Fmc Camellia

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 40119 Based on observations, review of facility policies, and staff interviews, it was determined the facility failed to ensure the staff: 1. Performed hand hygiene per the facility policy. 2. Cleaned and disinfected equipment before returning it to a common clean area. 3. Observed and ensured transducer protectors were dry, unclamped, and pressure lines were free of fluid. 4. Cleaned and disinfected the dialysis station between patients per the facility policy. 5. Labeled and covered the mixed bleach solutions. 6. Properly labeled and stored medications. 7. Cleansed the medication vial diaphragm (rubber septum/stopper) with an alcohol pad each time the vial was accessed with a needle. 8. Secured pre-drawn medications under the preparer’s control or in a locked designated medication storage area. 9. Cleaned the Central Venous Catheter (CVC) exit site according to the facility policy. This had the potential to negatively affect all patients who dialyze at this facility. Refer to V 113, V 116, V 120, V 122, V 143, and V 147.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 30952 Based on observations, review of facility policies and procedures, manufacturer’s instructions for use (IFU), personnel files, and interviews, it was determined the facility failed to ensure the water used for dialysis was safe and staff competency validations were performed and documented for operation of the DADU (Dry Acid Dissolution Unit) and GranuFlo (acid concentrate solution) batch preparation. This had the potential to negatively affect all 78 patients who dialyze at this facility. Refer to V 196, V 229, and V 260.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 40119 Based on review of facility policy, manufacturer’s instructions for use (IFU), staff interviews, the facility GranuFlo Mixing log, and personnel files, it was determined the Medical Director failed to: 1. Implement an ongoing training program designed to evaluate staff’s proficiency and maintain the operator’s knowledge for GranuFlo (acid concentrate) Preparation/Mixing. 2. Ensure the staff who prepared a batch of GranuFlo and the staff who confirmed the operator’s test results/actions adhered to the facility policy for Acid Concentrate Mixing and Handling. This had the potential to negatively affect all 78 patients who dialyze at this facility. Refer to V 713 and V 715.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 40119 Based on review of facility policy, manufacturer’s instructions for use (IFU), staff interviews, the facility GranuFlo Mixing log, and personnel files, the Governing Body failed to ensure governance of the health and safety of patients in that facility policies were not enforced to protect and promote the health and safety of patients by ensuring the staff who prepared a batch of acid concentrate (GranuFlo) and the staff who confirmed the operator’s test results/actions: 1. Adhered to the facility policy for Acid Concentrate Mixing and Handling. 2. Had knowledge and/or maintained their knowledge and skills in the GranuFlo Preparation/Mixing. This had the potential to negatively affect all 78 patients who dialyze at this facility. Refer to V 751.”

“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: 49603 Based on observations, facility policy, and staff interview, it was determined the facility staff failed to ensure emergency medications and supplies were not expired and ready for immediate use. This deficient practice had the potential to negatively affect all patients receiving treatment at the facility. Findings include: Facility Policy: Emergency Medication, Equipment and Supplies Document Number: FMS-CS-IC-II-130-007A Effective Date: 01/28/2015 Purpose...this policy is to provide guidelines for staff when determining and maintaining emergency equipment and supplies. ...Emergency Box/Cart Emergency supplies must be contained in a box or cart that is locked ... ...Checked monthly or after use for contents, expiration dates... ...Items approaching expiration are reordered and replaced prior to the actual expiration date. 1. An observation of the Emergency Cart and contents was conducted on 2/5/24 at 12:33 PM. The cart was observed to be unlocked. The following medications were found in the emergency cart ready for immediate patient emergency use: Two 10 % Calcium Chloride Injections 1,000 mg/mL (milligram/milliliter), expiration date was 1/2024. An interview was conducted on 2/5/23 at 1:32 PM, EI (Employee Identifier) # 2, Charge Nurse, confirmed staff had failed to ensure all emergency medications were ready for immediate patient use and not expired and failed to ensure the cart was locked and secured. 2. An observation of the Emergency Box and contents was conducted on 2/5/24 at 1:30 PM. The following supplies and medications were found in the emergency evacuation equipment box ready for immediate patient emergency use: Two Wing Eater Safety Arteriovenous (AV) Fistula Needle sets 16 Gauge x 1 inch with clamp, expiration date was 11/08/2022. One Heparin 30,000 units / 30 mL, expired on 11/01/2022. BD (brand) vacutainer safety lock 23 g (gauge) needle, 3/4 (three quarter inch) long, total of seven locks with expiration date 1/31/23. One box of Alcohol Antiseptic Pad, two hundred pads, expiration date was 6/9/2023. An interview was conducted on 2/5/24 at 2:00 PM, EI # 2 confirmed staff had failed to ensure all emergency evacuation medications and supplies were ready for immediate patient use and not expired.”

“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: 49603 Based on review of the facility Emergency Preparedness (EP) documentation, facility policy and staff interview, it was determined the facility staff failed to ensure annual testing of the EP program had been completed and documented per facility policy. This deficient practice had the potential to affect all patients served by this facility and staff. Findings include: Facility Policy: Guidelines for Emergency Preparedness Version: 11 Published: 07/03/2023 Purpose ... of this policy is to provide guidelines for emergency preparedness of in-center ... Background ... through emergency preparedness and disaster planning, provides matrixes and guidelines to help facilities prepare for emergencies or disasters. Community Based Drill Annually, each facility MUST participate in a community-based disaster drill. If unable to participate, document who you contacted in the community and why the clinic was unable to participate on the Facility Specific Disaster Safety Plan form. If the Emergency Operations Center (EOC) or similar agency has not performed a community-based drill, or it will be missed for a particular year, the Director of Operations (DO) should coordinate a dialysis facility area-based drill. Actual Emergency If facility is involved in an actual disaster, it can take the place of community-based drill or tabletop drill. ... document the event. Review of the EP Program on 2/7/24 revealed documentation of a tabletop exercise completed on 7/13/23. Further review of the EP Program revealed no documentation of a full-scale exercise which was community-based or individual, a facility-based functional exercise, or a mock disaster drill. The facility failed to ensure annual testing of the EP program was completed and documented for 2022 and 2023. An interview was conducted on 2/08/24 at 11:30 AM with EI (Employee Identifier) # 1, Facility Administrator, who verbalized there was no additional testing performed at the facility.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 30952 Based on observation, facility policy and interview, it was determined the staff had failed to display the current CMS (Centers for Medicare and Medicaid Services) Performance Score Certificate in a prominent area in the facility viewable to patients and families. This had the potential to negatively affect the seventy-eight patients treated at the facility. Findings include: Fresenius Kidney Care Government Reporting and Clinical Informatics Title-Annual Posting of the Performance Score Certificates Date: December 20, 2017 Purpose: The purpose....is to provide directions to facilities regarding the mandatory posting of the Calendar Year... Performance Score Certificate (PSC)... Facility Action: ...The PSC must be signed by the Medical Director prior to posting. Post the PSC within 15 business days of it being made available. Share and discuss the PSC with the facility staff... During the facility tour on 2/5/24 at 10:25 AM, the surveyor observed the facility 2021 CMS performance score posted in the lobby. There was no 2024 PSC posted in a prominent location visible for patients and families. An interview was conducted on 2/5/24 at 4:30 PM with Employee Identifier # 1, Facility Administrator, who confirmed the 2024 PSC was available and the staff had failed to display the 2024 PSC in the facility as required.”

