Davita River Center Dialysis

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 30177 Based on document review, interview, and review of the facility’s “Emergency Management Plan,” the facility did not ensure that the “Teammate Emergency Contact List” contained contact information for all staff members to be used in the event of an emergency. The failure to ensure the contact list contained contact information for all staff members had the potential to hinder the facility’s ability to respond promptly to an emergency, thus negatively affecting the 67 in-center hemodialysis patients receiving care at this facility. Findings include: Review of the facility’s “Emergency Management Plan,” revised in April 2024, revealed, “Refer to ‘Teammate Emergency Contact List’ ... Emergency contact information will be reviewed quarterly and updated as necessary. In the event of an unforeseen or emergency ... recall of off-duty teammates may be required ... Communicate with Biomed as additional equipment maintenance, monitoring, and adjustments may be required ... Each evacuation kit(s) should contain a roster of all facility teammates’ emergency contact information. Update information as needed.” Review of the undated “Teammate Emergency Contacts” located in the “Emergency Management Plan,” revealed the document failed to include a primary and alternate means for communicating with the Facility Administrator and the Biomedical Technician. In an interview with the Facility Administrator on 06/04/24 at 11:00 AM, the Facility Administrator confirmed the emergency contact list did not contain two staff members (the Facility Administrator and the Biomedical Technician). When the Facility Administrator was asked how often the “Teammate Emergency Contact List” is updated, he/she replied, “yearly.” The Facility Administrator confirmed the “Teammate Emergency Contact List” should have included a primary and alternate means of communication with all staff.”

“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: 30177 Based on interview and the facility’s “Emergency Management Plan” review, the facility failed to ensure two of two staff (Patient Care Technician (PCT4) and Registered Nurse (RN1)) were knowledgeable of emergency procedures, including informing patients of what to do, where to go, and whom to contact if an emergency occurs while the patient is not in the dialysis facility; including informing patients of an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls. Failure to ensure staff was trained and competent in all aspects of the emergency preparedness plan could potentially lead to a delay in staff response during an emergency and hinder the welfare and safety of the 67 patients receiving in-center hemodialysis at this facility. Findings include: Review of the facility’s “Emergency Management Plan,” revised in April 2024, revealed that the Facility Administrator or designee is responsible to provide training of the “Emergency Management Plan” annually and the appropriate hazard policies per the Hazard Vulnerability Assessment. Emergency contact numbers for the facility will be communicated to the teammates, patients, and Medical Director, to include primary and secondary facility phone numbers when unable to contact the facility or the facility is closed unexpectedly...” In an interview on 06/04/24 at 9:40 AM, PCT4 was asked have you been trained on informing patients of what to do, where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated, and whom to contact if an emergency occurs while the patient is not in the dialysis facility, including informing patients of an alternate phone number for instances when the dialysis facility is unable to receive phone calls during an emergency. PCT4 stated, “No, I have not really been told anything.” In an interview on 06/04/24 at 9:50 AM, RN1 was asked, “Have you been trained in informing patients of what to do and where to go?” RN1 replied, “Honestly, it is not happening.” RN1 was then asked, “were you trained in informing the patients of whom to contact, including informing patients of an alternate phone number for instances when the dialysis facility is unable to receive phone calls during an emergency?” RN1 stated, “It is outside of my realm.” In an interview on 06/22/23 at 12:45 PM, the Facility Administrator was asked to provide evidence of staff training on informing patients of what to do, where to go, and whom to contact, as well as training staff on the facility’s alternate emergency phone number. The Facility Administrator revealed he/she had no documentation indicating that staff had been trained to inform patients what to do, where to go, whom to contact, and an alternate phone number in the event of an emergency. The Facility Administrator confirmed that he/she had no documentation that the staff was provided the emergency alternate phone number. The Facility Administrator also confirmed that the staff is responsible for educating the patients on what to do, where to go, whom to contact, and an alternate emergency phone number.”

