Fresenius Kidney Care Silver Springs

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 30177 Based on interview, review of the “Emergency Preparedness Plan,” document review, and review of the “Hazard Vulnerability Assessment,” the facility failed to meet the Conditions for Coverage (CfC) for Emergency Preparedness when the facility failed to 1) ensure that the “Emergency Preparedness Plan” encompassed man-made disasters and interruptions in communication, including cyber-attacks. 2) Ensure emergency medications/supplies were not expired and address how it would obtain emergency drugs in the event of shortages. 3) Implement an emergency preparedness patient orientation program that reflected the potential risks identified by the facility’s “Hazard Vulnerability Assessment.” 4) Provide initial training in emergency preparedness policies and procedures to all new and existing staff. 5) Ensure the facility identified or participated in a community-based full-scale exercise within the last two years. 6) Ensure patients were trained and orientated in emergency preparedness, including what to do, where to go, whom to contact, how to shelter-in-place, how they would be notified of an emergency, and provided with an alternate emergency phone number if an emergency occurred while the patient was absent from the dialysis facility. Failure to meet the CfC for emergency preparedness had the potential to impact the facility’s ability to evaluate the effectiveness of the overall emergency preparedness program, identify gaps in the program, and prepare patients and staff to respond safely to emergencies. The failed practice had the potential to delay treatment and care during an emergency and adversely impact the 51 in-center hemodialysis patients receiving care at this facility. Findings include: 1.The facility failed to ensure the emergency plan included provisions for man-made disasters and potential communication interruptions, such as those caused by cyber-attacks. Refer to E0004. 2. The facility failed to ensure that emergency medications and supplies were not expired and did not address how to obtain emergency drugs in the event of shortages. Refer to E0028. 3. The facility failed to implement an emergency preparedness patient orientation program that reflected the potential risks identified by its “Hazard Vulnerability Assessment.” Refer to E0036. 4. The facility failed to ensure that all new and existing staff received training in emergency preparedness policies and procedures. Refer to E0038. 5. The facility failed to ensure it participated in a community-based full-scale exercise within the last two years. Refer to E0039. 6. The facility failed to ensure patients were provided emergency preparedness orientation and training. Refer to E0040.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 30177 Based on observation, staff interview, review of the facility’s documents, manufacturer instructions for use (IFU) review, and facility policy review, the facility failed to meet the Condition for Coverage (CfC) for Water and Dialysate Quality when the facility failed to: 1) Ensure staff preparing acid concentrate was competent in following the manufacturer’s IFU. 2) failed to label the dry acid dissolution unit (DADU) tank, making it difficult for staff to identify its contents. 3) Ensure the DADU was disinfected per the manufacturer’s IFU. 4) Ensure it maintained an ongoing training program, including instruction for the staff according to the manufacturer’s IFU, with regular assessment of their skills and awareness of the risks and hazards associated with improperly prepared concentrate and bacterial issues. Findings include: 1. The facility failed to ensure staff assigned responsibility for acid concentrate preparation demonstrated competency in following the manufacturer’s IFU. Refer to V226. 2. The facility failed to label the DADU tank, which made it difficult for anyone using the contents of the mixing tank to identify the chemical composition or formulation of the contents. Refer to V228. 3. The facility failed to follow the manufacturer’s IFU for disinfecting the DADU after pre-filling or wetting it with treated water for four hours or more. Refer to V230. 4. The facility failed to implement a training program that regularly assessed staff skills and awareness of the risks and hazards associated with improperly prepared concentrate and bacterial issues. Refer to V260.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 30177 Based on interview and review of the facility’s “Emergency Preparedness Plan,” the facility failed to ensure that the “Emergency Preparedness Plan” encompassed man-made disasters and interruptions in communication, including cyber-attacks. This failure had the potential to hinder the facility’s ability to prepare and respond timely to emergent situations, which could potentially impact the safety and well-being of the 51 in-center hemodialysis patients receiving treatments at this facility. Findings include: Review of the facility’s undated “Emergency Preparedness Plan,” binder with the Clinical Manager revealed that he/she was not able to provide specific strategies to address man-made disasters that were listed on the “Hazard Vulnerability Assessment.” In addition, the documentation did not contain strategies to mitigate interruptions in communication, including cyber-attacks. When asked to view a copy of the emergency preparedness plan during an interview on 10/09/24 at 11:15 AM, the Clinical Manager was unable to provide a copy and revealed that he/she was unable to locate the emergency preparedness plan in the “Binder.” The Clinical Manager confirmed that he/she is unfamiliar with the emergency preparedness plan. He/she was asked to describe how the facility would handle cyber-attacks, including interruptions in communication. The Clinical Coordinator was unable to explain the facility’s process to manage cyber-attacks, including disruption in communication, and confirmed the facility’s “Emergency Preparedness Plan,” failed to encompass a man-made disaster.”