“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: 49894 Based on observations, review of facility policies, and staff interviews, it was determined the facility failed to ensure patients and staff performed hand hygiene per the facility policy. This did affect Patient Identifier (PI) # 12, one of five treatment floor observations, PI # 24 and PI # 17, two of seven parenteral medication preparation and administration observations, Unsampled Patient # 1, two of eight discontinuation of dialysis with an Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) observations, PI # 26, one of five discontinuation of dialysis with an Central Venous Catheter (CVC), and PI # 13, one of seven preparation of the Hemodialysis Machine/Extracorporeal Circuit observations. This deficient practice had the potential to affect all patients who dialyze at the facility. Findings include: Facility Policy: Hand Hygiene Published: 11/06/23 Reference Number: 47664 Version 8 Responsibility: All Staff, patients ...must follow the same requirements for hand hygiene. Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: Before and after direct contact with patients. Entering and leaving the treatment area. ...Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications. Immediately after removing gloves. After contact with inanimate objects near the patient. ...After contact with other objects within the patient station or treatment space. ...Hand hygiene: Patients ...Gloves must be provided to patients when...holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed. Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 ...Purpose: To administer medications with the goals of patient safety ...and infection control. Policy: Infection Control: The following steps must be taken to ensure infection control: 1. Perform hand hygiene prior to accessing supplies, handling vials and IV solutions, and preparing or administering medications 2. Aseptic technique will be used to prepare and administer IV medications 1. A observation was conducted on 2/5/24 at 11:24 AM with Employee Identifier (EI) #11, Certified Clinical Hemodialysis Technician (CCHT). EI # 11 entered station 7, donned a glove to one hand, and documented on the dialysis machine for PI # 12 without performing hand hygiene prior to donning the glove. EI # 11 then exited station 7, obtained clean supplies from the supply cart with the used glove still on, and returned to station 7 to continue patient care. EI # 11 failed to remove glove and perform hand hygiene prior to obtaining clean supplies from the supply cart. An interview was conducted 2/8/24 at 11:40 AM with EI #1, Facility Administrator (FA), who confirmed EI # 11 failed to follow the facility policy for hand hygiene. 2. An observation of care was conducted on 2/5/24 at 12:40 PM at the medication preparation area with EI # 12, RN (Registered Nurse) for heparin preparation and administration for PI # 24. After preparation of heparin 2000 units, EI # 12 exited the medication preparation area and entered station 12, donned gloves without first performing hand hygiene, then administered the heparin. An interview was conducted on 2/8/24 at 8:30 AM with EI # 1, and EI # 3, Director of Operations, who confirmed staff failed to follow the facility policy and perform hand hygiene before donning gloves. 3. An observation of care was conducted on 2/5/24 at 2:15 PM at station 6 with EI # 11 who was holding a bleeding access site after treatment discontinuation on an unsampled patient. EI # 11 exited the station, removed his/her gloves, and discarded the gloves. EI # 11 retrieved gloves from the clean glove supply, donned the gloves and returned to the station. EI # 11 failed to perform hand hygiene after glove removal and before contact with clean patient supplies. An interview was conducted on 2/8/24 at 8:30 AM with EI # 1 who confirmed staff failed to follow the facility policy and perform hand hygiene after glove removal. 4. An observation was conducted on 2/5/24 at 2:20 PM at Station 14 for the discontinuation of dialysis with a CVC for PI # 26. After reinfusing the extracorporeal circuit, EI #12, RN, removed gloves without performing hand hygiene, exited the station and went to the nurse’s station to retrieve supplies, returned to station 14, donned gloves without performing hand hygiene, and continued with CVC care. EI #12 failed to perform hand hygiene after glove removal, prior to obtaining clean supplies, and prior to donning gloves, An interview was conducted 2/8/24 at 8:00 AM with EI # 1 who confirmed staff failed to follow the facility policy for hand hygiene. 5. An observation was conducted on 2/6/24 at 9:12 AM with EI # 4, RN, at station 17 for the preparation of the Hemodialysis Machine/Extracorporeal Circuit for PI # 13. During the observation, EI # 4 started the machine alarm and internal functions testing then removed gloves and gown and exited the treatment floor to obtain a bath jug for PI # 13. EI # 4 failed to perform hand hygiene after removing gloves and gown and prior to exiting the treatment floor. An interview was conducted on 2/8/24 at 8:20 AM with EI # 1 who confirmed staff failed to follow the facility policy for hand hygiene. 6. An observation was conducted on 2/6/24 at 9:45 AM to observe EI # 4 prepare Heparin for PI #17. During the observation, EI #4 failed to perform hand hygiene prior to preparing the heparin. An interview was conducted 2/8/24 at 8:00 AM with EI #1 who confirmed staff failed to perform hand hygiene prior to medication preparation. 30952 40119”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 30952 Based on observation, review of facility policy, and interview, it was determined the facility failed to ensure the staff cleaned and disinfected equipment before returning it to a common clean area. This had the potential to affect the seventy-eight patients served by this facility. Facility Policy: Dialysis Precautions Published: 1/4/12 Version 4 ...Policy Dialysis precautions will be followed by all employees with potential exposure to blood borne pathogens and other potentially infectious material in the dialysis setting. All employees will be educated regarding Dialysis Precautions ...as mandated by OSHA (Occupational Safety and Health Association) and recommended by the CDC (Centers for Disease Control). ...Clean Versus Dirty Area Clean Area: An area designated for clean and unused equipment, supplies, and medications. Dirty area: An area where there is potential for contamination with blood or body fluids and areas where contaminated or used supplies, equipment, ...are stored or handled. Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies or equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment...are handled or stored. 1. During observations of care on 2/6/24 at 8:00 AM, the surveyor observed EI (Employee Identifier) # 13, Registered Nurse, perform a post treatment assessment at station nine using a stethoscope. EI # 13 accompanied PI # 21 to the scales wearing a glove on the left hand and carrying the stethoscope. After PI # 21 weighed, EI # 13 removed the left glove, wrapped the stethoscope in the dirty glove, and laid the dirty glove and stethoscope on the clean counter where dialyzers and bloodlines were stored. An interview was conducted on 2/8/24 at 8:28 AM with EI # 1, Facility Administrator, and EI # 3, Director of Clinical Services who confirmed staff failed to follow the facility infection control policy for clean versus dirty.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 49894 Based on observations, review of facility policies, and staff interviews, it was determined the facility failed to ensure staff observed and ensured transducer protectors were dry, unclamped, and pressure lines were free of fluid. This did affect Patient Identifier (PI) # 28, one of five treatment floor observations, and had the potential to affect all patients dialyzing at the facility. Findings include: Facility Policy: Maintenance of the Transducer Protectors Procedure Published: 11/1/21 Reference Number: 45670 Version: 2 Purpose: The purpose of this policy is to ensure accurate measurement of the arterial and venous pressures by maintaining clean, dry, transducer protectors and to prevent cross transmission of bloodborne pathogens due to a contaminated internal transducer protector. Responsibility: Direct patient care. Policy: External transducer protectors must be changed when they become wet with blood or other fluid. Facility Policy: Patient Assessment and Monitoring Published 9/29/18 Reference Number: Not documented Version: 3 Policy: Monitoring During Treatment: Machine Parameters and Extracorporeal Circuit: Observe and ensure that: The transducer protectors are dry, unclamped, and pressure line is free of fluid. 1. An observation was made on 2/5/24 at 11:59 AM at Station 20 for PI #28. The transducer cover on the venous drip chamber was wet and the pressure line was full of blood, which continued until the treatment was terminated at 12:23 PM. An interview was conducted on 2/8/24 at 11:40 AM with EI #1, Facility Administrator, who confirmed the staff failed to observe and ensure transducer protectors were dry, unclamped, and pressure lines were free of fluid. .”

“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: 49894 Based on observations, facility policies and procedures, and interviews, it was determined the facility failed to ensure staff followed the facility policy for: 1. Cleaning and disinfection of the dialysis station between patients. 2. Labeling and covering the mixed bleach solutions. This affected three of eight observations of dialysis station cleaning/disinfection and two of five treatment floor observations and had the potential to affect all patients who dialyze at this facility. Findings include: Facility Policy: Mixing Bleach Published: 8/25/2020 Reference Number: Not documented Version: 4 Procedure: Follow the steps...for mixing bleach: ...4. Label opaque container with “Bleach Solution”, strength of solution, date, and time prepared... 5. Cover opaque container with lid... Facility Policy: Cleaning and Disinfecting of the Dialysis Station Published: 09/05/2023 Reference Number: 47806 Version: 14 Purpose: ...to provide guidelines to prevent the spread of infectious disease...maintain a clean, safe...environment for patients, staff, and visitors. Responsibility: All dialysis facility staff. Procedure: Follow the steps below to disinfect the dialysis station after each dialysis treatment:... 3. Use a cloth wetted with 1:100 (one part bleach, 100 parts water) bleach solution...to clean and disinfect the dialysis station...chair, tables, machine, IV (intravenous) pole, B/P (blood pressure) cuff, hand sanitizer dispenser and holder, chaise wall box behind the machine... 4. Clean all surfaces. Make surfaces glisteningly wet and allow to air dry ... Cleaning of the Dialysis Wall Boxes: Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood ...with 1:100 bleach solution. 1. An observation on the dialysis treatment floor on 2/5/24 at 10:55 AM revealed one 1:10 bleach container uncovered and one uncovered 1:100 bleach container uncovered next the nurse’s station. The bleach container labels failed to include the date and time the solution was prepared. An interview was conducted on 2/8/24 at 8:20 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed staff failed to follow the facility policy for bleach preparation. 2. An observation on the dialysis treatment floor on 2/5/24 at 11:16 AM revealed one 1:10 bleach container, one 1:100 bleach container labeled “clamps”, and one 1:100 bleach container labeled “solution” on the cart located across from station ten. There was no date and time the bleach was prepared documented on the bleach container labels. An interview was conducted in 2/5/24 at 11:17 AM with EI # 11, Certified Clinical Hemodialysis Technician (CCHT), who confirmed there was no date/time of preparation documented on the four bleach container labels. An interview was conducted on 2/8/24 at 8:30 AM with EI # 1 and EI # 3, Director of Operations, who confirmed staff failed to follow the facility policy for bleach preparation. 3. An observation was conducted on 2/5/24 at 1:13 PM of the cleaning and disinfection of the dialysis station at the end of the treatment day with EI # 6, CCHT. During the observation, EI # 6 failed to disinfect the dialysis wall box or countertop behind the machine. An interview was conducted on 2/8/24 at 8:20 AM with EI #1 who confirmed staff failed to disinfect the dialysis wall box or countertop behind the machine at the end of the treatment day per the facility policy. 4. An observation of cleaning and disinfection of dialysis station two was conducted on 2/5/24 at 2:30 PM with EI # 16, PCT (Patient Care Technician). EI # 16 failed to clean the top section of the intravenous (IV) pole including the four hooks on the IV pole. EI # 16 failed to clean inside the wire basket and failed to clean the television remote. An interview was conducted on 2/8/24 at 8:30 AM with EI # 1 and EI # 3, who confirmed staff failed to follow the policy for cleaning and disinfection of the dialysis station. 5. An observation was conducted on 2/5/24 at 2:35 PM at station 12 of the cleaning and disinfection of the dialysis station at the end of the treatment day with EI # 8, CCHT. During the observation, EI # 8 failed to disinfect the dialysis wall box or countertop behind the machine. An interview was conducted on 2/8/24 at 11:40 AM with EI #1 who confirmed staff failed to disinfect the dialysis wall box or countertop behind the machine at the end of the treatment day per the facility policy. 30952 40119”

