Davita Woodburn Dialysis

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 47148 Based on interview, review of facility personnel files, review of patients’ medical records, review of policies and procedures and review of the facility’s Emergency Preparedness binder, it was determined the facility failed to comply with the Federal Emergency Preparedness (EP) requirement to establish and maintain a comprehensive EP program, 42 CFR § 494.62 - Condition of participation: Emergency preparedness. Findings: The facility failed to: 1. Develop and implement policies and procedures specific to those hazards identified in the Hazard Vulnerability Risk Assessment dated “11/14/23.” The hazards identified were: a. Flood, external b. Winter/Ice Storm c. Earthquake d. Wildfire e. Infectious disease f. Fire, internal g. Bomb threat h. Utility outages 2. Develop and implement the policies and procedures based on the emergency plan. Those include, but not limited to: a. Emergency Preparedness Training and Testing program i. The clinic failed to provide documentation of participation in any emergency preparedness exercises for the last year. Those include any exercises to test the facility EMP, full-scale or table-top exercises, facility-based exercises, or community-based exercises. ii. 14 of 17 staff members failed to have documentation of emergency preparedness training during orientation. iii. 2 of 17 staff members failed to have documentation of completed computer-based training for emergency preparedness. iv. 7 of 10 patient records reviewed failed to have documentation of any disaster training. b. Fire Safety Preparedness program i. The clinic failed to provide any documentation of both staff and patient participation in fire drill exercises for the past four quarters. c. Water Contingency Plan d. Concentrate Contingency Plan e. Emergency contact information for utilities, such as electric and water. 3. Little to no evidence that an emergency preparedness communication plan was developed and maintained. Examples included, but were not limited to: a. An undated “Staff Emergency Contact Information” b. There was no current documentation of entities providing services under contract and patients’ physicians. c. There was no contact documentation of Federal, State, tribal, regional or local emergency preparedness staff. Review of the facility policy titled “Facility Emergency Management Plan (ICHD, HOME)” dated as last revised “October 2023” stipulated: - “Facility EMP shall be maintained ... Electronically ... Hard copy in a location accessible to all facility teammates ... Readily available in an emergency ... Documentation at least 4 years.” - “Training and Education ... Emergency Management Plan ... The FA, or designee, is responsible to provide training of EMP ... Teammates ... Annually ... Policy Facility Emergency Management Plan ... Appropriate hazard policies ... Facility specific emergency responses procedures ... Quarterly ... Fire Safety Preparedness.” And “Patients ... Annually ... Policy Facility Emergency Management Plan ... Facility specific emergency response procedures ... Quarterly ... Fire Safety Preparedness.” And for “Physicians ... Annual basis ... Policy Facility Emergency Management Plan ... Appropriate hazard policies, per HVA ... Clinical emergency policies ... Facility specific emergency response procedures.” - “Emergency Drills ...The FA or designee, will maintain the emergency preparedness training and testing based on the facility EMP... 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.” - “Fire safety drills ... Required on a quarterly basis ... One drill to be conducted for each shift of patients ... Include patient emergency take off procedure policy: Termination” - “At a minimum, this facility specific water contingency plan will be printed and placed with facility’s emergency and disaster plan.” During interview with the FA and GFA on 12/15/2023 at 1345, they confirmed that the emergency binder failed to contain the required documentation, and that the facility failed to conduct both quarterly fire drills and emergency education for staff and patients. This Condition-level deficiency substantially limits the capacity of the clinic to furnish services of an adequate level of quality.”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice 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: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[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 the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID 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: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, it was determined that the facility failed to develop an emergency plan that was based on a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach that included all required elements. Findings: Refer to findings identified in Tag E0003.”

“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: 47148 Based on interview and review of documentaiton, it was determined the facility failed to 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 failed to 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. Findings: Refer to findings identified in Tag E0003.”

