Fresenius Medical Care Mission Bend

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, the facility failed to ensure patients receive hemodialysis treatments based on physician’s orders in 2 of 9 sampled patients. Patient #s 1 and 2 Findings: Patient #1 On 06/13/2024 at 7:23 a.m. Patient #1 was observed on the treatment unit of the facility at station number 9. The patient was utilizing hemodialysis machine #15. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 600 mls/ minute. The patient was utilizing dialysate solution of 2 mEq potassium and 3 mEq calcium via a left upper arm vascular access. Review of the patient’s medical record located in the computer attached to the hemodialysis machine, revealed a physician’s order dated 06/06/2024 for dialysate solution of 2 mEq potassium and 3 mEq calcium. The surveyor requested Patient Care Technician (C) open the panel on the hemodialysis machine to validate the patient’s prescription. Review of the setting on the patient’s hemodialysis machine revealed it was set to deliver 2 mEq potassium and 2.5 mEq calcium. The Surveyor immediately notified the Facility’s Charge Nurse that the patient’s hemodialysis machine was not set to deliver the patient’s prescription of 2 mEq potassium and 3 mEq calcium. The Charge Nurse states “ The patient’s treatment started at 6:10 a.m.” Patient #2 On 06/13/2024 at 7:45 a.m. Patient #2 was observed on the treatment unit of the facility at station number 11. The patient was utilizing hemodialysis machine #16. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 600 mls/ minute via a right double lumen central venous catheter. The patient was utilizing dialysate solution of 2 mEq potassium and 2.5 mEq calcium via a left upper arm vascular access. Review of the patient’s medical record located in the computer attached to the hemodialysis machine revealed a physician’s order dated 3/12/2024 for dialysate s solution of 2 mEq potassium and 2.5 mEq calcium. The Surveyor requested Patient Care Technician (G) open the panel on the hemodialysis machine to validate the patient’s prescription. Review of the setting on the patient’s hemodialysis machine revealed it was set to deliver 2 mEq potassium and 3 mEq calcium. The Surveyor immediately notified the Facility’s Charge Nurse that the patient’s hemodialysis machine was not set to deliver the patient’s prescription of 2 mEq potassium and 2.5 mEq calcium. The Charge Nurse states “ The patient’s treatment started at 7:08 a.m.” He said the patient’s prescription and hemodialysis machine was set up by Patient Care Technician (G)”

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, the facility failed to ensure patient’s albumin level was monitored by drawing and reviewing laboratory values in 1 of 9 sampled patients. Patient #1 Findings: Patient #1 On 06/13/2024 at 7:23 a.m. Patient #1 was observed on the treatment unit of the facility at station number 9. The patient was utilizing hemodialysis machine #15. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 600 mls/ minute. Review of the patient’s clinical record ( laboratory results) revealed documentation which indicated the most recent laboratory result for albumin on the patient’s clinical record was dated 10/12/2023. Review of the patient’s comprehensive care plan dated 5/1/2024 revealed documentation which indicated albumin level of 4.0 g/ dl. There is no further/ current albumin level available in the patient’s clinical record. Review of the patient’s nutritional progress notes dated 5/31/2024 revealed the following entry “ Albumin goal; assessment at goal.” On 06/13/2024 at 11:30 a.m. the surveyor reviewed the patient’s clinical record with the facility’s clinical coordinator. Interview on 06/13/2024 at 12:29 p.m. via the telephone with the Facility’s Registered Dietician, The surveyor informed him that the most current laboratory result for albumin on record for patient (#1) is dated 10/12/2023. The Registered Dietician states” It was an oversight on my part, I was focused on the patient having his surgery.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, the facility failed to document and track adverse events in 1 of 1 patient sustaining a fall post hemodialysis treatment while on the treatment floor. Patient #4 Findings: Review of the facility’s current Policy and Procedure on Patient Safety Event Reporting and Documentation, Policy # 61085, published 2/06/2023, directs staff as follows: “Purpose: The purpose of this policy is to provide guidelines for all clinical staff on identifying, reporting and documenting patient related Near Misses, Safety Events and Serious Events in the In- Center and Home therapy setting to: Provide a standardized process for management of all patient related safety events as defined in this policy Promote a culture of patient safety.” “Safety event result in mild to moderate patient clinical harm, not due to an underlying disease or condition. Requires additional