“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: 49894 Based on observations, review of facility policy, and staff interviews, it was determined the facility failed to ensure staff: 1. Properly labeled and stored medications. 2. Cleansed the medication vial diaphragm (rubber septum/stopper) with an alcohol pad each time the vial was accessed with a needle. 3. Secured pre-drawn medications under the preparer’s control or in a locked designated medication storage area. This did affect, Patient Identifier (PI) # 26 and PI # 5, two of five observations of care, PI # 14 and Unsampled Patient # 1, two of seven medication preparation and administration observations. This had the potential to affect all patients who dialyze at the facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. Policy: Labeling: All medication in syringes not being administered immediately shall be labeled appropriately with the name of medication, route, dose, name of patient, date, time, and initials of person who prepped the medication. Pre-drawing medications: Medications may be pre-drawn for up to 4 hours prior to administration. These pre-drawn medications shall be labeled and kept under the preparer’s control or in a locked designated medication storage area ...until delivery to the appropriate patient for administration. Infection Control: ...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. Allow to dry before inserting a device into the vial. Securement: All medications will be kept in a locked cabinet except when in use. 1. A observation was conducted on 2/5/24 at 11:35 AM with Employee Identifier (EI) # 4, Registered Nurse (RN), to observe the preparation and administration of Hectorol for PI # 14. EI # 4 obtained three vials of Hectorol 4 mcg (micrograms)/ 2 ml (milliliter). EI # 4 cleansed the diaphragm of one vial of Hectorol then punctured with the needle to withdraw the medication. EI # 4 then proceeded to puncture the two-remaining vial with the needle without cleaning the diaphragm. EI # 4 failed to cleanse the diaphragm of two of three vials prior to puncturing with needle to withdraw the Hectorol. An interview was conducted on 2/8/24 at 8:20 AM with EI # 1, Facility Administrator, who confirmed the staff failed to follow the facility policy for medication preparation. 2. A treatment floor observation was conducted on 2/5/24 at 11:50 AM at station 14 for PI # 26. The surveyor observed two Heparin syringes on the top of the patient’s machine unsecured and not under the preparer’s control, with no documentation of the time prepared or the preparer’s initials. At 11:55 AM on 2/5/24, the surveyor observed the medication storage drawers containing unconstituted Intravenous antibiotics at the nurse’s station, which were not secured. An interview was conducted on 2/8/24 at 11:40 AM with EI # 1 who confirmed staff failed to follow the facility policy for medication preparation and storage. 3. A treatment floor observation was conducted on 2/5/24 at 12:20 PM at station 18 for PI # 5. The surveyor observed two Heparin syringes on the top of the patient’s machine unsecured and not under the preparer’s control. An interview was conducted on 2/8/24 at 8:20 AM with EI # 1 who confirmed staff failed to follow the facility policy for medication preparation and storage. 4. An observation was conducted on 2/6/24 at 11:00 AM with EI # 4, RN, for medication preparation for an unsampled patient # 1. EI # 4 retrieved supplies, cleansed the heparin vial diaphragm with alcohol and prepared a syringe with Heparin 3000 units. EI # 4 entered the heparin vial a second time with a needle but failed to cleanse the heparin vial diaphragm before puncturing the septum and withdrawing 4000 units heparin for another patient. EI # 4 placed the heparin 4000 units in a locked drawer, exited the medication preparation area to station 13 and administered heparin 3000 units to unsampled patient # 1. An interview was conducted on 2/8/24 at 8:28 AM with EI # 1 and EI # 3 Director of Operations, who confirmed the medication vial diaphragm must always be disinfected prior to withdrawing the medication to prevent cross contamination of the medication vial. 30952 40119”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 49894 Based on observations, facility policy and procedure, and interview, it was determined the facility failed to ensure staff cleaned the Central Venous Catheter (CVC) exit site according to the facility policy. This did affect Patient Identifier (PI) # 25 and PI # 13, two of four CVC exit site care observations conducted, and had the potential to negatively affect all patients who dialyze with a CVC. Facility Policy: Changing the Catheter Dressing Procedure Published: 5/2/22 Reference Number: 45664 Version: 7 Purpose: The purpose of this policy is to provide instruction for cleaning the hemodialysis (HD) catheter exit site, changing the catheter dressing... ...Removal of Dressing and Inspection of Site. ...5. Inspect and remove the old dressing... 8. Discard dressing and remove gloves. Perform hand hygiene. Cleaning the Site: Follow the steps below to clean the catheter exit site: ...2. Remove swab stick from package...2% (percent) Chlorhexidine (SP) and 70% alcohol (Chloraprep): Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward in the area of the size of the dressing to be applied in a concentric circle for 30 seconds... 1. An observation was conducted on 2/6/24 at 10:12 AM at station 17 with Employee Identifier (EI) # 4, Registered Nurse (RN), to observe CVC exit site care for PI # 13. EI # 4 removed the old dressing using gloves on the CVC exit site, discarded the old dressing, then proceeded to cleanse the CVC exit site with Chloraprep. EI # 4 failed to remove the gloves used to remove the old CVC exit site dressing and perform hand hygiene prior to cleansing the CVC exit site. An interview was conducted on 2/8/24 at 8:20 AM with EI # 1, Facility Administrator, who confirmed staff failed to follow the facility policy for CVC exit site care. 2. An observation was conducted on 2/6/24 at 10:50 AM at station 3 with EI # 13, RN, to observe CVC exit site care for PI #25. While performing CVC exit site care, EI #13, RN, cleansed the CVC exit site and the skin around the exit site with Chloraprep, then returned to the exit site and cleansed the CVC exit site again, which recontaminated the exit site. An interview was conducted on 2/8/24 at 11:40 AM with EI # 1 who confirmed staff failed to follow the facility policy for CVC exit site care. 40119”

“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: 49603 Based on review of the facility policy, facility Log Readings Report for Total Chlorine (TCL) documentation, and interview, it was determined staff failed to follow the facility policy to perform and document total chlorine testing at least every four hours while patients dialyzed. This had the potential to negatively affect all patients who dialyze at the facility. Findings include: Facility Policy: Carbon Filtration Monitoring for Incenter Central Water Systems Policy Published: 11/07/2022 Reference Number: 46310 Version: 9 Purpose of this policy is to provide instructions to...staff on carbon filtration monitoring of central water systems in Incenter facilities. Test Rationale...Total chlorine testing will be the only testing methodology used to ensure the carbon filters are reducing total chlorine levels below...0.10 ppm (parts per million)...testing for both free chlorine and chloramines. What to Test... Worker Carbon Filter... When to Test... Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours... Routine Total Chlorine Testing will be documented in the approved electronic documentation system... 1. Review of the facility Log Readings Report for TCL dated 2/2/24 revealed the Patient Care Technician tested the chlorine at 10:10 AM and not again until 3:57 PM which was five hours forty-seven minutes and not every four hours per policy. In an interview conducted on 2/7/24 at 12:33 PM, Employee Identifier # 1, Facility Administrator, confirmed staff failed to perform chlorine tests at least every four hours.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 30952 Based on staff interviews, review of facility policy, and the facility GranuFlo (an acid concentrate) Mixing Log documentation, it was determined the facility failed to ensure the staff who prepared a batch of acid concentrate (GranuFlo) and the staff who confirmed the operator’s test results/actions completed the required Dry Acid Dissolution Unit (DADU) batch production record documentation. The deficient practice had the potential to jeopardize the health and safety of the 78 in-center hemodialysis patients who dialyze at this facility. Findings include: Facility Policy Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit (DADU) Published: 09/05/2023 Reference Number: 25910 Version: 7 ...Introduction The DADU...a device used to prepare acid concentrate solution (GranuFlo...) from a dry powder and RO (reverse osmosis) water... Trained Staff Prior to being allowed to operate the DADU, the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include one or more of the following: Preparing of GranuFlo...concentrate batches. Performing specific gravity (ratio of the density of a liquid to the density of water) tests Disinfection procedures Completing batch records using...DADU batch production record...or approved...electronic records system... Acid Concentrate Mixing and Handling: DADU Policy (facility policy). Disposal of acid concentrate if required by state or local requirements. Competency and proficiency training will be documented and maintained in the staff’s personnel record... Batch Records Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation. All data derived by mixing a batch of GranuFlo...concentrate will be recorded on the GranuFlo...Batch Mixing Log... The batch record will contain the following: Case catalog # (number) Each box # Potassium Value... Operator, date, and time ...Solution temperature... Low and high specific gravity Pass/fail checked Operator’s signature Verifier’s signature Time of transfer to holding tank ... A tour of the water treatment room was conducted on 2/6/24 at 1:10 PM with EI (Employee Identifier) # 8, Certified Clinical Hemodialysis Technician). During the tour, EI # 8 reported he/she was a “certified opener and closer” whose responsibilities included GranuFlo preparation, testing and batch documentation. EI # 8 reported the facility mixed/prepared acid twice weekly. Review of the facility GranuFlo Mixing Log for December 2023 revealed no GranuFlo batch production was documented from 12/1/23 to 12/18/23, which was seventeen days. The log documentation revealed only three batches of GranuFlo were prepared for December 2023, on 12/18/23, 12/23/23, and 12/27/23. Review of the facility GranuFlo Mixing Log for January 2024 revealed no GranuFlo batch production was documented from 1/1/24 to 1/23/24, which was twenty-two days. There was documentation only two batches of GranuFlo were prepared in January 2024, on 1/23/24 and 1/30/24. The staff failed to document all acid concentrate batch preparation, quality assurance/safety testing performed, test results, and reviewer verification on the GranuFlo Mixing Log after acid batch completion per facility policy during December 2023 and January 2024. An interview was conducted on 2/7/24 at 12:45 PM with EI # 2, Charge Nurse who reported based on facility census, and dialysis treatment time, the minimal number of times GranuFlo is mixed/prepared for patient use was eight to ten times a month. EI # 2 confirmed staff had failed to ensure GranuFlo batch preparation was documented, final verification of batch testing was performed, and verified by two qualified staff members at the end of the batch preparation per facility policy.”

