Davita Hopi Dialysis Center

“EP Program Patient Population CFR(s): §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(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 the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[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. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: 28154 Based on interview and review of the facility’s Emergency Management Plan, last facility review 04/03/24, (Emergency Preparedness Plan (EPP), the facility failed to ensure the EPP policies identified the patient population served, their vulnerabilities, the services the facility could provide or how the facility would continue operations during an emergency. This failure had the potential to affect the current 33 in-center the facility and any outpatients that receiving care in the facility. Findings include: Review of the facility’s EPP on 09/04/24 at 12:55 PM, with the Facility Administrator (FA) and Manager of Clinical Services (MCS), revealed that the EPP did not identify the patient population that would be at risk in the event of an emergency event, the services the facility would be able to provide during an emergency, or how the facility planned to continue operations during an emergency. During an interview on 09/04/24 at 1:50 PM while reviewing the EPP, the MCS pointed out on policy 04-07-01, under “Transfer Agreements” it stated: “3. Agreement(s) should: ...c. Take into account: i. Patient population ii. Ability of receiving facility to provide continuity of services . . .” At 2:05 PM, the FA stated there was only the transfer agreement area and at 2:08 PM, the MCS and FA confirmed the facility was connected to the hospital generator but that nothing about the continuance of operations and/or services was identified in the policies.”

“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: 28154 Based on interview and review of the facility’s Emergency Management Plan, last facility review 04/03/24 (Emergency Preparedness Plan (EPP), the facility failed to ensure the alternate means of communication addressed in the EPP was available in the facility for use during an emergency. This failure had the potential to affect the 33 current patients receiving care in the facility, any outpatients that receiving care in the facility, and could hinder the facility’s ability to communicate in an emergency. Findings include: Review of the facility’s EPP on 09/04/24 at 12:55 PM, with the Facility Administrator (FA) and Manager of Clinical Services (MCS) revealed that the EPP stated: “ ...7. Backup communications systems MAY be required in the event of an emergency based on severity of event, to include, but not limited to: ...b. Analog phone i. Facility will maintain an analog phone onsite for use with facility fax line . . .” In an interview on 09/04/24 at 2:49 PM the FA and MCS stated there was no analog phone in the facility.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 28154 Based on observation, interview, and policy review, the facility failed to ensure the water room environment was maintained in a clean and safe manner. Failure to ensure the water room floor, valves, drainpipes, and storage pallets are clean could negatively impact the safety of all of the 32 patients receiving hemodialysis treatment in the facility. Findings include: Observation on 09/02/24 at 6:50 PM showed the floor under the acid tank valve was no longer smooth making it no longer cleanable. The pallet under the boxes of “Granuflo” had two sections with an accumulated mound of crystal material in the bottom. The crystals in one area were white and the crystals in the second section were brownish colored. At the back of the water room the cement floor was cracked, extending from one wall to the other, some areas appeared to have been filled in with an off-white material that was chipping away. The only drain in the water room had all drainpipe outlets below the floor level, with no air gap to prevent contamination in the case of a sewer line back up. During an interview on 09/02/24 at 6:50 PM Registered Nurse (RN) 1 confirmed the non-smooth floor condition, the crack in the floor, identified the crystals as “Granuflo” from broken containers, and the drainpipes outlet were below floor level. During an interview and tour on 09/03/24 at 4:30 PM, the Facility Administrator confirmed the issues identified, with the exception of the crystals which had been cleaned up. Review of the facility’s policy titled, “Physical Environment,” revised April 2018, showed: “ ...1. The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. 2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public. . . .” Review of professional reference from the International Association of Plumbing & Mechanical Officials, “Air Gap and Air Break Required” retrieved on 01/09/23 from http://forms.iapmo.org/email_marketing/codespotlight/2017/July13.htm, revealed in pertinent part that for a plumbing air gap the “the minimum vertical distance as measured from the lowest point of the indirect waste pipe or the fixture outlet to the flood-level rim of the receptor shall be not less than 1 inch.””