“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: 47148 Based on interview, review of patients’ medical records and review of documentation, it was determined the facility failed to participate in a full-scale community-based drill to test the emergency plan at least annually per facility policy. The facility also failed to ensure fire drills were conducted quarterly for each shift of patients including staff members. Findings: Refer to findings identified in Tag E0003.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation for 91 patients reviewed, it was determined the facility failed to have systems in place to ensure the HBV serological status of all patients was known before admission. Review of the facility’s “Vaccinations and Surveillance Report,” created “12/11/2023,” that included documentation of Hepatitis B vaccination status of 91 patients revealed 8 patients with their Hep B serological status as “Unknown/Results not Available” and lacked documentation of a lab value for HBcAb. Review of the facility policy titled, “HEPATITIS B SURVEILLANCE, VACCINATION INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE,” dated “October 2023” stipulated “All permanent patients including AKI patients will have HBV serologic testing drawn immediately upon admission to the facility and results known within seven (7) days of admission (i.e., Hepatitis B Surface antigen [HBsAg], Total Hepatitis B Core Antibody [total anti-HBc or HBcAb], and Hepatitis B Surface Antibody [anti-HBs or HBsAb]). During an interview with the GFA on 12/12/2023 at 1250, they were able to locate Hep B lab values for 6 of the 8 patients in a previously used electronic health record stating that the values were not transferred to the new CWOW EHR in October 2022. They were not able to find any documentation for the other two patients and confirmed the above findings.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 47148 Based on observation it was determined that the facility failed to ensure that the water treatment and storage system was located in a secure area. Findings: Observations at the facility on 12/11/2023, revealed that the water treatment area was unlocked and accessible. The area was just off the treatment floor where the fire door separating the areas remained unlocked, open and unattended for the days the surveyors were on-site. The water treatment area was accessible via a open framed section of a shared wall between the storage area and the water treatment room. The framed section failed to provide a secured entry that prevented unauthorized personnel access to the water treatment room. During an interview with the GFA and FA on 12/11/2023 at about 1530, the above findings were confirmed.”

“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: 47148 Based on observation and interview, it was determined the facility failed to maintain a safe treatment environment by failing to ensure that expired medications and supplies were not available for use and that medications were labeled as required. Findings: Observation of the facility treatment area on 12/11/2023 beginning at 0955 revealed: - 4 30 mL Aerobic culture bottles with an expiration date of “2023-09-07” - 21 6 mL lab tubes with an expiration date of “2023-04-30” - 16 6 mL lab tubes with an expiration date of “2023-06-30” - 24 6 mL lab tubes with an expiration date of “2023-10-31” - 33 8 oz bottles of “Conductivity Standard Solution” with an expiration date of “22/09/2023” - 2 10 mL MDVs of “1% Lidocaine Injection” lacked a date, time and the initials of the person who opened them. - 4 30 mL MDVs of “Heparin Sodium Injection” lacked a date, time and the initials of the person who opened them. - One bottle of “Minncare Residual Test Strips with an expiration date of “2023-04-20” During an interview with the FA and GFA on 12/11/2023 at 1530, the above findings were confirmed.”

“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: 37898 Based on interview and review of documentation, it was determined the facility failed to maintain a program to ensure that all equipment was monitored and operated in accordance with the manufacturer’s recommendations. Findings: Review of the “CWP Daily Water Log” revealed that on 09/04/2023 the “Rejection Rate, %” was recorded as “15%.” Indication of a properly functioning RO device is determined by a rejection rate >/= 90%. The form used by the facility stipulates “Acceptable Limit(s) ... >/= 90%.” The form also stipulates “contact biomed if <90%.” Review of facility policy 2-04-02 titled “Daily Water Treatment System Monitoring,” dated as last revised “April 2023” stipulated “5. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log.” During interview with the Biomed on 12/12/2023 at 1436, the finding was presented. The Biomed stated that they had not been notified of the finding and “I need to double check that with them on the floor.” No further information was provided. During FHM review on 12/13/2023 at approximately 1100, documentation failed to reflect that the 15% reading was noted during monthly log review and/or that any action had been taken based on the reading. During interview with the GFA on 12/13/2023 at approximately 1145, the findings were confirmed.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 47148 Based on observation, it was determined the facility failed to prominently display the current State agency and ESRD network mailing addresses and telephone complaint numbers where it can be easily seen and read by patients. Findings: During observation of the facility lobby/waiting area on 12/11/2023 at 1015, the facility failed to have any information posted providing the mailing addresses and contact information for the applicable ESRD Network and the State survey agency as well as the complaint telephone numbers for each. During an interview with the GFA on 12/12/2023 at 1415, the above findings were confirmed.”