“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: 30952 Based on review of facility policy, manufacturer’s instructions for use (IFU), staff interviews, the facility GranuFlo Mixing log, and personnel files, the facility failed to implement an ongoing training program designed to evaluate staff’s proficiency and maintain the operator’s knowledge, which includes periodic actual observation of skills for four of five staff members who were assigned the responsibility for preparing, testing, and batch production documentation for GranuFlo acid Concentration. The failure to train staff and implement an ongoing training program did not allow the facility to periodically evaluate staff competency and procedural compliance. This failed practice did not ensure staff had knowledge and/or maintained their knowledge and skills to care for the complex needs of the 78 in-center hemodialysis patients receiving care at this facility and placed the patients at risk for severe injury or death. Findings include: Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit Published: 09/05/23 Reference Number: 25910 Version: 7 Purpose This document defines Dry Acid Dissolution Unit (DADU)...and details...policy regarding the operation and disinfection requirements of the DADU. Introduction The DADU is a device used to prepare acid concentrate solution (GranuFlo...) from a dry powder and RO (reverse osmosis-purified water) at a central location... Responsibility ...CM (clinical manager)...Ensure facility staff is trained in use of the DADU mixer. ...Medical Director...The day-to-day responsibility for maintaining water quality lies with the health care professionals...under the leadership of the facility’s Medical Director. Acronyms and Definitions ...GranuFlo...an acid concentrate used for bicarbonate-based dialysis that uses acetic acid as the primary acidifying agent. ...Operator...A staff member that meets the qualifications...is the primary staff member making the current batch of acid concentrate. Specific Gravity...The ratio of the density of a liquid to the density of water. Verifier...A staff member that meets the qualifications...that will confirm the operator’s test results/actions when required or will repeat the required test/actions themselves and document as required. Manufacturer IFU The DADU will be operated in accordance with the manufacturers printed IFU in the DADU Operators Manual. Trained Staff Prior to being allowed to operate the DADU the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include one or more of the following areas: Preparing of GranuFlo...concentrate batches. Performing specific gravity tests. Disinfection procedures. Completing batch records... Acid Concentrate Mixing and handling: DADU Policy.... Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation thereafter. Quality Assurance Testing Final verification of the batch is done through the measurement of the batch temperature...followed by a specific gravity test with a comparison of these results...GranuFlo Dry Acid Table of Specific Gravities... Batch Records Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation... GranuFlo Concentrate Dissolution Unit 1 Version 2 Operators Manual IFU Page 1 Important Safety Symbols and Instructions ...Proper training and demonstrated user competence must be completed and documented before a designated operator can be authorized to use the GranuFlo Dissolution Unit to make acid concentrate. Review of the facility December 2023, January 2024, and February 2024 GranuFlo Mixing Log documentation revealed the following: On 12/18/23, EI (Employee Identifier) # 14, CCHT (Certified Clinical Hemodialysis Technician), date of hire (DOH) 7/14/14 documented both preparation of the GranuFlo and review/verification of accuracy of the GranuFlo preparation. On 12/23/23, EI # 15, CCHT, DOH 4/7/21, documented the review/verification of accuracy, and EI # 8, CCHT, DOH 1/7/19 documented GranuFlo preparation and log completion. On 12/27/23, EI # 14, documented the GranuFlo preparation and GranuFlo Log completion. On 1/23/24, EI # 16, PCT (Patient Care Technician), DOH 9/19/22, documented the review/verification and EI # 15 documented GranuFlo preparation and log completion. On 1/30/24, EI # 15 documented review/verification and EI # 16 documented GranuFlo preparation and log completion. On 2/5/24, EI # 8 documented the review/verification for accuracy and EI # 16 documented GranuFlo preparation and log completion. Review of personnel files for EI # 14, EI # 15, EI # 16, and EI # 8 failed to include validation of successful training for the facility dry acid dissolution system and hydrometer use for acid concentrate mixing, preparation, and handling. The facility failed to ensure all staff were trained and competent to perform operational responsibilties for GranuFlo batch preparation and quality assurance testing. Further review of the personnel files for EI # 14, EI # 15, EI # 16, and EI # 8 revealed no documentation the Medical Director certified the employees had demonstrated water skill competencies for GranuFlo mixing, preparation, quality/safety testing, and review/verification. An interview was conducted on 2/7/24 at 12:45 PM with EI # 2, Charge Nurse, who verified there was no documentation the four employees were trained, competent and certified by the Medical Director for GranuFlo acid batch production.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 49603 Based on observations, review of facility policies, the Combiset True Flow Series manufacturer’s directions for use (DFU) and staff interviews, it was determined the facility failed to ensure: 1. Medications located at the nurse’s station and available for use, were not expired. 2. The staff followed the Combiset True Flow Series manufacturer’s DFU during dialysis treatments by maintaining the arterial and venous drip chambers (pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at the required fill level. 3. Water treatment test strips available for use were not expired. 4. Equipment on the dialysis treatment floor had been inspected for safety, which included a portable electric heater. This did affect unsampled patient # 1, Patient Identifier (PI) # 28, and PI # 20, four of five observations of care and had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: Fresenius Medical Care Combiset True Flow Series manufacturer’s DFU Published: Not documented Priming Precautions: ...5. Prime pre-pump arterial chamber 85 to 95 % full...post-pump arterial and venous chambers 65 to 75% full. Dialysis Treatment Precautions- ...b. Maintain fluid level in pre-pump arterial drip chamber at 85 to 95% full, post pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during treatment due to changes in pressure or flow rate. Readjust levels as needed. During Termination of the Treatment: a. Maintain a proper fluid level in chambers to ensure that no air is returned to the patient. Facility Policy: Medication Preparation and Administration Reference Number: 47488 Published: 02/06/2023 Version: 9 Purpose: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. Responsibility: Licensed nursing staff... Monitoring Expired Medications Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and / or state law. 1. A tour of the water treatment area was conducted on 2/5/24 at 10:45 AM with EI (Employee Identifier) # 9, Biomedical Technician. Observations conducted during the tour of the water treatment area revealed the following expired supplies: One bottle of Water Check Residual Chlorine test strips and the expiration date on the bottle was 12/2023. One bottle of Mesa labs (brand name) Standard Buffer Solution 7.0 pH (potential of hydrogen) and the expiration date on the bottle was 1/25/24. One bottle of HACH (brand name) Steri Chek Low Range Water Hardness strips and the expiration date on the bottle was 01/2024. An interview was conducted on 2/5/24 at 11:00 AM with EI # 9 who confirmed the supplies available for use were expired. 2. Observations of care were conducted on 2/5/24 at 10:55 AM and revealed one bottle of Water Check RC Residual Chlorine test strips with the expiration date of 10/23. An interview was conducted on 2/8/24 at 8:20 AM with EI # 1, Facility Administrator, who confirmed the test strips available for use were expired. 3. Observations of the dialysis treatment floor were conducted on 2/5/24 at 11:15 AM and revealed one bottle of Water Check RC Residual Chlorine test strips with the expiration date of 12/2023. An interview was conducted on 2/5/24 at 11:16 AM with EI # 11, CCHT (Certified Clinical Hemodialysis Technician) who confirmed the test strips available for use were expired. 4. An observation of care was conducted on 2/5/24 at 11:40 AM at station ten for an unsampled patient. The surveyor observed the arterial drip chamber less than 40 % full. An interview was conducted on 2/5/24 at 11:42 AM with EI # 8, CCHT, who confirmed the arterial drip chamber was not at the required fill level. EI # 8 promptly filled the chamber level as required per policy and manufacturer’s DFU. 5. An observation of care was conducted on 2/5/24 at 11:59 AM at station 20 on PI # 28. The surveyor observed the arterial drip chamber was empty, causing air bubbles in the blood lines and dialyzer. The venous chamber was completely full, causing the pressure lines and transducer cover to become full of fluid. They remained this way until termination of treatment at 12:23 PM. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1 who confirmed the arterial drip chamber and venous chamber were not filled per the facility policy and manufacturer’s DFU. 6. A tour was conducted on 2/5/24 at 12:33 PM of the nurse’s station. The following medications were expired and available for patient use: Atropine Sulfate injection 1 mg (milligram) per 10 mL (milliliter) x 7 with the expiration date of 11/23. 10 % Calcium Chloride injection 1000 mg/mL (100 mg/mL) x 4 with the expiration date of 1/01/24. 25 % Mannitol Injection 12.5 g (grams) / 50 mL (250 mg/mL) x 21 with an expiration date of 12/01/23. An interview was conducted on 2/5/24 at 1:32 PM with EI # 2, Charge Nurse, who confirmed the expired medications were available for patient use. 7. An observation of care was conducted on 2/6/24 at 8:00 AM at station # 12 for PI # 20 when the surveyor observed the arterial drip chamber less than 30% full. The drip chamber remained at this level until 8:40 until dialysis was discontinued. An interview was conducted on 2/8/24 at 8:20 AM with EI # 1 who confirmed the arterial drip chamber was not filled per the facility policy and manufacturer’s DFU. 8. Observations of care conducted on the dialysis treatment floor on 2/6/24 at 8:25 AM revealed one bottle of HACH Steri Chek Sensitive Low-Range Water Hardness Reagent strips. The expiration date on the bottle was 01/2024. An interview was conducted on 2/6/24 at 8:26 AM with EI # 7, CCHT who confirmed the Reagent strips available for use had expired. 9. During observations of care on the dialysis treatment floor on 2/6/24 at 10:50 AM, the surveyor observed a portable heater plugged into an electrical outlet which was powered on stored under the nurse desk. An interview was conducted on 2/6/24 at 10:52 AM with EI # 9 who observed the heater on the treatment floor. EI # 9 confirmed the portable heater had not been inspected for safety and should not be on the treatment floor. 49894 30952 49797”

“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: 49894 Based on observations, review of facility policy, and staff interviews it was determined the facility failed to ensure that patients kept their access visible during dialysis treatment. This affected Patient Identifiers (PI) # 22, PI # 28, PI # 31, PI # 14, PI # 7, PI # 18, and PI # 29 in observation over two of three survey days and had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 9/29/18 Reference Number: Not documented Version: 3 ...Monitoring During Treatment: Follow the steps below for monitoring patient ...during treatment: ...2: During nursing rounds, the Registered Nurse will review the data collected and assess the following parameters as needed: ...Access: Observe connections are secure and visible. ...Ensure access remains uncovered throughout the treatment Observe and ensure: ...Tape is secure...Needles are intact...No bleeding or infiltration is noted. 1. During a treatment floor observation on 2/5/24, the surveyor observed the following patients with vascular access sites covered: PI # 22 access site was covered from 10:54 AM to 11:17 AM, which was 23 minutes. PI # 28 access site was covered from 10:55 AM to 11:22 AM, which was 27 minutes. PI # 31 access site was covered from 8:00 AM through 11:04 AM, which was 184 minutes. PI # 14 access site was covered from 11:08 AM through 12:42 PM, which was 94 minutes. PI # 7 access site was covered from 11:11 AM to 12:48 PM, which was 59 minutes. PI # 7 then recovered the access site from 12:50 PM to 1:10 PM, which was 20 minutes. An interview was conducted on 2/7/24 at 11:40 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed it is facility policy for patient accesses to be uncovered and visible during treatment. 2. During a treatment floor observation on 2/6/24, the surveyor observed the following patients with vascular access sites covered: PI # 18 access site was covered from 7:53 AM through the end of treatment at 8:43 AM, which was 50 minutes. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1 who confirmed it is facility policy for patient accesses to be uncovered and visible during treatment. 3. An observation was conducted on 2/6/24 at 8:00 AM for the discontinuation of dialysis with a Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) with EI # 8, Certified Clinical Hemodialysis Technician (CCHT) at station 4 for PI #29. The patient’s access was covered during treatment, EI # 8 reinfused the extracorporeal circuit then uncovered the patient’s access. The patient’s cannulation sites were bleeding, saturating the patient’s underwear and blanket when EI # 8 uncovered the patient’s access. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1 who confirmed it is facility policy for patient accesses to be uncovered and visible during treatment. 40119”

“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: 49894 Based on review of medical records (MR), observations, facility policies, and staff interviews it was determined the facility failed to ensure treatments and medications were administered per physician’s order for: 1. Dialysate bath. 2. Heparin Lock Flush to CVC (Central Venous Catheter). This affected Patient Identifiers (PI) # 7, one of seven MR’s reviewed and PI # 9, one of five observation of care, and had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: Facility Policy: Pretreatment Safety Checks Procedure Published: 2/6/23 Reference Number: 47798 Version: 3 Predialysis Safety Checks Verify the following by two direct patient care staff members prior to treatment initiation ...Prescribed dialysate composition: ...Verify proper delivery of dialysate prescription: Machine is connected to an acid concentrate that matches prescription. Verify by matching label on valve panel or concentrate jug. ...After the patient is seated: The clinician initiating treatment must verify the prescription set up matches the patient: ...Dialysate concentration Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose: to administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. ...Medication orders: Medications must be administered with an order by a physician (or physician extender where allowed) on the medical staff of the facility. ...Preparing and Administering Medications During Hemodialysis Treatment: Prior to administration of the medication: ...Verify there is a physician order. 1. PI # 7 was admitted to the facility on 11/22/21 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet dated 2/2/24 revealed the nurse documented a heparin lock flush was administered. Review of the Physician Orders revealed no documentation of a physician order for a heparin lock flush. An interview was conducted on 2/7/24 at 11:40 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed there was no documentation of a physician’s order for a heparin lock flush for PI # 7. 40119 2. PI # 9 was admitted to the facility on 8/3/19 with a diagnosis of ESRD. Review of the Hemodialysis orders dated 1/9/24 revealed an order for a 2.0 K (potassium) and 3.0 Ca (Calcium) bath. A observation of care was conducted on 2/6/24 at 7:55 AM to verify the bath for PI # 9 at station 16. The surveyor observed PI # 9 was dialyzing with a 2.0 K and 2.5 Ca bath. The staff failed to provide the physician ordered 3.0 Ca bath on 2/6/24 for PI # 9. An interview was conducted on 2/8/24 at 8:17 AM with EI # 2, Charge Nurse, who confirmed staff failed to dialyze the patient with the physician ordered bath.”