monitoring, intervention, and /or medical care.” “Reporting. Clinical staff to notify: Physician Clinical Manager or facility designee Biomedical Services if applicable. Clinical Manager or facility designee to notify : Director of Operations Regulator; State Reporting if applicable. Documentation: Clinical staff will complete documentation in the patient’s medical record. Patient safety Data entry site. Clinical Manager or facility designee will: Submit Notice of Potential Professional / General Liability Claim Form if applicable. Review during Quality Assessment and Performance Improvement.” “Category; fall. Event Description; falls Definition: an unplanned decent to the floor or ground. May include a decrease in elevation from a walking, standing, or sitting position. May include medical devices such as wheelchairs , or mechanical lifts.” Patient #4 On 06/13/2024 at 8:10 a.m. Patient #4 was observed on the treatment unit at station # 16. The patient’s blood pressure was observed to be elevated 235/87 , pulse rate of 61. The patient was observed to be vomiting in a clear bag. The registered nurse reassess the patient and the patient repeat blood pressure was 230/93. Hemodialysis treatment was not initiated. Review of the patient’s treatment sheet dated 05/30/2024 revealed the following documentation by the registered nurse: “05/30/ 2024 14:26 p.m. : “Pt’s Bps right after tx before taking his post weight were noted within acceptable ranges.” 12:49. p.m.: Post treatment documented blood pressure 157/65. 05/30/2024 14:27 “Pt had a fall after he weighed post tx.; states he tripped on his shoes, fell slowly on his back but did not hit his head. “ it doesn’t hurt. Upon assessment, Bp noted to be elevated- 203/82 & 213/89 mmHg. Pt remains asymptomatic”. 05/30/2024: 14:29 p.m. “Denies complaints when asked: “ The record revealed EMS was called and patient transported to the hospital . Review of the adverse event documentation dated 05/06/2023- 06/04/2024 revealed no documentation of the patient sustaining a fall and sent to the hospital. Interview on 06/13/2024 with the Facility’s Clinical Manager revealed she said she did not report or document the patient’s fall as an adverse event.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility registered nurses failed to assess patient post hemodialysis treatment, addressing unusual findings identified during pre- treatment assessment in 2 of 9 sampled patients Patient #s 2 and 4 Findings: Texas Board of Nursing RN Scope of practice. Rule 15.28. Assessment The comprehensive assessment is the first step, and lays the foundation for the nursing process. The comprehensive assessment is the initial and ongoing, extensive collection, analysis and interpretation of data. Nursing judgment is based on the assessment findings. The RN uses clinical reasoning and knowledge, evidence- based outcomes, and research as the basis for decision-making and comprehensive care. Based upon the comprehensive assessment the RN determines the physical and mental health status, needs, and preferences of culturally, ethnically, and socially diverse patients and their families using evidence-based health data and a synthesis of knowledge. Surveillance is an essential step in the comprehensive assessment process. The RN must anticipate and recognize changes in patient conditions and determines when reassessments are needed. Patient Diagnosis/Problem Identification/Planning The second step in the nursing process is analyzing data gathered during the assessment and problem identification. The role of the RN is to synthesize comprehensive assessment data to identify problems, formulate goals/outcomes, and develop plans of care for patients, families, populations, and communities using information from evidence-based practice and published research in collaboration with these groups and the interdisciplinary health care team, as appropriate for their educational background and scope. The third step in the nursing process is planning. The RN synthesizes the data collected during the comprehensive assessment to identify problems, participate in the patient diagnoses, and to formulate goals, teaching plans and outcomes. A nursing plan of care for patients is developed by the RN, who has the overall responsibility to coordinate nursing care for patients. Teaching plans address health promotion, maintenance, restoration, and prevention of risk factors. The RN utilizes evidence-based practice, published research, and information from patients and the interdisciplinary health care team during the planning process. Implementation Implementing the plan of care is the fourth step in the nursing process. The RN may begin, deliver, assign, or delegate certain nursing tasks within the plan of care for patients within legal, ethical, and regulatory parameters and in consideration of health restoration, disease prevention, patient independence, wellness, and promotion of healthy lifestyles. The RN ’ s duty to patient safety when making assignments to other nurses or when delegating tasks to unlicensed staff is to consider the education, training, skill, competence, and physical and emotional abilities of those to whom the assignments or delegation is made. The RN is responsible for reasonable and prudent decisions regarding assignments and delegation. The RN scope of practice may include the supervision of LVNs or other RNs. Supervision of LVN staff is defined as the process of directing, guiding, and influencing the outcome of an individual’s performance and activity. 