“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 “Facility Emergency Management Plan” review, 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 “Facility Emergency Management Plan.” The failure to participate in a community-based exercise had the potential to negatively impact the facility’s ability to assess staff knowledge, emergency response skills, and readiness in an emergency. This failure could potentially affect all staff and the 67 patients receiving in-center hemodialysis at this facility. Findings include: A review of the facility’s policy titled “Facility Emergency Management Plan,” revised April 2024, indicated, “The facility will conduct an/or participate in one exercise to test the facility “Emergency Management Plan” at least annually, conducted on opposite years, one-year full-scale exercise that is community-based, next year facility-based/exercise of choice... The purpose is to test the effectiveness of the facility’s emergency plan, emergency response, hazard and risk assessment ... The intent is that the testing exercise provide a comprehensive testing and training for staff, volunteers, and individuals providing services under arrangement as well as community partners.” In an interview on 06/04/24 at 11:35 AM, the Facility Administrator confirmed that the facility had not identified or participated in a full-scale community-based exercise within the last two years. When asked if the facility experienced an actual emergency event or activated a relevant emergency plan, the administrator responded, “No.””

“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, review of the facility’s “Emergency Management Plan,” and review of the facility’s “Hazard Vulnerability Assessment,” the facility failed to provide emergency preparedness orientation and training to patients (Patient (P) 7 and P8). In addition, the facility could not ensure that patients received training on whom to contact and provided an alternate emergency phone number if an emergency occurred while the patient was away from the dialysis facility. Failure to ensure patients are adequately trained to respond to emergencies could result in a delayed or inappropriate response for all 67 in-center hemodialysis patients receiving care at this facility. Findings include: Review of the facility’s “Emergency Management Plan,” revised in April 2024, revealed the “Facility Administrator or designee is responsible to provide training of the Emergency Management Plan and appropriate hazard policies per the Hazard Vulnerability Assessment. The Hazard Vulnerability Assessment serves as a needs assessment for the Emergency Management Plan.” A review of the facility’s “Hazard Vulnerability Assessment” revealed that “Active Shooter and Civil Disorder” were all identified and selected as potential hazards requiring patient education. In an interview on 06/04/24 at 9:39 AM, P7 was asked to describe their emergency preparedness orientation to the facility regarding emergency protocols and procedures. P7 replied, I don’t remember. P7 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. P7 replied, “No.” In an interview on 06/04/24 at 9:47 AM, P8 was asked to describe their emergency preparedness orientation to the facility in terms of emergency protocols and procedures. P8 replied, “I am not sure.” P8 stated he/she does not recall being given an alternate emergency phone number or knowing whom to contact if an emergency occurred while he/she was not at the dialysis facility. In an interview with the Facility Administrator on 06/04/24 at 11:00 AM, he/she was asked to provide documentation that P7 and P8 received training on the “Emergency Management Plan,” policies per the “Hazard Vulnerability Assessment.” The Facility Administrator revealed no evidence of emergency preparedness training for Active Shooter and Civil Disorder as identified in the “Hazard Vulnerability Assessment.” The Facility Administrator revealed that there had been no active shooter and civil disorder training and confirmed that the training should have been conducted for patients. The Facility Administrator stated the patients are provided with an alternate emergency phone number upon admission. The Facility Administrator was then asked about the patients who had been at the facility for years. No response.”

“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: 37913 Based on observations, staff interviews, and facility policy the facility failed to ensure that all disposable supplies that were brought into the patient area were disposed of at the end of the treatment. This deficient practice had the potential to affect all 67 in-center hemodialysis patients. Findings include: Observation on 06/03/24 at 10:30 AM at Stations 4, 6, 8, 12, 15 and 17 revealed boxes of disposable gloves were being left after all patient treatments within the splash zone (an area that can be contaminated with spraying of blood). Interview on 06/03/24 at 10:30 AM the Facility Administrator confirmed that boxes of gloves are being left on the shelf behind the patient chairs that are within the splash zone at Stations 4, 6, 8, 12, 15 and 17. Review of the facility’s policy titled, “Infection Control for Dialysis Facilities” dated April 2023, indicated, “ ...unused supplies (syringes, alcohol swabs, tape, ect.) or medications (including multiple dose vials containing diluents) taken into the station should be used only for that patient and should not be returned to common clean area or used on other patients. “”