“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: 49894 Based on observations, review of facility policy, medical record (MR) and staff interviews, it was determined the facility failed to ensure: 1. The Registered Nurse (RN) staff performed post-treatment patient assessments per policy. 2. The staff notified the nurse with abnormal changes in the patient’s condition, including changes in the blood pressure (BP) and pulse. 3. The nurse and/or physician was notified of the patient leaving 1.0 kg (kilograms) over or below the EDW (Estimated Dry Weight). This affected Patient Identifiers (PI) # 1, PI # 4, PI # 6, PI # 3 and PI # 5, five of seven MR’s reviewed, PI # 28, PI # 22, and PI # 23, three of eight discontinuation of dialysis with an Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) observations, PI # 26, one of five discontinuation of dialysis with a Central Venous Catheter (CVC), and had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 9/29/18 Reference Number: Not documented Version: 3 Pre-Treatment Assessment and Data Collection... Post-Treatment... An abnormal finding confirmed by the RN will be reported to the attending physician... ...Monitoring During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed... Follow the steps below for monitoring patient...parameters during treatment. 1. Blood Pressure...Report to nurse: ...Diastolic greater than 100 mm/Hg (millimeter of mercury). BP less than or equal to 100 mm/Hg Systolic. ...Pulse...Report to the nurse patients whose heart rates have dropped below 60, risen above 100... Post-Treatment: ... The RN will assess/re-assess any findings addressed pre-treatment prior to discharge. During Nursing rounds, the RN will review the data collected by direct patient care staff and assess the following parameters as needed: Assess patient for symptoms: The nurse should ask the patient if they had shortness of breath, chest pain or cough, cramping, loss of appetite or vomiting or diarrhea. Lung Sounds: Auscultate the lungs sounds for ... Edema: Assess the patient for edema Heart: Listen for: rate and rhythm Post-Treatment Assessment and Data Collection: Follow the steps for post-treatment data collection: Weight: Obtain the patient’s post weight. Ensure the post weight is consistent with the goal set of the machine. ...Lung Sounds, Edema, Heart Sounds: The RN will assess/re-assess post treatment as indicated. 1. PI # 1 was admitted to the facility on 8/5/21 with a diagnosis of End Stage Renal Disease (ESRD). Review of the treatment sheets dated 1/24/24, 1/26/24, 1/29/24, 1/31/24, 2/2/24, and 2/5/24 revealed the nurse documented pitting edema on the Pre-treatment Nursing Assessment. There was no documentation the edema was assessment on the post-treatment assessment. An interview was conducted on 2/7/24 at 11:40 am with Employee Identifier (EI) # 1, Facility Administrator, who confirmed the nurse failed to follow the facility policy for post-treatment nursing Assessment. 2. An observation was conducted on 2/5/24 at 12:23 PM with EI # 6, Certified Clinical Hemodialysis Technician (CCHT), for the discontinuation of dialysis with a AVF/AVG on PI # 28 at station 20. After EI # 6 discontinued the dialysis treatment, PI # 28 walked to the scales and exited the treatment floor without a post treatment assessment conducted by the RN to include evaluation of lung sounds, edema, and heart sounds. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1 who confirmed the RN failed to follow the facility policy and conduct a post treatment patient assessment. 3. An observation of care was conducted on 2/5/24 at 12:31 PM during discontinuation of dialysis and post access care for an AVF/AVG for PI # 22 at station five. EI # 12, RN, reinfused the extracorporeal circuit, placed the temperature strip in PI # 22’s mouth, then exited the station. After EI # 16, PCT (Patient Care Technician), removed the needles and hemostasis was achieved, EI # 16 assisted PI # 22 to the scales via wheelchair. PI # 22 exited the treatment floor without a post treatment assessment conducted by the RN to include evaluation of lung sounds, edema, and heart sounds. An interview was conducted on 2/8/24 at 8:30 AM with EI # 1 and EI # 3, Director of Operations who confirmed the RN failed to follow the facility policy and conduct a post treatment patient assessment. 4. An observation was conducted on 2/5/24 at 2:20 PM with EI # 12, RN, to observe the discontinuation of dialysis using a CVC for PI # 26, at station 14. After EI #12 discontinued the dialysis treatment, PI # 26 walked to the scales then exited the treatment floor without a post treatment assessment conducted by the RN to include evaluation of lung sounds, edema, and heart sounds. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1 who confirmed the RN failed to follow the facility policy and conduct a post treatment patient assessment. 30952 5. An observation of care was conducted on 2/5/24 at 12:47 PM during discontinuation of dialysis and post access care for an AVF/AVG for PI # 23 at station one. EI # 12, RN assisted in holding pressure to needle site one, and exited the station. EI # 16 held pressure to needle site two. After hemostasis was achieved EI # 16 accompanied PI # 23 to the scales. PI # 23 exited the treatment floor without a post treatment assessment conducted by the RN to evaluate lung sounds, edema, and heart sounds. An interview was conducted on 2/8/24 at 8:30 AM with EI # 1 and EI # 3 who confirmed the nurse failed to follow the facility policy for post treatment patient assessment. 6. PI # 4 was admitted to the facility on 1/5/21 with a diagnosis including ESRD. Review of the Treatment Sheet dated 1/30/24 revealed at 5:00 AM the treatment was initiated, and the treatment was terminated at 8:39 AM. The was no RN post treatment assessment evaluation of heart and lung sounds, and edema documented. An interview was conducted on 2/8/24 at 11:50 AM with EI # 1 who confirmed the RN failed to conduct and document a post treatment patient assessment of heart and lung sounds and edema. 40119 7. PI # 6 was admitted to the facility on 5/27/21 with a diagnosis of ESRD. Review of the Treatment Sheet dated 12/28/23 revealed the following: 10:10 AM, the patient’s BP was 98/82 with a pulse of 107. 11:00 AM, the patient’s pulse was 105. 11:30 AM, the patient’s BP was 120/102 with a pulse of 44. There was no documentation the PCT notified the nurse of the diastolic BP above 100, systolic BP below 100, pulse below 60, and pulse above 100 per the facility policy. Review of the Treatment Sheet dated 12/30/23 revealed the following: 10:31 AM, the patient’s BP was 89/73 with a pulse of 56. 11:31 AM, the patient’s pulse was 106. 12:03 PM, the patient’s BP was 89/45 with a pulse of 114. After immediately re-checking, the patient’s BP was 95/50 with a pulse of 101. 12:32 PM, the patient’s BP was 97/82. There was no documentation the PCT notified the nurse of the systolic BP below 100, pulse below 60, and pulse above 100 per the facility policy. Further review of the Treatment Sheet dated 12/30/23 revealed no documentation of a pretreatment and post treatment nursing assessment. Review of the Treatment Sheet dated 1/2/24 revealed the following: 11:00 AM, the patient’s BP was 91/51 with a pulse of 113. 12:08 PM, the patient’s BP was 90/57. 1:06 PM, the patient’s pulse was 110. 1:35 PM, the patient’s BP was 90/52. There was no documentation the PCT notified the nurse of the systolic BP below 100 and pulse above 100 per the facility policy. An interview was conducted on 2/7/24 at 11:39 AM with EI # 1 who confirmed there was no documentation the nurse was notified of the blood pressure and pulse per policy. 49797 8. PI # 5 was admitted to the facility on 1/8/24 with a diagnosis of ESRD. Review of the Hemodialysis orders dated 2/5/24, revealed an EDW of 114 kg Review of treatment sheet dated 1/26/24, revealed a post weight of 115.30 kg. There was no documentation the physician was notified of the post EDW greater than 1.3 kg. Review of treatment sheet dated 1/29/24, revealed a post weight of 115.70 kg. There was no documentation the physician was notified of the post EDW greater than 1.7 kg. An interview was conducted on 2/7/24 at 12:26 PM with EI # 18, Charge Nurse II, who confirmed the nurse failed to notify the physician of the post EDW greater than 1 kg. 9. PI # 3 was admitted to the facility on 12/27/23 with a diagnosis of ESRD. Review of the Hemodialysis orders dated 2/5/24, revealed an EDW of 95.5 kg. Review of treatment sheet dated 1/24/24, revealed a post weight of 98.3 kg. There was no documentation the physician was notified of the post EDW greater than 2.8 kg. Review of treatment sheet dated 1/26/24, revealed a post weight of 96.9 kg. There was no documentation the physician was notified of the post EDW greater than 1.4 kg. Review of treatment sheet dated 1/29/24, revealed a post weight of 97.4 kg. There was no documentation the physician was notified of the post EDW greater than 1.9 kg. Review of treatment sheet dated 2/5/24, revealed a post weight of 96.8 kg. There was no documentation the physician was notified of the post EDW greater than 1.3 kg. An interview was conducted on 2/7/24 at 12:39 PM with EI # 1 who confirmed the nurse failed to notify the physician of the post EDW greater than 1 kg.”