“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: 37898 Based on interview, review of medical records and review of documentation, it was determined that the facility failed to ensure that patients received hemodialysis treatments as prescribed for 6 of 10 patient records reviewed (Patients #3-6, 9 and 10). Findings: Patient #3 Review of 13 treatment sheets dated 11/13/2023 to 12/11/2023 revealed: * On 11/24/2023 a DFR of 600 was prescribed. The treatment was started at 1510 with a DFR of 500, where it remained throughout the treatment. Documentation failed to reflect a reason the treatment was not given as prescribed. * On 12/04/2023 a BFR of 400 was prescribed. The treatment was started at 1458 with a BFR of 300. At 1630 the BFR was increased to 350, where it remained for the rest of the treatment. Documentation failed to reflect a reason the treatment was not given as prescribed. * Similar findings were noted on treatment sheets dated 12/06/2023 and 12/08/2023. Patient #4 Review of 6 treatment sheets dated 11/28/2023 to 12/09/2023 revealed: * On 11/30/2023 a BFR of 350 was prescribed. The treatment was started at 1352 with a BFR of 355. At 1430 the BFR was reduced to 300. At 1500 the BFR was reduced to 250, where it remained for the rest of the treatment. Documentation failed to reflect a reason the treatment was not given as prescribed. * On 12/09/2023 a DFR of 600 was prescribed. The treatment was started at 1431 with a DFR of 500, where it remained throughout the treatment. Documentation failed to reflect a reason the treatment was not given as prescribed. Patient #5 Review of 13 treatment sheets dated 11/10/2023 to 12/08/2023 revealed: * On 11/10/2023 a BFR of 400 was prescribed. The treatment was started at 1036 with a BFR of 350, where it remained throughout the treatment. Documentation failed to reflect that the RN was notified of the change and a reason the treatment was not given as prescribed. * Similar findings were noted on treatment sheets dated 11/13/2023, 11/15/2023 and 12/06/2023. * On 11/17/2023 a BFR of 400 was prescribed. The treatment was started at 1054 with the prescribed BFR; at 1131 the BFR was reduced to 350, where it remained for the rest of the treatment. Documentation failed to reflect that the RN was notified of the change and a reason the treatment was not given as prescribed. * Similar findings were noted on treatment sheets dated 11/19/2023, 11/27/2023, and 12/04/2023. Patient #6 Review of 13 treatment sheets dated 11/11/2023 to 12/09/2023 revealed: * On 11/22/2023 orders for Heparin included “Stop time for hourly dose before end of treatment: 0 minutes.” At 1601, a PCT documented “Heparin infusion completed” and the treatment terminated 67 minutes later at 1708. Documentation failed to reflect a reason the treatment was not given as prescribed. Patient #9 Review of 13 treatment sheets dated 11/13/2023 to 12/09/2023 revealed: * All 13 treatments indicated an “Ordered Maximum Ultra Filtration (UF) Rate” of 13.0 mL/kg/hr was prescribed. The “Actual UFR” for the respective hemodialysis treatments were: - On 11/13/2023, it was 15.3 mL/kg/hr. - On 11/15/2023, it was 16.5 mL/kg/hr. - On 11/19/2023, it was 16.8 mL/kg/hr. - On 11/21/2023, it was 13.5 mL/kg/hr. - On 11/24/2023, it was 17.3 mL/kg/hr. - On 11/27/2023, it was 18.4 mL/kg/hr. - On 12/04/2023, it was 23.5 mL/kg/hr. Patient #10 Review of 13 treatment sheets dated 11/09/2023 to 12/09/2023 revealed: * On 11/14/2023 a BFR of 400 and a DFR of 800 was prescribed. The treatment was started at 0618 with a BFR of 350 and a DFR of 500, where they remained throughout the treatment. Documentation failed to reflect a reason the treatment was not given as prescribed. * Similar findings on treatment sheets dated 12/02/2023, 12/05/2023, 12/07/2023 and 12/09/2023. * On 11/20/2023 orders for Heparin included “Stop time for hourly dose before end of treatment: 60 minutes.” At 0950, a PCT documented “Treatment terminated” and the Heparin “Infusion Start/End” as “06:21 PST - 09:53 PST. Documentation failed to reflect a reason the treatment was not given as prescribed. * On 12/05/2023 orders for Heparin included “Stop time for hourly dose before end of treatment: 60 minutes.” At 0950, a PCT documented “Treatment terminated” and the Heparin “Infusion Start/End” as “06:17 PST - 09:50 PST. Documentation failed to reflect a reason the treatment was not given as prescribed. Review of facility policy 1-03-08 titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a last revision date of October 2023, stipulated “Intradialytic Data Collection/Assessment ... 