Davita Northern Star Dialysis

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 43037 Based on record review and interview, the facility failed to conduct practice activities to test the emergency preparedness plan in 1 of 1 Emergency Preparedness Plan reviewed. Findings: A review of facility policy 4-07-01, “Facility Emergency Management Plan” last revised 4/2023 revealed, “...Emergency Drills...e. Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP [Emergency Management Plan] at least annually, conducted on opposite years (one year full-scale exercise, next year facility-based/exercise of choice): 1. Full-scale exercise that is community-based: a. Required when available b. Defined as an operations-based exercise that typically involves multiple agencies, jurisdictions, and disciplines performing functional (for example, joint field office, emergency operation centers, etc.) and integration of operational elements involved in the response to a disaster event, i.e. “boots on the ground” response activities c. Participation with any of the following: i. Emergency management agency ii. Local, state, and/or federal emergency response agencies iii. Healthcare coalition 2. Individual facility-based exercise: a. Tabletop exercise that includes a group discussion led by the FA b. Scenario situation must be based on hazards relevant to facility c. Designed to challenge facility EMP d. Actions taken will be simulated and not disrupt patient treatments e. Facility may choose to participate instead in a full-scale community based exercise...” A review of facility emergency drills revealed no exercises performed in 2023. A review of facility policy 4-07-01,”Facility Emergency Management Plan” last revised 4/2023 revealed, “...3. Fire safety drills:...b. Required on a quarterly basis c. One drill to be conducted for each shift of patients...” A review of facility fire drill records revealed 1 fire drill performed on 3/23/2023 and a second fire drill performed on 8/23/2023. No other records of fire drills were located. An interview was conducted with Facility Administrator [FA] A on 1/9/2024 at 10:30 AM. When asked if there were any full-scale emergency exercises performed in 2023 FA A stated, “No.” FA A stated that there were no community-based emergency exercises in 2023 in which the facility could participate but there was one planned for 6/2024. When asked if the facility should have performed a facility-based exercise FA A stated, “Yes.” When asked if fire drills have been performed quarterly per policy, FA A stated, “No.” When asked if they should have been performed quarterly, FA A stated, “Yes.””

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 29963 Based on record review, observation and interview, the facility staff failed to ensure patients completed hand hygiene after glove removal and holding dialysis access sites until bleeding stopped for 2 of 2 patients (Patients #7,13) observed holding access sites in a total universe of 16 observations of patient care. Findings include: A review of the facility’s policy #1-05-01 titled, “Infection Control for Dialysis Facilities,” last revised April 2023 revealed, “...2. Patients and caregivers will be encouraged to ... b. Perform hand hygiene after treatment before leaving treatment area...” During an observation on 01/09/2024 at 10:20 AM, Patient Care Technician (PCT) E discontinued dialysis on Patient #7’s fistula. Patient #7 held access sites with gloved hand, removed the glove, left the treatment area to use the bathroom. PCT E did not offer hand sanitizer to Patient #7 prior to leaving the treatment area. During an observation on 01/10/2024 at 10:52 AM, PCT I discontinued dialysis on Patient #13’s fistula. Patient #13 held access sites with gloved hand, removed the glove, left the treatment area to obtain weight without completing hand hygiene. PCT I did not offer hand sanitizer to Patient #13 prior to leaving the treatment area. During an interview on 01/10/2024 at 12:15 PM, the observation findings were discussed with Clinical Coordinator B and Facility Administrator A. Clinical Coordinator B stated all patients should be offered hand sanitizer before they leave the treatment area.”