“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: 30177 Based on observation, interview, and policy review, the facility failed to ensure emergency medications/supplies were not expired. In addition, the facility failed to address how it would obtain emergency drugs in the event of shortages. The failure had the potential to hinder the facility’s ability to treat patients who required an emergency drug or supplies. The failed practice had the potential to negatively affect all 51 in-center hemodialysis patients receiving care at this facility. Findings Include: 1. Observation on 10/09/24 at 9:15 AM of the emergency drugs located in the treatment area with Registered Nurse (RN) 1 revealed the following expired medications/supplies: Two 0.9% Sodium Chloride, 250 milliliters (mL) bags with a manufacturer’s expiration date of April 2024 Two Intravenous (IV) Administration Set 15 drops/milliliters (mL). with a manufacturer’s expiration date of 09/20/24. During an interview on 10/09/24 at 9:25 AM, RN1 confirmed that the two .9% Sodium Chloride, 250 milliliters (mL) bags had a manufacturer’s expiration date of April 2024, and the two IV Administration Sets were noted with a manufacturer’s expiration date of 09/20/24. RN1 stated that the facility is required to have non-expired emergency medications and supplies on hand in the event of an emergency. A review of the facility’s policy titled “Medication Preparation Administration,” published 02/06/23, revealed, “Expiration dates for all stored medication are to be monitored on a monthly basis. Expired medications are to be discarded...” 2. Interview during observation of the “Emergency Cart” on 10/09/24 at 11:25 AM, the Clinical Manager was asked how the facility would obtain emergency drugs in the event of shortages. The Clinical Manager was unaware of the facility’s process for obtaining emergency drugs in the event of shortages. A policy was requested for the facility’s process of acquiring emergency drugs in the event of a shortage. The Clinical Manager stated that the facility had not developed a policy to address obtaining emergency drugs in the event of shortages and provided no additional documentation.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 30177 Based on interview, “Emergency Preparedness Plan” binder review, and review of the facility’s “Hazard Vulnerability Assessment,” the facility failed to implement an emergency preparedness patient orientation program for three of seven patients (Patient (P) 8, P9 and P10) that reflected the potential risks identified by the facility’s “Hazard Vulnerability Assessment.” Failure to ensure the patients’ orientation program included training on the potential risk identified in the “Hazard Vulnerability Assessment” had the potential to delay patients’ response during an emergency. This failure placed all 51 incenter hemodialysis patients at this facility at risk for possible adverse outcomes. Findings include: Review of the facility’s undated “Hazard Vulnerability Assessment” revealed “Tornado, ice storm, and blizzards,” all selected by the facility as potential hazards likely to occur in the facility’s geographic area that may affect the facility’s ability to provide dialysis services to its patients. In an interview on 10/09/24 at 10:50 AM, the Clinical Manager and Administrative Assistant were asked for Emergency Preparedness training, including training on the potential risk identified in the “Hazard Vulnerability Assessment” for patients (P8, P9, and P10). In an interview with the Clinical Manager on 10/09/24 at 11:15 AM, he/she was asked to provide documentation of the facility’s emergency preparedness plan, including the risk assessment, policies and procedures, communication plan, and evidence of patient training on potential hazards identified in the facility’s “Hazard Vulnerability Assessment.” The Clinical Manager revealed that patients had not been educated on the potential hazards of tornados, ice storms, and blizzards. By the survey exit on 10/9/24 at 2:45 PM, the facility failed to provide documentation of Emergency Preparedness training, including training on the potential risk identified in the “Hazard Vulnerability Assessment” and documentation of emergency preparedness patient orientation program.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 22198 Based on interview and review of the facility’s “Emergency Management Plan,” the facility failed to ensure one of two contracted staff (Registered Nuse (RN)1) had been trained in emergency preparedness at least every two years. Failure to ensure individuals providing services were trained in emergency preparedness had the potential to delay response during an emergency, placing all 51 in-center hemodialysis patients at this facility at risk for possible negative outcomes. Findings include: During a review of the “Personnel Files” education section for the two contracted staff currently working at this facility revealed, RN1 (contracted 09/23/24) did not have facility specific EP training. During an interview on 10/09/24 at 10:52 AM the Clinical Manager confirmed that RN1 did not have specific EP training for this facility. A request was made for the policy and procedure (P&P) for the EP training requirement for the facility’s staff. During an interview on 10/09/24 at 2:00 PM the Clinical Manager Registered Nurse (CN-RN) 1 stated that the facility does not have a P&P specific to contracted staff receiving facility specific EP training. CN-RN1 stated that the facility sends the contract company a checklist of required competencies and training that must be completed prior to the first day of work, however, confirmed that it was not facility specific training.”

“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: 30177 Based on interview and review of the “Emergency Preparedness” binder, the facility failed to ensure it identified or participated in a community-based full-scale exercise within the last two years to evaluate the effectiveness of the “Emergency Preparedness Plan.” The failure to participate in a community-based exercise did not allow the facility to test the effectiveness of the facility’s emergency plan and emergency response, including staff skills and facility readiness needed in an emergency. The failed practice had the potential to affect all staff and the 51 patients receiving in-center hemodialysis at this facility. Findings include: A review of the facility’s undated “Emergency Preparedness” binder with the Clinical Manager revealed an undated “Hazard Vulnerability Assessment” with the following selected Tornado, ice storm, and blizzards,” by the facility as potential hazards for the facility that may impact the facility’s care. In an interview on 10/09/24 at 11:15 AM, the Clinical Manager confirmed that the facility had not activated its emergency program or identified or participated in a community-based full-scale exercise within the last two years. The Clinical Manager was given an opportunity to present additional information by the exit for the findings discussed. No further information was provided. The Clinical Manager revealed in an interview on 10/09/24 at 11:35 AM that there was no evidence of participating in, identifying, or activating an emergency plan within the last two years. When asked if the facility participated in a community-based full-scale exercise within the previous two years, he/she replied, “No.” The Clinical Manager was asked how the facility measured the strength of the facility’s emergency preparedness plan and potential gaps or identified additional training and education needs if education regarding the plan had not been completed. The Clinical Manager stated, “That’s a good point.””