10. 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.” During interview on 12/12/2023 at 1450 with the FA and GFA, the findings were confirmed.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 47148 Based on interview and review of documentation, it was determined the facility failed to ensure that all susceptible patients were offered vaccination against Hepatitis B. Findings: Review of the facility’s “Vaccinations and Surveillance Report,” created “12/11/2023,” that included documentation of Hepatitis B vaccination status of 91 patients revealed 12 patients who were determined susceptible lacked documentation of receiving the vaccine series, the vaccine series was incomplete or the vaccine series was incorrectly administered. Review of the facility policy titled, “HEPATITIS B SURVEILLANCE, VACCINATION INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE,” dated “October 2023” stipulated “On annual retesting of immune patients due to vaccination, HBsAb less than (<) 10 mIU/mL, with nephrologist order, administer a booster dose of vaccine.” The policy provided guidelines for offering vaccination series or booster doses. During interview with the GFA on 12/12/2023 at 1250, the above findings were presented. Detailed information was discussed with the GFA and the above findings were confirmed.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 37898 Based on interview, review of documentation and review of personnel records, it was determined that the facility failed to ensure that 17 of 17 staff (Staff #s 2-18) had an up-to-date personnel file reflecting that the staff met the qualifications and demonstrated competencies required to meet the comprehensive needs of the patients. Findings: Review of the “Personnel Audit Tool” completed by the FA on 12/13/2023 revealed the following: - 11 of 17 staff (Staff #s 2-4, 7, and 9-15) had a TB evaluation while surveyors were onsite. One staff (Staff #17) did not have a TB evaluation documented. - 5 of 17 staff (Staff #s 6-10) “Competencies and Skills Documented” reflected completion dates in August 2022. - 3 of 17 staff (Staff #s 3, and 11-12) did not have a completion date documented for infection control training. 4 of 17 staff (Staff #s 4, 6-7, and 18) infection control completion dates were greater than one year old. - 6 of 17 staff (Staff #s 2, 9, 11-12, and 14-15) did not have an “Emergency Procedures Initial Training” completion date documented. - One of 17 staff (Staff #5) most recent “Machine Training” completion date reflected 10/04/2021. 9 of 17 staff (Staff #s 3-4, and 6-12) “Machine Training” entries reflected completion dates in August 2022. - 11 of 17 staff (Staff #s 3-8, 10-11, and 13-15) “Date of Last Annual Evaluation” completion dates were greater than one year old. - 14 of 17 staff (Staff #s 2-7, 9-15, and 17) lacked documentation of an “EP Training Orientation ALL Facility Personnel” completion date. - 2 of 17 staff (Staff #s 2 and 18) lacked documentation of an “EP Training Annual ALL Facility Personnel” completion date. Review of the facility policy 8-02-01, titled “Teammate Qualifications, Licensure and Adequate Teammate Staffing,” dated as last revised “October 2017” stipulated, “3. The dialysis facility’s teammates (or contractors) will meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive need of the patients. The dialysis facility’s teammates (or contractors) will have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions ... 16. Patient Care Dialysis Technician Standards: Patient care dialysis technicians will ... Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician.” During interview with the GFA and FA on 12/13/2023 at 1130, they confirmed that personnel file documentation was not complete.”