Davita Portland Gateway Dialysis

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 37237 Based on observation and the review of documentation, it was determined the facility failed to ensure visitors wore PPE appropriately. Findings: Observation of the treatment area on 05/22/2024 at 1440 revealed one visitor failed to don PPE during the time of initiation, during treatment while sitting in the patient treatment area, and/or during termination of dialysis. Review of the facility policy “1-15-01” titled, “Infection Control for Dialysis Facilities,” dated as last revised “April 2023” stipulated “PPE ... 6. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physicians ... and visitors when in the treatment area.” This regulation requires visitors to be provided impervious cover garments if they are in the treatment area during initiation or termination of dialysis.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 37237 Based on review of documentation, it was determined the facility failed to ensure the first chlorine test result of the day was accurately documented . Findings: Review of the facility’s “Routine Total Chlorine Testing Log” from 03/01/2024 through 04/30/2024 revealed the times used to document when the first morning test was conducted were consistently on the hour or on the half hour. For example, the first test of the day was routinely documented at “0400” or “0430.” When the “Water Monitoring Log Summary” was reviewed, the times the “First TM Check” were completed were consistently different from the times logged on the “Routine Total Chlorine Testing Log.” Examples include, but are not limited to: - 03/07/2024 - The staff logged the 1st test was completed at 0430. The “First TM Check” was recorded on the water monitoring log at 0515, 75 minutes later. - 03/20/2024 - The staff logged the 1st test was completed at 0400. The “First TM Check” was recorded on the water monitoring log at 0443, 43 minutes later. - 04/24/2024 - The staff logged the 1st test was completed at 0500. The “First TM Check” was recorded on the water monitoring log at 0728, 109 minutes later. - Similar findings were identified for numerous dates in March 2024 and April 2024.”

“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 and interview, it was determined the facility failed to ensure that the lobby and treatment area were maintained to provide patients, staff and the public a safe, functional, and comfortable environment. Findings: Observation of the facility on 05/21/2024 beginning at 0925 revealed: - 1 bag of IV administration sets that expired on 03/23/2023. - 3 bags of IV administration sets that expired on 12/04/2023. - 1 bag of IV administration sets that expired on 03/14/2024. - 1 box of monoject filter needles that expired on 04/01/2024. - 1 box containing 44 “BD Vacutainer ... Blood Collection Set” kits that expired on 02/29/2024. - 1 box of “Monoject Filter Needles” that expired on 01/01/2024. - 2 bottles of “BACT/ALERT” Culture Media-Aerobic that expired on 03/31/2024. - 3 bottles of “BACT/ALERT” Culture Media-Anaerobic that expired on 04/14/2024. - 5 packages of “Uni Swab Sample Packet” that expired on 03/31/2024. - An upholstered cushion in the lobby had a large tear that left the foam pad exposed. Observation of the facility on 05/22/2024 beginning at 1430 revealed: - An opened MDV of lidocaine that lacked the date the MDV was opened. - The treatment chair at station #3 had a rip in the upholstery. - The treatment chair in the isolation room had a rip in the upholstery of the back cushion. The above findings were confirmed on 05/21/2024 at 1515 by the FA, MCS and MD and on 05/22/2024 at 1330 by the FA and MCS.”