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 30177 Based on interview and review of the facility’s “Emergency Preparedness Plan,” binder the facility failed to provide emergency preparedness orientation and training to two of seven patients (Patients (P)8, P9 and P10), including what to do, where to go, whom to contact, shelter-in-place policy, and how patients would be notified of an emergency. Failure to ensure patients are trained and are familiar with the facility’s processes for responding to an emergency could result in a delayed or inappropriate response, thereby exposing all 51 in-center hemodialysis patients at this facility to possible adverse outcomes. Findings include: Review of the facility’s “Emergency Preparedness,” binder with the Clinical Manager revealed there was documentation of a comprehensive “Emergency Preparedness Plan/Program” that included the emergency preparedness orientation and training for patients. In an interview with the Clinical Manager on 10/09/24 at 11:15 AM, he/she was asked to provide documentation that patients (Patient (P) 8, P9, and P10) were provided an alternate emergency phone number for instances when an emergency occurs while the patient is not in the dialysis facility, provided information on identifying an alternate location for treatment in the event of a facility closure, information on sheltering-in-place, and information on how patients would be notified of an emergency. The Clinical Manager revealed that he/she did not have documentation of training that P8, P9, and P10 received training for the emergency preparedness program, including what to do, where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; whom to contact if an emergency occurs while the patient is NOT in the dialysis facility including an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency. When asked if the facility can forward calls to a working phone number in emergencies, the Clinical Manager stated, “I am not sure how to do it.” In an interview on 10/09/24 at 9:30 AM, P8 was asked if he/she had received training upon admission or thereafter on whom to contact if an emergency occurred while he/she was not at the dialysis facility. P8 replied, “No.” When asked if he/she received any training on what to do, including sheltering-in-place, where to go on occasions when the geographic area of the dialysis facility must be evacuated, and information on how he/she would be notified of an emergency, P8 stated, “No.” In an interview on 10/09/24 at 10:05 AM, P9 was asked to describe their orientation to the facility regarding emergency protocols and procedures. P9 stated, “I’m not sure.” In an interview on 10/09/24 at 9:45 AM, P10 denied knowing whether he/she received training upon admission or thereafter on whom to contact if an emergency occurred while he/she was not at the dialysis facility. P10 stated he/she does not recall being provided with an alternate emergency phone number if an emergency occurred while he/she was not at the dialysis facility. In an interview on 10/09/24 at 11:50 AM, the Clinical Manager confirmed the absence of documentation for P8, P9, and P10 Emergency Preparedness training and revealed that the “Emergency Preparedness Program needs some work.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 30177 Based on observation, interview and policy review, the facility failed to ensure potentially contaminated supplies were not stored in an area with clean or sterile items. In addition, during initiation and termination of treatment, during a time of high risk for spurting or spattering of blood and contact might occur with potentially contaminated surfaces, the facility failed to ensure staff removed personal protective equipment (PPE) prior to entering the patient/visitor waiting area designated as clean for one out of three survey days. This failure had the potential to expose patients and visitors to the transmission of bloodborne pathogens and other potential infectious materials (OPIM). The failed practice promoted the risk for cross-contamination and had the potential to adversely affect the 51 in-center hemodialysis patients receiving care at this facility. Findings include: Observation of the “Clean Supply Storage Room,” on 10/09/24 at 9:30 AM revealed a rolling cart with four cases of 50 milliliters (mL) syringes and blood collection vacutainers (needles) was noted with a build-up of white crystalized substance. Observation of the “Water Room” on 10/09/24 at 9:40 AM revealed a used face shield, alcohol prep pads, tape, and a bottle of unopened blood-leak test strips were stored in a purple storage container. In an interview on 10/09/24 at 9:45 AM, Biomedical Technician (BMT) 1 confirmed that the face shield had been used and belonged to staff and stated, “The face shield should not have been stored in the container with clean supplies.” During observation of hemodialysis care (initiation and termination of treatments) on 10/08/24 at 10:38 AM, Patient Care Technician (PCT) 3 entered the patient/visitor waiting area designated as clean in potentially contaminated personal protective equipment (PPE) [face shield, mask, gown]. In an interview with PCT 3 on 10/08/24 at 10:40 AM, when asked in an interview if staff members can enter the lobby in PPE, PCT3 replied, “No.” When asked if the lobby was considered designated as a clean area, PCT3 responded, “Yes.” In an interview on 10/08/24 at 10:45 AM, RN1 was asked if the facility maintained a separation of clean and dirty areas. He/she replied, “Yes.” When asked if the lobby was designated as a clean area, RN1 responded, “Yes.” He/she was then asked if staff who are providing patient care during initiation and termination of treatments are allowed to enter the patient/visitor waiting area in the same PPE used to provide care for patients. RN1 stated, “No.” Review of the facility’s policy titled, “Personal Protective Equipment,” revised on 11/06/23, revealed, “All personal protective equipment shall be removed prior to leaving the treatment area.””

“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: 30177 Based on observation, interview, and review of the facility’s policies, the facility failed to ensure 18 of 18 hemodialysis station’s ( Stations 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18) recessed wall boxes (located behind dialysis machines to supply water, concentrate, and dispose of waste) were free of spatters of a white crystalized substance. The failure to clean the dialysis wall boxes and remove any build-up had the potential to lead to contamination and risk of infections. This deficient practice could potentially affect the 51 patients receiving treatment in the dialysis unit. Findings include: Interview and observation on 10/08/24 at 10:22 AM with Registered Nurse (RN) 1 revealed that the wall boxes at Stations 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 contained splatters and an accumulation of a white crystalized substance. RN1 confirmed that the splatters and build-up of a white crystalized substance were observed on the wall boxes of Stations 1- 18. In an interview on 10/08/24 at 10:30 AM, RN1 was asked if the wall boxes are cleaned on a routine basis. RN1 responded, “I am not sure.” RN1 was then asked if wall boxes are part of the patient station and are considered contaminated or dirty. RN1 replied, “Yes.” A review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated,”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. All surfaces shall be disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentrate solution.””

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 22198 Based on personnel file reviews and interviews, the facility failed to ensure for two of two contracted staff (Registered Nuse (RN) 1 and Patient Care Technician (PCT) 4) and one of seven employees (PCT 3) was up to date on the annual Infection Control training. This failure to ensure that the facility has a policy and procedure for training its contracted staff puts all 51-center hemodialysis patients and all staff and visitors at potential risk for cross contamination. Findings include: During a review of the “Personnel Files” education section for the two contracted staff currently working at this facility revealed, contracted RN1 (contracted on 09/23/24) and PCT4 (contracted on 02/26/24) did not have facility specific Infection Control training on file. Further review revealed there was no documentation of Infection Control training for PCT3. During an interview on 10/09/24 at 10:52 AM the Clinical Manager confirmed that RN1, PCT4, and PCT3 did not have Infection Control training specific to this facility. A request was made for the policy and procedure (P&P) for the contracted staff training requirement for the facility. During an interview on 10/09/24 at 2:00 PM, the Clinical Manager Registered Nurse (CN-RN) 1 stated that the facility does not have a policy and procedure specific to contracted staff receiving facility specific training. CN-RN1 stated that the facility sends the contract company a checklist of required competencies and training that must be completed prior to the first day of work, however, confirmed that the checklist was not facility specific training. CN-RN1 also confirmed the staff did not have the Infection Control training.”