“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: 49894 Based on observations, review of facility policies, review of medical records (MR), and staff interviews, it was determined that the facility failed to ensure: 1. Staff followed physician’s orders for Blood Flow Rate (BFR). 2. Staff followed physician’s orders for Dialysate Flow Rate (DFR). 3. Against Medical Advice (AMA) forms were completed and signed by the patient(s) for each early treatment termination event per the facility policy. This affected Patient Identifiers (PI) # 18, one of five treatment floor observations, PI # 7, PI # 1, PI # 4, PI # 2 , PI # 6, PI # 3 and PI # 5 seven of seven MR’s reviewed, and had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 9/29/18 Reference Number: Not documented Version:3 Policy: ...Monitoring During Treatment. ...Machine Parameters and Extracorporeal Circuit: Check machine settings and measurements ...Check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and prescribed flow is being delivered. ...Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes... Facility Policy: Access Flow Rate Testing Published 9/4/19 Version: 4 Procedure: Machine Programming for Access Flow Monitoring Follow the steps ...for access flow testing 1. Prior to initiating the patient’s treatment, enable OLC and program 6 OLC tests. ...3. ...initiate dialysis with a maximum blood flow rate of 300ml/min. If patient’s prescribed blood flow rate is greater than 300ml/min, the flow should stay at 300 until completion of the test. 4. NOTE: Access flow test requires a minimum blood flow rate of 300ml/min in order to evaluate the flow of the access. 5. The first OLC test will begin approximately 15 minutes after the start of dialysis. 6. Upon completion of this OLC test approximately 25 minutes from the start of dialysis... ...8. If unable to continue Acess Flow (AF) testing, disable access flow, return blood flow to prescribed/achievable flow rate. Document AF test discontinued. ...14. Access flow testing takes 10-12 minutes. ...18. Press confirm, start blood pump, and increase the blood flow to the prescribed/achievable BFR. Facility Policy: Early Termination or Arriving Late for Treatment Published: 11/7/22 Reference Number: 45263 Version: 3 Purpose: The purpose of this policy is to provide guidelines for staff when patients...request early termination of treatment... Background: Treatment duration...is prescribed by a patient’s physician... Serious health related consequences may result from...terminating treatments earlier than prescribed. Early Termination: If a patient insists on terminating treatment early...the patient must take full responsibility for consequences of the...shortened treatment. If a patient requests to leave treatment early: ...The RN (Registered Nurse) who evaluates the patient must document the rationale for early termination and reinforce the consequences of not receiving the entire prescribed treatment. The RN is responsible to...document on the...AMA form... AMA forms are: Signed by the patient and witnessed by the supervising nurse... Signed with each early termination event and filed in the patient’s medical record... 1. A treatment floor observation was conducted on 2/6/24 at 7:53 AM, to verifiy the Hemodialysis prescription verification for PI # 18, at station 5 with Employee Identifier (EI) # 15, Certified Clinical Hemodialysis Technician (CCHT). EI # 15 verified the patient’s BFR was 300 and verbalized the patient was at a BFR of 300 for AF testing. The patient’s prescribed BFR is 475. Review of the Treatment Sheet (TS) dated 2/6/24 revealed the patient’s treatment started at 4:54 AM with a BFR of 300 ml/min until 9:00 AM which was 4 hours and 6 minutes. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1, Facility Administrator, who confirmed the staff failed to follow the facility AF Testing. 2. PI # 7 was admitted to the facility on 11/22/21 with a diagnosis of ESRD. Review of the TS dated 2/2/24 revealed a HDO for a BFR of 450 and DFR of 800 . Review of the TS dated 2/2/24 revealed the treatment was started at 10:46 AM with a BFR of 350 and DFR of 500. The 350 BFR and 500 DFR continued until 11:30 AM and was changed to BFR of 450 and DFR of 800. At 12:31 PM the BFR was changed to 350 and DFR was changed to 500. There was no documentation of the reason the BFR was not at the ordered rate of 450 and DFR of 800. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1 who confirmed staff failed to follow physician orders for BFR. 3. PI #1 was admitted to the facility on 8/5/21 with a diagnosis of ESRD. Review of the TS’s dated 1/26/24, 1/29/24, and 1/31/24 revealed a HDO for a treatment time of 4 hours with a BFR of 350. Review of the TS dated 1/26/24 revealed the patient’s treatment started at 6:25 AM with the BFR of 350. At 7:02 AM the BFR was increased to 400, which continued until the end of treatment at 10:28 AM. There was no documentation of the reason the BFR was not at the ordered rate of 350. Review of the TS dated 1/29/24 revealed the patient’s treatment started at 6:35 AM with BFR of 400, which continued until the treatment ended at 10:34 AM. There was no documentation of the reason the BFR was not at the ordered rate of 350. Review of the TS dated 1/31/24 revealed the patient’s treatment started at 6:22 AM and ended at 8:53 AM, which was 2 hours and 31 minutes. There was no AMA early treatment termination form completed by the nurse and signed by the patient. An interview was conducted on 2/7/24 at 11:40 AM, with EI #1 who confirmed the staff failed to follow the facility AMA policy and physician’s orders for BFR. 30952 4. PI # 4 was admitted to the facility on 1/5/21 with a diagnosis including ESRD. Review of the HDO dated 9/9/23 revealed physician’s orders for BFR of 450 and treatment time three hours thirty minutes three times a week. Review of the TS dated 1/23/24 revealed the treatment was started at 5:10 AM with a BFR 350. The 350 BFR continued throughout the treatment, which ended at 7:43 AM. There was no documentation of the reason the BFR was not at the ordered rate of 450. Review of the TS dated 1/26/24 revealed the treatment was started at 6:45 AM and ended at 8:31 AM. There was no documentation an AMA form was signed by the patient for the one hour forty-six minute treatment. Review of the TS dated 1/27/24 revealed the BFR was 400 at 5:03 AM. The BFR remained at 400 until the end of the treatment at 8:15 AM. There was no documentation of the reason the BFR was not at the ordered rate of 450. Review of the TS dated 1/30/24 revealed the BFR was 350 at 5:00 AM, treatment initiation. The BFR remained at 350 until the end of the treatment at 8:39 AM. There was no documentation of the reason the BFR was not at the ordered rate of 450. Review of the TS dated 2/2/24 revealed the dialysis treatment began at 9:35 AM and ended at 11:35 AM, for a treatment time of two hours. There was no AMA early treatment termination form completed by the nurse and signed by the patient. Review of the TS dated 2/3/24 revealed the dialysis treatment began at 10:32 AM and ended at 1:04 PM, for a treatment time of two hours thirty-five minutes. There was no AMA early treatment termination form completed by the nurse and signed by the patient. An interview was conducted on 2/8/24 at 11:50 AM with EI # 1 who confirmed staff failed to follow physician’s orders for BFR and failed to document AMAs per facility policy. 40119 5. PI # 2 was admitted to the facility on 5/25/23 with a diagnosis of ESRD. Review of the HDO dated 2/3/24 revealed physician’s orders for DFR of 500. Review of the TS dated 2/3/24 revealed the treatment was started at 7:40 AM with a DFR of 500. At 9:01 AM the DFR was documented as 800, which continued until 10:30 AM. There was no documentation of the reason the DFR was not at the ordered rate of 500. An interview was conducted on 2/7/24 at 12:29 PM with EI #1 who confirmed staff failed to follow physician orders for DFR. 6. PI # 6 was admitted to the facility on 5/27/21 with a diagnosis of ESRD. Review of the HDO dated 11/7/23 revealed physician’s orders for a treatment time of 3 hours and 45 minutes. Review of the TS dated 12/12/23 revealed the treatment was started at 9:55 AM and ended at 1:23 PM. There was no documentation an AMA was signed by the patient for the 3 hours and 28 minute treatment. Review of the TS dated 12/28/23 revealed the treatment was started at 9:55 AM and ended at 11:49 AM. There was no documentation an AMA was signed by the patient for the 1 hour and 54 minute treatment. An interview was conducted on 2/7/24 at 11:39 AM with EI # 1 who confirmed staff failed to document AMAs per facility policy. 49797 7. PI # 3 was admitted to the facility on 12/27/23 with a diagnosis of ESRD. A review of the HDO dated on 2/5/24, revealed an ordered treatment time of four hours, BFR 400 and DFR 800. Review of the treatment sheet dated 1/24/24, revealed a treatment time 2:50 which was one hour and ten minutes early. Review of the treatment sheet dated 2/2/24, revealed the DFR was decreased to 500 at 11:02 AM to 12:00 PM then decreased again to 500 at 12:32 PM until 1:34 PM. There was no documentation of reason or physician order to decrease the DFR. Review of the treatment sheet dated 2/5/24, revealed a treatment time 2:55 which was one hour and five minutes early. An interview was conducted on 2/7/24 at 12:31 PM with EI # 1 who confirmed there was no AMA form completed and no reason or physician order to decrease the DFR. 8. PI # 5 was admitted to the facility on 1/8/24 with a diagnosis of ESRD. A review of the HDO dated 2/5/24, revealed an ordered BFR of 400 and DFR of 700. A review of treatment sheet dated 1/24/24, revealed the BFR was decreased to 350 at 11:33 AM until 1:30 PM then decreased to 350 at 2:04 PM to 2:45 PM end of treatment. There was no documentation of reason or physician order to decrease the BFR. A review of treatment sheet dated 1/31/24, revealed the BFR was decreased to 350 at 11:31 AM, then decreased to 300 at 12:01 PM. At 12:52 PM the BFR was 300 and DFR 500 until 3:01 PM end of treatment. There was no documentation of reason or physician order to decrease the BFR and DFR. An interview was conducted on 2/7/24 at 12:31 PM with EI # 1 who confirmed there was no documentation of reason or physician order to decrease the BFR and DFR.”