“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: 29963 Based on record review, observation and interview, facility staff failed to ensure open multi-dose vials were labeled appropriately per facility policy in in 2 of 2 opened vials in a total of 2 opened multi-dose vials observed. Findings include: A review of the facility’s policy #01-06-01 titled “Medication Policy” last revised October 2023 revealed, “ ... If multi-dose vials are used to prepare saline flush syringes, they must be dated upon opening and discarded within 28 days ...” During an observation on 01/09/2024 at 9:25 AM, a multi-dose vial of Heparin (a blood thinning medication) was observed open without a date or time. During an observation on 01/10/2024 at 10:05 AM, a multi-dose vial of Heparin was observed open without a date or time. During an interview on 01/09/2024 at 9:26 AM, the observation findings were discussed with RN (Registered Nurse) C who stated, “I should have labeled the Heparin when I opened it; I will do it now.””

“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: 43037 Based on record review and interview the facility failed to ensure portable conductivity meters were documented as calibrated daily per policy in 2 of 2 calibration logs reviewed. Findings: A review of facility policy 2-08-01A, “Calibration Check and Calibration of Portable Myron L Conductivity Meter (D-1)” last revised 10/2022 revealed, “...This procedure is to be performed prior to daily use or whenever inaccurate readings are suspected...” A review of facility calibration logs revealed blank pages with no documentation. An interview was conducted with Clinical Coordinator B on 1/10/2024 at 7:35 AM. Clinical Coordinator B stated there are 3 Myron meters. One is kept in the water room and 2 are kept on the treatment floor. Clinical Coordinator B stated staff were unable to locate the completed calibration logs for these devices and new blank calibration logs were just placed in a binder for use on 1/9/2024. When asked if staff were calibrating the meters but not documenting the calibration, Clinical Coordinator B stated, “Maybe. I don’t know.” When asked if calibration should be done daily and as needed, Clinical Coordinator B stated, “Yes.” An interview was conducted with Biomedical Technician M on 1/9/2024 at 10:54 AM. When asked about conductivity calibration logs Biomedical Technician M stated that staff do not calibrate meters unless it is needed. Technician M stated that if staff check the meter and it is supposed to have a reading of 14 and it does have a reading of 14, then no calibration is required. In fact staff are unable to calibrate the meter because it is already at the reading it is supposed to have. If they find that it does not have the reading of 14 then they must recalibrate the meter and they do. “I’ve seen them do this.” When asked why there is nothing on the calibration log Technician M stated, “I don’t know, but I just put new log sheets in the binder and told them they need to document on them.” An interview was conducted with Patient Care Technician E on 1/10/2024 at 8:48 AM. Patient Care Technician E stated the Myron meter is checked every morning, as long as it is within normal range, it is not calibrated. Patient Care Technician E stated the facility staff was not documenting that the check/calibration were being completed daily.”

“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: 43037 Based on record review and interview the facility failed to ensure the administration of the pre-treatment Heparin (anticoagulant medication) bolus was at least 3 to 5 minutes prior to the initiation of dialysis per facility policy in 1 of 4 in-center hemodialysis patients (Patient #1) with current active orders for Heparin boluses in a total sample of 7 medical records reviewed. Findings: A review of policy 1-03-08F “Treatment Initiation Utilizing Fresenius 2008 Series Dialysis Delivery Systems With All Single Use Dialyzer Types and Streamline or Combiset or Nipro Blood Lines” last revised 10/2021 revealed, “...7. Establish access per procedure and administer Heparin loading dose per procedure, as applicable. Wait a minimum of three (3) to five (5) minutes following administration of Heparin loading dose prior to actual initiation of treatment...” A review of Patient #1’s medical record revealed a nephrologist order for Heparin 500 units Intravenous push every dialysis treatment. Treatment sheet dated 1/1/2024 revealed Heparin bolus dose given at 7:51 AM and initiation of treatment started at 7:48 AM (3 minutes before Heparin given). Treatment sheet dated 1/8/2024 revealed Heparin bolus dose given at 8:00 AM and treatment started at 8:00 AM (at the same time Heparin bolus dose given). An interview was conducted with Clinical Coordinator B on 1/10/2024 at 12:21 PM. When asked how Heparin boluses should be administered, Clinical Coordinator B stated, “They have to wait 3 to 5 minutes to start treatment when they give it.””

