Davita Klamath Falls 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: 37237 Based on interview 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: Refer to findings cited at Tag E0039 under 42 CFR §494.62(d)(2) - EP Testing Requirements that requires facilities to conduct exercises to test the emergency plan annually. The only documentation provided was a tabletop exercise completed in March of 2024. The facility failed to provide evidence that any other annual exercises had been conducted.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 37237 Based on interviews, review of medical records and review of documentation, it was determined that the facility failed to ensure that patients received hemodialysis treatments as prescribed and VS monitoring was completed according to facility policy for 7 of 7 patients (Patients 1-7). The cumulative effect of the failure of staff to ensure patients were checked and visualized as required resulted in this condition-level deficiency that substantially limits the capacity of the facility to provide safe and adequate care. Findings: Refer to findings cited at Tag V503 under CfC §494.80(a)(2) - Standard: Appropriateness of Dialysis Prescription that stipulates the patient’s comprehensive assessment must include evaluation of the appropriateness of the dialysis prescription. * The facility failed to ensure staff followed facility policy to visualize patients and check vital signs every 30 minutes. * The facility failed to ensure patients’ dialysis prescriptions were followed as ordered by the MD.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 31224 Based on interviews and review of documentation, it was determined that the facility failed to continuously monitor its performance, take actions that resulted in performance improvements, and track performance to ensure that improvements were sustained over time. This Condition level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: Refer to findings under the following: *Tag E-0003, 42 CFR §494.62: Condition for Coverage: Establishment of the EP Program Dialysis, that reflects the facility failed to comply with the Federal Emergency Preparedness (EP) requirement to establish and maintain a comprehensive EP program to ensure it was tested annually (Tag E-0039). *Tag V-0500, 42 CFR §494.80: Condition: Patient Assessment, for findings under V0503, 42 CFR 494.80(a)(2) Appropriateness of Dialysis Prescription, that reflects the facility failed to ensure that patients received hemodialysis treatments as prescribed and VS monitoring was completed according to facility policy for 7 of 7 patients (Patients 1-7). The cumulative effect of the failure of staff to ensure patients were checked and visualized as required resulted in this condition-level deficiency that substantially limits the capacity of the facility to provide safe and adequate care.for widespread prevalence of missed patient assessment and monitoring (Tag V-503). Refer to findings under the following that indicated repeat citations from the recertification and relicensure survey dated 10/16/2019: *Tag E-0039, 42 CFR §494.62(d)(2): EP Testing Requirements, that reflects the facility failed to conduct exercises to test the emergency plan annually. *Tag V-0403, 42 CFR §494.60: Standard: Physical Environment- Equipment Maintenance- Manufacturer’s DFU, that reflects the facility failed to ensure that all equipment was maintained and operated in accordance with the manufacture’s recommendations for failure to monitor medication refrigerator temperatures and to act when temperatures fell out of established parameters. *Tag V-0506, 42 CFR §494.80(a)(3): Patient Assessment-Immunization/Medication History, that reflects the facility failed to implement facility policy that ensured pneumococcal vaccines were offered to qualifying patients for 38 of 69 patients reviewed (Patient #s 4, 5, 7, 8, 9, 11, 13, 16, 17, 20, 23, 24, 25, 30-33, 38, 40-44, 46, 48, 50, 53, 58-62, 64, 65, 67, 68 and 69.)”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 31224 Based on observations, interviews and review of documentation, it was determined the Medical Director failed to ensure that a system was designed, implemented, monitored and evaluated to provide quality patient care in a safe and sanitary environment. This condition level deficiency substantially limits the capacity of the facility to furnish services of an adequate level of quality. Findings: *Tag E0003, 42 CFR §494.62: Condition for Coverage: Establishment of the EP Program Dialysis, for failure to implement testing of the facility’s EP Plan. *Tag V0500, 42 CFR §494.80: Condition: Patient Assessment, for findings under V0503, 42 CFR 494.80(a)(2) Appropriateness of Dialysis Prescription, for widespread prevalence of missed patient assessment and monitoring. *Tag V0625, 42 CFR §494.110: Condition: Quality Assessment and Performance Improvement, for failure to identify patient care and safety concerns and to implement plans of correction to prevent repeat citations. Refer to findings under the following that indicated repeat citations from the recertification and relicensure survey dated 10/16/2019: *Tag E0039, 42 CFR §494.62(d)(2): EP Testing Requirements, for failure to conduct an annual test of the facility’s EP Plan. *Tag V0401, 42 CFR §494.60: Standard: Physical Environment- Safe/Functional/Comfortable Environment, for failure to monitor medication refrigerator temperatures and to act when temperatures fell out of established parameters. *Tag V0506, 42 CFR §494.80(a)(3): Patient Assessment-Immunization/Medication History, for failure to ensure patients received pneumococcal vaccines as indicated.”