“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: 28154 Based on medical record review, staff interview, and review of the facility’s policy, the facility failed to ensure a physician’s order was implemented as prescribed for one of 11 sampled patients (Patients (P) 7). Failure to follow the physician’s dialysis prescription could negatively impact the effectiveness of the dialysis treatment for all 32 in-center hemodialysis patients receiving treatment at this facility Findings include: Review of P7’s medical record revealed a prescription for a Blood Flow Rate (BFR) of 350 mL/min. Review of eight of P7’s “Hemodialysis Record,” from 08/07/24 to 08/30/24 showed on 08/28/24 a treatment started at 4:49 PM with a BFR of 350 mL/min, then at 5:33 PM the BFR was dropped to 300 mL/min where it remained through the last documented BFR at 7:33 PM (the next entry was at 7:52 PM when treatment ended and did not have a documented BFR). Further review of the 08/28/24 treatment and other nurse documentation did not show a documented reason for the decreased BFR. During an interview on 09/04/24 at 4:54 PM, the Facility Administrator stated that the BFR would be at the prescribed rate or there would be a documented reason for the change and the nurse informed. A review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, showed: “Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge .... 3. Patient identity, prescription and machine settings ... The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by law .... Intradialytic Data Collection/Assessment ... 9. Intradialytic treatment monitoring and data collection which may be performed by the PCT [Patient Care Technicians] or licensed nurse includes: ... b. At a minimum, obtain and document the following: ... iii. Blood and dialysate flows ... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed flood flow rate) the reason will be documented and the licensed nurse informed. . . .””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 28154 Based on record review, interview, and review of the facility’s policy and procedure, the facility failed to ensure the staff reported and documented information for one patient (Patient (P) 8) out of five sampled patients regarding the occurrence of high blood pressures during hemodialysis treatment out of a total sample of 11 patients. The facility failed to follow the policy and procedure for monitoring and reporting hypertensive (high blood pressure) during treatment. Failure to report and document these hypertensive episodes had the potential to adversely affect P8’s cardiovascular status and health. Findings include: Review of four of P8’s hemodialysis treatment records from 08/21/24 to 08/28/24 showed on 08/26/24 a pre-treatment nurse assessment blood pressure taken while standing of 193/121 and sitting of 202 /127. The start of treatment at 3:23 PM showed a blood pressure of 184/107 with a note the Registered Nurse (RN) was aware. Subsequent blood pressures recorded were: 3:30 PM 200/115 4:00 PM 183/100 4:30 PM 183/124 5:00 PM 180/109 5:30 PM 192/110 6:00 PM 196/98 6:30 PM 183/97 6:46 PM 196/114 (the Patient Care Technician (PCT) noted “RN [initials] informed” but did not note what the RN was informed about 7:00 PM 187/116 7:04 PM 171/100 (the PCT noted “uf [ultra filtration] turned off due to c/o [complaints of] cramping; RN [initials] informed”) 7:10 PM 190/109 (PCT noted treatment ended) Further review of P8’s medical record including treatment records revealed no documentation that the RN was notified prior to 6:46 PM of the elevated blood pressure readings or that the RN addressed the elevated blood pressures. During an interview on 09/04/24 at 4:54 PM, the Facility Administrator stated, “that blood pressures would be monitored at the beginning and every 30 minutes; if outside parameters, notify the RN, ensure that it’s documented, and if high at the beginning and not going down and if patient is leaving with a higher BP that the doctor is notified and that it’s documented.” During an interview on 09/04/24 at 7:05 PM, PCT 1 stated patients were to be monitored every 30 minutes and if there were issues we might monitor every 15 minutes and notify the RN. During an interview on 09/04/24 at 8:15 PM, RN1 (note, not the RN on 08/26/24) stated the documentation should be there, “I try hard to get all the documentation in, but I might miss occasionally.” A review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, showed: “Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. Policy: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: ...ii Measurement of patient Blood Pressure (BP) 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in the patient electronic record or flow sheet) ... Intradialytic Data Collection/Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: . . . b. At a minimum, obtain and document the following: i. Blood Pressure . . . 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notified the physician (or NPP [non-physician practitioner], if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record. Post Treatment Data Collection/Assessment 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. Abnormal Findings: Unless other abnormal parameters are established by the facility Governing Body ...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record .... Blood Pressure: Pre-dialysis -Systolic greater than 180 mm/Hg [millimeters of mercury] or less than 90 mm/Hg -Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure-Intradialytic: -Systolic greater than 180 mm/Hg or less than 90 mm/Hg -Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure Post Treatment: -If the patient can stand: - - Standing systolic [first number] BP greater than 140 mm/Hg [millimeters of mercury] or less than 90 mm/Hg - - Standing diastolic [second number] BP greater than 90 mm/Hg or less than 50 mm/Hg ... -Sitting BP for patient’s that cannot stand: - - Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg - - Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ...””

“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: 28154 Based on record review, interview, and policy review, the facility failed to ensure the charge nurse and/or physician were notified of post hemodialysis treatment (the mechanical removal of toxins when kidneys fail) weights above one kilogram (kg) of the prescribed target dry weight for three of five patients (Patient (P) 7, P8, and P10) reviewed. This failure had the potential to affect the efficacy and safety of treatment for any of the 32 patients receiving hemodialysis treatment in the facility. Findings include: 1. Review of eight of P7’s hemodialysis treatment records from 08/07/24 to 08/30/24 showed a prescribed target dry (post-treatment) weight of 62.0 kg and on 08/23/24 an actual dry weight of 64.2 kg; and on 08/28/24 a post weight of 63.7 kg with no documentation regarding the nurse or physician being notified of the post weight being over one kg above prescription. 2. Review of four of P8’s hemodialysis treatment records from 08/21/24 to 08/28/24 showed on 08/26/24 a prescribed target dry weight of 82 kg and an actual post treatment weight of 83.3 kg with no documentation the nurse or physician was notified of the post weight being over one kg above the prescription. 3. Review of 10 of P10’s hemodialysis treatment records from 08/05/24 to 08/30/24 showed on 08/26/24 a prescribed target dry weight of 102.5 kg and an actual dry weight achieved of 106.4 kg with no documentation regarding the nurse or physician being notified of the post weight being over one kg above prescription. During an interview on 09/04/24 at 4:55 PM, the Facility Administrator stated an expectation that “post weights would be within parameters; if more than one kilogram, notify the nurse. The nurse should notify the physician, document notification, and educate the patient at chairside.” A review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised April 2024, indicated, “Policy: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. . . . Post Treatment Data Collection/Assessment 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre dialysis findings. 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP [non-physician practitioner] as applicable) is necessary prior to discharge of the patient from the facility. Abnormal Findings: Unless other abnormal parameters are established by the facility Governing Body ...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record .... Fluid Status: ... Post-treatment: -If patient is above or below 1 kg [kilogram] from the target weight.””