“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: 37237 Based on interview, reviews of logs and the review of documentation, it was determined that the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacture’s recommendations. Findings: 1. Review of the facility’s “Oxygen Concentrator Weekly Cleaning and Safety Checklist” revealed filter cleaning was typically done on Saturdays and one or more weeks were missed for all oxygen concentrators, numbered 1-7. Examples of weeks where cleaning and safety checks were missed include, but were not limited to: 04/20/2024, 03/02/2024, 03/23/2024, 03/30/2024, 02/03/2024, 01/20/2024, 01/27/2024 and 11/18/2023. Review of facility policy titled, “Use of Oxygen Concentrators,” dated as last revised in October 2023, stipulated, “Follow Manufacturer Instructions for Use regarding any additional cleaning/maintenance of the device and document on the Oxygen Concentrator Filter Cleaning Log, as applicable.” 2. Review of the facility’s “Citric Acid Containers, Uptake Wands and Caps Disinfection Log[s]” between November 2023 and April 2024 revealed: - Disinfection was missed the weeks of 03/27/2024 and 01/14/2024. 3. Review of the facility’s “Bicarb Mix Log - Conductivity with Myron-L 4P or 6P Meter” revealed: - The time was not recorded for tests completed on both 04/29/2024 and 04/30/2024. - There was no “Second Teammate Verification” for tests completed on 03/30/2024 at 0830. - The result was recorded as out of range for “Bicarb mixing tank [conductivity]... Test results (48 - 52 mS)” for 03/22/2024. There was no follow-up documented for the out-of-range result. - The date, “7-31-25,” was recorded between the dates of 03/25/2024 and 03/26/2024. The actual date could not be determined. - For tests completed between 12/07/2023 and 12/16/2023 the “50 ms Standard Solution Expiration Date” was recorded as “1/7/23.” - For tests completed between 12/18/2023 and 12/27/2023 the “50 ms Standard Solution Expiration Date” was recorded as “1/18/23.” - There was no “Second Teammate Verification” for tests completed on 11/01/2023. 4. Review of the facility’s “Bicarb System Daily Rinse Log[s]” revealed: - The following dates were missed: 02/09/2024, 02/12/2024, 01/05/2024 and 01/10/2024. - The date 11/23/2023 was recorded two days in a row. 5. The “Fresenius Dialysis Delivery System Clean and Disinfect Log” for April 2024 lacked staff initials for machines #1-17 on 04/25/2024. 6. Review of the “Granuflo (132 Gallon) Batch Production Record” logs for the dates 11/06/2023 through 04/29/2024 revealed: - 11/20/2024 - The date and time was blank for “15 ... Date, time, signature Granuflo batch transferred to Storage Tank.” - 01/02/2024 - The date and time was blank for “15 ... Date, time, signature Granuflo batch transferred to Storage Tank.” - 01/05/2024 - The time was blank for “15 ... Date, time, signature Granuflo batch transferred to Storage Tank.” - 02/05/2024 - The time was blank for “15 ... Date, time, signature Granuflo batch transferred to Storage Tank.” - 04/22/2024 - The Licensed Nurse Signature was blank for “14 ... Catalog Number on Granuflo mixer and Batch Production Record matched Catalog Number on Storage Tank to be filled” and the time was blank for “15 ... Date, time, signature Granuflo batch transferred to Storage Tank.” 7. Review of the facility’s glucometer logs, “Procedure: 1-08-06A” (no title listed for this procedure) for daily glucometer calibration for Meter #EE23AA08852 revealed tests were not performed on 04/15/2024, 03/14/2024, 03/30/2024, 02/28/2024, 01/25/2024, 01/17/2024, 01/16/2024 and 12/14/2023. - Review of the facility’s glucometer logs, “Procedure: 1-08-06A” (no title listed for this procedure) for daily glucometer calibration for Meter #EE20BB01221 revealed tests were not performed on 04/01/2024, 04/02/2024, 04/03/2024, 04/09/2021, 04/10/2024, 04/12/2024, 04/13/2024, 04/16/2024 - 04/19/2024 and 04/22/2024 - 04/26/2024. * Similar findings were identified for the glucometer logs between November 2023 through March 2024. During interview with the Biomed Tech on 05/22/2024 at approximately 1030, 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: 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 monitoring or that the dialysis prescription was followed for 6 of 7 patients (Patients #s 1, 2, 3, 4, 6 and 7). Findings: 1. Review of Patient #1’s dialysis orders and treatment sheets dated 04/25/2024 through 05/18/2024 (11 hemodialysis treatments) reflected the following: * The treatment flowsheets reflected vital signs and access checks were missed: - On 05/03/2024, the PCT documented a VS and access check at 0811. The next VS and access check was documented 51 minutes later at 0902. The next VS and access check was documented 63 minutes later at 1005. - On 05/04/2024, the PCT documented a VS and access check at 1503. The next VS and access check was documented 91 minutes later at 1634. - Similar findings were noted on 04/25/2024, 05/09/2024, 05/14/2024, and 05/15/2024. * The treatment flowsheets reflected the physician orders for BFR reflected the following - On 05/07/2024, the physician order for BFR was 450 mL/min. The PCT noted the BFR was 400 mL/min with no documentation to show why the BFR was changed or that the RN was notified. - On 05/09/2024, the physician order for BFR was 400 mL/min. The PCT noted the BFR was 360 mL/min at 1434, 350 mL/min at 1643, and 300 mL/min at 1643, with no documentation to show why the BFR was changed or that the RN was notified. - Similar findings were noted on 05/15/2024. 