Davita Roseburg Mercy Dialysis

“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: 47148 Based on interview, review of personnel files and review of documentation, it was determined the facility failed to ensure all staff received required training on the facility’s EMP and emergency procedures. Findings: The review of documentation included an audit worksheet of the facility staff training records which was completed by the FA on 03/12/2025. The worksheet revealed gaps in the required personnel documentation. Examples included, but were not limited to: - 2 of 22 staff (Staff #19 with a hire date of 03/20/2022 and staff #20 with a hire date of 07/25/2022) lacked documentation of initial “EP Training” upon hire. - 1 of 23 staff (Staff #23) lacked documentation of receiving annual “EP Disaster Training”. During review of the facility policy titled, “Facility Emergency Management Plan” dated “April 2024” stipulated, “The FA, or designee, is responsible to provide training of EMP ... i. Annually ... Policy Facility Emergency Management Plan ... Facility specific emergency response procedures ... III ... Upon Hire ...” During an interview with the FA on 03/12/2025 at 1600, the above findings were confirmed.”

“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: 47148 Based on interview and review of documentation, it was determined that the facility had failed to ensure that staff members that were not immune to Hepatitis B were offered Hepatitis B vaccination. Findings: The review of documentation included an audit worksheet document of the facility staff presonnel records which was completed by the FA on 03/12/2025. Review of the worksheet document revealed a column titled, “Hepatitis B Vaccine or Decline” and the following: - 1 of 22 staff (Staff #15) with a DOH of 01/17/2025 lacked documentation that the employee had received or declined the Hepatitis B vaccine. - 1 of 22 staff (Staff #17) with a DOH of 12/11/2023 lacked documentation that the employee had received or declined the Hepatitis B vaccine. Review of the facility policy titled, “Teammate Hepatitis B Monitoring and Follow-up Guidance” dated “April 2024” stipulated, “New teammates who are not able to provide documentation of Hepatitis B surface antibodies of 10 mIU/ml or greater from any time in the past, regardless of documentation indicating completion of the Hepatitis B vaccine series, will be screened for Hepatitis B surface antigen (HBsAg) and Hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results.” During an interview with the FA on 03/12/2025 at 1600, the above findings were confirmed.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 47148 Based on observation, interview, and review of documentation it was determined that the facility failed to ensure that medications were prepared and stored correctly. Findings: Observation of the treatment floor and medication preparation areas on 03/11/2025 at 0930 revealed: - Two prefilled syringes labeled with a preprinted patient label indicating “Heparin” and two prefilled syringe labeled with a preprinted patient label indicating “Lidocaine” on the chairside table in a patient station. Each label on the syringes lacked the time and the preparer’s initials. - Two prefilled syringes labeled with a preprinted patient label indicating “Heparin” on the chairside tables in three additional patient stations. Each label on the syringes lacked the time and the preparer’s initials. - Two prefilled syringes labeled with a preprinted patient label indicating “Heparin” on the counter of three separate medication preparation areas. Each label on the syringes lacked the time and the preparer’s initials. Review of the facility policy titled, “Medication Preparation and Administration” dated “02/06/2023” stipulated, “All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of the patient, date, time and initials of the person who prepared the medication” ... “When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT must place the date and time the vial was opened on the medication label along with their initials” ... “All medications will be kept in a locked cabinet except when in use.” During an interview on 03/11/2025 at 1545, the FA 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 and interview, 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 03/11/2025 beginning at 0930 revealed the water purification and storage system was located in a space within the supply room. The supply area had an entrance door off of a general access hallway and had 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 03/11/2025 at 1545, 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: 31224 Based on observation, interview, and review of documentation, it was determined that the facility failed to ensure that the building was constructed and maintained to ensure the safety of the patients, staff and the public. Findings: Observation of the treatment floor on 03/11/2025 beginning at 0930 revealed: - Dried brownish-red drips and staining under the sink in the laboratory area. - Disposable underpads stored under the sink in the laboratory area. - 4 boxes of vanilla protein supplement beverages stored under the sink in the medication preparation area. - Black foam tape on the countertops not allowing them to be cleaned for infection control purposes. - White precipitate and old tape on two of the rolling privacy screens - Old tape and exposed drywall around the light switch in the isolation room - White precipitate on the patient chair in the isolation room - Green colored corrosive drain cover and yellow colored chunks of an unknown substance in the sink in the isolation room During interview on 03/11/2025 at 1545, the FA and CC RN confirmed the above 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: 31224 Based on interview and 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. Observation of the facility on 03/11/2025 beginning at 0930 revealed: - The fire extinguisher located in the lobby lacked a “MONTHLY INSPECTION RECORD” tag documenting monthly inspections were completed. - The “MONTHLY INSPECTION RECORD” tag on the fire extinguisher located in the hall near staff offices indicated no check was completed in 02/2025. - The “MONTHLY INSPECTION RECORD” tag on the fire extinguisher located in the hall near the exit/staff break room indicated no check was completed in 02/2025. - The “MONTHLY INSPECTION RECORD” tag on the fire extinguisher located in the storage room indicated no check was completed in 02/2025. During interview on 03/11/2025 at 1545, the FA confirmed the above findings.”

