Fmc Moses Lake Dialysis Unit

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 37913 Based on observation staff interview, and policy review, the facility staff failed to provide a safe environment for facility staff and patients by not properly maintaining sharps container per facility protocal. This deficient practice had the potential to cause injuries to anyone who may inadvertently place their hand in the open lid of the sharps container, effecting 104 incenter hemodialysis patients and the staff. Findings include: Observation on 11/13/24 at 09:30 AM revealed the sharps by dialysis station 16 was more than three-quarters full. Sharps containers are used to discard dirty needles and are required to be disposed of when reach three-quarters full. There were clear visual indicators and written on the needle bucket was instructions that indicated when the needle bucket is past three quarters full, it needs to be disposed. During an interview on 11/13/24 at 09:30 AM, the Charge Nurse (CN) confirmed that the sharps container needed to be replaced and that it was above the safe level to be on the floor. Review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines” published 11/04/24, indicated “Contaminated needles and sharp container. . .all containers for storage or disposal of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to ¾ full. . . “”

“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: 37913 Based on observations, staff interviews, and policy review, the facility failed to ensure that all personal care items used by the facility staff for patient care were properly stored and disinfected between each patient’s use. Failure to ensure that personal care items are properly stored has the potential to affect 104 patients receiving dialysis treatments at the facility. Findings include: Observation on 11/13/24 at 8:50 AM, revealed a blood pressure cuff and nasal cannular were improperly placed on a shelf within the splash zone (an area designated around the patient’s chairs that could potentially be contaminated by splashing blood) behind Stations 1 and 2 During an interview on 11/13/24 at 9:00 AM, Charge Nurse (CN) confirmed that personal care items used for patient care should not be placed or stored within the splash zone. During an interview on 11/14/24 at 1:00 PM, the Certified Clinical Hemodialysis Technician (CCHT)1, was asked about the storage of personal care items being stored behind patient’s chairs during dialysis treatment. CCHT1 said “nothing should be stored behind patient’s chairs”. Review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines” published 11/04/24, revealed “ ... supplies or patient belongings should not be kept or stored behind the machine at patients stations.””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37913 Based on observation, staff interview, and policy review, the facility staff failed to ensure expired medical supplies were not available for use during one of three survey days. The failure to remove expired medical supplies could have resulted in staff using medical supplies that were expired this could affect 104 in-center patients receiving dialysis. Findings include: Observation on 11/13/24 at 9:30 AM revealed that a box containing eight vials of Naloxone Hydrochloride 0.4 Milligram/milliliter that was stored in the medication preparation area expired on 06/24. During an interview on 11/13/24 at 9:30 AM, Charge Nurse (CN) stated, “this box needs to be discarded, and we need to order a new box of naloxone hydrochloride.” Review of the facility’s policy titled, “Medication Preparation and Administration,” published 02/06/23, section “Monitoring Expired Medications” states in part, “Expiration dates for all stored mediations are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off- site return program or in accordance with local and /or state laws...””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 28297 Based on interview, personal file review and policy review, the facility failed to ensure two of six files reviewed had completed annual water training as required. The failure to have annual water training had the potential for staff not to be updated on any changes with the water testing procedure and this could affect 104 in-center patients. Findings include: Review of the personal file review form provided by the Facility Administrator indicated that Certified Clinical Hemodialysis Technician (CCHT) 5 had their last annual water skills validation on 06/29/23, four months 25 days late and CCHT11 had their last annual water skills validation on 08/09/23, three months and five days late. During an interview on 11/13/24 at 3:10 PM the Facility Administrator confirmed the two CCHT’s were late for their skills validation on water testing because their regular biomedical technician had been out on leave. He/she stated there had been email communication with the Area Technical Operations Director, however they were not able to get it done as required. The Facility Administrator confirmed CCHT 11 had been off on medical leave for the past two weeks. During an interview on 11/14/24 at 12:30 PM the Area Technical Operations Director stated he was unaware that the two CCHT’s had not been up to date on their annual water competency and that “They were not his employees.” Review of the facility policy titled. “Knowledge, Skills and Competency Evaluation for Clinical Staff,” revised 06/04/24, indicated, “ ...Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given timeframe ...””