“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: 37913 Based on observation, interview, and review of the facility’s policies and procedures, the facility failed to ensure that cleaning and disinfection of contaminated equipment surfaces was completed properly and according to facility policy for one of three survey days. Failure to adequately disinfect contaminated surfaces increases the risk for cross contamination and has the potential to expose patients, staff, and others to blood-borne pathogens. This deficient practice had the potential to affect 67 patients receiving treatment in the dialysis unit. Findings include: Observation on 06/03/24 at 9:00 AM of Stations 1, 3, 4, 5, and 14 revealed tape residues on the dialysis side tables. Tape residue can harbor bacteria and must be removed leaving a smooth surface area to be disinfected. Observation on 06/03/24 at 9:00 AM, of Stations 1, 2, 3, 4, 5, 8, 9, 10, and 17 revealed the walls behind the dialysis chairs had brownish red spots and had not been disinfected. Observation on 06/03/24 at 2:00 PM revealed four out of five staff chairs located in the nursing station had torn backs. Torn chair covering prevent proper disinfection. Interview on 06/03/24 at 10:00 AM the Facility Administrator confirmed the findings that tape residue was on the chair side table at Stations 1, 3, 4, 5, and 14 and that brownish red spots were located behind the dialysis chair at Stations 1, 2, 3, 4, 5, 8, 9, 10, and 17. Interview with Facility Administrator on 06/03/24 at 2:00 PM confirmed the torn staff chairs located in the nursing station. Review of the facility’s policy titled, “Infection control for dialysis facilities” dated April 2023, indicated “Cleaning and /or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials.””

“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: 37913 Based on observation, staff interview, and review of facility policies, the facility staff failed to ensure that medications are labeled with date and time when they are opened. The failure to label medications could have resulted in staff using medical supplies that were expired or not longer effective and could affect 67 in-center patients. Findings include: Observation on 06/03/24 at 9:50 AM revealed that an open vial of nitroglycerin sublingual tablets [lot #17221874] located in the medication draw near the nurse’s station, was not labeled with the date and time it was opened. An open container of Naturalyte potassium 1 (K) 2.5 calcium (Ca) (A medication used during dialysis treatment) [catalog # 81251] was not labeled with date and time it was opened, was on the shelf behind patient’s chair at Station 10. During an interview on 06/03/24 at 9:50 AM, Registered Nurse (RN)1 stated, “both the bottle of nitroglycerin sublingual tablets and open container of Naturalyte 1K 2.5CA should have been labeled with the date and time the vial and container were opened.” Review of the facility’s policy titled, “Medication Policy,” published October 2023, stated in part, “ ...the medications must be labeled with the ... date, and time ...””

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 37913 Based on review of the “Daily Water Treatment” log, interviews and facility policy, the facility staff failed to properly document all the results of the water hardness test in the “Daily Water Treatment” log. Failure to test the water quality for hardness has the potential to affect 67 in-center patients receiving dialysis treatments at the facility. Findings include: Review of the “Daily Water Treatment” log from 05/01/24 through 05/16/24 revealed that the facility staff did not document the end of day hardness test results within the log. An interview on 6/03/24 at 12:30 PM with Biomedical Technician 5 confirmed that the end of day hardness test was not documented in the “Daily Water Treatment” log from 05/01/24 to 05/16/24. Review of the facility’s policy titled, “Hardness test using RPC water hardness test strips” dated September 2015, stated “ ...Document test results in the daily water treatment log ...” Review of “Nephrology News” issued July 2013 indicated, “Water hardness test is a test used to determine if there is a build-up of dissolved calcium and magnesium in the reverse osmosis water purification system. The test is performed at the end of the day and is a requirement to be documented on the daily water treatment log. A build-up of dissolved calcium and magnesium can cause damage to the dialysis water purification system’s membrane.””

