Fmc - Nalco Home Program

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 50873 Based on interview, record review, and review of the facility’s policy, the facility failed to vaccinate all susceptible patients against hepatitis B for 1 of 5 sampled patients (Patient (P) 1). The findings include: Review of the facility’s policy titled, “Patient Vaccination for Hepatitis B,” dated 02/07/2022, revealed “The Hepatitis B vaccine shall be offered to all susceptible patients including peritoneal and home hemodialysis patients.” Further review of the policy revealed “A protective antibody response is 10 or more milliinternational units (mIU) per milliliter [mL] (anti-HBs > 10mIU/mL).” Review of the policy revealed “Protection against hepatitis B is not maintained when antibody titers fall below 10 mIU/mL” and the policy indicated “A vaccine declination must be signed by the patient each year the vaccine is offered and refused.” Review of P1’s laboratory immunochemistry results for laboratory tests drawn on 10/14/2024 revealed the patient’s hepatitis B surface antibody had a result of “< [less than] 10 [mIU/mL].” During a review of P1’s medical record on 11/19/2024 at 11:09 AM with Registered Nurse (RN) 4, she confirmed that the patient’s laboratory results for laboratory tests drawn on 10/14/2024 indicated that the patient was susceptible to hepatitis B. RN4 stated the patient refused the vaccination, but there was no evidence in the medical record of the patient’s refusal. During a review of P1’s medical record on 11/21/2024 at 11:25 AM with the Home Therapies Clinic Manager for Eastern Kentucky, she confirmed that the patient’s laboratory results for laboratory tests drawn on 10/14/2024 demonstrated the patient was susceptible to hepatitis B and needed the vaccine series. She stated the expectation would be for the vaccination series to be started as soon as possible or there should be a signed declination from the patient in their medical record. She confirmed that there was no evidence in the patient’s medical record of the initiation of the hepatitis B vaccine or of the patient having signed a declination for the vaccine. During an interview on 11/21/2024 at 11:35 AM, the Medical Director confirmed the facility’s expectation was to educate the patients, offer them the vaccine, and have them sign a declination if needed. He stated the expectation was for staff members to bring any declinations to his attention so he could review it with the patient.”

“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: 50873 Based on interview, record review, and review of the facility’s policy, the facility failed to ensure that equipment was operated per facility policy for 1 of 5 sampled patients (Patient (P) 4). The findings include: Review of the facility’s policy titled, “Initiation of Treatment with a NxStage Hemodialysis Machine using a Central Venous Catheter,” dated 11/04/2024, revealed “If using a cartridge equipped with the SecureClip, attach to the venous catheter limb per manufacturer’s instructions for use. If SecureClip is not available attach HemaClip to venous bloodline and venous catheter limb.” Further review of the policy revealed “Document all required patient and machine data in chairside, the patient’s hemodialysis treatment sheet, or electronic medical record.” Review of the facility’s policy titled, “NxStage Machine: Set-up,” dated 10/06/2023, instructed patients to “Test battery and position of the Fluid Detection Sensor.” Review of the facility’s policy titled, “Home Therapies Patient Non-Adherence,” dated 09/06/2021, revealed “Examples of simple non-adherence may include: Inconsistent treatment record documentation.” Further review revealed “When simple non-adherence is identified, IDT [interdisciplinary team] member(s) shall discuss the identified concern with the patient (and care partner, as applicable) which may include: reviewing the importance of adherence and any potential safety concerns. Exploring patient reasons/barriers and identify potential solutions. Note: reasonable accommodations to remove barriers and comply with specific patient requests should be considered. Providing education, counseling, or additional support, as needed.” Review of the policy revealed “Discussions, interventions, and action plans implemented to address treatment non-adherence shall be documented in the patient’s medical record.” Review of P4’s treatment flowsheets dated 10/19/2024, 10/25/2024, and 11/05/2024, revealed under “Equipment” the patient had marked “N/A [not applicable]” for “NxStage Fluid Detection System used” and for “Bloodline connector clip used.” During a review of P4’s medical record with Registered Nurse (RN) 4 on 11/19/2024 at 12:35 PM, she confirmed there was no documentation of the patient utilizing the bloodline connector or fluid detection system during treatments on 10/19/2024, 10/25/2024, and 11/05/2024. RN4 confirmed that there was no evidence of education related to these safety checks in the patient’s record. RN4 stated the facility expectation would be that the missing safety check documentation would be addressed with the patient and documented in the medical record. During an interview on 11/20/2024 at 3:02 PM, RN6 confirmed that the use of the fluid detection system was required for all home hemodialysis patients and a bloodline clip was required for patients with a central venous catheter (CVC). RN6 confirmed that P4 had a CVC and performed home hemodialysis. RN6 stated the patient would be required to perform both safety checks. She stated she performed the home training with the patient. During an interview on 11/21/2024 at 11:35 AM, the Medical Director confirmed the facility’s expectation was that safety checks were performed per policy and that the RN would review the importance of the safety checks with the patient.