2. Review of Patient #3’s treatment sheets dated 04/23/2024 through 05/18/2024 (12 hemodialysis treatments) reflected the following: * The treatment flowsheets reflected vital signs and access checks were missed: - On 04/20/2024 the PCT documented a VS and access check at 1205. The next VS and access check was documented 74 minutes later at 1319. The PCT later documented a VS and access check at 1401, but the next VS and access check was documented 70 minutes later at 1511. - On 05/14/2024, the PCT documented a VS and access check at 1034. The next VS and access check was documented 76 minutes later at 1150. The PCT later documented a VS and access check at 1237, but the next VS and access check was documented 62 minutes later at 1339. - Similar findings were noted on 04/23/2024, 04/27/2024, 05/02/2024, 05/04/2024, 05/09/2024, 05/11/2024, 05/16/2024, and 05/18/2024. 3. Similar findings of missed VS and access checks were noted for Patient #s 2, 6 and 7. 4. Review of Patient #4’s treatment sheets dated 04/23/2024 through 05/18/2024 (12 hemodialysis treatments) reflected the following: * The treatment flowsheets for 04/23/2024, 04/30/2024 and 05/14/2024 revealed a prescription for “Dialysate (Start of Treatment) ... 1K, 2.5 Ca, Acid - Liquid ... Dialysate Bath Treatment Time (Start of Treatment) ... 2 h 0 m (120 min)” and “Dialysate (End of Treatment) ... 2K, 2.5 Ca, Acid - Dry, Granuflo ... Dialysate Bath Treatment Time (End of Treatment) ... 2 h 30 m (150 min).” Further review of the treatment flowsheets for 04/23/2024, 04/30/2024 and 05/14/2024 revealed there was no documentation that the Dialysate Bath was changed after two hours. - During interview with the MCS on 05/22/2024 at 1330 they stated there should be documentation that the bath was changed. * The treatment flowsheets reflected vital signs and access checks were missed: - On 04/23/2024, the PCT documented a VS and access check at 1536. The next VS and access check was documented 83 minutes later at 1659. - Similar finding were noted on 04/25/2024, 04/30/2024, 05/02/2024, 05/11/2024, 05/14/2024, and 05/16/2024. * On 04/23/2024 the patient’s target weight was documented as 82.0 kg. The actual post weight was documented 89.0 kg, a difference of 7 kg over. - Similar findings were noted for all 12 treatments. 4. Review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated as last revised 04/2024, stipulated: - “Intradialytic treatment monitoring and data collection which my be performed by the PCT or licensed nurse includes: a. Vital signs and treatment monitoring for non-nocturnal treatments is completed at least every thirty (30) minutes” and includes vital signs, access checks and BFR. - “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 05/22/2024 at 1545, the MCS verified the above findings. Refer also to the findings cited at Tag V726 under CFR §494.170 - Standard: Medical Records that reflects inconsistencies in RN/PCT documentation of patient safety checks and VS monitoring in the EHR.”

“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 offer pneumococcal vaccination to patients based on assessment of status as required by facility policy and CDC guidelines for 19 of 62 patients (Patient #s 4, 5, and 8-24). Findings: Review of the “Vaccinations and Surveillance Report,” printed on 05/21/2024, revealed 19 patients were eligible to receive the PCV20 vaccine, but it was not administered. Examples included: * Patient #5 had documentation showing they received the PPSV23 in 2013, 2018, and 2020. According to facility policy and CDC guidelines, this patient should have received a pneumococcal vaccine in 2021. * Patient #11 had documentation showing they received the PCV13 in 2016 and 2018. They also received the PPSV23 in 2017. Vaccines were administered to Patient 11 prior to the age of 65 years. According to facility policy and CDC guidelines, this patient should have received a pneumococcal vaccine in 2023. * Patient #12 had documentation showing they received the PPSV23 in 2014 and 2019. According to facility policy and CDC guidelines, this patient should have received a pneumococcal vaccine in 2020. Similar findings were noted for Patient #s 4, 8-10, and 13-24. Review of the facility policy titled, “Pneumococcal Vaccine for Adult Patients,” dated 10/2023, stipulated the following: * Patients of any age who have only received PPSV23 required “PCV20 at least one year after most recent PPSV23” to complete the vaccination series. * Patients who received PPSV23 before age 65 and also received PCV13 required “PCV20 at least 5 years after most recent pneumococcal dose” to complete the vaccination series. CDC pneumococcal vaccine recommendations for patients with chronic renal failure were found at https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html#adults and included: * Patients who have only received PPSV23 regardless of risk condition required “1 dose of PCV15 or PCV20 at least 1 year after the most recent PPSV23 vaccination.” * Patients who have received PCV13 and 1 dose of PPSV23 required 1 dose of PCV20 “at least 5 years after the last pneumococcal vaccine” to be complete. During on 05/21/2024 at 1300, the RN CC confirmed the above findings and that the patients were not reevaluated under the 10/2024 policy.