“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: 37237 Based on interview and review of documentation, it was determined the facility failed to conduct exercises to test the emergency plan annually. Findings: Review of facility emergency preparedness documentation revealed the only exercise the facility participated in was a tabletop exercise on 03/24/2024. No further documentation was presented that demonstrated the facility had ever participated in a community/facility wide drill or any other tabletop exercises. Review of facility policy 4-07-01 titled, “Facility Emergency Management Plan,” with a last revision date of October 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.” On 05/09/2024 at 1155, the FA confirmed that there was no further documentation of prior EP community/facility exercises and/or tabletop exercises. The facility was cited for lack of exercises during the previous recertification survey completed on 10/16/2019.”

“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: 31224 Based on observation, interview and record review, it was determined the facility failed to ensure chlorine test results were accurately documented to ensure tests were performed approximately every 4 hours. Findings: During observation on 05/07/2024 starting at 1403, the PCT performed the chlorine test. The time entered on the log and in the IT Clinical System for when the test was conducted was “1400,” the time when the test was scheduled. Review of the facility’s “ROUTINE CHLORINE TESTING LOG” from 03/01/2024 through 05/08/2024 revealed the times used to document when the test was conducted were consistently on the hour or on the quarter hour. For example, the first test of the day was routinely documented at “0300” or “0315.” On days when multiple tests were required, testing was documented as performed at the exact same time. For example, for the four days of 4/15/2024-4/18/2024, the logs reflected testing was performed at exactly 0315, 0500, 0800, 1100, and 1400 each day. During interview on 05/07/2024 at 1315, the BSS stated the time documented on the logs should be the actual time the test was performed and not the time the test was scheduled. Review of facility policy titled “TOTAL CHLORINE TEST USING RPC [company name] ULTRA LOW TOTAL CHLORINE TEST STRIP,” dated 10/2023, stipulated, “Document tests [sic] results on Routine Total Chlorine Testing Log and in IT Clinical System and take any necessary actions per policy...” There were no specific instructions regarding how to document time to ensure an accurate log. During interview on 05/07/2024 at 1630, the FA confirmed the above findings.”

“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: 37237 Based on observation, interview and review of documentation, it was determined the facility failed to ensure a functional, clean, sanitary, safe and comfortable setting for patients, visitors and staff. Findings: 1. Observation of the facility on 05/07/2024 at 1220 revealed the water flow in all the hand washing sinks on the treatment floor never warmed above a cool temperature. 2. Observation of the facility on 05/07/2024 at beginning at 0845 revealed the floor had a long ripple under the laminate along treatment stations 1 - 4. The ripple posed a potential tripping hazard for staff and patients. The laminate floor in front of the medication fridge had gaps where the seams failed to meet and an accumulation of dirt. Similar gaps along the floor seams were noted throughout the treatment area. During observations, staff stated an area where the floor was caving in was repaired, but the remaining floor issues were not yet fixed and plans were to complete the repairs in sections. On 05/08/2024, the FA presented a “Flooring - Carpet/Tile” work order for “Warped flooring in the treatment room in front of station 1 - 2, in the patient prep hallway, and in the utility teammate hallway. Damaged epoxy flooring in water heater closet and janitor’s closet (flooring in both areas rated a 2). Business office carpet is completely detached in most areas.” The “Target Start” date on the work order was “02/21/2024 4:25 PM.” The “Actual Start” date was blank. 3. Observations on 05/07/2024 beginning at 0845 revealed: - All chairs used by staff at the nursing stations had upholstery that was ripped and frayed. - Many of the stools that are rolled from station to station also had holes and tears. - At least two treatment chairs had rips in the upholstery. - Wall areas throughout the facility had unfilled holes and chipped paint with exposed sheet rock. - An accumulation of dirt and debris along the seams where the wall and floor base met. - Areas where the floor base was not flush with the wall, leaving gaps where dirt and debris could accumulate. - An excessive amount of white precipitate had built up inside at least one of the the chases.”