5 The RN may have to directly observe and evaluate the nursing care provided depending on the LVN ’ s skills and competence, patient conditions, and level of urgency in emergent situations. The RN may determine when it is appropriate to delegate tasks to unlicensed personnel and maintains accountability for how the unlicensed personnel perform the tasks. The RN is responsible for supervising the unlicensed personnel when tasks are delegated. The proximity of supervision is dependent upon patient conditions and skill level of the unlicensed personnel. In addition, teaching and counseling are interwoven throughout the implementation phase of the nursing process. Evaluation and Re-assessment A critical and final step in the nursing process is evaluation. The RN evaluates and reports patient outcomes and responses to therapeutic interventions in comparison to benchmarks from evidence-based practice and research findings and plans any follow-up care and referrals to appropriate resources that may be needed. The evaluation phase is one of the times when the RN reassesses patient conditions and determines if interventions were effective and if any modifications to the plan of care are necessary. Review of the facility’s current Policy and Procedure on Patient Assessment and Monitoring Policy # 45284 , published 05/01/2023 directs staff as follows: “Follow the steps for obtaining post- treatment assessment data: Weight: Obtain the patient’s post weight. Ensure the post weight is consistent with the goal set of the machine. Blood pressure, pulse, respirations, temperature, observations: ensure vital signs and overall conditions are stable for discharge. Access; evaluate access prior to discharge for bleeding swelling, any changes during the treatment. Reported by Patient. State of wellbeing/ Reported by the patient/General observation; Ask the patient if he or she has anything more to report or any additional observations prior to discharge. Lung sounds, Edema, Heart sounds: the registered nurse will assess /reassess post treatment as indicated.” Patient #2 On 06/13/2024 at 7:45 a.m. Patient #2 was observed on the treatment unit of the facility at station number 11. The patient was utilizing hemodialysis machine #16. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 600 mls/ minute via a right double lumen central venous catheter. Review of the patient’s hemodialysis treatment sheets for the following days revealed the following documented findings: 06/06/2024 : Review of the patient’s pre- treatment assessment conducted by the registered nurse on 06/06/2024 at 07:17 a.m. revealed the patient with “ankle edema bilateral 1+ 2 mm or less, disappears rapidly.” The record revealed data collection by the Licensed Vocational Nurse which indicated a sitting post treatment blood pressure of 163/95. Review of the patient post treatment record revealed no assessment completed by the registered nurse assigned to the patient. 06/11/2024: Review of the patient’s pre- treatment assessment conducted by the registered nurse on 06/11/2024 at 07:29 a.m. indicated the patient’s lungs with decreased breath sounds. Review of a post treatment documentation by the registered nurse revealed no indication of the registered nurse’s assessment of the patient’s breath sounds post hemodialysis treatment to determine if the decreased breath sound in the patient’s lungs was still present. Patient #4 On 06/13/2024 at 8:10 a.m. Patient #4 was observed on the treatment unit at station # 16. The patient’s blood pressure was observed to be elevated 235/87 and pulse rate of 61. The patient was observed to be vomiting in a clear bag. The registered nurse reassessed the patient and the patient repeated blood pressure was 230/93. Hemodialysis treatment was not initiated. The patient was sent to the hospital. Review of the patient’s treatment sheet dated 06/11/2024 revealed a pre- treatment assessment conducted by the registered nurse on 06/11/2024 at 07:55 a.m. which revealed the patient’s lungs with “ decreased breath sounds and ankle edema bilateral 1+ 2 mm or less, disappears rapidly. Lower legs edema bilateral 1+ 2 mm or less, disappears rapidly.” The record revealed the patient was administered oxygen 3 L/ min via nasal canulae during hemodialysis treatment. Review of a post treatment documentation by the registered nurse revealed no indication