Davita Willamette Valley Renal Center

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 37898 Based on interview and review of documentation, it was determined the facility failed to ensure that fire drills and patient emergency preparedness training were conducted according to facility policies and procedures. Findings: 1. Review of facility fire drill documentation presented revealed the following: - Quarter 1: A drill was performed Wednesday 03/22/2023, “at changeover.” Documentation failed to reflect a drill performed for the Tuesday/Thursday/Saturday shifts. - Quarter 2: A drill was performed Friday 06/02/2023 during “Shift 1.” Documentation failed to reflect a drill performed for Monday/Wednesday/Friday Shift 2, and the Tuesday/Thursday/Saturday shifts. - Quarter 3: A drill was performed Saturday 07/15/2023 during “Shift 1 and 2.” Documentation failed to reflect a drill performed for the Monday/Wednesday/Friday shifts. Review of facility policy 4-07-01 titled “Facility Emergency Management Plan,” with a last revision date of April 2023, stipulated “Fire safety drills: ...Required on a QUARTERLY basis ... One drill to be conducted for each shift of patients.” 2. Review of patient participation in facility fire drill documentation revealed the following: - A form titled “Dialysis Emergency Procedure” was presented as documentation of patient participation in fire drills. Only one form was provided for each patient. - Inconsistencies in documentation were noted as follows: * Patient #1: Patient admitted 07/17/2023; the form was signed by the teammate on the date of admission, but the “Teammate to review with patient” section was blank and the date the patient signed the form was blank. *Patient #2: Patient admitted 05/03/2023; form signed 05/08/2023. Documentation failed to include additional forms reflecting participation in, or discussion of, drills performed 06/02/2023 and 07/15/2023. *Patient #3: Patient admitted 07/19/2023; form signed 11/15/2023, after surveyors were onsite. *Patient #5: Patient admitted 04/07/2023; form dated only “2023.” Further review of facility policy 4-07-01 titled “Facility Emergency Management Plan,” with a last revision date of April 2023, stipulated “Document training for both teammates and patients ... Patients use Reggie form ‘Emergency Evacuation Acknowledgment Form’.” 3. Review of patient “Emergency Preparedness Training” form documentation revealed: * Patient #3: Admitted 07/19/2023; form signed 11/15/2023, after surveyors were onsite. * Patient #5: Admitted 04/07/2023; form signed 11/14/2023, after surveyors were onsite. Review of facility policy 4-07-01 titled “Facility Emergency Management Plan,” with a last revision date of April 2023, stipulated “Training and Education ... Emergency Management Plan ... The FA, or designee, is responsible to provide training of EMP: ... Patients: ... Upon admission to facility.” During interview with the MCS and FA on 11/14/2023 at 1545, they confirmed the findings.”

