Fmc - Home Dialysis Network Inc.

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 1 of 1 emergency cart, the Facility failed to ensure that emergency intravenous solutions were not expired and available for use. Findings include: 1. The Facility’s policy titled, “Emergency Medications, Equipment and Supplies”, dated 5/1/2023 was reviewed, and required, “An emergency cart, sometimes called ‘crash cart’ contains emergency equipment and medications for medical emergencies such as cardiac arrest...The following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible and immediately available...IV[intravenous] solutions and administration sets...Locked when not in use. Checked monthly or after use for contents, expiration dates...Items approaching expiration must be reordered and replaced prior to the actual expiration date...” 2. On 11/1/2023 at 9:30 AM, an observational tour of the facility was conducted. During the tour, the emergency cart (stored in the hallway), was observed for the required contents. The unlocked emergency cart contained 5 of 5 normal saline (0.9 %) bags that expired on 9/2023. The attached emergency cart’s checklist indicated that 5 normal saline bags should be included in the cart. The list was last documented on 2/2023 (9 months prior). 3. On 11/1/2023 at 10:35 AM, an interview was conducted with the Clinical Manager (E #1). E #1 stated that the emergency cart should be checked monthly and expired medications should be discarded and re-ordered as needed. E #1 stated that the cart should be locked when not in use.”

“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: 34411 Based on document review, observation, and interview, it was determined that 1 of 1 medication storage area, the Facility failed to ensure that expired medications were discarded and not available for patient use. Findings include: 1. The Facility’s policy titled, “Medication Preparation and Administration” (dated 2/6/2023), was reviewed, and required, “...Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via [Facility] off-site return program or in accordance with local and/or state law. Any open multi dose vials must be discarded 28 days after opening or per manufacturer’s expiration date..” 2. On 11/1/2023 at 9:30 AM, an observational tour of the medication storage area was conducted, and the following was observed: - 1 of 1 tuberculin (TB) vial was dated as opened on 7/25/2023 -23 vials of Ceftriaxone (antibiotic) with manufacturer’s expiration date of 10/2023 3. On 11/1/2023 at 10:40 AM, an interview was conducted with the Clinical Manager (E #1). E #1 stated that the TB vial is the only one that they have in the clinic and if they needed it for a new patient, they could borrow it from another facility. E #1 stated that there have not been any new admissions this year, just transfers. E #1 stated that although the Ceftriaxone just expired, the inventory was just checked yesterday and that should have been caught and the medications should have been tossed away.”