“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: 31224 Based on interview, review of patient medical records and review of documentation, it was determined that the facility failed to ensure that patients received appropriate and timely hemodialysis treatment and monitoring for 6 of 12 patients (Patients #s 7-12). Findings: 1. Review of Patient #7’s Treatment Details Reports dated 01/30/2025 through 03/08/2025 (13 treatments) revealed Patient #7 had systolic blood pressure readings greater than 180 mm/Hg and diastolic blood pressure readings greater than 100 mm Hg noted by the PCT on the following treatment dates. - On 02/01/2025 at 0632, the PCT documented the RN was aware of the blood pressure reading of 200/103. Blood pressure readings remained elevated and outside of parameters until treatment ended at 0957, when the blood pressure reading was 166/89. There was no documentation indicating the RN took measures to reevaluate the patient or administer a PRN medication to lower the patient’s blood pressure. - On 02/22/2025 and 02/27/2025, Patient #7 was documented as having elevated blood pressure readings with systolic blood pressures measuring as high as 213 and diastolic blood pressure readings measuring as high as 107. There was no documentation to indicate the blood pressure was rechecked and/or the licensed nurse was notified. Review of facility policy 1-03-08 titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a last revision date of April 2024, stipulated “Abnormal findings ...will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy)... Abnormal Findings...Systolic greater than 180 mm/Hg ... Diastolic greater than or equal to 100 mm/Hg ...” 2. Review of Patient #7’s dialysis orders and Treatment Details Reports dated 01/30/2025 through 03/08/2025 (13 treatments) revealed: - Physician orders for BFR was 400 mL/min. - On 02/11/2025, the PCT initiated treatment at 0626 with the BFR set at 300 mL/min, where it remained for the duration of treatment. At 0639, the RN verified “that the patient’s prescription matches what is currently being delivered during the dialysis treatment.” There was no documentation to show why the physician orders were not followed. - On 02/15/2025, the PCT initiated treatment at 0622 with the BFR set at 400 mL/min. At 0631, the PCT decreased the BFR to 300 mL/min, where it remained for the duration of treatment. There was no documentation to show the why the physician orders were not followed or that the RN was notified of the change. - Similar findings were noted on 02/18/2025, 02/25/2025, 02/27/2025, 03/06/2025, and 03/08/2025. - Similar findings were noted for Patient #s 8 and 10. Review of facility policy 1-03-08 titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a last revision date of April 2024, stipulated: - “Patient identity, prescription and machine settings are verified by a teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour soft treatment initiation along with the nursing assessment or as allowable by state law.” - “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed flow rate) the reason will be documented and the licensed nurse informed.” 3. Review of Patient #7’s Treatment Details Reports dated 01/30/2025 through 03/08/2025 (13 treatments) revealed: - Physician orders included a Maximum Ultra Filtration (UF) Rate of 13.0 mL/kg/hr. - 10 of 13 treatments reviewed indicated the actual UFR ranged from 13.4 mL/kg/hr to 16.0 mL/kg/hr. Review of facility policy 1-03-08 titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a last revision date of April 2024, stipulated, “If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed flow rate) the reason will be documented and the licensed nurse informed.” 4. Review of Patient #8’s Treatment Details Reports dated 01/27/2025 through 03/10/2025 (13 treatments) revealed: - On 01/27/2025, the PCT documented a patient and VS check at 1404. The next check was documented by the PCT at 1506, 58 minutes later. - On 02/17/2025, the PCT documented a patient and VS check at 1203. The next check was documented by the PCT at 1305, 62 minutes later. The PCT later documented a check at 1337, but the next check was not documented until 1429, 52 minutes later. - Similar findings were noted on 02/03/2025, 02/07/2025, 02/21/2025, 02/24/2025, and 03/03/2025. -Similar findings were noted for Patient #s 9, 11 and 12. Review of facility policy 1-03-08 titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a last revision date of April 2024, stipulated, “Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: ... Vital signs and treatment monitoring... [for] Non-nocturnal treatments are completed at least every thirty (30) minutes.” 5. Review of Patient #12’s dialysis orders and Treatment Details Reports revealed: - On 02/27/2025, the “Treatment Time” ordered was 210 minutes. “Intradialytic Vitals Stat Line” documentation indicated treatment started at 1152 and ended at 1440; a total of 166 minutes, 66 minutes less than ordered. The “Close Treatment Reason” indicated “Patient Choice (AMA, feels unwell/cramping, patient behavioral issue).” - On 03/06/2025, the “Treatment Time” ordered was 210 minutes. “Intradialytic Vitals Stat Line” documentation indicated treatment started at 1144 and ended at 1401; a total of 138 minutes, 72 minutes less than ordered. The “Close Treatment Reason” indicated “Patient Choice (AMA, feels unwell/cramping, patient behavioral issue).” Patient #12’s medical record failed to include an AMA form signed by the patient for the shortened treatments on 02/27/2025 or 03/06/2025 Review of facility policy 1-01-09 titled “Prescribed Treatment Time Not Met,” with a last revision date of April 2024, stipulated: - “1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient’s specific needs. NOTE: Shortened/Early Termination of the dialysis treatment includes all reasons the prescribed dialysis time is not met by 30 or more minutes. This includes but is not limited to: the late initiation of treatment with termination at scheduled time, early termination at the end of treatment, and interruptions of dialysis during the treatment i.e. machine or access problems or use of the bathroom by the patient.” - “4. A completed copy of the ‘Early Termination of Treatment Against Medical Advice’ form will be kept in the patient’s health record.” 6. During interview on 03/13/2025 at 1210, the CC RN and SMCS confirmed the above findings.”