“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: 37898 Based on interview and review of documentation, it was determined the facility failed to conduct exercises to test the emergency plan annually, and to analyze the facility’s response to all drills as required by this regulation and facility policy. Findings: Review of facility emergency preparedness documentation revealed a “Certificate of Participation as a registered participant of the 2022 Great Oregon ShakeOut.” Documentation lacked an attendance sheet, scenario summary, discussion and analysis of the drill. Documentation of participation in a drill, tabletop exercise or actual emergency event in 2021 was absent. Review of facility policy 4-07-01 titled “Facility Emergency Management Plan,” with a last revision date of April 2023, stipulated “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.” The policy further stipulated “Documentation is required ... Utilize FACILITY EMERGENCY PLAN ACTIVATION template and document: Event that occurred ... Plan and policies activated ... Evaluation of plan ... Plan revisions required ... Governing Body review.” During interview with the MCS and FA on 11/14/2023 at 1545, they confirmed the findings.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 31224 Based on interview and review of documentation, it was determined that the facility failed to ensure that all susceptible patients were offered Hepatitis B vaccination or Hepatitis B vaccine boosters as required to manage care appropriately for 23 of 50 patients. Findings: Review of the “Vaccinations and Surveillance Report” for Hepatitis B, created 11/13/2023, revealed 23 of 50 patients (Patients #1-23) had lab results that showed they were susceptible to Hepatitis B. * Patients #1-14 were susceptible and had no history of either having or being offered the vaccine. * Patients #15-23 had HBsAb results that had dropped below 10, which indicated they were no longer immune and required a booster vaccine. There was no documentation to indicate Patients #15-23 were offered a booster. Review of the facility policy titled “HEPATITIS B SURVEILLANCE, VACCINATION, INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE” and dated 10/2023 stipulated: * If a patient’s status is “Susceptible”, then the vaccine series should be offered. * If a patient was previously immune due to vaccination, but the HBsAb dropped below 10, then an annual booster should be offered. During interview on 11/14/2023 at 1445, the MCS 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: 31224 Based on observation, it was determined that the water purification and storage system were not secured or restricted to prevent access by unauthorized users. Findings: Observation of the facility on 11/13/2023 beginning at 1130 revealed the water purification and storage system was located in a space located off of the supply room. The supply area had an entrance door off of a general access hallway that was accessible with a keyless entry lock which utilized a security door code. This door code was the same code for all other secured areas and could be entered by anyone with the door code, including those not trained in water monitoring and maintenance. During interview on 11/13/2023 at 0945, a PCT/AA reported the security door code was the same for all doors in the dialysis facility. During interview on 11/13/2023 at 1000, the FA confirmed the door code was the same and that unauthorized individuals could access this equipment.”

“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: 37898 Based on observation and interview, it was determined the facility failed to ensure that the treatment area was maintained to provide patients, staff and the public a safe, functional, and comfortable environment. Findings: Observation of the treatment floor on 11/13/2023 at 1200 revealed a bottle of “E-Z Chek Blood Leak Test Strips” in the lab area with an expiration date of “2023-08-31.” Observation of the treatment floor on 11/14/2023 at 1145 revealed a treatment chair at Station 10 that could not be effectively cleaned for infection control purposes due to: *An approximately 2 inch section of seat pad seam that had come undone creating a gap that exposed the inner foam cushion. *Cracks in the upholstery on the footrest that exposed the fibers underneath. During interview with the FA and the MCS on 11/14/2023 at 1545, they confirmed the findings.”

“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 the review of documentation, it was determined the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacturer’s recommendations. Findings: 1. Review of the facility log titled “Oxygen Concentrator Weekly Cleaning and Safety Checks,” dated “Year: 2023,” revealed documentation of the “Clean Exterior” and “Clean Filter” procedures was recorded on only two dates for the year, 07/26/2023 and 09/28/2023. During interview with the MCS and FA on 11/14/2023 at 1545, the MCS stated that there “used to be” a policy requiring weekly inspection and cleaning but it could no longer be accessed because the corporate policy regarding use of oxygen concentrators had just been updated in October 2023 to reflect that manufacturer’s directions for cleaning/maintenance of the device should be followed. The MCS stated that the facility used two types of concentrators: - “AirSep Corporation: NewLife Service Manual” stipulates “Cleaning the Air Intake Gross Particle Filter ... The patient must clean this filter weekly, as described below.” - “DeVilbiss Oxygen Concentrator: Maintenance” stipulates “The air filter should be inspected periodically and cleaned as needed by the user or caregiver. Frequency of inspection and cleaning of filter may be dependent upon environmental conditions like dust and lint.” The MCS confirmed that the oxygen concentrator maintenance was not performed as required. 2. Review of the facility log titled “2% Citric Acid Mixing Log,” beginning 03/10/2023, revealed an entry indicating citric acid was mixed on 09/19/2023. Review of the facility log titled “Citric Acid Containers, Uptake Wands and Caps Disinfection Log,” beginning 03/10/2023, revealed the log lacked documentation of disinfection on 09/19/2023. Review of facility policy 2-10-04 titled “Citric Acid Container, Uptake Wand and Cap Disinfection,” with a last revision date of September 2013, stipulated “All citric acid containers, uptake wands, and caps will be disinfected every seven (7) calendar days or when the citric acid solution is discarded and fresh citric acid is prepared.” During interview with the MCS and FA on 11/14/2023 at 1545, they confirmed the findings. 3. Review of the facility logs titled “Procedure: 1-08-06A” [for blood glucometer testing], dated September and October 2023, revealed “Low Control” testing was not within the acceptable range on 09/28/2023, 10/07/2023 and 10/27/2023. Documentation failed to reflect any action taken as a result of the out of range results. Review of facility procedure 1-08-06C titled “EMBRACEPRO Blood Glucose Monitor: Quality Control,” with a last revision date of September 2020, stipulated “The result should fall within the range. If control solution results are out of this range, repeat the test ... If the monitor does not read control solution values accurately, it may not read patient blood glucose values accurately and is not safe to use. Following the manufacturer’s DFU, the meter must be assessed for the cause of the malfunction.” During interview with the MCS and FA on 11/14/2023 at 1545, the MCS confirmed that the log lacked documentation of appropriate action taken based on the low control testing results.”

