Davita Newington Dialysis

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 42929 Based on interviews and facility document review, it was determined the facility failed to contact the local emergency preparedness agency at least annually. The findings include: The facility’s policy titled “Facility Emergency Management Plan” last revised April 2024, states in part: ... 11. The FA [facility administrator], or designee, shall have communication at least on an ANNUAL basis with the following local agencies regarding emergency preparedness, event collaboration and communication, needs of the dialysis patients and facility and reviewing agency’s emergency plan. Communication template available on the DEM webpage. NOTE: documentation of contact is important: a. Local Emergency Management Agency ... On September 17, 2024, the surveyor reviewed the facility’s emergency preparedness documentation provided by Staff Member #1. The last documentation that the facility contacted the local emergency preparedness agency was dated August 6, 2021. On September 17, 2024, Staff Member #1 confirmed that there was no documentation that the facility contacted the local emergency preparedness agency as per the regulation and the facility’s policy, but Staff Member #1 had reached out to the local emergency management that day.”

“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: 42929 Based on interviews and facility document review, it was determined the facility staff failed to analyze/evaluate the dialysis facility’s response to annual exercises. The findings include: On September 17, 2024, the surveyor reviewed the facility’s emergency preparedness binder provided by Staff Member #1. There was no documentation of exercises to test the emergency plan documented for 2023. The exercise guide for “Active Shooter” and “Power Utility Outage” were documented as reviewed on July 16, 2024, but there was no documentation that the facility’s response to the exercise was analyzed/evaluated. The above was discussed with Staff Member #1. A review of the facility’s policy titled “Emergency Management Plan” last revised April 2024 states in part: ... Emergency Drills 1. The FA, or designee, will maintain the emergency preparedness training and testing based on the facility EMP 2. EMP training exercises: a. The purpose is to test effectiveness of the facility’s emergency plan, emergency response, hazard and risk assessment, and the support of the patient population served. b. Testing exercises should vary, based on the facility’s requirements, by cycles and frequency of testing. c. The intent is that testing exercise provide a comprehensive testing and training for teammates, volunteers, and individuals providing services under arrangement as well community partners. d. Testing exercise must be based on the facility’s identified hazards, to include natural or manmade disasters. e. Frequency: i. The facility will conduct and/or participate in one (1) exercise to test the facility EMP 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 f. If the facility experiences an actual emergency event or response of sufficient magnitude that requires activation of the relevant emergency plans meets the full-scale exercise requirement and exempts the facility for engaging in their next required community-based full-scale exercise or individual, facility-based exercise for following the actual event. i. Documentation is required 1. Utilize Facility Emergency Plan Activation template and document: a. Event that occurred b. Plan and policies activated c. Evaluation of plan d. Plan revisions required e. Governing Body review ii. Maintain copy with facility EMP...”

“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: 42929 Based on interviews, medical record review, and facility document review, it was determined the facility staff failed to provide documentation that appropriate emergency preparedness orientation and training were provided to four (4) of five (5) patient’s sampled (Patient #2, Patient #3, Patient #4, and Patient #5). The findings include: The facility’s policy titled “Emergency Management Plan” revised April 2024, states in part: ... Training and Education. Emergency Management Plan 1. The FA [facility administrator], or designee, is responsible to provide training of EMP: ... b. Patients: ... ii. QUARTERLY. 1. Fire Safety Preparedness. 2. Emergency Take-off procedures. iii. Upon admission to the facility. iv. Any changes and/or updates to EMP [emergency management plan] or facility specific emergency procedures. v. Document training on applicable forms ... On September 17, 2024, the surveyor reviewed the medical records for five (5) patients. The records for Patient #2, Patient #3, Patient #4, and Patient #5 revealed no documentation of quarterly emergency preparedness training as per the facility’s policy. Staff Member #1 confirmed that there was no emergency preparedness training documentation in the four (4) patient’s medical records, Patient #2, Patient #3, Patient #4, and Patient #5.”

“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: 42042 Based on observations, interview, and document review, it was determined the facility staff failed to maintain a sanitary environment by not disinfecting the prime waste receptacle during cleaning of the dialysis station for one (1) of two (2) observations. Additionally, the facility failed to prevent contamination of a Central Venous Catheter (CVC) exit site during dressing change during two (2) of two (2) observations. The findings include: On 09/16/2024 at 11:25 AM, the surveyor initiated observations of the dialysis treatment area. On 09/16/2024 at 4:53 PM, the surveyor observed Staff Member #7 clean and disinfect Dialysis Station #6 following patient treatment. The surveyor observed the staff member emptying the contents of the prime waste receptacle and return it to the machine without ever disinfecting the internal or external surfaces of the container. On 09/16/2024 at 12:17 PM, the surveyor observed Staff Member #9 perform a CVC dressing change for Patient #6 at Dialysis Station #11. The surveyor observed the staff member cleanse the CVC exit site area following the removal of the old dressing. Following disinfection of the CVC area, the surveyor observed the patient’s shirt (dirty) touching the CVC exit site. The surveyor observed there were no tape or clamps used to prevent the clothing from making contact with the CVC insertion site. On 09/16/2024 at 12:35 PM, the surveyor observed Staff Member #7 perform a CVC dressing change for Patient #7 at Dialysis Station #6. Similar to the previous observation, the surveyor observed the patient’s clothing make contact with the CVC access site following cleaning of the CVC area. [Note: The surveyor confirmed the aforementioned observations despite a clamp being used most likely in an effort by the technician to secure the patient’s clothing.] In the afternoon of 09/17/2024, the surveyor reviewed the facility document titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” (with last revision date of 10/2023). The document outlines the procedure for CVC catheter care including dressing changes. On page three, the document stated, in part, “Verify patient’s clothing is secured away from the exit site/work area”, with the following rationale, “Securing the patient’s clothing away from the work area minimizes the risk of cross-contamination”. The surveyor was also provided a copy of the facility policy titled, “Infection Control for Dialysis Facilities” (with last revision date of 04/2023). Under “Disinfection” header, the document stated, in part, “Priming containers are to be emptied prior to disinfection”. On 09/17/2024 at approximately 5:30 PM, the surveyor informed both Staff Member #1 and Staff Member #10 regarding the observations who both demonstrated understanding.”