“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 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 Filter Cleaning Log (as required by manufacturer)” revealed the “designated cleaning frequency when specified by manufacturer instructions ...” was “Weekly.” Further review of the logs revealed filter cleaning was typically done on Saturdays and one or more weeks were missed for all oxygen concentrators, numbered 01-15. Examples of weeks missed include, but are not limited to: * Machine 1, 04/27/2024 * Machine 2, 04/20/2024 * Machine 3, 4/20/2024, 4/27/2024 * Machine 4, 4/20/2024, 4/27/2024 Similar findings were identified for Machines 5-15. Review of facility policy titled, “Use of Oxygen Concentrators,” dated 10/2023, 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.” During interview on 05/07/2024 at 1630, the FA confirmed the above findings. 2. a. Review of the January 2024 “Medication Refrigerator Management Log” for the lab refrigerator revealed numerous days when the fridge temperature was recorded below the acceptable range of 2°C to 8°C (36°F to 46°F): * On 01/08/2024 the PM temperature was recorded as 1°C. In the section “Action Taken if out of Range & Final Temperature, or Actions taken for Daily Refrigerator Check Miss,” the RN documented “[increased] temp.” * On 01/09/2024 the AM temperature was recorded as -1°C. In the section “Action Taken if out of Range & Final Temperature, or Actions taken for Daily Refrigerator Check Miss,” the RN documented “[increased] temp.” * On 01/10/2024 the AM temperature was recorded as -1°C. In the section “Action Taken if out of Range & Final Temperature, or Actions taken for Daily Refrigerator Check Miss,” the RN documented “[increased] temp.” * On 01/11/2024 the AM temperature was recorded as 0°C and the PM temperature was recorded as 1°C. In the section “Action Taken if out of Range & Final Temperature, or Actions taken for Daily Refrigerator Check Miss,” the RN documented “[increased] temp.” * On 01/12/2024 the AM temperature was recorded as 0°C and the PM temperature was recorded as 0°C. In the section “Action Taken if out of Range & Final Temperature, or Actions taken for Daily Refrigerator Check Miss,” the RN documented “temp inside 5°.” * Similar temperatures were recorded as out of range on 01/15/2024, 01/16/2024, 01/18/2024, 01/19/2024, 01/20/2024 and 01/22/2024. - Similar findings were identified for March 2024 b. Review of the February 2024 “Medication Refrigerator Management Log” for “TX Floor Meds” revealed numerous days when the fridge temperature was not recorded or a temperature was recorded that was out of range: * The PM temperature was not recorded on 02/12/2024. * The PM temperatures recorded on 02/13/2024 - 02/15/2024 lacked initials of the staff that recorded the temperature. * On 02/29/2024 the AM temp was recorded as 0.3°C. In the section “Action Taken if out of Range and Final Temperature, or Actions taken for Daily refrigerator Check Miss,” the RN documented “NA”. Review of the February 2024 “Medication Refrigerator Management Log” for “TX Floor Meds” revealed numerous days when the fridge temperature was recorded below the acceptable range of 2°C to 8°C (36°F to 46°F): * On 03/01/2021 the AM temperature was recorded as 0.2°C. In the section “Action Taken if out of Range and Final Temperature, or Actions taken for Daily refrigerator Check Miss,” the RN documented “[increased] temp.” * On 03/02/2021 the PM temperature was recorded as 1.2°C. In the section “Action Taken if out of Range and Final Temperature, or Actions taken for Daily refrigerator Check Miss,” the RN documented “[increased] temp.” * Similar temperatures were recorded as out of range on 03/05/2024, 03/07/2024, 03/11/2024, 03/13/2024, 03/15/2024 and 03/18/2024, 03/20/2024, 03/21/2024, 03/22/2024, 03/25/2024 03/26/20240 and 3/29/2024. On 03/29/2024, an RN documented “new thermometer.” Review of the Digital Data Logger, DDL, for 03/30/2024 through 05/07/2024 revealed multiple times the medication refrigerator went below the acceptable range. Examples include, but were not limited to: * On 04/01/2024 the temperature was recorded below 2°C for 4 hours and 14 minutes. * On 04/17/2024 the temperature was recorded below 2°C for 3 hours and 25 minutes and again from 1752 till 0522 on 04/18/2024, a total of 11 hours and 30 minutes. The lowest temperature was -6.9°C. * On 