“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: 37913 Based on observation, interview and policy review, the facility failed to ensure that the drain near the booster pump in the water room was properly cleaned. Failure to properly clean the water room floor has the potential to affect 67 in-center patients receiving dialysis treatments at the facility. Findings include: During an observation of the water room on 06/03/24 at 10:00 AM, a thick black substance was found in the drain next to the booster pump. An interview on 06/03/24 at 10:00 AM, the Assistant Facility Administrator confirmed the thick back substance in the drain next to the booster pump. Review of the facility’s policy titled “Physical Environment” revised 04/18 revealed, “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public. ... The dialysis facility will implement and maintain a program to verify that all equipment including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.””

“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: 30177 Based on clinical record review, staff interview, and review of the facility policy, the staff failed to follow the individualized physician’s orders for Dialysate Flow Rate (DFR) for three of three sampled patients (Patient (P)1, P2, and P3) whose medical records were reviewed for documentation compliance. Failure to follow the medical provider’s dialysis prescription could adversely impact the hemodialysis treatment’s effectiveness. This failed practice had the potential to negatively affect all 67 incenter hemodialysis patients receiving treatments at this facility. Findings include: 1. Review of P1’s “Treatment Details Report” from 05/20/24- 06/03/24 revealed the following: On 05/20/24, “Dialysis Prescription” revealed that a prescribed DFR of 500 milliliters/minute (ml/min) was ordered. The DFR was documented at 510 ml/min at 12:41 PM, 1:11 PM, 1:15 PM, and 2:11 PM without documenting why the physician’s prescribed DFR order of 500 ml/min was not followed. On 05/22/24, “Dialysis Prescription” revealed that a prescribed DFR of 500 ml/min was ordered. The DFR was recorded at 510 ml/min at 12:02 PM and 12:32 PM, and there was no documented reason why it was not reached. On 05/24/24, “Dialysis Prescription” revealed a prescribed DFR of 500 ml/min was ordered. The DFR was recorded at 490 ml/min at 12:01 PM and 510 ml/min at 12:31 PM, 1:04 PM, 1:34 PM, and 2:32 PM, and there was no documented rationale as to why the hemodialysis machine was unable to reach the prescribed DFR of 500 ml/min. On 05/27/24, “Dialysis Prescription” revealed that a prescribed DFR of 500 ml/min was ordered. The DFR was recorded at 510 ml/min at 1:01 PM, 510 ml/min at 1:31 PM, 2:01 PM, and 510 ml/min at 2:23 PM. There was no documented reason why the hemodialysis machine could not achieve the required 500 ml/min DFR. On 05/31/24, the “Dialysis Prescription” indicated a prescribed DFR of 500 ml/min. The DFR was recorded at 510 ml/min at 12:01 PM, 1:31 PM, and 2:31 PM, and there was no documented reason why the hemodialysis machine could not obtain the required 500 ml/min DFR. On 06/03/24, the “Dialysis Prescription” indicated a prescribed DFR of 500 ml/min. The DFR was recorded at 510 ml/min at 12:28 PM, 12:58 PM, 2:28 PM, and 2:58 PM, and there was no documented reason why the hemodialysis machine could not obtain the required 500 ml/min DFR. 2. Review of P2’s “Treatment Details Report” from 05/15/23- 06/03/23 revealed the following: On 05/15/24, the “Dialysis Prescription” indicated a prescribed DFR of 800 ml/min. The DFR was recorded at 810 ml/min at 6:19 AM, 820 ml/min at 6:48 AM, and 820 ml/min at 7:48 AM. There was no documented reason why the hemodialysis machine could not achieve the prescribed DFR of 800 