“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: 42042 Based on document review and interview, it was determined the facility failed to evaluate the appropriateness of dialysis treatment by not administering the dialysate flow rate (DFR) as prescribed for one (1) of six (6) patients sampled. The findings include: On 09/17/2024 at approximately 10:00 AM, the surveyor initiated review of medical records-including the past two weeks of treatment flowsheets-for five (5) in-center hemodialysis patients, Patient # (1-5). The surveyor reviewed the treatment orders for Patient #1 which revealed the patient was to receive dialysis at a dialysate flow rate (DFR) of 600 milliliters-per-minute (mL/min). During review of the patient’s treatment flowsheet documentation for 09/09/2024, the surveyor confirmed the patient was dialyzed with a DFR of 800 mL/min throughout their duration of treatment [4:52 PM until 8:56 PM]. There was no documentation surrounding the discrepancy between the dialyzed rate and the prescription order. In the afternoon of 09/17/2024, the surveyor reviewed the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (with last revision date of 04/2024). Under “Intradialytic Data Collection/Assessment” section, the document stated, in part, “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed” [sic]. On 09/17/2024 at approximately 5:30 PM, the surveyor informed both Staff Member #1 and Staff Member #10 regarding the observations who both demonstrated understanding.”

“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: 42042 Based on document review and interview, it was determined the facility staff failed to perform nursing assessments within one hour of dialysis initiation for two (2) of five (5) patients; failed to adequately monitor and report abnormal vital signs for two (2) of five (5) patients; and failed to document significant disparities between post-treatment and target weights for two (2) of five (5) patients. The findings include: On 09/17/2024 at approximately 10:00 AM, the surveyor initiated review of medical records-including the past two weeks of treatment flowsheets-for five (5) in-center hemodialysis patients, Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5. The surveyor identified the following patient treatments in which the nursing assessment was not completed within one hour of treatment initiation without any supporting documentation: Patient #1: 09/03/2024: Treatment initiated on 12:27 PM, Nursing Assessment completed at 1:36 PM. 09/13/2024: Treatment initiated on 4:55 PM, Nursing Assessment completed at 7:21 PM. Patient #4: 09/02/2024: Treatment initiated on 11:27 AM, Nursing Assessment completed at 12:33 PM. 09/04/2024: Treatment initiated on 11:34 AM, Nursing Assessment completed at 12:38 PM. 09/13/2024: Treatment initiated on 11:23 AM, Nursing Assessment completed at 1:21 PM. The surveyor identified the following patient treatments in which abnormal pulse/heart rate and/or blood pressure were recorded without any documentation of intervening to report the abnormal vital signs: Patient #2: 09/14/2024: Heart rate recorded between (104-117) beats/minute (bpm) during treatment between 2:00 PM until 5:11 PM. 09/14/2024: Diastolic blood pressure recorded between (104-111) millimeters per mercury (mmHg) during treatment between 1:53 PM until 3:54 PM. Patient #4: 09/06/2024: Heart rate recorded between (107-117) beats/minute (bpm) during treatment between 2:30 PM until 2:50 PM. The surveyor identified the following patient treatments in which the post-weight exceeded the target weight or estimated dry weight (EDW) by greater than 1 kg without appropriate documentation: Patient #2: 09/03/2024: Target weight: 34.5 kilograms (kg), Post-weight: 36.9 kg 09/07/2024: Target weight: 34.5 kg, Post-weight: 35.9 kg Patient #4: 09/04/2024: Target weight: 83.0 kg, Post-weight: 84.2 kg 09/09/2024: Target weight: 83.0 kg, Post-weight: 85.0 kg In the afternoon of 09/17/2024, the surveyor reviewed the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (with last revision date of 04/2024). Under “Intradialytic Data Collection/Assessment” section, the document stated, in part, “The licensed nurse will ...complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law” [sic]. Under “Abnormal Findings” section of the same document, the policy stated, “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”. “Post-treatment: If patient is above or below one (1) kg from the target weight” [sic]. “Blood Pressure-Intradialytic: Diastolic greater than or equal to a hundred (100) mm/Hg ...” [sic]. “Heart or Pulse Rate Pre/Intra/Post: ...greater than a hundred (100) beats per minute and/or an irregular heartbeat” [sic]. On 09/17/2024 at approximately 5:30 PM, the surveyor informed both Staff Member #1 and Staff Member #10 regarding the observations who both demonstrated understanding.”