05/02/2024 the temperature was recorded below 2°C for a total of over 10 hours. In an email dated 05/13/2024 at 1330, the FA stated that the DDL data could not be pulled for January. Review of the facility policy, “Medications Requiring Refrigeration,” dated as last revised December 2022 stipulated “The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented on the ‘Medication Refrigerator Management Log’ ... Twice daily temperature checks located on the Digital Data Logger (DDL) display, at the beginning and end of the day ... Verify that the temperatures remains between 2°C and 8°C (36°F and 46°F) ... Temperature excursions and issues noted during daily check will be noted on log and actions taken and outcome(s) ... Refrigerators that do not maintain temperature in the stated range will be repaired or replaced as soon as possible.” Review of the CDC’s “Vaccine Storage and Handling Toolkit,” updated 03/29/2024, found at: https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, stipulated in “Section 3: Vaccine Storage and Temperature Monitoring Equipment” that “Refrigerators should maintain temperatures between 2° C and 8° C (36° F and 46° F) ... Temperature excursions or inappropriate storage conditions for any vaccine require immediate action. Any temperature reading outside the recommended ranges in the manufacturers’ package inserts is considered a temperature excursion ... CDC recommends the following steps in the event of a temperature excursion ... 1. Any staff who hears an alarm or notices a temperature excursion on the DDL should notify the primary or alternate vaccine coordinator immediately or report the problem to their supervisor. 2. Notify staff by labeling exposed vaccines ‘DO NOT USE’ and placing them in a separate container apart from other vaccines (do not discard these vaccines). 3. The vaccine coordinator, supervisor, or if necessary, the person reporting the problem, should begin to document the event with the following information ... 4. Implement your facility SOPs to adjust unit temperature to the appropriate range ... 5. Contact your immunization program and/or vaccine manufacturers ... 6. Complete you documentation of the event, including ... Action taken ... Results.” During interview on 05/09/2024 at 1155, 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: 1. VS checks and patient visualizations were completed regularly and on time for 7 of 7 patients (Patient #s 1-7). 2. Patients received their hemodialysis treatments as prescribed for 3 of 7 patients (Patient #s 1, 3, and 5) Findings: 1. Review of patients’ treatment flowsheets, “Treatment Details Reports,” revealed two sections titled “Intradialytic Vitals Stat Line.” The first section included a brief table of times and dialysis machine readings, at mostly routine times. The second section included two more detailed entries. One entry, “System Posted,” included the patient’s VS and other prescription readings taken from the dialysis machine and were automatically recorded every 30 minutes. The second entry was by PCTs/RNs and time stamped when staff did the actual patient evaluation, face and access visualization and heparin documentation. Patient 1 Patient visualization and vital sign checks were late and/or missed for 13 of 13 treatments. - Review of the 05/06/2024 “Intradialytic Vitals Stat Line” section of the “Treatment Details Reports” revealed: * The PCT documented treatment start time as 1053. * The PCT documented visualization/heparin checks and comments at 1053, 1128, 1218 (50 minutes later), 1334 (76 minutes later) and 1434 (60 minutes later). The system continued to automatically document at 1052, 1101, 1201, 1231, 1301, 1329, 1333, 1337, 1401 and 1421. * Treatment end time was documented by the system at 1421 and by the PCT at 1434. * The staff failed to visualize the patient for periods up to and over an hour and missed numerous checks throughout the patient’s treatment. - Review of the 05/03/2024 “Intradialytic Vitals Stat Line” section of the “Treatment Details Reports” revealed: * The PCT documented treatment start time as 1116. * The PCT documented visualization/heparin checks and comments at 1150, 1409 (139 minutes later) and 1506 (57 minutes later). The system continued to automatically document at 1201, 1231, 1301, 1331 and 1401, 1431 and 1452. * Treatment end time was documented by the system at 1454 and by