“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: 49894 Based on medical record (MR) review and staff interview, it was determined the facility failed to ensure staff administered Intravenous (IV) Mircera (IV medication used for treatment of anemia in patients with chronic kidney disease) per physician’s order. This affected Patient Identifier (PI) # 7, PI # 6, and PI # 5, three of seven MR’s reviewed, and had the potential to negatively affect all patients who are dialyzed at the facility. Findings include: 1. PI # 7 was admitted to the facility on 11/22/21 with a diagnosis of ESRD (End Stage Renal Disease). Review of the Orders Summary Review dated 1/17/24 revealed an order for IV Mircera 225 mcg (micrograms) to be administered during dialysis every two weeks. Review of 6 Treatment Sheets (TS) dated 1/24/24 to 2/5/24 revealed the dose of Mircera was ordered for 1/17/24 and not administered. It was not rescheduled and administered until 1/31/24. An interview was conducted on 2/7/24 at 11:40 AM with EI # 1, Facility Administrator, who confirmed on 1/17/24 the Mircera was not administered per physician’s order. 40119 2. PI # 6 was admitted to the facility on 5/27/21 with a diagnosis of End Stage Renal Disease. Review of the Orders Summary Report dated 10/31/23 revealed an order for IV Mircera 50 mcg to be administered during dialysis every four weeks. Review of TS dated 12/28/24 and 12/30/24 revealed the last dose of Mircera was administered on 11/28/23. There was no documentation the Mircera was administered per the physician’s order of every four weeks. An interview was conducted on 2/7/24 at 11:39 AM with EI # 1 who confirmed the Mircera was not administered per the physician’s order. 49797 3. PI # 5 was admitted to the facility on 1/8/24 with a diagnosis of ESRD. A review of the Orders Summary Report dated 1/23/24 revealed an order for IV Mircera 75 mcg to be administered during dialysis every 2 weeks. Review of the treatment sheets dated 1/29/24, 1/31/24 and 2/2/24, revealed there was no dose of Mircera administered as ordered by the physician. An interview was conducted on 2/7/24 at 12:26 PM with EI # 18, Charge Nurse II, who confirmed the Mircera was not administered per physician’s order.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 40119 Based on review of the facility Quality Assessment and Performance Program (QAPI), facility policy and staff interviews, it was determined the facility failed to implement a plan to ensure improvement for the water system and meters/test strips was achieved and sustained. This had the potential to negatively affect all patients who dialyzed at the facility. Findings include: Facility Policy: QAPI Published: 5/2/22 Reference Number: 25799 Version: 5 Purpose: This policy outlines the purpose, structure, and required activities of the facility QAPI Program. Policy: ...QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. ...QAPI Meeting Objectives: The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement...action plans that result in sustainable improvements in patient care. Elements to be reviewed will include: ...Technical Operations, including water and dialysate quality and safety... An effective and successful review of the QAPI meeting and program activies will include: ...Prioritizing identified opportunities for improvement. Performing a Root Cause Analysis on the identified opportunities... Following a Root Cause Analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have potential to affect patient health and safety as a higher priority... The facility must take immediate and appropriate actions to address any serious threats and ensure patient safety. 1. An interview was conducted on 2/6/24 at 1:10 PM with EI (Employee Identifier) # 8, Certified Clinical Hemodialysis Technician). EI # 8 reported he/she was a “certified opener and closer” whose responsibilities included GranuFlo preparation, testing and batch documentation. EI # 8 reported the facility mixed/prepared acid twice weekly. Review of the facility GranuFlo Mixing Log for December 2023 revealed no GranuFlo batch production was documented from 12/1/23 to 12/18/23, which was seventeen days. The log documentation revealed only three batches of GranuFlo were prepared for December 2023, on 12/18/23, 12/23/23, and 12/27/23. The staff failed to document all acid concentrate batch preparation, quality assurance/safety testing performed, test results, and reviewer verification on the GranuFlo Mixing Log after acid batch completion per facility policy during December 2023. An interview was conducted on 2/7/24 at 12:45 PM with EI # 2, Charge Nurse who reported based on facility census, and dialysis treatment time, the minimal number of times GranuFlo is mixed/prepared for patient use was eight to ten times a month. EI # 2 confirmed staff failed to ensure GranuFlo batch preparation was documented, final verification of batch testing was performed, and verified by two qualified staff members at the end of the batch preparation per facility policy. Review of the facility QAPI documentation revealed the Water Quality Logs for December 2023 contained the following: “Granuflo - Only 3 entries for the month. No entries prior to 12/18.” Further review of the facility QAPI program revealed no documented root cause analysis, action plan or actions taken to address the GranuFlo preparation/mixing entries for the month of December 2023. The facility failed to take actions which would result in performance improvements for the identified issue with the GranuFlo preparation/mixing entries in the month of December 2023. An interview was conducted, during the review on 2/8/24 at 9:17 AM, with EI # 2 who confirmed the facility had not performed a root cause analysis, created an action plan or taken actions to address the GranuFlo preparation/mixing entries for the month of December 2023.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 40119 Based on review of facility policy, manufacturer’s instructions for use (IFU), staff interviews, the facility GranuFlo Mixing log, and personnel files, it was determined the Medical Director failed to implement an ongoing training program designed to evaluate staff’s proficiency and maintain the operator’s knowledge, which includes periodic actual observation of skills for four of five staff members who were assigned the responsibility for preparing, testing, and batch production documentation for GranuFlo acid Concentration. The failure to train staff and implement an ongoing training program did not allow the facility to periodically evaluate staff competency and procedural compliance. This failed practice did not ensure staff had knowledge and/or maintained their knowledge and skills to care for the complex needs of the 78 in-center hemodialysis patients receiving care at this facility and placed the patients at risk for severe injury or death. Findings include: Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit Published: 09/05/23 Reference Number: 25910 Version: 7 Purpose This document defines Dry Acid Dissolution Unit (DADU)...and details...policy regarding the operation and disinfection requirements of the DADU. Introduction The DADU is a device used to prepare acid concentrate solution (GranuFlo...) from a dry powder and RO (reverse osmosis-purified water) at a central location... Responsibility ...Medical Director...The day-to-day responsibility for maintaining water quality lies with the health care professionals...under the leadership of the facility’s Medical Director. Acronyms and Definitions ...GranuFlo...an acid concentrate used for bicarbonate-based dialysis that uses acetic acid as the primary acidifying agent. ...Operator...A staff member that meets the qualifications...is the primary staff member making the current batch of acid concentrate. Specific Gravity...The ratio of the density of a liquid to the density of water. Verifier...A staff member that meets the qualifications...that will confirm the operator’s test results/actions when required or will repeat the required test/actions themselves and document as required. Manufacturer IFU The DADU will be operated in accordance with the manufacturers printed IFU in the DADU Operators Manual. Trained Staff Prior to being allowed to operate the DADU the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include one or more of the following areas: Preparing of GranuFlo...concentrate batches. Performing specific gravity tests. Disinfection procedures. Completing batch records... Acid Concentrate Mixing and handling: DADU Policy.... Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation thereafter. Quality Assurance Testing Final verification of the batch is done through the measurement of the batch temperature...followed by a specific gravity test with a comparison of these results...GranuFlo Dry Acid Table of Specific Gravities... Batch Records Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation... GranuFlo Concentrate Dissolution Unit 1 Version 2 Operators Manual IFU Page 1 Important Safety Symbols and Instructions ...Proper training and demonstrated user competence must be completed and documented before a designated operator can be authorized to use the GranuFlo Dissolution Unit to make acid concentrate. Review of the facility December 2023, January 2024, and February 2024 GranuFlo Mixing Log documentation revealed the following: On 12/18/23, EI (Employee Identifier) # 14, CCHT (Certified Clinical Hemodialysis Technician), date of hire (DOH) 7/14/14 documented both preparation of the GranuFlo and review/verification of accuracy of the GranuFlo preparation. On 12/23/23, EI # 15, CCHT, DOH 4/7/21, documented the review/verification of accuracy, and EI # 8, CCHT, DOH 1/7/19 documented GranuFlo preparation and log completion. On 12/27/23, EI # 14, documented the GranuFlo preparation and GranuFlo Log completion. On 1/23/24, EI # 16, PCT (Patient Care Technician), DOH 9/19/22, documented the review/verification and EI # 15 documented GranuFlo preparation and log completion. On 1/30/24, EI # 15 documented review/verification and EI # 16 documented GranuFlo preparation and log completion. On 2/5/24, EI # 8 documented the review/verification for accuracy and EI # 16 documented GranuFlo preparation and log completion. Review of personnel files for EI # 14, EI # 15, EI # 16, and EI # 8 failed to include validation of successful training for the facility dry acid dissolution system and hydrometer use for acid concentrate mixing, preparation, and handling. The facility failed to ensure all staff were trained and competent to perform operational responsibilties for GranuFlo batch preparation and quality assurance testing. Further review of the personnel files for EI # 14, EI # 15, EI # 16, and EI # 8 revealed no documentation the Medical Director certified the employees had demonstrated water skill competencies for GranuFlo mixing, preparation, quality/safety testing, and review/verification. An interview was conducted on 2/7/24 at 12:45 PM with EI # 2, Charge Nurse, who verified there was no documentation the four employees were trained, competent and certified by the Medical Director for GranuFlo acid batch production.”

“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: 40119 Based on staff interviews, review of facility policy, and the facility GranuFlo (an acid concentrate) Mixing Log documentation, it was determined the Medical Director failed to ensure the staff who prepared a batch of acid concentrate (GranuFlo) and the staff who confirmed the operator’s test results/actions adhered to the facility policy for Acid Concentrate Mixing and Handling. The deficient practice had the potential to jeopardize the health and safety of the 78 in-center hemodialysis patients who dialyze at this facility. Findings include: Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit (DADU) Published: 09/05/2023 Reference Number: 25910 Version: 7 Purpose This document defines Dry Acid Dissolution Unit (DADU)...and details...policy regarding the operation and disinfection requirements of the DADU. Introduction The DADU is a device used to prepare acid concentrate solution (GranuFlo...) from a dry powder and RO (reverse osmosis-purified water) at a central location... Responsibility ...Medical Director...The day-to-day responsibility for maintaining water quality lies with the health care professionals...under the leadership of the facility’s Medical Director. Trained Staff Prior to being allowed to operate the DADU, the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include on more of the following: Preparing of GranuFlo...concentrate batches. Performing specific gravity (ratio of the density of a liquid to the density of water) tests Disinfection procedures Completing batch records using...DADU batch production record...or approved...electronic records system... Acid Concentrate Mixing and Handling: DADU Policy. Disposal of acid concentrate if required by state or local requirements. Competency and proficiency training will be documented and maintained in the staff’s personnel record... Batch Records Each batch record must be reviewed and verified as complete by two qualified staff members and the end of batch preparation. All data derived by mixing a batch of GranuFlo...concentrate will be recorded on the GranuFlo...Batch Mixing Log... The batch record will contain the following: Case catalog # (number) Each box # Potassium Value... Operator, date, and time ...Solution temperature... Low and high specific gravity Pass/fail checked Operator’s signature Verifier’s signature Time of transfer to holding tank A tour of the water treatment room was conducted on 2/6/24 at 1:10 PM with EI (Employee Identifier) # 8, Certified Clinical Hemodialysis Technician. During the tour, EI # 8 reported he/she was a “certified opener and closer” whose responsibilities included GranuFlo preparation, testing and batch documentation. EI # 8 reported the facility mixed/prepared acid twice weekly. Review of the facility GranuFlo Mixing Log for December 2023 revealed no GranuFlo batch production was documented from 12/1/23 to 12/18/23, which was seventeen days. The log documentation revealed only three batches of GranuFlo were prepared for December 2023, on 12/18/23, 12/23/23, and 12/27/23. Review of the facility GranuFlo Mixing Log for January 2024 revealed no GranuFlo batch production was documented from 1/1/24 to 1/23/24, which was twenty-two days. There was documentation only two batches of GranuFlo were prepared in January 2024, on 1/23/24 and 1/30/24. The staff failed to document all acid concentrate batch preparation, quality assurance/safety testing performed, test results, and reviewer verification on the GranuFlo Mixing Log after acid batch completion per facility policy during December 2023 and January 2024. An interview was conducted on 2/7/24 at 12:45 PM with EI # 2, Charge Nurse who reported based on facility census, and dialysis treatment time, the minimal number of times GranuFlo is mixed/prepared for patient use was eight to ten times a month. EI # 2 confirmed staff had failed to ensure GranuFlo batch preparation was documented, final verification of batch testing was performed, and verified by two qualified staff members at the end of the batch preparation per facility policy.”

