuous-reading monitors that measure product water conductivity (or total dissolved solids (TDS)). 5.2.7 Reverse osmosis: Refer to RD62:2001, 4.3.7 Reverse osmosis: When a reverse osmosis system is the last chemical purification process in the water treatment system, it [should] include a means to prevent patient exposure to unsafe product water, such as diversion of the product water to drain, in the event of a product water conductivity or rejection alarm. This Standard is not met as evidenced by: 48387 Based on observation and interview, the facility failed to ensure that the audible alarm was functioning in the treatment area in 1 of 1 dialysis facilities. Findings include: 1. During an observation on 08/08/2024 at 10:20 AM, all operating dialysis machines in the treatment area were alarmed with a low conductivity message, and no audible alarm was heard or visible in the treatment area to alert staff of unsafe water. 2. During an interview on 08/08/2024 at 11:05 AM, the Chief Technician indicated that the bicarb container was completely empty; an audible alert for the treatment room should have sounded to let the staff know when the bicarb container became low before the container became empty; the alarm in the treatment area did not alarm as it was supposed to. He indicated no preventive maintenance policy for alarms in the treatment area or scheduled testing for alarms. 3. During an interview on 08/08/2024 at 2:30 PM, the facility administrator (FA) indicated no policy for alarms to be evaluated regularly. 4. During an interview on 08/12/2024 at 2:15 PM, Patient Care Technician (PCT) 2 indicated no alarm sounded in the treatment room on 08/08/2024. 5. During an interview on 08/13/2024 at 12:12 PM, Registered Nurse (RN) 1 indicated no audible alarm sounded in the treatment room on 08/08/2024 when the bicarb container was empty.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48387 Based on observations, record review, and interview, the staff failed to secure prepared medication for 1 of 2 observed medications (PCT 1). Findings include: 1. An October 2023 revised policy titled “Medication Policy” indicates that non-refrigerated medication is to be stored in a cabinet and locked at the close of each business day or if not under the supervision of a licensed teammate. 2. During a Medication Preparation and Administration observation on 08/07/2024 at 2:20 PM, Patient Care Technician (PCT) 1 left a medication-filled syringe on the counter in the center of the treatment floor while PCT 1 provided care to the patient in the observation room. PCT 1 failed to properly secure medication in a locked drawer. 3. During an interview on 08/13/2024 at 12:12 PM, Registered Nurse (RN) 1 indicated that after medication has been prepared for a patient, it should be given to the patient or secured in a locked drawer until ready to administer. 4. During an interview on 08/13/2024 at 12:45 PM, PCT 5 indicated that Heparin can be prepared before administering it to the patient but would need to be stored in a locked drawer until ready to administer and not left on the counter in the treatment area.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 48387 Based on record review and interview, the facility failed to ensure the nurse completed a nursing assessment timely for 3 of 5 in-center record reviews (Patients #1, #3, #5) Findings include: 1. A policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” indicated a licensed nurse should assess the patient within 1 hour of the initiation of the treatment. 2. A review of Patient #1’s record evidenced the following: Treatment Detail Report dated 07/24/2024 indicated Patient #1 started treatment at 10:24 AM. RN 2 assessed Patient #1 at 11:31 AM, 1 hour and 7 minutes later. Treatment Detail Report dated 07/26/2024 indicated Patient #1 started treatment at 11:41 AM. RN 2 assessed Patient #1 at 1:54 AM, 2 hours and 13 minutes later. 3. A review of Patient #3’s record evidenced the following: Treatment Detail Report dated 07/26/2024 indicated Patient #5 started treatment at 5:57 AM. RN 2 assessed Patient #3 at 7:12 AM, 1 hour and 15 minutes later. 4. A review of Patient #5’s record evidenced the following: Treatment Detail Report dated 07/17/2024 indicated Patient #5 started treatment at 9:24 AM. RN 2 assessed Patient #5 at 10:31 AM, 1 hour and 7 minutes later. Treatment Detail Report dated 07/24/2024 indicated Patient #5 started treatment at 9:37 AM. RN 2 assessed Patient #5 at 11:35 AM, 1 hour 58 minutes later. 5. During an interview on 08/13/2024 at 12:12 PM, RN 1 indicated she usually tries to do the preassessment on patients within 30 minutes of the patient starting treatment, but sometimes, if something goes wrong with one of the patients or the work environment being fast-paced could cause a delayed assessment, resulting in time to be over the approved preassessment time.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 48387 Based on the record review and interview, the facility failed to ensure that staff followed Heparin (medication used to prevent blood clotting) prescribed orders and were recorded appropriately for 1 of 1 record reviews with a Heparin pump ordered. (Patients #5) Findings include: 1. A policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” indicated Heparin should be monitored every 60 minutes. The policy indicated that if the dialysis prescription was not followed or met, the reason should be documented. All documentation should be reviewed for accuracy. 2. A review of Patient #5’s prescription order indicated Heparin was to stop 60 minutes before the end of treatment. A review of Patient #5’s Patient Summary Report indicated Heparin was not stopped 60 minutes before the end of treatment for the following dates: A review of Patient #5’s Treatment Details Report dated 07/19/2024 indicated in the medication administration section that the Heparin pump was stopped at 12:30 PM; the treatment ended at 1:02 PM. The Heparin was not stopped at 12:02 PM, 60 minutes before the end of treatment. The facility failed to stop the Heparin 60 min before the end of treatment as ordered and failed to accurately document when the Heparin ended. A review of Patient #5’s Treatment Details Report dated 07/24/2024 indicated in the medication administration section that the Heparin pump was stopped at 1:08 PM; the treatment ended at 1:06 PM. The Heparin was not stopped at 12:06 PM, 60 minutes before the end of treatment. The facility failed to stop the Heparin 60 min before the end of treatment as ordered and failed to accurately document when the Heparin ended. A review of Patient #5’s Treatment Details Report dated 07/26/2024 indicated in the medication administration section that the Heparin pump was stopped at 1:46 PM; the treatment ended at 1:42 PM. The Heparin was not stopped at 12:42 PM, 60 minutes before the end of treatment. The facility failed to stop the Heparin 60 min before the end of treatment as ordered and failed to accurately document when the Heparin ended. A review of Patient #5’s Treatment Details Report dated 08/07/2024 indicated in the intradialytic vital stat line section that Heparin pump was marked started at 9:44 AM and was stopped at 12:31 PM, at 11:59 AM, Patient Care Technician (PCT) 1 noted Heparin was not started at 9:44 AM, the medication administration section indicated no Heparin pump was administered. A review of Patient #5’s Treatment Details Report dated 08/05/2024 indicated in the medication administration section that the Heparin pump was stopped at 12:32 PM; the treatment ended at 1:05 PM. The Heparin was not stopped at 12:05 PM, 60 minutes before the end of treatment. The facility failed to stop the Heparin 60 min before the end of treatment as ordered and failed to accurately document when the Heparin ended. 3. During the daily conference on 08/12/2024 at 4:15 PM, the facility administrator indicated that the Heparin stop time was a documentation issue, not a medication error; staff should be accurately entering Heparin stop time in patient charts. 4. During an interview on 08/13/2024 at 12:45 PM, PCT 5, indicated the stop time on Heparin should have been documented an hour before the end of treatment. PCT indicated that she will sometimes document Heparin at the same time as vitals are taken, not when Heparin is stopped.”