“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 and review of documentation, it was determined that the facility failed to assess and offer vaccines as indicated. The facility failed to: * Identify the appropriate timeframe to offer the next available dose of the pneumococcal vaccine for 3 of 101 patients (Patient #s 18, 22, and 23). * Reassess prior refusal of the pneumococcal or Hepatitis B vaccines for 9 of 101 patients (Patient #s 13-21). Findings: Review of the facility’s “Vaccination and Surveillance Report,” dated 03/11/2025, for both Hepatitis B and Pneumococcal vaccinations revealed: 1. Patient #s 18, 22, and 23 were eligible to receive the PCV20 vaccine due to their documented vaccination status. * Patient #18 received one dose of PPSV23 on 05/02/2023 and was eligible to receive PCV20 as of 05/02/2024, but there was no documentation to show it was offered or received. * Patient #22 received one unknown pneumococcal vaccine on 03/19/2019 and was eligible to receive PCV20 as of 03/19/2020, but there was no documentation to show it was offered or received. * Patient #13 received one dose of PPSV23 on 10/04/2023 and was eligible to receive PCV20 as of 10/04/2024, but there was no documentation to show it was offered or received. 2. Patient #s 13-21 had a prior history of refusing the Hepatitis B and/or the pneumococcal vaccine, however there was no documentation to show they were reassessed annually or that the refusal was noted on the corresponding vaccination tracker. For Example: * Patient #13 refused the Hepatitis B vaccine on 08/18/2023, however there was no documentation to show they were reassessed since then. * Patient #18 refused the Hepatitis B vaccine on 07/12/2022, however there was no documentation to show they were reassessed since then. *Patient #20 refused the pneumococcal vaccine on 01/01/2024, however there was no documentation to show they were reassessed since then. 3. Review of the facility policy titled, “Pneumococcal Vaccination for Adult Patients,” dated as last revised “October 2023,” stipulated: * Patients of any age who received only PCV13 or PPSV23 would be given PCV20 at least one year after the most recent vaccine to complete the series. * The policy did not address what should be administered to a patient with an unknown vaccination history. * The policy did not address reassessing whether a patient wished to receive the pneumococcal vaccine after a refusal. 4. Review of the facility policy titled, “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance,” dated as last revised “April 2024,” did not address reassessing whether a patient wished to receive the Hepatitis B vaccines after a refusal. 5. Review of the facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” dated as last revised “October 2024,” stipulated: * “Assessment criteria will include ... immunization history...” * “A comprehensive re-assessment of each patient and a revision of the plan of care will be conducted: - At least annually for stable patients ... - At least monthly for unstable patients ...” 6. The CDC guidelines for administering pneumococcal vaccines to adults age 14-49 with ESRD or age 50 and older at https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html#note-pneumo included: * “Not previously received a dose of PCV13, PCV15, PCV20, or PCV21 or whose previous vaccination history is unknown: 1 dose PCV15 or 1 dose PCV20 or 1 dose PCV21. * “Previously received only PPSV23: 1 dose PCV15 or 1 dose PCV20 or 1 dose PCV21 at least 1 year after the last PPSV23 dose. - If PCV15 is used, no additional PPSV23 doses are recommended.” 7. During interview on 03/13/2025 at 1210, the CC RN and SMCS confirmed the above findings.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 31224 Based on interview, review of 6 of 12 patients’ plan of care (Patient #s 2, 5, 7-9 and 12) and review of documentation, it was determined that the facility failed to ensure that plans of care were signed by the patient and/or the patient’s designee or that a reason for refusal was documented. Findings: Review of medical records of Patient #2 included a Plan of Care dated 12/31/2024 that lacked the signature of the patient or patient’s designee. The Plan of Care also lacked documentation that showed if the patient chose not to sign the plan of care or why the signature was not provided. Review of the medical records of Patient #5 included a Plan of Care dated 12/31/2024 that lacked the signature of the patient or patient’s designee. The Plan of Care also lacked documentation that showed if the patient chose not to sign the plan of care or why the signature was not provided. Similar findings were identified for Patient #s 7-9, and 12. Review of the facility policy, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE,” dated as last revised in 10/2024, stipulated, “The patient’s plan of care will be completed by the facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.” During interview on 03/12/2025 at 1530, the CC RN and SMCS confirmed the above findings.”