ml/min. On 05/20/24, the “Dialysis Prescription” indicated a prescribed DFR of 800 ml/min. At 6:28 AM, the treatment began with a DFR of 790 ml/min. At 7:57 AM, the DFR was documented at 820 ml/min; at 8:57 AM, it was noted at a rate of 830. There was no rationale for why the hemodialysis machine could not achieve the required 800 ml/min DFR. On 05/22/24, the “Dialysis Prescription” indicated a prescribed DFR of 800 ml/min. At 6:29 AM, the treatment began with a DFR of 790 ml/min. At 6:59 AM, the DFR was documented at 820 ml/min; at 8:29 AM, it was noted at a rate of 810; and at 9:14 AM, it was recorded at 820 ml/min. There was no rationale for why the hemodialysis machine could not achieve the required 800 ml/min DFR. On 05/24/24, the “Dialysis Prescription” indicated a prescribed DFR of 800 ml/min. At 6:23 AM, the treatment began with a DFR of 510 ml/min. At 7:23 AM, the DFR was documented at 820 ml/min, and there was no rationale as to why the hemodialysis machine could not achieve the required 800 ml/min DFR. On 06/03/24, the “Dialysis Prescription” indicated a prescribed DFR of 800 ml/min. At 3:18 PM, the treatment began with a DFR of 820 ml/min. At 4:18 PM, the DFR was documented at 830 ml/min, and there was no rationale as to why the prescribed DFR of 800 ml/min could not be achieved. 3. Review of P3’s “Treatment Details Report” on 05/10/24 and 05/14/24 revealed the following: On 05/10/24, the “Dialysis Prescription” indicated a prescribed DFR of 500 ml/min. At 11:55 AM, the treatment began with a DFR of 720 ml/min. At 12:25 PM, the DFR was documented at 810 mil/min, at 12:55 PM, the DFR was documented at 810 mil/min. At 1:25 PM, the DFR was documented at 820 mil/min. At 1:55 PM, the DFR was documented at 820 mil/min. At 1:57 PM, the DFR was documented as 820 mil/min. At 1:57 PN, the DFR was documented at 810 mil/min. At 2:25 PM, the DFR was recorded at 820 mil/min. At 2:56 PM, the DFR was recorded at 810 mil/min. There was no documented explanation for why the prescribed DFR of 500 ml/min could not be achieved. On 05/14/24, the “Dialysis Prescription” indicated a prescribed DFR of 500 ml/min. At 10:36 AM, the DFR was recorded at 480 ml/min. At 12:06 PM, the DFR was recorded at 510ml/min with no documented reason the prescribed DFR of 500 ml/min could not be achieved. In an interview with the Facility Administrator on 06/05/24 at 4:00 PM, the above data for P1, P2, and P3 was reviewed and confirmed that the provider’s orders for P1, P2, and P3 were not met. When asked about expectations in cases where the provider’s orders are not met or unable to be met, the Facility Administrator replied, “Expectations and policy require staff to document the justification for any change in the treatment prescribed by the physician.” Review of the facility’s policy titled, “CWOW Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2021, indicated, “The Nursing assessment will be performed and documented by a licensed nurse ...The assessment includes review of patient reports, data collection complaints, and response to treatment, verification that machine safety checks have been completed and documented, verification of prescription including machine parameters, review of documentation for accuracy, completion, and patient data. Patient identity, prescription and machine settings are verified by teammate prior to the initiation of treatment. The prescription components are confirmed by a licensed nurse within one hour of treatment initiation ... Prescription components include but are not necessarily limited to the dialyzer make and model, treatment time, target weight, BFR, and DFR ... If the dialysis prescription is not being met including DFR, the reason will be documented, and the licensed nurse informed.””