“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: 29963 Based on record review and interview, the facility staff failed to ensure that nursing assessment documentation addressed patients leaving above or below 1 kilogram (kg) of their target weight in 2 of 6 (Patients #3, 4) and failed to ensure nursing documentation addressed patients ultra filtration rate higher than physician ordered maximum ultra filtration rate in 2 of 6 (Patients #3, 4) in-center medical records reviewed in a total universe of 7 medical records reviewed. Findings include: A review of the facility’s policy #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment,” last revised October 2023 revealed, “ ...Intradialytic Data Collection/Assessment ...9...a. Vital signs and treatment monitoring ...is completed at least every thirty (30) minutes...b. At a minimum, obtain and document the following ...Blood pressure...11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. 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 notifies the physician as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record...Abnormal Findings ...Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ...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 ...” Examples of Not Meeting Target Weight: A review of Patient #4’s current in-center hemodialysis orders revealed a Target Weight (TW) of 61 kilograms (kgs). The treatment sheet dated 11/28/2023 revealed Patient #4’s post dialysis weight was documented as 65 kgs, 4 kgs over the TW. The treatment sheet dated 12/12/2023 revealed Patient #4’s post dialysis weight was documented as 69.1 kgs, 8.1 kgs over the TW. The treatment sheet dated 12/14/2023 revealed Patient #4’s post dialysis weight was documented as 69.1 kgs, 8.1 kgs over the TW. The treatment sheet dated 01/08/2024 revealed Patient #4’s post dialysis weight was documented as 73.4 kgs, 12.4 kgs over the TW. There was no documented contact of the physician to report the patient leaving above the target weight. A review of Patient #3’s current in-center hemodialysis orders revealed a Target Weight (TW) of 105 kilograms (kgs). The treatment sheet dated 01/04/2024 revealed Patient #3’s post dialysis weight was documented as 109.5 kgs, 4.5 kgs over the TW. There was no documented contact of the physician to report the patient leaving above the target weight. Examples of Removing More Fluid than the Maximum Allowed by Physician Order: A review of Patient #4’s current in-center hemodialysis orders revealed an ordered maximum ultra filtration rate (UFR) of 13.0 mL/kg/hr (milliliter/kilogram/hour. Treatment sheet dated 11/28/2023 revealed Patient #4’s actual UFR of 20.0 mL/kg/hr. Treatment sheet dated 12/12/2023 revealed Patient #4’s actual UFR of 18.3 mL/kg/hr. Treatment sheet dated 12/14/2023 revealed Patient #4’s actual UFR of 14.8 mL/kg/hr. Treatment sheet dated 12/19/2023 revealed Patient #4’s actual UFR of 17.1 mL/kg/hr. Treatment sheet dated 01/08/2024 revealed Patient #4’s actual UFR of 27.5 mL/kg/hr. There was no documented contact of the physician to report the patient had more fluid removed per hour than what was ordered. A review of Patient #7’s current in-center hemodialysis orders revealed an ordered maximum ultra filtration rate (UFR) of 10.0 mL/kg/hr. Treatment sheet dated 12/30/2023 revealed Patient #7’s actual UFR of 13.8 mL/kg/hr. Treatment sheet dated 01/02/2024 revealed Patient #7’s actual UFR of 12.7 mL/kg/hr. Treatment sheet dated 01/04/2024 revealed Patient #7’s actual UFR of 13.8 mL/kg/hr. Treatment sheet dated 01/06/2024 revealed Patient #7’s actual UFR of 13.8 mL/kg/hr. There was no documented contact of the physician to report the patient had more fluid removed per hour than what was ordered. During an interview on 01/10/2024 at 9:29 AM, the medical record review findings were discussed with and confirmed by Clinical Coordinator B who stated if the patient is leaving dialysis +/- 1 kg of the target weight, the physician should be notified, and a note should be documented in the medical record. Clinical Coordinator B also stated that if the actual ultra filtration rate is higher than the ordered maximum Ultra Filtration rate, the physician should be notified.