the PCT at 1454. * The staff failed to visualize the patient for periods up to and over 2 hours and missed numerous checks throughout the patient’s treatment. - Review of the 04/29/2024 “Intradialytic Vitals Stat Line” section of the “Treatment Details Reports” revealed: * The PCT documented treatment start time as 1053. * The PCT documented visualization/heparin checks and comments at 1056, 1107, 1133, 1220 (47 minutes later) and 1429 (129 minutes later). The system continued to automatically document at 1053, 1101, 1131, 1201, 1231, 1303, 1331, 1401 and 1425. * Treatment end time was documented by the system at 1425 and by the PCT at 1425. * The staff failed to visualize the patient for periods up to and over 2 hours and missed numerous checks throughout the patient’s treatment. - Review of the 04/19/2024 “Intradialytic Vitals Stat Line” section of the “Treatment Details Reports” revealed: * The PCT documented treatment start time as 1110. * The PCT documented visualization/heparin checks and comments at 1150, 1224 and 1525 (181 minutes later). At 1527, the PCT documented the comment, “machine malfunction treatment terminated early.” The system continued to document at 1104, 1130, 1200, 1230, 1300, 1330 and 1400. * Treatment end time was documented by the system at 1400 and by the PCT at 1400. * The staff failed to visualize the patient and missed numerous checks throughout the patient’s treatment. * Similar findings were identified for 05/01/25024, 04/26/2024, 04/24/2024, 04/22/2024, 04/17/2024, 04/12/2024, 04/10/2024, 04/08/2024 and 04/05/2024. Patient 6 Patient visualization and vital sign checks were late and/or missed for 12 of 13 treatments. - Review of the 05/06/2024 “Intradialytic Vitals Stat Line” section of the “Treatment Details Reports” revealed: * The PCT documented treatment start time as 1455. * The PCT documented visualization/heparin checks and comments at 1533, 1618 (45 minutes later) and 1939 (201 minutes later). At 1940, the PCT documented the comment, “Treatment terminated.” The system continued to document at 1454, 1531, 1602, 1631, 1701, 1731 and 1802. * Treatment end time was documented by the system at 1832 and by the PCT at 1832. The termination time on “Intradialytic Vitals Stat Line” table was documented at 1802. *The prescription for “Heparin Pork-Hourly Rate” was “Order stop time for hourly dose before end of treatment ... 0 minutes.” The heparin infusion was started at 1454 and ended at 1820. - Review of the 05/03/2024 “Intradialytic Vitals Stat Line” section of the “Treatment Details Reports” revealed: * The PCT documented treatment start time as 1445. * The PCT documented visualization/heparin checks and comments at 1545 (60 minutes post start of treatment), 1711 (86 minutes later), and 1803 (52 minutes later) * There were no 30-minute system checks posted in the detailed “Intradialytic Vitals Stat Line” section. * Treatment end time was documented by the system at 1800 and by the PCT at 1800. * The prescription for “Heparin Pork-Hourly Rate” was “Order stop time for hourly dose before end of treatment ... 0 minutes.” The heparin infusion was started at 1445 and ended at 1811. * Similar findings were identified for 04/29/2024, 04/26/2024, 04/22/2024, 04/19/2024, 04/15/2024, 04/12/2024, 04/08/2024, 04/01/2024, 03/29/2024 and 03/25/2024 * Similar findings were identified for Patient #s 2, 3, 4, 5 and 7. 2. Patient 1 Review of Patient #1’s dialysis orders and treatment sheets dated 04/05/2024 through 05/06/2024 (13 treatments) reflected the following: * The physician order for Max UFR from 04/05/2024 through 05/06/2024 was 13.0 mL/kg/hr. * The Max UFR exceeded 13.0 mL/kg/hr for 9 of 13 treatments with no documentation to reflect why the physician orders were not followed. Examples included: - On 04/08/2024, the actual UFR was 14.2 mL/kg/hr. - On 04/24/2024, the actual UFR was 14.8 mL/kg/hr. - On 05/03/2024, the actual UFR was 16.2 mL/kg/hr. * Similar findings were identified for 04/10/2024, 04/12/2024, 04/17/2024, 04/22/2024, 04/26/2024, and 04/29/2024. * The 04/10/2024 treatment sheet reflected the dialysis order included “Blood Flow Rate - 375 mL/min.” The treatment was initiated at 1040 where the BFR was set at 350 mL/min and remained for the duration of the treatment. There was no documentation as to why the rate was changed and no documentation of RN notification or RN