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 50873 Based on interview, record review, and review of the facility’s policy review, the facility failed to provide dialysis treatment adherence education for 1 of 5 sampled patients (Patient (P) 5). The findings include: Review of the facility’s policy titled, “Home Therapies Patient Non-Adherence,” dated 09/06/2021, revealed “Examples of simple non-adherence may include: occasional missed or shortened treatment or missed clinic visits.” Further review of the policy revealed “When simple non-adherence is identified, IDT [interdisciplinary team] member(s) shall discuss the identified concern with the patient (and care partner, as applicable) which may include: reviewing the importance of adherence and any potential safety concerns. Exploring patient reasons/barriers and identify potential solutions. Note: reasonable accommodations to remove barriers and comply with specific patient requests should be considered. Providing education, counseling, or additional support, as needed.” Review of the policy revealed “Discussions, interventions, and actions implemented to address treatment non-adherence shall be documented in the patient’s medical record.” Review of P5’s treatment summary flowsheets revealed the patient completed the following: -4 out of 6 prescribed treatments during the week of 09/22/2024. -5 out of 6 prescribed treatments during the week of 09/29/2024. -5 out of 6 prescribed treatments during the week of 10/06/2024. -5 out of 6 prescribed treatments during the week of 10/13/2024. -5 out of 6 prescribed treatments during the week of 10/20/2024. -5 out of 6 prescribed treatments during the week of 11/03/2024. During a review of P5’s medical record with Registered Nurse (RN) 7 on 11/20/2024 at 9:34 AM, she confirmed that the patient had missed two treatments for one week and one treatment for five weeks out of the eight weeks reviewed. RN7 confirmed that there was no evidence of the missed treatments being addressed with the patient. She stated the facility expectation would be for the nurse to review the missed treatments with the patient, provide education, and document the intervention. During an interview on 11/21/2024 at 11:35 AM, the Medical Director confirmed that the facility’s expectation was that the nurses educate the patients on treatment adherence. He stated that he only got printouts of home hemodialysis patient adequacy to review and acknowledged he should follow peritoneal dialysis patients more closely.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 50873 Based on interview, record review, and review of the facility’s policy, the facility failed to include monitoring of the End Stage Renal Disease (ESRD) Network Cooperation in its Quality Assessment and Performance Improvement (QAPI) Program, which had the potential to impact all 28 patients who received care at the facility. The findings include: Review of the facility’s policy titled, “Quality Assessment and Performance Improvement Program,” dated 11/04/2024, revealed “The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven QAPI program with participation by the professional members of the interdisciplinary team (IDT). The program must reflect the complexity of the organization and services must focus on indicators related to improved patient health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its QAPI program including continuous monitoring for the Centers for Medicare & Medicaid Services (CMS) review.” Further review of the policy revealed “The QAPI committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. Elements to be reviewed will include: internal and external regulatory reviews.” During QAPI review with the Home Therapies Program Manager (HTPM) on 11/20/2024 at 2:00 PM, she was unable to demonstrate communication or coordination with the ESRD Network in any QAPI records for the last twelve months, which included meeting minutes and electronic records. During an interview on 11/20/2024 at 3:01 PM, the HTPM stated she was new to the role and was just informed of the necessity to communicate with the ESRD Network and was given log in information to access network information, including required actions. She confirmed that on the QAPI meeting minutes template, the ESRD Network communication was listed under the section heading of upcoming items, but stated she was not sure what that was in reference to. During an interview on 11/21/2024 at 1:30 PM, the Director of Operations confirmed there was no dashboard item in the electronic QAPI system to monitor the ESRD Network communication. She confirmed that there was a line in the QAPI meeting minutes outline for the ESRD Network communication, but it was unable to be utilized due to it not being able to be “clicked on.” She stated any discussion in QAPI about the ESRD Network relationship would have to be documented in the notes section of the meeting minutes. During an interview on 11/21/2024 at 11:35 AM, the Medical Director stated there had been confusion and uncertainty about the ESRD Network communication requirement and stated the Clinic Manager should be documenting this in the meeting minutes.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 50873 Based on observation, interview, record review, and review of the facility’s policy, the facility failed to safeguard patient information from unauthorized use for 26 of 28 patients who received treatment at the facility (Patients (P) 1, 2, 4, 5, and 7 through 28). The findings include: Review of the facility’s policy titled, “Confidentiality of Patient Information,” dated 05/06/2024, revealed “All PHI [patient health information] will be physically safeguarded to protect against inappropriate or inadvertent disclosure to unauthorized individuals and inappropriate use by authorized individuals. Any printed treatment information that may be required for safe patient treatment (example: clinic treatment information) will be stored in a secure location (example: locked drawer/cabinet).” Review of the facility’s document titled, “Patient Rights,” dated 2016, revealed patients have the right to “Privacy and confidentiality in your personal medical records.” During an observation on 11/18/2024 at 10:55 AM in the Medication Room, a clipboard was out on the counter next to the sink. The clipboard had on it a “HT [home therapies] Medication Tracking” log that included patient names, dates, and medications. During a concurrent interview, the Home Therapies Program Manager (HTPM) confirmed the clipboard in the Medication Room was stored on the counter and not secured in a locked cabinet or drawer. The HTPM stated the Medication Room did not lock, which meant the patients’ information was not secured. During an observation on 11/18/2024 at 11:00 AM in the Laboratory Room, a binder labeled “2024 Daily Lab [Laboratory] Collection Log” was located on the counter. This binder included P1, P2, P5, and P7 through P27’s name, medical record number, date of birth, laboratory tests drawn, and collection dates. Further review of the binder revealed the name, medical record number, laboratory tests drawn, and collection dates for P4 and P28. During a concurrent interview, the HTPM confirmed the laboratory collection log in the Laboratory Room was stored on the counter and not secured in a locked cabinet or drawer. The HTPM stated the Laboratory Room did not lock, which meant the patients’ information was not secured. During an interview on 11/21/2024 at 11:35 AM, the Medical Director confirmed the Medication and Laboratory Rooms should have been locked, and the patient’s records secured. He stated he did not realize the rooms did not have locks.”