“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: 30177 Based on observation, interview, policy review, and Manufacturer’s instruction for use (IFU), the facility failed to ensure medications were discarded per the facility’s policy in that one of three multi-dose vials of Tuberculin Purified Protein Derivative [medication used to aid in the diagnosis of tuberculosis infection (TB)] was accessed (needle punctured), and not dated as to when the medication was accessed. The failure to date multi-dose vials upon opening had the potential to permit the administration of the medication beyond-use date (the date that indicates the date by which the product must be used). This deficient practice had the potential to affect the potency of the medication and could affect all 51 in-center hemodialysis patients receiving treatment at this facility. Findings include: Observation with Registered Nurse (RN) 1 of the medication preparation and storage area on 10/09/24 at 10:03 AM revealed that one multi-dose vial of Tuberculin Purified Protein Derivative was accessed and not dated as to when the medication was opened. Follow up interview with RN1 on 10/09/24 at 10:03 AM, he/she was asked if the Tuberculin Purified Protein Derivative had been needled punctured, and RN1 replied, “Yes.” When asked if the medication contained a date as to when the medication was opened or accessed, RN1 replied, “No.” RN1 was then asked how he/she determined the discard date of the medication to prevent beyond-the-use date administration. RN1 replied, “I wouldn’t be able to.” RN1 confirmed that the Tuberculin Purified Protein Derivative should be dated when opened, and undated opened multi-dose vials should not be available for patient use. Review of the facility’s policy titled, “Medication Preparation and Administration,” revised on 02/06/23, indicated, “Any open multi dose vials must be discarded 28 days after opening...” A review of the “Tuberculin Purified Protein Derivative PPD Tubersol manufacturer’s IFU revealed, “A vial of Tubersol which has been entered and in use for 30 days should be discarded.””

“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: 22198 Based on personnel file reviews and interviews, the facility failed to ensure that one of seven staff (Patient Care Technician (PCT) 4) with the potential to perform color specific strip testing in the water room or on the dialysis treatment floor had a colorblind test on file. This failure to ensure that all staff performing color tests have color-blind testing on file could potentially put all 51-center hemodialysis patients for a miss read color test. Findings include: During a review of the “Personnel Files” of competencies and testing section revealed, PCT4 did not have a color-blind test on file. During an interview on 10/09/24 at 10:52 AM the Clinical Manager confirmed that PCT4 did not have a color-blind test on file. During an interview on 10/09/24 at 2:00 PM the Clinical Manager Registered Nurse (CN-RN) 1 from another facility, confirmed that the facility sends the contract company a checklist of required competencies and training that must be completed prior to the first day of work, and confirmed the facility could not find the color-blind test for PCT4.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 30177 Based on staff interview, policy review, and manufacturer’s instructions for use (IFU), the facility failed to ensure staff assigned responsibility for acid concentrate preparation demonstrated competency in following the manufacturer’s IFU in that Patient Care Technician (PCT) 3 failed to ensure the dry acid dissolution unit (DADU-a machine that mixes dry acid powder with hemodialysis quality water resulting in liquid acid concentrate) was not wetted with treated water for four or more hours, failed to flush 3.5 gallons of solution prior to sample testing, failed to fill the hydrometer cylinder two-thirds full, and failed to rinse the hydrometer (a tool used to measures the density or specific gravity of a liquid) with reverse osmosis (RO) water before checking the specific gravity (measures the density of a substance). Additionally, PCT 3 inserted the hydrometer cylinder (container used to hold a liquid sample for testing with a hydrometer) in the DADU mix tank rather than filling the cylinder using the transfer nozzle. The failures did not ensure that PCT3 demonstrated proficiency in acid concentrate preparation and testing to ensure the concentrate was safe for patient use. The failed practice had the potential to adversely affect the 51 in-center hemodialysis patients receiving care at this facility. Findings Include: Interview and observation of the Water Room with Biomedical Technician (BMT) 1 on 10/08/24 at 10:00 AM, the DADU was observed to be filled with a clear liquid substance. BMT1 confirmed the liquid substance was RO water and stated that the water could remain in the DADU for two hours. On 10/08/24 at 1:30 PM, acid concentrate preparation and testing were observed with PCT3, who verified responsibility for acid concentrate mixing, testing, and transfer. PCT3 added eight cases (three bags per case) of dry acid powder to the DADU. When asked how long the RO water had been in the tank, PCT3 stated, “I filled the tank when I came in this morning at about 4:00 AM.” PCT3 stated the mixing process takes a while and instructed to alert Surveyor 2 when the next steps begin. At 2:15 PM, PCT3 continued the process by filling the hydrometer cylinder and inserting the cylinder into the DADU mix tank to collect a sample to check the specific gravity. PCT3 failed to retrieve the sample after flushing 3.5 gallons to the drain and failed to fill the hydrometer cylinder two-thirds full. When asked how much solution the hydrometer cylinder should be filled with, PCT3 stated, “I just fill it up.” PCT3 then retrieved the hydrometer without rinsing it with RO water and dipped it into the sample. In an interview with PCT3, the Clinical Manager, BMT1, and the Area Technical Operations Manager (ATOM) on 10/08/24 at 3:45 PM, PCT3 confirmed the water in the DADU should not have exceeded four hours, 3.5 gallons of acid solution should have been flushed to get a pure sample, the hydrometer cylinder should not have been dipped into the DADU or overfilled. The hydrometer cylinder should have been filled with the transfer nozzle, filled two-thirds full, and the hydrometer should have been rinsed before use with RO water. When asked if the hydrometer cylinder is considered a foreign object, BMT1 stated, “Yes.” Review of the facility’s policy titled “Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit,” with a published date of 09/05/23, revealed, “The Dry Acid Dissolution Unit will be operated in accordance with the manufacturers printed IFU in the DADU Operators Manual ... The DADU mix tank must be completely empty prior to the preparation of a batch of acid concentrate ... Prior to mixing a batch of acid concentrate the DADU must be run through an automated rinse cycle ... There are five occasions in which you will need to discard the acid solution in the DADU. Those occasions are described as follows ... Any foreign object falling into the DADU tank after the dry acid product has been added... Disinfection of the DADU will be performed in accordance with IFU....” Review of the facility’s policy titled “Acid Concentrate Specific Gravity Testing Procedure,” published on 07/05/22, revealed, “Rinse the hydrometer and hydrometer cylinder with purified water before checking solution specific gravity ... Slightly open the transfer nozzle valve and flush 3.5 gallons of solution in the residual solution bucket ... Fill the hydrometer cylinder by inserting nozzle into cylinder and slowly opening transfer nozzle valve. As solution begins to fill, tilt the cylinder to minimize bubbles while filling the cylinder 2/3 full. Once disposal of the residual acid is complete, rinse out the residual solution bucket, hydrometer cylinder, and hydrometer before storing equipment.” Review of the manufacturer’s IFU, “Obtain the clean hydrometer and measure the specific gravity of the solution in the hydrometer cylinder. If the hydrometer or the surface of the solution is not clean, discard the contents of the hydrometer cylinder into the residual solution bucket. Clean the hydrometer and the hydrometer cylinder and restart. Warning! Failure to flush the transfer hose with 3.5 gallons prior to measuring specific gravity may result in an incorrect specific gravity reading, and/or supply of an incorrect concentrate formulation to the hemodialysis machines, which may result in patient injury or death. Warning! The flush solution is a mixture of concentrate from the previous batch and the new batch ... If a DADU is found to be standing for four or more hours with treated water or wetted with treated water, then a disinfection cycle must be completed before the dissolution cycle is started ... Do not leave the dry acid dissolution unit with only treated water or wetted with only treated water for four or more hours since the dry acid solution unit is susceptible to bacteria growth.””