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 30177 Based on record review, interview, policy and procedure review, the facility failed to implement an ongoing program for vascular access surveillance to detect hemodialysis access failure early. This failure could hinder timely interventions and patient referrals when there were indications of impending access failure. The failed practice had the potential to affect all patients with an arteriovenous fistula (AVF) or arteriovenous graft (AVG) vascular access receiving in-center hemodialysis treatments at this facility. Findings include: In an interview on 06/05/24 at 11:55 AM, the Facility Administrator was asked what the facility’s program for vascular access surveillance is for early detection of hemodialysis access failure. The Facility Administrator revealed that the facility used dynamic venous pressure (DVP) for surveillance of vascular access. The Facility Administrator was asked what the threshold for action is and how the staff knows when the DVP is outside of normal parameters. He/she responded that there is no threshold set. When asked how the facility reviews the DVP data documentation to identify adverse trends to take action if indicated, he/she responded that there is no trend analysis of data, and aggregate data is not reviewed. In an interview with the Patient Care Technician (PCT)3 on 06/04/24 at 2:45 PM, he/she was asked what the expected value for DVP for access integrity is. He/she responded, “About 100.” PCT3 was also asked if the clinical staff were required to report the DVPs to the nurse. He/she replied, “No, we just document them in the chart.” In an interview with the Clinical Coordinator/Charge Nurse/Nurse Manager on 06/04/24 at 3:45 PM, he/she was asked to describe the facility’s process for access surveillance. He/she responded, DVP. He/she was then asked what the threshold for action or concerns is. The Clinical Coordinator/Charge Nurse/Nurse Manager stated, “I think 200.” When asked if he/she tracks trends and analyzes the aggregate data, he/she said, “No.” Review of the facility’s policy titled, “Vascular Access Monitoring and Surveillance,” revised in October 2020, revealed, “Surveillance is documented and trended in patient’s medical record. Data from the clinical assessment, monitoring and dialysis adequacy measurements should be collected, trended, and maintained for each patient’s access and made available to all teammates. The cumulative access data should be tabulated and tracked within each facility as part of a Facility Health Meeting (FHM).” Review of the facility’s procedure titled, “Vascular Access Surveillance: Using Dynamic Venous Pressure,” revised in April 2023, revealed, “Initiate dialysis per procedure, setting blood flow as prescribed for at least two minutes, but less than five minutes, then decrease blood flow to 200 milliliters per minute (ml/min). Observe and document the DVP ... This establishes a baseline for comparing subsequent pressure measurements. Pressure must exceed the threshold three times in succession to be significant and should be reported to the Nephrologist.””

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 30177 Based on staff interviews and a review of the facility’s policies and procedures, it was evident that the facility has not ensured the establishment of a threshold for monitoring dynamic venous pressure (DVP) for vascular access surveillance by the Medical Director. This oversight has prevented the facility from setting a baseline for surveillance of trend analysis in patients with arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular accesses. The absence of a clear threshold for DVP readings and the lack of trend analysis had the potential to lead to missed opportunities for early access intervention for all patients with an AVF or AVG receiving in-center hemodialysis treatments at this facility. Findings include: An interview with the Facility Administrator on 06/05/24 at 11:55 AM revealed that the facility uses DVP as vascular access surveillance for early recognition of signs and symptoms of access dysfunction to eliminate needle placement variation effects. When asked what is the threshold when clinical staff should report the DVP as concerning, the Facility Administrator revealed that the policy does not include an established threshold set by the Medical Director. The Facility Administrator agreed that the patient care policies are an essential reference for clinical staff and should include established thresholds where applicable. During an interview with the Medical Director on 06/05/24 at 9:57 AM, he/she stated that the policy should have included an established threshold for the facility to use for monitoring and trend analysis of the DVP for vascular access surveillance. The Medical Director confirmed that parameters should have been set to provide guidance and a reference to indicate when clinical staff should notify the Nephrologist of their concerns. A review of the facility’s policy titled “Vascular Access Monitoring and Surveillance,” revised in October 2020, revealed, “To promote routine monitoring and surveillance of arteriovenous fistula (AVF) and arteriovenous graft (AVG) vascular accesses for early recognition of signs and symptoms of stenosis, infection, or other access dysfunction ... The Medical Director is responsible for the technique (s) used by the facility for vascular access monitoring, surveillance, frequency, and acceptable parameters. A review of the facility’s procedure, “Vascular Access Surveillance: Using Dynamic Venous Pressure,” revised in April 2023, revealed, “The Medical Director is responsible for establishing the threshold used by the facility. Trend analysis is more important than any single measurement.””