of the registered nurse’s assessment of the patient’s breath sounds and edema of the patient’s ankle and leg, post hemodialysis treatment. On 06/13/2024 the surveyor reviewed the patients’ treatment sheet with the Facility’s Director of Operations who concurred the findings:”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 22676 Based on observation, interview, a policy review, and a review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that 4 out of 4 wall boxes (dialysis water and dialysate dispensing outlets) (Stations #1, #2, #3 and #4) observed were cleaned, and the buildup of a dark yellow substance removed. This deficient practice had the potential to cause bacteria to grow in the wall boxes and cause harm by infecting the 82 patients receiving in-center hemodialysis at the facility. Findings included: During an observation of the wall boxes on 03/04/24 at 12:10 PM, at each dialysis station, Stations #1, #2, #3, and #4 revealed a dark yellow sediment with white sediment build-up on the wall boxes. During an interview on 03/04/24 at 12:10 PM, the Facility Administrator confirmed the wall boxes were visibly dirty with a dark yellow build-up. A review of the facility’s policy titled “Cleaning and Disinfection of the Dialysis Station” dated 09/05/23 indicated, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be surface disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentrate solution. If concentrate leaks are noted at the wall box, staff should notify biomedical services for repair.” A review of the “CDC Dialysis Safety” located on the CDC website at www.cdc.gov titled “Wall boxes and Drains” indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities ... ... More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer.””

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 22676 Based on observation, interview, review of a policy, and manufacturer’s directions for use (DFU), the facility failed to ensure the staff checked the expiration date for one of one calibration solution (Mesa Lab 14.0 conductivity calibration solution) used to calibrate the Myron L D-6 meter. This deficient practice had the potential to affect the conductivity reading of the meter and cause harm to all 82 in-center hemodialysis patients receiving treatment and staff at this facility. Findings include: An observation in the water treatment area on 03/04/24 at 9:30 PM revealed one bottle of Mesa Lab 14.0 conductivity calibration solution was dated as being opened on 01/29/24 and expired on 02/29/24. A review of the manufacturer’s DFU label on the bottle of Mesa Lab 14.0 conductivity calibration solution revealed that the solution “expires 30 days after opening.” During an interview on 03/04/24 at 9:30 AM, the Biomedical Technician confirmed the Mesa Lab 14.0 solution was open for more than 30 days and should not have been used after 02/29/24. A review of the facility’s policy titled, “Myron L D6 Meter Maintenance Procedures” dated 09/01/22 revealed, “At the beginning of the shift check conductivity solution ...expiration dates.””

“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: 22676 Based on medical record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for three of eight sampled in-center dialysis patients (P) (P4, P5, and P8). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 82 patients receiving in-center dialysis treatments at this facility. Findings include: 1. A review of P4’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (ml/min). A review of one of three “Post Treatment” flowsheets from 12/22/23 through 12/27/23, in the EMR indicated the following: a. On 12/22/23, the BFR was documented at 300 ml/min from 6:27 PM until 10:55 PM. There was no documented rationale for the change to the prescribed BFR. 2. A review of P5’s EMR revealed a prescribed dialysis flow rate (DFR) was 500 ml/min. A review of one of six “Post Treatment” flowsheets from 02/20/24 through 03/02/24, in the EMR indicated the following: a. On 02/27/24, the DFR was documented at 600 ml/min from 7:56 AM until 10:50 AM. There was no documented rationale for the change to the prescribed DFR. 3. A review of P8’s EMR revealed a prescribed BFR was 400 ml/min. A review of one of six “Post Treatment” flowsheets from 02/09/24 through 03/01/24, in the EMR indicated the following: a. On 03/01/24 BFR was documented at 350 ml/min from 12:00 PM until 4:00 PM. There was no documented rationale for the change to the prescribed BFR. During an interview on 03/05/24 at 11:15 AM, the Facility Administrator confirmed the above findings and confirmed that the staff did not follow the physician’s order for dialysis treatment. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check the prescribed blood flow rate is being achieved or the reason is documented in the medical record if unable to meet prescribed flow rate. Check dialysate flow rate setting is correct, and the correct prescribed flow is being ...””