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 30177 Based on staff interviews and observations, the facility failed to label the dry acid dissolution unit (DADU) tank, which made it difficult for anyone using the contents of the mixing tank to identify the chemical composition or formulation of the contents. The failure to permit identification of the DADU’s mixing tank contents had the potential to lead to inadvertently mismatching dialysate components or adding acid granules to already prepared acid concentrate. The failed practice had the potential to negatively affect the 51 in-center hemodialysis patients at this facility. Findings Include: During a tour of the Water Treatment/Dialysate Preparation Area with Patient Care Technician (PCT) 3, who was observed preparing, mixing, and testing the aid concentrate, Biomedical Technician (BMT) 2, and the Area Technical Operations Manager on 10/08/24 at 3:55 PM, the DADU mixing tank was observed without proper identification of its contents. When PCT3 was asked how anyone could identify the chemical composition or formulation of the contents of the mixing tank, he/she responded, “I’m not sure.” In an interview with PCT3, the Clinical Manager, BMT1, and the Area Technical Operations Manager (ATOM) on 10/08/24 at 3:45 PM, the ATOM confirmed the mixer was not labeled, identifying its contents. PCT3 stated he/she was aware that the tanks should be labeled to identify the contents but failed to do so. BMT1 revealed the facility dispensed two potassium (2K), 2.5 calcium (ca), and 3K/2.5ca. A policy indicating the need to label the storage/dispensing tanks was requested. The facility failed to provide a policy by the survey’s exit date.”

“MIXING SYSTEMS-CLEANING CFR(s): 494.40(a) 6.4.1 Mixing systems: cleaning Concentrate mixing equipment should be either: (1) completely emptied, cleaned, and disinfected according to the manufacturer’s instructions; or (2) cleaned and disinfected using a procedure demonstrated by the facility to be effective in routinely producing concentrate meeting [these regulations related to allowable bacterial and endotoxin levels]. The disinfection data should be recorded for each ...disinfection cycle using a dedicated log. This Standard is not met as evidenced by: 30177 Based on staff interview, policy review, and manufacturer’s instructions for use (IFU), the facility failed to follow the manufacturer’s IFU to disinfect the Dry Acid Dissolution Unit (DADU) after the system was found to have been pre-filled or wetted with treated water for four or more hours. The failed practice increases the susceptibility to bacteria growth, which had the potential to negatively affect the 51 in-center hemodialysis patients receiving care at this facility. Findings include: In an interview with Patient Care Technician (PCT)1 on 10/08/24 at 3:45 PM, he/she confirmed that he/she filled the DADU mixing tank with Reverse Osmosis (RO) water at about 4:00 AM and that he/she did not empty the tank, perform a disinfection or rinse cycle before mixing acid. PCT1 was asked if he/she was aware that per manufacturer’s IFU, “If a DADU is found to be standing for four or more hours with treated water or wetted with treated water, then a disinfection cycle must be completed before the dissolution cycle is started and that the DADU unit should not be left with treated water or wetted with treated water for four or more hours since the dry acid solution unit is susceptible to bacteria growth.” PCT1 replied, “No.” PCT1 confirmed that he/she failed to follow the manufacturer’s IFU to ensure the acid concentrate mixing tank was emptied before mixing another batch of acid concentrate. Review of the GranuFlo Concentrate Dissolution Unit IFU revealed, “If a granuflo dissolution unit is found to be standing for four or more hours with treated water or wetted with treated water, then a disinfection cycle must be completed before the dissolution cycle is started. Do not leave the granuflo dissolution unit with only treated water or wetted with treated water for four or more hours since the GranuFlo Dissolution Unit is susceptible to bacteria growth.” In a joint interview on 10/08/24at 4:00 PM with the Area Technical Operations Manager (ATOM), the Clinical Manager, and the Biomedical Technician (BMT) 1, the ATOM confirmed that the mixing tank should have been disinfected after being wetted with RO water for four hours or more and stated that facility failed to follow the manufacturer’s IFU. Review of the facility’s policy titled “Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit,” with a published date of 07/05/22, revealed, “The Dry Acid Dissolution Unit (DADU) will be operated in accordance with the manufacturer’s printed Instructions for Use (IFU) in the DADU Operators Manual ... The DADU mix tank must be completely empty prior to the preparation of a batch of acid concentrate.”