“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: 34411 Based on document review, observation, and interview, it was determined that for 1 of 2 patient restrooms, the Facility failed to maintain a functioning call light system to ensure patient safety. Findings include: 1.The Facility’s “Emergency Patient Call Device-PM [preventive maintenance]-Monthly” sheet (date created 11/1/2023), was reviewed. The sheet included, “Procedures: Emergency Patient Call Device. Instructions: Verify proper operation of each unit by activating call devices and evaluating visual and audio alarms. Ensure that all alarm indicators are active at the call device and at the nurse’s monitoring station. Inspect for any damaged parts...” 2. On 11/1/2023 at 9:30 AM, an observational tour of the facility was conducted with the Clinical Manager (E #1). During the tour, it was noted that the call light system in the patient’s restroom, located right outside of the training rooms, was not functioning (not alarming when cord pulled). 3. On 11/1/2023 at 9:45 AM, an interview was conducted with the Clinical Manager (E #1). E #1 acknowledged that the restroom’s call system was not working. E #1 stated that patients do use that restroom and the call system should be functioning if the patient needs to call for emergency assistance in the restroom. 4. On 11/1/2023 at 2:00 PM, an interview was conducted with the Area Technical Operations Manager (E #2). E #2 stated that the clinic’s assigned Biomed Technician should conduct monthly inspections on the call system to make sure they are properly. E #2 stated that if they are not working, then the call system’s company should be called to fix it. E #2 stated that E #2 was not able to locate any monthly inspection reports.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that for 1 of 2 (Pt #3) clinical records reviewed for home hemodialysis patients, the Facility failed to manage the patient’s fluid volume status, by not obtaining a physician’s order to adjust the dry weight (weight without fluid gains), as required. Findings include: 1. The Facility’s policy titled, “Hypertension” (dated 9/7/2021), was reviewed, and required, “Prevention of Hypertension: Consider initiating the CMAB Fluid Management algorithm [per physician order]. Reevaluate patient’s dry weight at least monthly. Monitor and make timely changes to estimated dry weights...” 2. The Facility’s “CMAB Recommended NxStage System One Adjustment of Prescription” Algorithm (dated 8/5/2020), was reviewed, and included, “Goals: Patient’s weight will be less than +/- 1 kg [kilograms] from Estimated Dry Weight (EDW) without signs or symptoms of hypervolemia [fluid overload] or hypovolemia [volume depletion]...This algorithm should be ordered when the patient is prescribed hemodialysis utilizing NxStage System One...Adjustments to patient’s EDW: Decreases greater than 0.5 kg per treatment must be per physicians/NP/PA order...5. Adjust Dialysis Frequency, Total Weekly Time, or Total Dialysate Volume and Dialysis Prescription...if weight is greater than or equal to +/- 1 kg from EDW for 3 treatments per month.” 3. The clinical record for Pt #3 was reviewed on 11/1/2023. Pt #3 was admitted on 9/6/2023, with a diagnosis of ESRD (end stage renal disease). Pt #3’s hemodialysis order (dated 9/8/2023), included an EDW order at 120.5 kg. Pt #3’s home treatment flowsheets from 10/23/2023-10/31/2023, were reviewed and included post treatment weights greater than 1 kg from the ordered EDW, on: - 10/23/2023: Post weight: 122.6 kg (2.1.5 kg above EDW) - 10/24/2023: Post weight: 122.5 kg (2 kg above EDW) - 10/26/2023: Post weight: 123.5 kg (3 kg above EDW) - 10/27/2033: Post weight: 123.2 kg (2.7 kg above EDW) - 10/30/2023: Post weight: 126.3 kg (5.8 kg above EDW) - 10/31/2023: Post weight 124.6 kg (4.1 kg above EDW) - Pt #3’s most recent nursing note was dated 10/30/2023, and the note lacked documentation of an adjustment or an order change for Pt #3’s EDW. 4. On 11/1/2023 at 2:10 PM, an interview was conducted with a Hemodialysis Registered Nurse (E #3). E #3 stated that if a patient’s target weight is less or greater than 1 kg from ordered weight, then the nurse should let the MD know to see if there needs to be an adjustment.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 34411 Based on document review and review, it was determined that for 1 of 2 (Pt #1) clinical records reviewed for peritoneal dialysis, the Facility failed to ensure that treatment flowsheets that contained self-monitoring data were completed, as required. Findings include: 1. The Facility’s policy titled, “Review and Documentation of Home Therapies Patient Health Data” (dated 5/1/2023), was reviewed, and required, “...The patient will create a treatment record for every dialysis treatment according to policy and regulatory requirements. Treatment data will be reviewed by the home therapies nurse in order to identify trends, determine if patients are following their treatment plans or having problems with their dialysis at home...At a minimum, the home therapies nurse will perform a comprehensive monthly review of all treatment data, regardless of the method of data submission...” 2. The clinical for Pt #1 was reviewed on 11/1/2023. Pt # 1 was admitted with a diagnosis of ESRD (end stage renal disease) on 3/20/2019. Pt #1’s physician orders (dated 3/29/2023), included an ordered EDW (estimated dry weight/weight without fluid gains) at 60 kilograms. Pt #1’s home treatment flowsheets from 8/24/2023-10/3/2023, were reviewed. The treatments sheets lacked any recorded treatment weights. The flowsheets also lacked any recorded body temperatures. 3. On 11/1/2023 at 2:10 PM, an interview was conducted with a Peritoneal Dialysis Registered Nurse (E #3). E #3 stated that the patients should record a weight and body temperature on their flowsheets. E #3 stated that if the patient does not record them, then the nurse should re-educate the patient and then the nurse should document the education. E #3 acknowledged that Pt #1’s clinical record lacked re-education of completing the flowsheet in its entirety.”