follow-up. * Similar findings were identified for 04/17/2024. Patient 3 Review of Patient # 3’s dialysis orders and treatment sheets dated 04/06/2024 through 05/04/2024 (13 treatments) reflected the following: * The physician order for Max UFR from 04/06/2024 through 05/05/2024 was 13.0 mL/kg/hr. * The Max UFR exceeded 13.0 mL/kg/hr for 12 of 13 treatments with no documentation to reflect why the physician orders were not followed. Examples included: - On 04/09/2024, the actual UFR was 16.9 mL/kg/hr. - On 04/11/2024, the actual UFR was 17.3 mL/kg/hr. - On 04/18/2024, the actual UFR was 17.2 mL/kg/hr. * Similar findings were noted on 04/06/2024, 04/13/2024, 04/20/2024, 04/23/2024, 04/25/2024, 04/27/2024, 04/30/2024, 05/02/2024, and 05/04/2024. Patient 5 Review of Patient# 5’s dialysis orders and treatment sheets dated 04/08/2024 through 05/06/2024 (13 treatments) reflected the following: * The 04/08/2024 treatment sheet reflected the dialysis order included “Blood Flow Rate - 350 mL/min” and treatment started at 0537. At 0604, a PCT documented the BFR was changed to 300, where it remained for the duration of the treatment. There was no documentation as to why the rate was changed and no documentation of RN notification or RN follow-up. * The 05/01/2024 treatment sheet reflected the dialysis order included “Blood Flow Rate - 350 mL/min” and treatment started at 0523. At 0531, a PCT documented the BFR was changed to 300, where it remained for the duration of the treatment. There was no documentation as to why the rate was changed and no documentation of RN notification or RN follow-up. 3. Patient# 3 Review of Patient #3’s treatment sheets dated 04/03/2024 through 05/02/2024 (13 treatments) revealed vital signs were missed. For example: * On 04/30/2024, the PCT documented treatment was started at 0928. The first set of vital signs were not documented until 0944 when the RN conducted the pre-treatment nurse assessment. The next vital signs were not documented until 1102, 78 minutes later. Patient# 5 Review of Patient #5’s treatment sheets dated 04/08/2024 through 05/06/2024 (13 treatments) revealed vital signs were missed. For example: * On 05/01/2024, a set of vital signs were documented at 0531. The next vital signs were not documented until 0631, 60 minutes later. Later during the same treatment, vital signs were documented at 0731. The next vital signs were not documented until 0831, 60 minutes later. * On 05/03/2024, a set of vital signs were documented at 0530. The next vital signs were not documented until 0628, 58 minutes later. * On 05/03/2024, a set of vital signs were documented at 0539. The next vital signs were not documented until 0630, 51 minutes later. Similar findings were identified for Patient #4 and Patient #7. 4. Review of Patient #5’s physician orders and treatment sheets dated 04/08/2024 through 05/06/2024 (13 treatments) revealed the following: * The physician order for treatment time was 195 min. * On 04/08/2024, the treatment duration was 154 min by patient’s choice and was discharged to home. The treatment time was shortened by 41 minutes and there lacked documentation to show the patient was informed of the risks of shortening treatment or that an AMA form was completed. * On 04/09/2024, the treatment duration was 22 min by patient’s choice and was discharged to home. The treatment time was shortened by 173 minutes and there lacked documentation to show the patient was informed of the risks of shortening treatment or that an AMA form was completed. 5. Review of the facility policy, “CWOW- Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” dated April 2024, stipulated: * “Patient identity, prescription, and machine settings are verified by teammate prior to initiation of treatment ... Prescription components include but are not necessarily limited to... UFR and Max UFR ...” * “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.” * “Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: * “Vital signs and treatment monitoring ... are completed at least every 30 minutes.” * “At a minimum, obtain and document the following ... Blood pressure ... Heart or pulse rate ... Blood and dialysate flows, arterial and venous pressures ... Fluid removal and/or replacement ... Vascular access visible and line connections intact ... Patient subjective statement(s) i.e., patient report on overall health, any complaints.” 