“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: 30177 Based on interview, document review, manufacturer’s instructions for use (IFU), and policy review, the facility failed to implement a training program with regular assessment of staff skills and awareness of the risks and hazards associated with improperly prepared concentrate and bacterial issues for two of two staff members (Patient Care Technician (PCT)3, and Biomedical Technician (BMT) 1) who were assigned the responsibility for preparing, mixing, and testing acid Concentration. The failure to train staff and implement an ongoing training program, including instruction for the staff according to the manufacturer’s IFU, did not allow the facility to 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 51 in-center hemodialysis patients receiving care at this facility. Findings include: Observation on 10/08/24 at 1:30 PM of acid preparation, mixing, and testing revealed PCT3 failed to follow the manufacturer’s IFU in that he/she did not ensure the dry acid dissolution unit (DADU-a machine that mixes the dry acid powder with hemodialysis quality water, resulting in liquid acid concentrate) was empty and not wetted with treated water for four or more hours prior to use, failed to flush 3.5 gallons of the solution prior to sample testing, failed to fill the hydrometer cylinder two-thirds full, and failed to rinse the hydrometer (a tool used to measures the density or specific gravity of a liquid) with reverse osmosis (RO) water before checking the specific gravity (measures the density of a substance). Additionally, PCT3 inserted the hydrometer cylinder (container used to hold a liquid sample for testing with a hydrometer) in the DADU mix tank rather than filling the cylinder using the transfer nozzle and failed to label the DADU mixer to identify its contents to avoid inadvertently mix-ups. PCT3 observed the mixer was wetted with dechlorinated water and failed to empty the tank, perform a disinfection, or rinse cycle before use. In a joint interview with BMT1 and the Area Technical Operations Manager (ATOM) on 10/08/24 at 3:45 PM, BMT1 was asked if he/she was assigned the responsibility for preparing, mixing, and testing of GranuFlo acid Concentration. He/she replied, “Yes.” BMT1 was then asked, after preparing the acid and prior to testing if he/she flushed 3.5 gallons to ensure an accurate or non-skewed sample. BMT1 replied he was unaware that he/she should flush 3.5 gallons prior to retrieving a sample for testing. When asked if he/she was aware that the mixer must be disinfected if wet or water is left in the mixer for four hours or more. BMT1 replied, “No.” The document review for PCT3 acid mixing, preparation, and testing competencies for the DADU was requested. The Clinic Manager provided two documents titled, “Direct Patient Care (DPC) Water Skills Validation,” dated 11/14/23 and 02/20/24. In a review of the document, it could not be determined what skills were validated or what product was in use, for example, (GranuFlo or Citrasate dry acid) as the skills validation form documented headings only and not skills validated. In a review of the most recent skills review, dated 01/20/24, the document was incomplete as the document included a column for the validator to complete indicating, “Met, Not Met, N/A,” but the form in its entirety was left blank and not completed for all heading/topic, including DADU and Hydrometer Use. The skills validation did not include or indicate training in quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues, nor was the document was not specific to the products in use or functions performed (i.e., mixing, disinfection, and testing). Document review of “Technical Skills Validation,” dated 01/24.24, for BMT1 revealed it could not be determined what skills were validated as the skills validation form documented headings only and not skills validated. The skills validation did not include or indicate training in quality testing or the risks and hazards of improperly prepared concentrate, nor was the document specific to the products in use (i.e., mixing, disinfection, and testing) or functions performed. In an interview on 10/09/24 at 11:00 AM during document review of PCT 3’s “(DPC) Water Skills Validation” and BMT1’s “Technical Skills Validation,” the Clinical Manager confirmed the above findings. Review of the facility’s policy titled “Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit,” with a published date of 07/05/22, revealed, “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 GranuFlo/and or Citrasate dry concentrate batches, performing specific gravity tests, disinfection procedures, completing batch records using DADU batch production record, 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 training thereafter. The Dry Acid Dissolution Unit (DADU) will be operated in accordance with the manufacturer’s printed Instructions for Use (IFU) in the DADU Operators Manual. . .The DADU mix tank must be completely empty prior to the preparation of a batch of acid concentrate.” A review of the GranuFlo Concentrate Dissolution Unit IFU revealed, “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. Obtain the clean hydrometer and measure the specific gravity of the solution in the hydrometer cylinder. If the hydrometer or the surface of the solution is not clean, discard the contents of the hydrometer cylinder into the residual solution bucket. Clean the hydrometer and the hydrometer cylinder and restart. Warning! Failure to flush the transfer hose with 3.5 gallons prior to measuring specific gravity may result in an incorrect specific gravity reading, and/or supply of an incorrect concentrate formulation to the hemodialysis machines, which may result in patient injury or death. Warning! The flush solution is a mixture of concentrate from the previous batch and the new batch. . .If a DADU is found to be standing for four or more hours with treated water or wetted with treated water, then a disinfection cycle must be completed before the dissolution cycle is started. . .Do not leave the dry acid dissolution unit with only treated water or wetted with only treated water for four or more hours since the dry acid solution unit is susceptible to bacteria growth.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 30177 Based on observation, interview, and review of the facility’s policies, the facility failed to maintain the integrity of surfaces and maintain equipment in good repair in the patient treatment area for 18 of 18 hemodialysis machines in (Stations 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18). The failure to maintain the integrity by ensuring the outer surfaces of the hemodialysis machines were intact and free from damage rendered the surface porous and had the potential to inhibit effective cleaning and increase the potential for microbial growth. This deficient practice provided a mode of cross-contamination for the potential spread of infection in the facility and has the potential to affect the 51 patients receiving in-center hemodialysis treatment in the facility. Findings include: During the interview and observation conducted on 10/08/24 at 10:22 AM with Registered Nurse (RN) 1, it was noted that the outer surface of the hemodialysis machines in Stations 1 through 18 exhibited signs of damage and were not intact. RN1 confirmed the findings of the hemodialysis machines in Stations 1 through 18. A review of the facility’s policy titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated that “The nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease period. Hepatitis B virus is a very resilient virus. Live hepatitis B virus has been identified in blood spills and can survive on the surfaces for up to seven days. The dialysis station could become contaminated with blood and other body fluids during treatment. Externally disinfect the dialysis machine with one: 100 bleach solutions after each dialysis treatment.””