“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: 31224 Based on interview, review of 2 of 5 patients’ medical records (Patient #s 1 and 2), and review of facility policies and procedures, it was determined the facility failed to ensure timely VS and treatment monitoring of the patient were completed during dialysis. Findings: Patient #1 Review of documentation revealed Patient #1 admitted to the facility in 07/2023. Review of Treatment Details Reports dated 10/16/2023 through 11/10/2023 (12 hemodialysis treatments), revealed that Patient #1’s access or safety was not monitored in a timely manner during hemodialysis treatment for 2 of 12 treatments. * Treatment Details Report dated 11/08/2023 revealed the PCT checked Patient 1’s access and safety at 1121. The next documented check was at 1229, which indicated 68 minutes had lapsed. Additionally, a PCT documented checking Patient #1 at 1230. The next documented check was at 1332, which indicated 62 minutes had lapsed between checks. * Treatment Details Report dated 11/10/2023 revealed the PCT checked Patient 1’s access and safety at 1332. The next documented check was at 1434, which indicated 62 minutes had lapsed between checks. Patient #2 Review of documentation revealed Patient #2 admitted to the facility in 05/2023. Review of Treatment Details Reports dated 10/14/2023 through 11/11/2023 (13 hemodialysis treatments), revealed that Patient #2’s access or safety was not monitored in a timely manner during hemodialysis treatment for 1 of 13 treatments. * Treatment Details Report dated 11/09/2023 revealed the PCT checked Patient #2’s access and safety at 0809. The next documented check was at 1009, which indicated 120 minutes had lapsed between checks. Review of facility policy titled “Incenter Hemodialysis Policies & Procedures” and dated 10/2023 stipulated: * Vital signs and treatment monitoring for non-nocturnal treatments is “completed at least every thirty (30) minutes.” * “At a minimum, obtain and document the following: ... vascular access visible and line connections intact ... Patient subjective statement(s), i.e., patient report on overall health, any complaints.” * “The vascular access site, blood line connections and the patient’s face should be visible throughout the dialysis treatment.” Failure to ensure accurate blood pressure measurements, timely assessments and interventions were done during hemodialysis treatments could compromise patient safety during dialysis treatment. Additionally, failure to assess and evaluate BP could contribute to patient health deterioration. During interview on 11/15/2023 at approximately 1230, the MCS and DCS confirmed the above findings. Refer to V726.”