6. Review of facility policy titled, “PRESCRIBED TREATMENT TIME NOT MET,” dated 04/2024, stipulated: * “The Registered Nurse (RN) will verify that a patent signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time. * “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.” * “A completed copy of the Early Termination of Treatment Against Medical Advice form will be kept in the patient’s health record.” * “Additionally, if the patient’s dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling the treatment times.” 7. During an interview on 05/08/2024 at 1535, the FA and SMCS confirmed the above findings. 8. 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: 37237 Based on interview, review of clinical vaccine records, review of documentation and CDC recommendations, it was determined the facility failed to implement facility policy that ensured pneumococcal vaccines were offered to qualifying patients for 38 of 69 patients reviewed (Patient #s 4, 5, 7, 8, 9, 11, 13, 16, 17, 20, 23, 24, 25, 30-33, 38, 40-44, 46, 48, 50, 53, 58-62, 64, 65, 67, 68 and 69.) Findings: Review of the “Vaccinations and Surveillance Report” printed on 05/07/2024 revealed the pneumococcal vaccination status for 69 patients on the facility census. One of the report filters set by the facility listed “All History” for the pneumococcal vaccine. The report revealed 29 of 69 patients lacked documentation that reflected which vaccine type was administered in the past, leaving their vaccination status as unknown. For example: * Patient #s 5, 7, 9, 11, 23, 30, 38, 40, 43, 50, 53, 58, 59, 61, 62, 67 and 68 had incomplete vaccine records that indicated they had received multiple doses of a pneumococcal vaccine. The vaccine type was unknown, and it could not be determined if another dose was indicated. * Patient #s 4, 8, 13, 17, 25, 33, 24, 41, 44, 46, 48, and 60 had incomplete vaccine records that indicated they received only one dose of a pneumococcal vaccine. The vaccine type was unknown. All were able to receive addition vaccines but had not been offered. Further review of the “Vaccinations and Surveillance Report” printed on 05/07/2024 revealed the following: * Patient #s 16, 31, 42 and 65 had incomplete vaccine records. All 4 patients received one dose of the PPSV23 vaccine. All were overdue for either PCV15 or PCV20. * Patient #s 20, 52, 69 had no pneumococcal vaccine history documented. * Patient #32 had documentation that they refused the vaccine on 11/16/2021. There was no further documentation that the vaccine was offered again. * Patient #64 received a “Pneumococcal Vaccine” on 05/23/2017. Documentation revealed the patient refused a “Pneumococcal Vaccine” on 10/15/2019. There was no further documentation that the vaccine was offered again. - 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 - Review of the facility policy titled “Pneumococcal Vaccination for Adult Hemodialysis Patients,” dated as last revised October 2023, included vaccination guidance based on which vaccine was administered (PCV13, PCV15, PCV20, or PPSV23). * For patients who had received only PPSV23, a dose of PCV20 or PCV15 could be administered at least one year after the most recent PPSV23 vaccine. * For no previous vaccine, a patient may receive PCV20 or PCV15 and PPSV23 at least one year later “(minimal interval is 8 weeks and can be considered in adults with an immunocompromising condition.)” The above results were confirmed on 05/09/2024 at approximately 1145 by the FA and the SMCS.”

“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 #5’s treatment sheets dated 04/08/2024 through 05/06/2024 (13 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 04/08/2024, 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 equal 30 minute intervals at 0601, 0631, 0701, and 0731, 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 0604, 0641, and 0735, with no documentation to show a RN/PCT check was conducted for the 0701 timeframe. * On 05/03/2024, 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 at 0524, 0530, 0628, 0631, 0701, 0731, 0800, 0830, and 0839. 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 0527, 0704, 0752, 0810, 0837, and 0839, with no RN/PCT checks conducted at 0600, 0630, and 0730 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 05/08/2024 at 1535, the SMCS 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.”