“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: 30177 Based on observation, staff interview, and policy review, the facility failed to maintain equipment in good repair in the water treatment area in that there was an excessive accumulation of rust on multiple components in the water treatment area. In addition, the facility failed to prevent expired supplies from remaining in active inventory and accessible for patient use and failed to ensure the arterial drip chamber fluid levels were at 85% -95% full per manufacturer’s instruction for use (IFU) for one of one observation days. The failures have the potential to negatively impact the safety and well-being of the 51 patients receiving in-center hemodialysis treatments at this facility. Findings Include: 1. Observation of the “Water Treatment Room,” on 10/07/24 at 11:30 AM with the Biomedical Technician (BMT) 1, the following observations were made and confirmed by BMT1: A buildup of grime and rust was noted on a metal wrench stored on a sink. A buildup of green substance was noted on multiple pipes. Metal bracket holders displayed noticeable and extensive rust accumulation Two of the two-floor drains had a thick buildup of dark-brown substance. Acid mixer and distribution equipment with splatters and a buildup of white crystalized substance. The floor was noted to have a considerable accumulation of white crystalized substance, dirt, and grime. Four of the rolling supply carts used to store clean supplies showed a notable accumulation of dust and an unknown white substance. 2. Observation of the facility’s “Clean Supply Storage Room” with Registered Nurse (RN) 1 on 10/08/24 at 12:40 PM revealed the following: Three bottle of Hach SteriCheck Sensitive Low-Range Water Hardness with an expiration date of 06/2024 Two bottle of Hach SteriCheck Sensitive Low-Range Water Hardness with an expiration date of 04/12/24 One bottle Blood Leak Test Strips with expiration date of 11/30/23 Five Volumat Line Standard Infusion Set with an expiration date of 06/9/24 and 60 with an expiration date of 08/25/24 50 bags 0.9% Sodium Chloride 250 mL with an expiration date of April 2024 100 tubing of intravenous (IV) Administration Set 15 drops/mL with an expiration date of 09/20/24 and 50 tubing with an expiration date of10/04/24 One box of 100 18 gauge Needle with an expiration date of 08/31/23 In an interview with RN1 on 10/08/24 at 12:40 PM, he/she confirmed that the above supplies had expired per the manufacturer’s guidelines. When asked if the supplies should have been removed from active inventory, RN1 replied, “Yes.” 3.During observation and interview on 10/07/23 at 10:15 AM, RN1 confirmed the arterial drip chamber fluid levels were less than 85% - 95% full in 11 of 18 Stations (1, 3, 4, 5, 6, 7, 9, 12, 15, 16, and 17) in use. Review of the manufacturer’s DFU indicated, “Maintain fluid level in pre-pump arterial chamber at 85% - 95% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air leaks will also cause the chamber levels to fluctuate. Maintain a proper fluid level in chambers to ensure that no air is returned to the patient.” Review of the facility’s policy titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” revision date 05/06/24, indicated, “The arterial chamber is 85-95% full ...” Review of the facility’s policy titled, “Initiation of Treatment Using a Centra Venous Catheter and Optiflux Single Use Ebeam Dialyzer,” revision date 05/06/24, indicated, “The arterial chamber is 85-95% full ...””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 22198 Based on medical record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of six sampled in-center dialysis patients (Patient (P)1 P2, P3, and P4). Failure to follow the medical providers’ dialysis prescription as well as failed to ensure safety checks were completed per policy had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 53 patients receiving in-center dialysis treatments at this facility. Findings include: 1. A review of P1’s “Dialysis Treatment Sheets” revealed that for five of the six treatment sheets, dated 09/25/24 through 10/07/24, revealed a physician dialysis prescription, dated 10/07/24, with a BFR at 450 milliliters per minute (ml/min) and the DFR to run at 1.5 auto flow (DFR 700 ml/min). Further review of the “Dialysis Treatment Sheets” revealed the following: a. On 09/25/24, from the last recording at 12:05 PM, the machine parameters and safety checks were not documented according to the policy until 2:04 PM (one hour and 59 minutes). b. On 09/27/24, from the start of treatment at 12:05 PM until 2:33 PM the DFR was running at 800 ml/min, and from the last recording at 12:05 PM the machine parameters and safety checks were not documented according to the policy until 2:08 PM (two hours and three minutes of the treatment). c. On 10/02/24 from the start of treatment at 11:22 AM until 2:17 PM, the DFR was running at 800 ml/min. d. On 10/04/24 from the start of treatment at 11:25 AM until 2:32 PM, the DFR was running at 800 ml/min. e. On 10/07/24 from the start of treatment at 11:36 AM until 2:36 PM, the DFR was running at 800 ml/min. 2. A review of P2’s “Dialysis Treatment Sheets” revealed that for one of the six treatment sheets, dated 09/25/24 through 10/07/24, revealed a “Physician Dialysis Prescription,” dated 09/06/24, had the BFR at 450 ml/min and the DFR to run at 1.5 auto flow (DFR 700 ml/min). On 10/04/24 at the start of treatment at 5:12 AM the BFR was 450 ml/min and the DFR was 300 ml/min. At 5:33 AM, the BFR was 400 ml/min and the DFR 600 ml/min. At 6:07 AM, the BFR was changed to 350 ml/min and the DFR to 600 ml/min until the end of treatment at 8:02 AM. a. On 09/27/24 from the start of treatment at 5:03 AM until 8:16 AM, the BFR was 400 ml/min and the DFR was 600 ml/min. 3. A review of P3’s “Dialysis Treatment Sheets,” revealed that for four of the six treatment sheets, dated 09/18/24 through 10/04/24, revealed the “Physician Dialysis Prescription,” dated 07/01/24, had the BFR at 450 ml/min and the DFR to run at 1.5 auto flow (DFR 700 ml/min). a. On 09/20/24, from the last recording at 12:35 PM the machine parameters and safety checks were not documented according to the policy through the end of treatment at 2:46 PM (two hour and 11 minutes). b. On 09/23/24 from the start of treatment at 11:35 AM until the end of treatment 3:01 PM the DFR was recorded at 800 ml/min. c. On 09/30/24 from the start of treatment at 11:54 AM until 2:42 PM the DFR was recorded at 800 ml/min. From the last recording at 12:51 PM the machine parameters and safety checks were not documented according to the policy until 2:05 PM (one hour and 14 minutes). d. On 10/04/24 at 11:56 AM the BFR was ran at 300 ml/min and the DFR was ran at 500 ml/min. At 12:34 PM, the BFR was changed to 400 ml/min and the DFR 500 ml/min. From the last recording at 12:34 PM the machine parameters and safety checks were not documented according to the policy until 2:31 PM (one hour and 57 minutes). 