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 31224 Based on review of patients’ medical records and review of documentation, it was determined that the facility failed to conduct a comprehensive reassessment at least monthly for unstable patients for 1 of 7 patients (Patient # 1). Findings: Review of Patient #1’s medical record revealed they were identified as “Unstable” during the 02/26/2024 Annual Assessment. The next comprehensive reassessment was not completed until 04/17/2024. Documentation to show a comprehensive reassessment was completed in 03/2024 was not found. Review of facility policy “1-14-01,” titled “Interdisciplinary Team Patient Assessment and Plan of Care,” with a last revision date of “July 2023” stipulated “7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted ... At least monthly for unstable patients including, but not limited to, patients with the following ... 12. ... The Plan of Care following re-assessments must be completed within 15 day of completing the reassessment. This process would occur monthly for unstable patients and annually for stable patients.” During interview on 05/22/2024 at 1545, the MCS 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: 37237 Based on review of documentation and review patient medical records, it was determined that the facility failed to ensure that 1 of 7 patients’ plans of care (Patient #4) was signed by all members of the IDT and by the patient in a timely manner. Findings: Review of the “Patient Plan of Care” for Patient #4 revealed the IDT meeting was held on 01/31/2024. The RN, RD and MD signed the POC on 01/31/2024. The space for the MSW’s dated signature was filled in with “not present.” The section “Reviewed with patient /responsible party on” lacked a date. The Patient signed the POC on 05/21/2024, 3 months and 3 weeks later. Review of the facility policy, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” dated last revised July 2023 stipulated “14. The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or patient’s personal representative.””

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 31224 Based on interview and medical record review, it was determined that the facility failed to ensure that the plan of care was updated within 15 days of the comprehensive patient assessment for 1 of 7 patients (Patient # 6). Review of Patient 6’s medical records revealed a comprehensive assessment was completed on 12/15/2023. The corresponding plan of care was documented as last updated on 01/08/2024, 24 days later. This plan of care was not reviewed by the IDT and signed as complete until 01/31/24, 47 days after the completion of the comprehensive assessment. Review of the facility policy titled, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE,” dated 07/2023, stipulated “The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment.” During interview on 05/22/2024 at 1545, 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 7 of 7 patients (Patient #s 1-7) whose treatment sheets were reviewed. Findings: Review of Patient #1’s treatment sheets dated 04/25/2024 through 05/06/2024 (11 treatments) revealed entries during treatment were time stamped at conspicuously equal interviews on the short treatment review form that did not appear to reflect the time the task was completed. For example: * On 5/04/2024, RN/PCT documentation under “INTRADIALYTIC VITALS STAT LINE” for VS, BFR/DFR, AP, VP, UFR, volume remaining, access visualization, face visualization and the heparin pump were time stamped at 1500, 1533, 1548, 1602, and 1630, giving the appearance that checks were done at these times and that no checks by the RN/PCT were missed. This documentation did not match the information on the long treatment review form that showed when the RN/PCT actually documented when they evaluated the patient. The actual time stamps were 1503 and 1634, with no documentation to show a RN/PCT check was conducted for the 1533, 1548, and 1602 timeframes. * On 05/14/2024, RN/PCT documentation under “INTRADIALYTIC VITALS STAT LINE” for VS, BFR/DFR, AP, VP, UFR, volume remaining, access visualization, face visualization and the heparin pump were time stamped at 1330, 1400, 1430, 1500 and then at 1321, 1330, 1400, 1430, 1500, 1510, 1524, 1530, 1600, 1604, 1630, and 1700. This information did not match the information on the long treatment review form that showed when the RN/PCT actually documented when they evaluated the patient. The actual time stamps were 1321, 1338, 1432, 1532, 1605, 1606 and 1702, with no RN/PCT checks conducted at 1400, 1500, and 1630 time frames. Similar findings were noted for the remaining treatments. Similar findings were noted in the treatment sheets for Patients 1, 2, 3, 4, 6, and 7. Review of the facility policy “CWOW-PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” dated April 2024 stipulated vital signs and treatment monitoring was “completed at least every thirty (30) minutes.” During interview on 05/22/2024 at 1545, the MCS confirmed the above findings. Refer to findings cited at Tag V503 under CFR §494.80 (a)(2) - Standard: Evaluation of the appropriateness of the dialysis prescription that reflects how this discrepancy resulted in a situation where missed vital signs and patient safety checks could go unidentified and for missed RN/PCT checks and missed vital signs.”