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to complete an “Refusal of Care/Treatment Against Medical Advice (AMA)” form, per policy, for 4 of 4 in-center hemodialysis patients (Patients #1, 2, 3, 4) with shortened treatment times in a total universe of 7 medical records reviewed. Findings include: A review of the facility’s policy #1-01-10 titled, “Refusal of Care/Treatment Against Medical Advice,” last revised October 2022 revealed, “...1. If a patient refuses care/treatment against medical advice, the RN (Registered Nurse) will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs. 2. If the patient refuses care/treatment, the RN will document the event in the patient’s medical record. Documentation will include, as appropriate, the following: A description of the care/treatment that was refused by the patient; The patient’s stated reason for refusing care/treatment; The date and time that the patient’s attending nephrologist was notified about the refusal of care/treatment ... A copy of the Refusal of Care/Treatment Against Medical Advice form signed by the patient ... The RN (Registered Nurse) will verify that a patient signs the ‘Refusal of Care/Treatment Against Medical Advice’ form if a patient: Refuses their entire dialysis treatment ...” A review of Patient #3’s medical record revealed a physician order for the duration of dialysis treatment to be 240 minutes. The treatment sheet dated 12/26/2023 revealed a treatment time of 206 minutes (34 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” The treatment sheet dated 01/01/2024 revealed a treatment time of 168 minutes (72 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” There were no AMA forms found for Patient #3 dated 12/26/2023 or 01/01/2024. A review of Patient #4’s medical record revealed a physician order for the duration of dialysis treatment to be 195 minutes. The treatment sheet dated 12/12/2023 revealed a treatment time of 147 minutes (48 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” The treatment sheet dated 12/19/2023 revealed a treatment time of 62 minutes (133 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” The treatment sheet dated 12/21/2023 revealed a treatment time of 103 minutes (92 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” The treatment sheet dated 01/08/2024 revealed a treatment time of 92 minutes (103 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” There was no AMA form found for Patient #4 dated 12/12/2023, 12/19/2023, 12/21,2023, and 01/08/2024. During an interview on 01/10/2024 at 9:37 AM, the medical record review findings were discussed with and confirmed by Clinical Coordinator B who stated an AMA form was expected to be completed, the physician should be notified, and the reason should be documented in the medical record. 43037 A review of Patient #1’s medical record revealed a physician order for the duration of dialysis treatment to be 210 minutes. The treatment sheet dated 1/8/2024 revealed a treatment time of 180 minutes (30 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” There were no AMA forms found for Patient #1 dated 1/8/2024. A review of Patient #2’s medical record revealed a physician order for the duration of dialysis treatment to be 240 minutes. The treatment sheet dated 12/27/2023 revealed a treatment time of 183 minutes (57 minutes short). The “Reason Rx [Prescribed] Tx [Treatment] Time Not Met” revealed, “Patient Choice (AMA, transportation, weather, has other appt [appointment].” There were no AMA forms found for Patient #2 dated 12/27/2023. An interview was conducted with Clinical Coordinator B on 1/10/2024 at 12:21 PM. Clinical Coordinator B stated an AMA form was expected to be completed, the physician should be notified and the reason should be documented in the medical record.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 29963 Based on record review, observation and interview, facility staff failed to use vascular access clamps per policy for 5 of 5 patients (Patients # 8, 10, 12, 14, 15) observed for discontinuation of dialysis with an AV Fistula/Graft in a total of 16 observations of patient care. Findings include: A review of the facility’s policy #1-04-08 titled, “Utilizing Vascular Access Clamps” last revised April 2019 revealed, “ ... Vascular access clamps should not be used routinely. However, if a patient is unable to hold his/her own sites, it is recommended that only one (1) clamp is used at a time ...” During an