4. A review of P4’s “Dialysis Treatment Sheets” revealed that for five of the six treatment sheets, dated 09/25/24 through 10/07/24, revealed the “Physician Dialysis Prescription,” dated 10/05/24, had the BFR at 450 ml/min and the DFR to run at 1.5 auto flow (DFR 700 ml/min). a. On 09/25/24 from the start of treatment at 11:06 AM until the end of treatment 1:51 PM the DFR was recorded as 800 ml/min. From 12:07 PM until 1:03 PM (one hour four minutes) the machine parameters and safety checks were not documented according to the policy. b. On 09/27/24 from the start of treatment at 11:11 AM until 1:44 PM, the DFR was recorded as 800 ml/min. From 11:36 AM until 1:07 PM (one hour 31 minutes) and from 1:03 PM until 1:50 PM (47 minutes) the machine parameters and safety checks were not documented according to the policy. c. On 09/30/24 from the start of treatment at 10:59 AM until 12:04 PM, the DFR was 800 ml/min. From the last recording at 12:04 PM through the remainder of the treatment 2:08 PM the staff failed to record the machine parameters and safety checks according to the policy. d. On 10/02/24 from the start of treatment at 11:23 AM until 1:34 PM, the BFR was recorded at 300 ml/min and the DFR 500 ml/min. At 1:34 PM, the BFR was changed to 400 ml/min and DFR 700 ml/min. e. On 10/07/24 from the start of treatment at 11:23 AM until 1:59 PM, the DFR was recorded at 800 ml/min. Review of the facility’s policy titled, “Auto Flow Dialysate,” dated 04/05/21, revealed, “Blood Flow Rate using Auto Flow 1.5 between 416 - 480, Dialysate Flow Rate 700.” During an interview on 10/08/24 at 4:00 PM the Clinical Manager confirmed that the prescription rates for P1, P2, P3, and P4 were not run as prescribed and the required machine parameters and safety checks according to the policy. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Gathering of objective and subjective information related to the patient’s health status as it corresponds to the ordered renal replacement. , .During Treatment Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations. . .Follow the steps below for monitoring patient and machine parameters during treatment:. . . Ultrafiltration Rate. . .Check machine settings and measurements: Check prescribed blood flow 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 the prescribed flow is being delivered.””

“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: 22198 Based on review of patient medical records, interviews, and policy review, , the facility failed to ensure that blood pressure (BP) concerns were managed and documented per policy for four of seven patients (Patient (P) 1, P3, P5, and P7). This has the potential to negatively affect all 51 incenter dialysis patients. Findings include: 1.Review of P1’s “Dialysis Treatment Sheets” revealed that for three of the six treatment sheets reviewed the staff failed to document and monitor blood pressure per policy as follows: a. On 10/04/24, no blood pressure was documented from 1:11 PM to 2:31 PM. (one hour and 15 minutes in between. b. On 09/27/25 no blood pressure was documented from 12:05 PM to 1:00 PM. (55 minutes). c. On 09/25/24, no blood pressure was documented from 12:05 PM to 1:04 PM (59 minutes) and from 1:33 PM to 2:35 PM (one hour and 2 minutes) 2. A review of P3’s “Dialysis Treatment Sheets” revealed that for two of the six treatment sheets reviewed the staff failed to document and monitor blood pressure per policy as follows: a. On 09/20/24, no blood pressure was documented from 11:48 AM to 12:35 PM (47 minutes). b. On 010/07/24 at 1:41 PM P3’s systolic blood pressure dropped below 100 and was recorded as 95/56 with a heart rate of 56. There was no documentation the Registered Nurse (RN) in charge was notified per policy. The RN evaluation documented at 2:48 PM reported, “No Unusual findings noted.” 3. A review of P5’s “Dialysis Treatment Sheets,” revealed that for three of the six treatment sheets reviewed the staff failed to document and monitor blood pressure per policy as follows: a. On 10/02/24, the blood pressure was documented as 213/89 and at 6:02 AM the blood pressure was recorded as 224/86. However, there was no documentation that the Patient Care Technician (PCT) notified the RN of the systolic blood pressure elevated above 200. b. On 09/27/24 at 5:48 AM, the blood pressure was documented as 204/81. At 6:11 AM the blood pressure was documented as 211/86. However, there was documentation that the PCT notified the RN of the systolic blood pressure elevated above 200. c. On 09/23/24 at 5:31 AM, the blood pressure was documented as 203/87. At 6:05 AM, the blood pressure was documented as 201/86. However, there was no documentation that the PCT notified the RN of the systolic blood pressure elevated above 200. 4. A review of P7’s “Dialysis Treatment Sheets” revealed that for one of the six treatment sheets reviewed the staff failed to document and monitor blood pressure per policy as follows: a. On 10/05/24 at 7:33 AM the blood pressure was documented as 123/81 and at 8:03 AM the blood pressure increased to 164/89 a systolic increase of 41, then at 8:31 AM had a 36-point systolic drop and a diastolic increase over 100 documented at 128/104. However, there was no documentation that the PCT notified the RN of the systolic blood pressure elevated greater than 20-point, the greater than 20-point drop in systolic or the diastolic elevation greater than 100 per policy. No blood pressure was recorded for the end of dialysis treatment at 9:00 AM. During an interview on 10/08/24 at 4:00 PM the Clinical Manager confirmed that the blood pressures for P1, P3, P5, and P7 were not monitored, recorded, or reported to the RN per policy. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23 revealed, “Gathering of objective and subjective information related to the patient’s health status as it corresponds to the ordered renal replacement. ... During treatment obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. ... Report to the nurse: Systolic blood pressures greater than 180 mm/Hg. Diastolic blood pressure greater than 100 mm/Hg. Blood Pressure less than or equal to 100 mm/Hg systolic. ... Report to the nurse patients whose heart rates have dropped below 60.””