“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: 31224 Based on interview, review of clinical records, facility documentation, and CDC recommendations, it was determined the facility failed to implement facility policy that ensured patients pneumococcal vaccination status was assessed and pneumococcal vaccines were offered to qualifying patients for 33 of 50 patients reviewed (Patient #s 1, 3-9, 10-15, 17, 20-23, 25, 27-39). Findings: 1. Review of the Vaccination and Surveillance Report for pneumococcal vaccines dated 11/15/2023 revealed the following: * Patient #s 1, 3-7, 10-14, 25 and 27 had no history of receiving or being offered any pneumococcal vaccine documented in their clinical record. * Patient #s 8, 9, 15, 17, 20-23, and 32-29 had record of receiving at least one dose of PPSV23 and were due to receive PCV20. No documentation was found to show it was offered. * Patient #s 28-31 had a record of receiving one dose of PPSV23 and one dose of an unknown pneumococcal vaccine, but were eligible to receive a dose of PCV20. No documentation was found to show it was offered. * Patient #32 had a record of receiving PCV13 and an unknown pneumococcal vaccine on 08/14/2020. Because the 2020 vaccine was unknown, it could not be determined if they were eligible to receive PCV20 at this time. 2. The CDC recommends pneumococcal vaccination for adults 19 to 64 with chronic renal failure and for all adults 65 and older. https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html 3. Review of the facility policy titled “PNEUMOCOCCAL VACCINATION FOR ADULT PATIENTS,” dated October 2023, included vaccination guidance based on which vaccine was administered (PCV13, PCV15, PCV20, or PPSV23). * For patients with no previous vaccine, PCV20 would be administered to complete the series. * For patients who had received only PPSV23 or PCV13, a dose of PCV20 could be administered at least one year after the most recent PPSV23 vaccine to complete the series. * For patients under age 65 who received PCV13 and PPSV23, a dose of PCV20 could be administered at least five years after the most recent pneumococcal dose. 4. During interview on 11/14/2023 at 1445, the MCS confirmed the above findings.”

“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: 31224 Based on interview, review of clinical records, and review of facility documentation, it was determined the facility failed to ensure clinical records were accurate for all patients receiving in-center hemodialysis treatments and for all patients with a history of pneumooccal vaccination administration. Findings: 1. Review of Treatment Details Reports for in-center hemodialysis patients revealed entries during treatment were time stamped at conspicuously equal intervals and did not appear to reflect the time the task was completed. For example, Patient #2’s treatment sheet for 11/09/2023, RN/PCT documentation for VS, BFR/DFR, AP, VP, UFR, volume remaining, access visualization, and face visualization were timed at equal 30 minute intervals at 0701, 0731, 0801, 0831, etc., with no variation. Review of the history in treatment record in CWOW revealed the actual times of RN/PCT documentation occurred. While the 11/09/2023 Treatment Details Report for Patient 2 indicated there were no missed 30 min checks by the RN/PCT, the history field revealed a two hour window between 0809 and 1008 when no RN/PCT checks occurred. Additionally, when a long form version of the Treatment Details Report was run, the actual times RNs/PCTs documented their checks could be seen and the two hour window could be identified. Similar findings of missed patient checks were noted for Patient #1. Review of the facility policy “CWOW-PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” dated April 2021 stipulated vital signs and treatment monitoring was “completed at least every thirty (30) minutes.” During interviews on 11/15/2023, the FA, MCS, and DCS confirmed the above findings. They stated the PCT or RN would enter certain data manually, but acknowledged that the Treatment Details Reports did not reflect the actual time these tasks were completed, but rather the times the machine was programmed to take vital signs and note machine settings. Refer to V504.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 37898 Based on interview and review of documentation, it was determined the facility failed to implement an effective internal grievance process. Findings: Review of the facility “Patient Grievance Log” revealed a grievance documented on 02/13/2023. Review of the corresponding “Grievance/Investigation Document,” revealed documentation of a description of the complaint, and “See attached” written under “Investigation.” The rest of the document, including “Describe the Plan of Resolution” and “Describe the Resolution,” was blank. Review of the unsigned, typewritten attachment revealed a more detailed description of the complaint, including that the patient had called the facility to complain multiple times. The narrative indicated that the patient’s care facility was contacted but failed to include documentation that the patient was spoken to directly by facility administration and whether or not the complaint had been resolved from the patient’s perspective. Review of facility policy 3-01-06 titled “Patient Grievance,” with a last revision date of October 2021, stipulated “The FA (or her/his designee) is to discuss the grievance with the patient, investigate and take appropriate action towards a solution, if possible ... If the patient’s grievance cannot be resolved by the FA, the ROD and Medical Director will be notified and a formal grievance conference will be coordinated.” During an interview with the MCS on 11/14/2023 at 1514, they confirmed that the investigation lacked documentation that the patient was spoken to directly and stated “There are lots of notes about the patient complaining but not much about what we are doing about it.””