“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: 37913 Based on observation, interviews and policy review, the facility failed to ensure that the door leading to the outside, adjacent to the storage room, was sealed to prevent insects and rodents from entering the facility. Failure to ensure that the facility was properly maintained the exterior entrance had the potential to affect 104 patients receiving in-center dialysis. Findings include: During observation on 11/13/24 at 10:00 AM, the door leading to the outside adjacent to the water room had a half inch gap between the bottom of the door and the floor. Insect and rodent traps were located on both sides of the door. During an interview on 11/13/24 at 10:00 AM, the Charge Nurse (CN) confirmed there was a gap at the bottom of the door and agreed that it was an entry point for insects and rodents to enter the facility. Review of the facility’s policy titled, “Equipment Installation, Operation, Maintenance and Repair and Disposal,” publication date 07/06/2021, states in part “ ...is essential to the safe operation of the facility this includes but is not limited to: Physical Plant (ceilings, floors ect.)” Review of the facility’s policy titled, “Quality Assessment and Performance Improvement Program,” publication date 11/04/24, in section “QAPI committee responsibilities” states “Technical services representative is responsible for ... reporting on technical related issues, including water and dialysate quality, equipment maintenance and physical plant issues.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 37913 Based on observations, staff interviews and policy review, the facility failed to ensure that the floor in the water room was thoroughly maintained and cleaned. Failure to properly clean the water room floor has the potential to affect 104 patients receiving dialysis treatments at the facility. Findings include: Observation on 11/13/24 at 9:45 AM, revealed in the water room that a two foot by two-foot area near the reverse osmosis machine (RO) under the water collection area that had an accumulation of water and a black substance on the tiles, the drain next to the RO had a black substance on and around it. The area next to the acid storage tank by the drain had a layer of a white crystal substance that was also on a pipe connection leading from the acid tank. During an interview on 11/13/24 at 9:45 AM, the Charge Nurse (CN) confirmed that there was an accumulation of water and a black substance on the tiles that were located under the water collection area and by the drain that was next to the RO had a black substance around it. The CN also confirmed that next a white substance was observed on the floor and the pipe leading to the acid tank. Review of the facility’s policy titled, “Equipment Installation, Operation, Maintenance and Repair and Disposal,” publication date 07/06/21, states in part “ ...is essential to the safe operation of the facility this includes but is not limited to: Physical Plant (ceilings, floors ect.)” Review of the facility policy titled, “Quality Assessment and Performance Improvement Program,” publication date 11/04/24, in section “QAPI committee responsibilities” states “Technical services representative is responsible for ... reporting on technical related issues, including water and dialysate quality, equipment maintenance and physical plant issues””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 37913 Based on observation, interview, and policy review, the End-Stage Renal Disease (ESRD) facility failed to ensure that patients’ hemodialysis access sites were always uncovered and visible to facility staff. Failure to ensure that patients’ access sites were uncovered and visible to staff, has the potential for patients to bleed at their access sites and the facility staff not being aware. This has the potential to affect 104 patients receiving dialysis at the facility. Findings include: Observation on 11/13/24 at 9:15 AM, revealed Patient (P)13) at Station 4 had their access sites covered with a blanket. During an interview on 11/13/24 at 9:15 AM, the Charge Nurse (CN) confirmed that P13 at Station 4 had their access sited covered with a blanket and confirmed that patient access sites must always be visible to staff. During an interview on 11/15/24 at 11:00 AM, Certified Clinical Hemodialysis Technician (CCHT)8 was asked about access being covered or not in view. CCHT8 stated that access site need to be visible at all times due to the possibility of needle becoming dislodged.” Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/23 revealed in the section titled “Access,” stated in part “ ...Ensure access remains uncovered throughout the treatment.””

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 28297 Based on interview, record review, and policy review, the facility failed to ensure one of ten sampled patients (Patient (P) 5, were monitored every 30 minutes as required. The failure to monitor patients every 30 minutes had the potential to not capture a potential adverse event in a timely manner and could affect all 104 in-center hemodialysis patients. Findings include: 1.Review of the medical record face sheet provided by the facility for P5 revealed the facility admitted the patient on 04/29/17 with a diagnosis including End Stage Renal Disease. Review of six dialysis flow records provided by the facility for P5 from 10/14/24 thru11/08/24 revealed the following: On 10/14/24 the patient’s blood pressure was checked at 5:02 PM with a reading of 139/73 and not again until 6:03 pm with a reading of 153/80, one hour and one minute late. The patient’s blood pressure was checked again at 6:33 PM with a reading of 154/81 and was not checked again until 7:16 PM, with a reading of 154/74, 43 minutes later. On 10/18/24 the patients’ blood pressure was checked at 5:31 PM with a reading of 93/52 and not checked again until 6:31 PM with a reading of 95/49, one hour later. On 11/08/24 the patients’ blood pressure was checked at 5:38 PM with a reading of 133/93 and not checked again until 6:31 PM with a reading of 156/83, 53 minutes late. During an interview on 11/15/24 at 1;30 PM the Charge Nurse confirmed the missing blood pressures for P5 and stated staff should be checking the patient’s blood pressure every 30 minutes to ensure the patient was safe. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/23 indicated, “ ...During Treatment, obtain blood pressure and pulse rate every 30 minutes or more often but not to exceed 45 minutes or per state regulation ...””