“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: 30952 Based on medical record (MR) review, facility policy, and interview, it was determined the facility failed to ensure the MR was complete and accurate for the events, and care provided during a cardiac arrest. This affected one of one record reviews with emergency care provided, including PI (Patient Identifier) # 13 and had the potential to negatively affect the 78 patients who dialyze at the facility. Findings include: Facility Policy: Guidelines for Staff Response during Cardiopulmonary Arrest Published: 05/01/2023 Reference Number: 46863 Version: 5 Purpose ...provide staff with guidelines for responding to a cardiopulmonary arrest. ...Background ...Reversible complications of dialysis...may be treatable even when CPR (cardiopulmonary resuscitation) and defibrillation is initially necessary... Policy Any patient who suffers a cardiopulmonary arrest will have full resuscitative measures performed unless... Direct patient care staff will provide basic life support... Beginning Resuscitative Measures ...2. If on hemodialysis: Return the patient’s blood unless a problem... 3. Feel for the presence of carotid pulse and check for respirations. 4. If the patient is unresponsive with no breathing or not normal...activate the emergency response system. 5. Retrieve the AED (automated external defibrillator)... 6. If a pulse is not felt within 10 seconds; begin CPR by placing the patient on the floor or...backboard under the patient in the dialysis chair... 7. Apply the AED... 8. If the patient is not breathing...open the airway and provide 2 slow breaths... (connect oxygen when possible...Ambu bag as soon as possible with oxygen at 10-15 L/minute. 9. A licensed...staff...phone the attending physician... 13. Resuscitate measures will be maintained until EMS (emergency medical services)... takes over. AED... Step 1...When carotid pulse is absent the AED should be immediately applied. Place pads while CPR is in progress Use of an AED...an important step in reducing time to defibrillation and improving sudden cardiac arrest survival rate. ...Step 3...After the AED has been applied...stop compressions, allow AED to analyze rhythm and shock when advised. Follow prompts for shocks or re-initiation of CPR. 4. After shocks, or any “no shock” indicated: Resume CPR...continue for 5 cycles...until the AED starts to analyze the rhythm... EMS Arrival... Step 1...provide...EMS...with patient information... Step 3...Provide...MR information... Notifications Notify the designated emergency department...the patient is being transported and will arrive with copies of...medical information. Notify...family...provide location the transport location... ...Notify Biomedical/Technical Services as applicable. Documentation Document all interventions including: The course of events including medications administered and defibrillation performed by rescue personnel...on the Cardiopulmonary Arrest Record (CAR). Scan the completed...completed CAR form into...medical record... ...Sequestering of Dialysis Machine When cardiopulmonary arrest occurs during treatment, the machine will be... Removed...from the treatment area. Collect dialysate sample for any concentrate used. Tag machine...machine tested by Biomedical staff...ensure proper function... 1. PI # 13 was admitted to the facility on 4/19/22 with diagnosis of End Stage Renal Disease. Review of the Treatment Sheet (TS) dated 12/6/22 revealed the patient was a Full Code (provide all resuscitative measures), treatment was initiated at 4:36 AM, and at 8:09 AM, the Registered Nurse documented “...blood pressure (bp) 68/48, ultrafiltration (uf) off access visible, bp bottom out, 800 cc normal saline (ns) was given for bp support. treatment ended.” Further review of the 12/6/22 TS revealed multidisciplinary note documentation at 80:07 (8:07 AM), “...patient called out he/she was feeling bad, staff turned off uf bolus 200 ns given, patient still responsive, then suddenly stopped breathing, started CPR (Cardiopulmonary resuscitation) 911 called. 08:12 emergency transport services (EMS) arrived and took over care. Discharged to the hospital”. Review of the MR revealed no documentation staff completed the Cardiopulmonary Arrest Record form. There was no documentation the extracorporeal circuit was returned, oxygen was administered, the time chest compressions were started, if the AED was applied, shock advised/number of shocks delivered, what care was provided by EMS, hospital staff and others were notified, and the outcome of the event. There was no documentation the dialysis machine was removed from the treatment floor, and dialysate sample was collected. An interview was conducted on 2/8/24 at 12:42 PM, with Employee Identifier # 19, Facility Administrator Number Two, who confirmed the MR failed to include the Cardiopulmonary Arrest Record documentation per policy.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 40119 Based on review of facility policy, manufacturer’s instructions for use (IFU), staff interviews, the facility GranuFlo Mixing log, and personnel files, the Governing Body failed to ensure governance of the health and safety of patients in that facility policies were not enforced to protect and promote the health and safety of patients. This practice failed to ensure the staff who prepared a batch of acid concentrate (GranuFlo) and the staff who confirmed the operator’s test results/actions adhered to the facility policy for Acid Concentrate Mixing and Handling and the staff had knowledge and/or maintained their knowledge and skills in the GranuFlo Preparation/Mixing to care for the complex needs of the 78 in-center hemodialysis patients receiving care at this facility and placed the patients at risk for severe injury or death. Findings include: Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit Published: 09/05/23 Reference Number: 25910 Version: 7 Purpose This document defines Dry Acid Dissolution Unit (DADU)...and details...policy regarding the operation and disinfection requirements of the DADU. Introduction The DADU is a device used to prepare acid concentrate solution (GranuFlo...) from a dry powder and RO (reverse osmosis-purified water) at a central location... Responsibility ...CM (clinical manager)...Ensure facility staff is trained in use of the DADU mixer. ...Medical Director...The day-to-day responsibility for maintaining water quality lies with the health care professionals...under the leadership of the facility’s Medical Director. Acronyms and Definitions ...GranuFlo...an acid concentrate used for bicarbonate-based dialysis that uses acetic acid as the primary acidifying agent. ...Operator...A staff member that meets the qualifications...is the primary staff member making the current batch of acid concentrate. Specific Gravity...The ratio of the density of a liquid to the density of water. Verifier...A staff member that meets the qualifications...that will confirm the operator’s test results/actions when required or will repeat the required test/actions themselves and document as required. Manufacturer IFU The DADU will be operated in accordance with the manufacturers printed IFU in the DADU Operators Manual. Trained Staff Prior to being allowed to operate the DADU the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include one or more of the following areas: Preparing of GranuFlo...concentrate batches. Performing specific gravity tests. Disinfection procedures. Completing batch records... Acid Concentrate Mixing and handling: DADU Policy.... Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation thereafter. Quality Assurance Testing Final verification of the batch is done through the measurement of the batch temperature...followed by a specific gravity test with a comparison of these results...GranuFlo Dry Acid Table of Specific Gravities... Batch Records Each batch record must be reviewed and verified as complete by two qualified staff members and the end of batch preparation. All data derived by mixing a batch of GranuFlo...concentrate will be recorded on the GranuFlo...Batch Mixing Log... The batch record will contain the following: Case catalog # (number) Each box # Potassium Value... Operator, date, and time ...Solution temperature... Low and high specific gravity Pass/fail checked Operator’s signature Verifier’s signature Time of transfer to holding tank GranuFlo Concentrate Dissolution Unit 1 Version 2 Operators Manual IFU Page 1 Important Safety Symbols and Instructions ...Proper training and demonstrated user competence must be completed and documented before a designated operator can be authorized to use the GranuFlo Dissolution Unit to make acid concentrate. Review of the facility GranuFlo Mixing Log for December 2023 revealed no GranuFlo batch production was documented from 12/1/23 to 12/18/23, which was seventeen days. The log documentation revealed the following three batches of GranuFlo were prepared for December 2023: On 12/18/23, EI (Employee Identifier) # 14, CCHT (Certified Clinical Hemodialysis Technician), date of hire (DOH) 7/14/14 documented both preparation of the GranuFlo and review/verification of accuracy of the GranuFlo preparation. On 12/23/23, EI # 15, CCHT, DOH 4/7/21, documented the review/verification of accuracy, and EI # 8, CCHT, DOH 1/7/19 documented GranuFlo preparation and log completion. On 12/27/23, EI # 14 documented the GranuFlo preparation and GranuFlo Log completion. Review of the facility GranuFlo Mixing Log for January 2024 revealed no GranuFlo batch production was documented from 1/1/24 to 1/23/24, which was twenty-two days. Documentation revealed the following two batches of GranuFlo were prepared in January 2024: On 1/23/24, EI # 16, PCT (Patient Care Technician), DOH 9/19/22, documented the review/verification and EI # 15 documented GranuFlo preparation and log completion. On 1/30/24, EI # 15 documented review/verification and EI # 16 documented GranuFlo preparation and log completion. The staff failed to document all acid concentrate batch preparation, quality assurance/safety testing performed, test results, and reviewer verification on the GranuFlo Mixing Log after acid batch completion per facility policy during December 2023 and January 2024. Review of the facility GranuFlo Mixing Log for February 2024 revealed the following two batches of GranuFlo were prepared: On 2/5/24, EI # 8 documented the review/verification for accuracy and EI # 16 documented GranuFlo preparation and log completion. Review of personnel files for EI # 14, EI # 15, EI # 16, and EI # 8 failed to include validation of successful training for the facility dry acid dissolution system and hydrometer use for acid concentrate mixing, preparation, and handling. The facility failed to ensure all staff were trained and competent to perform operational responsibilties for GranuFlo batch preparation and quality assurance testing. Further review of the personnel files for EI # 14, EI # 15, EI # 16, and EI # 8 revealed no documentation the Medical Director certified the employees had demonstrated water skill competencies for GranuFlo mixing, preparation, quality/safety testing, and review/verification. An interview was conducted on 2/7/24 at 12:45 PM with EI # 2, Charge Nurse who reported based on facility census, and dialysis treatment time, the minimal number of times GranuFlo is mixed/prepared for patient use was eight to ten times a month. EI # 2 confirmed staff had failed to ensure GranuFlo batch preparation was documented, final verification of batch testing was performed, and verified by two qualified staff members at the end of the batch preparation per facility policy and there was no documentation the four employees were trained, competent and certified by the Medical Director for GranuFlo acid batch production.”