observation on 01/09/2024 at 10:38 AM, PCT (Patient Care Technician) D applied two clamps to Patient #10’s fistula/graft access site. During an observation on 01/09/2024 at 10:53 AM, PCT E applied two clamps to Patient #8’s fistula/graft access site at the same time. During an observation on 01/09/2024 at 12:15 PM, PCT D applied two clamps to Patient #12’s fistula/graft access site at the same time. During an observation on 01/10/2024 at 10:58 AM, RN (Registered Nurse) C applied two clamps to Patient #15’s fistula/graft access site at the same time. During an observation on 01/10/2024 at 11:17 AM, PCT I applied two clamps to Patient #14’s fistula/graft access site at the same time. During an interview on 01/10/2024 at 9:20 AM, observation findings were discussed with RN B who stated, “We try to get rid of clamps. They know they should be clamping one at a time. It is not best practice to double clamp.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 29963 Based on record review and interview, the facility staff failed to document intradialytic monitoring every 30 minutes, per facility policy, for 3 of 6 in-center hemodialysis patients (Patients #3, 4, 7) in a total universe of 7 medical records reviewed. Findings include: A review of the facility’s policy #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised October 2023 revealed, “ ...Intradialytic Data Collection/Assessment ...Intradialytic treatment monitoring and data collection ...includes: Vital signs and treatment monitoring ...is completed at least every thirty (30) minutes ...At a minimum, obtain and document the following: Blood pressure ...Heart or pulse rate ...Blood and dialysate flows, arterial and venous pressures ...Fluid removal and/or replacement ...Vascular access visible and line connections intact ...Patient subjective statement(s) i.e., patient report on overall health, any complaints ...” A review of Patient #3’s treatment sheet dated 12/26/2023 revealed intradialytic monitoring, including blood pressure, pulse, blood and dialysate flow rates, venous and arterial pressures, ultrafiltration rate, volume removed, notes, and confirmation of visualized access was documented at 10:32 AM. There was no further documentation of access visualized or face visualized found until 11:32 AM, 60 minutes later. A review of Patient #4’s treatment sheet dated 11/28/2023 revealed intradialytic monitoring, including blood pressure, pulse, blood and dialysate flow rates, venous and arterial pressures, ultrafiltration rate, volume removed, notes, and confirmation of visualized access was documented at 12:32 AM. There was no further documentation of access visualized or face visualized found until 1:32 PM, 60 minutes later. There was documentation of the access and face visualized at 2:02 PM, there was not further documentation until 2:52 PM, 50 minutes later. Treatment sheet dated 12/12/2023 revealed an access and face visualized at 11:34 AM. There was no further documentation of access/face visualized found until 1:34 PM, 120 minutes later. There was documentation of the access and face visualized at 1:34 PM, there was not further documentation until 2:30 PM, 56 minutes later. Treatment sheet dated 12/21/2023 revealed an access and face visualized at 12:31 PM. There was no further documentation of access/face visualized found until 1:29 PM, 58 minutes later. Treatment sheet dated 01/08/2024 revealed an access and face visualized at 1:33 PM. There was no further documentation of access/face visualized found until 2:22 PM, 49 minutes later. A review of Patient #7’s treatment sheet dated 12/30/2023 revealed intradialytic monitoring, including blood pressure, pulse, blood and dialysate flow rates, venous and arterial pressures, ultrafiltration rate, volume removed, notes, and confirmation of visualized access was documented at 9:01AM. There was no further documentation of access visualized or face visualized found until 9:59 AM, 58 minutes later. Treatment sheet dated 01/04/2024 revealed an access and face visualized at 7:00 AM. There was no further documentation of access/face visualized found until 8:30 AM, 130 minutes later. During an interview on 01/10/2024 at 9:47 AM, the medical record review findings were discussed with and confirmed by Clinical Coordinator B who stated, “Every 30-minute checks should be documented.””