“POC-P/S COUNSELING/REFERRALS/HRQOL TOOL CFR(s): 494.90(a)(6) The interdisciplinary team must provide the necessary monitoring and social work interventions. These include counseling services and referrals for other social services, to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker, at regular intervals, or more frequently on an as-needed basis. This Standard is not met as evidenced by: 28297 Based on interview, record review and policy review, the facility failed to ensure a “Kidney Disease Quality of Life” KDQOL survey (a questionnaire given to patients to determine the burden of dialysis on patients) was completed as required for two of 10 sampled patients (Patient (P) 1, and P6). Failure to complete the KDQOL survey timely had the potential to cause a patient to not receive appropriate psychosocial services in a timely manner and could affect 128 facility patients. Findings include: 1.Review of the face sheet in the medical record for P1 revealed the facility admitted the patient on 05/01/24 with diagnosis including end stage renal disease (ESRD). The facility was unable to provide or show that the KDQOL survey due in September 2024 with the 90-day Assessment and Plan of Care was completed as required. During an interview on 11/13/24 at 2:30 PM P1 stated he/she did not recall being given a health survey since admission. 2. Review of the face sheet in the medical record for P6 revealed the facility admitted the patient on 12/08/22 with diagnosis including ESRD. The facility provided a completed KDQOL, dated 01/23/23, however the KDQOL due date was January 2024 with the annual assessment was not completed. During an interview on 11/14/24 at 9:35 AM the Home Hemodialysis Nurse stated the was no evidence that P1 completed the KDQOL Assessment as required. He/she stated the Social Worker had been in and out on sick leave the past six months and that they were responsible for getting the KDQOL completed by the patient. During an interview on 11/14/24 at 12:00 PM, the Social Worker confirmed they had been in and out on sick leave and currently only works 20 hours a week. The Social Worker confirmed the KDQOL Assessments were behind. He/she stated P1 KDQOL was given to home therapies to give to the patient however it was returned on his/her desk incomplete. For P6 the Social Worker stated the patient has been unstable due to noncompliance and he/she thought the KDQOL was not completed on unstable patients until they were stable. The Social Worker stated it was important for patients to complete the KDQOL Assessment as required to ensure patients receive mental health services if needed. During an interview on 11/15/24 at 1:30 PM the Charge Nurse stated there needed to be a better plan in place to ensure KDQOL Assessments were completed in a timely manner. Review of the facility’s policy titled. “Measuring Patient Physical and Mental Function,” revised 04/04/12, indicated, “ ...The KDQOL-36 is administered to patients new to dialysis between the 3rd and 4th month of starting dialysis as part of the patient’s 90-day assessment and plan of care. At minimum, the KDQPOL-36 will be administered annually with each patient as part of the annual assessment and plan of care ...””

“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: 28297 Based on interview, record review, and review of facility policy, the facility failed to ensure four of 10 (Patients (P) 1, P2, P6 and P7) were given the opportunity to attend and participate in their Plan of Care (POC). The failure to give patients opportunities to be involved in their POC had the potential for missed opportunities for improved care and this could affect 128 total facility patients. Findings include: 1.Review of the “Face Sheet” provided by the facility for P1 revealed the facility admitted the patient on 05/01/24 with a diagnosis of end stage renal disease (ESRD). Review of P1’s initial “POC” provided by the facility, dated 07/09/24, and the 90 day “POC,” dated 10/23/24, revealed there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” During an interview on 11/14/24 at 9:35AM the Home Hemodialysis Nurse confirmed P1 initial and 90-day Plan of Care was not signed by the patient as required. He/she confirmed the patient was in the clinic for training and home visits so they should have been signed. The Home Hemodialysis Nurse said they failed to print out the signature page to provide to the patient to sign and that they needed to do a better job to ensure the patient signs the Plan of Care. 2.Review of the “Face Sheet” provided by the facility for P2 revealed the facility admitted the patient on 05/08/23 with a diagnosis of ESRD. Review of P2’s annual “POC” provided by the facility, dated 09/26/24, revealed there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” 3. Review of the “Face Sheet” provided by the facility for P6 revealed the facility admitted the patient on 12/08/22 with a diagnosis of ESRD. Review of P6’s unstable “POC” provided by the facility, dated 09/20/24, revealed there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” 4. Review of the “Face Sheet” provided by the facility for P7 revealed the facility admitted the patient on 09/26/13 with a diagnosis of ESRD. Review of P7’s annual “POC” provided by the facility, dated 04/25/24, revealed there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” During an interview on 11/14/24 at 11:30 AM the Dietitian stated in the last few months he/she had been given the task of ensuring POC’s were gone over with the patient, print out the signature page on the same day, and get the patient signature. The Dietician stated prior to that everyone was responsible to get the POC’s signed however it was not getting done. The Dietician stated it was important for patients to sign the POC’s to ensure they understood the information given in the POC’s. During an interview on 11/15/24 at 1:30 PM the Charge Nurse stated the Dietician gave the list of POC’s due however there was not a good plan in place to have patients to sign off on the POC’s as required. The Charge Nurse confirmed the four POC’s were not signed as required. Review of the facility policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” revised 07/03/23, indicated, “ ...Patient Participation in Plan of Care The following are recommendations for involving the patient in the development and review of the plan of care: ...Encourage both patient and family to participate in the Plan of Care discussions in whatever format the facility and attending physician develop. Notify the patient inwriting of the time and date of the Plan of care review ...If the patient and or designee is unable or unwilling to attend the Plan of Care meeting ...the Registered Nurse may review the Plan of care as developed by the IDT at the meeting with the patient and obtain the patients’ signature and any comments. The patients’ level of participation is determined by the patients ...””