Fkc Nanticoke

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 19122 Based on a review of facility policy/procedure and documentation, and based on interview with the covering clinic manager (Employee #8) and the Administrator (Employee #8), the agency failed to ensure the emergency preparedness plan included a risk assessment review for one (1) of three (3) hazards for which an actual event was encountered by the facility. (Interruption in Medication Supply) Findings include: On June 4, 2025 at approximately 9:18, review of facility policy titled “Guidelines for Emergency Preparedness” revealed the following as documented under “Disaster Risk Assessment”: The Interdisciplinary Team...will annually complete the “Hazard Vulnerability Assessment (HVA) spreadsheet identifying hazardous event that may affect clinic operations. On June 4, 2025 at approximately 10:55 AM, review of the binder located at the medication preparation area revealed that effective immediately, the incenter stock of 90 milligram tablets of Cinacalcet (Sensipar-dialysis medication) had been depleted and that an alternate dosing process had been established. On June 4, 2025 at approximately 8:58 AM, review of the facility “Hazard Vulnerability Assessment Tool” dated 03/24/2025 failed to reveal that the HVA form included a risk assessment review for interruption in medication supply. During interview on June 6, 2025 at approximately 4:00 PM, the covering clinic manager and the Administrator confirmed the facility “Hazard Vulnerability Assessment Tool” dated 03/24/2025 failed to include a risk assessment review for interruption in medication supply.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 19122 Based on review of facility policy/procedure and personnel files, observational tour, and based on interview with the covering clinic manager (Employee #8) and the facility administrator (Employee #9), the facility failed to ensure two (2) of two (2) hemodialysis staff members performed hand hygiene in accordance with facility policy/procedure. (Employees # ) Findings include: On June 5, 2025 at approximately 1:05 PM, review of the facility policy titled “Hand Hygiene” revealed the following under “Policy”: Hands will be...Decontaminated using alcohol-based hand rub by washing hands with antimicrobial soap and water... When...Before and after direct contact with patients...Immediately after removing gloves... Review of personnel files between June 4, 2025 at approximately 1:12 PM and June 5, 2025 at approximately 12:02 PM revealed the following: Employee #4: The date of hire of the patient care technician (PCT) was 04/28/2024. Employee #7: The date of hire of the PCT was 04/12/2012. During observational tour conducted between June 3, 2025 at approximately 10:45 AM and June 5, 2025 at approximately 11:05 AM revealed the following: Employee #4: On June 5, 2025 at approximately 11:27 AM, the PCT disconnected the bloodlines from the central venous catheter (CVC) for the patient seated at Station B. The PCT disposed of supplies and removed and disposed the gloves. The PCT failed to perform hand hygiene prior to obtaining a new pair of gloves from the supply cart. Employee #7: On June 3, 2025 at approximately 11:22 AM, the PCT the first access needle for the patient seated at Station G. The PCT disposed of supplies and removed gloves. The PCT failed to perform hand hygiene prior to obtaining a new pair of gloves from the supply cart. The PCT removed and disposed of the bloodlines from the hemodialysis machine and then removed and disposed the gloves. The PCT failed to perform hand hygiene prior to obtaining a new pair of gloves from the supply cart. On June 4, 2025 at approximately 9:46 AM, the PCT disconnected the bloodlines from the CVC for the patient seated at Station I. The PCT disposed of supplies and removed and disposed the gloves. The PCT failed to perform hand hygiene prior to obtaining a new pair of gloves from the supply cart. During interview on June 6, 2025 at approximately 4:00 PM, the covering clinic manager and the Administrator confirmed hand hygiene is to be performed in accordance with the aforementioned requirements included in the agency policy titled “Hand Hygiene”.”

“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: 19122 Based on review of facility policies/procedures and personnel files, observational tour, and based on interview with the covering clinic manager (Employee #8) and the Administrator (Employee #9), the facility failed to ensure the hemodialysis (HD) machine disinfection process performed by two (2) of two (2) hemodialysis staff included disinfection of the full external portion of the sharps containers (containers utilized for disposing contaminated needles) which are mounted on the HD machines. (Employees #4 and #7) Findings include: On June 5, 2025 at approximately 1:09 PM, review of the facility policy titled “Cleaning and Disinfection of the Dialysis Station” revealed the following: Background...The Centers for Medicare and Medicaid (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The...dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses... Cleaning of the Dialysis Machine...Externally disinfect the dialysis machine with 1:100 beach solution after each dialysis treatment. Review of personnel files between June 4, 2025 at approximately 1:12 PM and June 5, 2025 at approximately 12:02 PM revealed the following: Employee #4: The date of hire of the patient care technician (PCT) was 04/28/2024. Employee #7: The date of hire of the PCT was 04/12/2012. During observational tour conducted between June 3, 2025 at approximately 10:45 AM and June 5, 2025 at approximately 11:05 AM revealed the following: Employee #4: During the HD machine disinfection process performed at Station J on June 5, 2025 at approximately 11:05 AM, the PCT (Employee #4) failed to disinfect the full external portion of the sharps container which is mounted to the HD machine. Employee #7: During the HD machine disinfection process performed at Station C on June 3, 2025 at approximately 10:45 AM, the PCT (Employee #7) failed to disinfect the full external portion of the sharps container which is mounted to the HD machine. During interview on June 6, 2025 at approximately 4:00 PM, the covering clinic manager and the Administrator confirmed HD machine disinfection is to include disinfection of the sharps containers which are mounted to the HD machines.”

“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: 19122 Based on review of agency policy/procedure and documentation, and based on interview with a registered nurse (RN-Employee #10), the Biomedical Technician (Employee #1), the Area Technical Operations Manager (ATOM-Employee #11), the covering clinic manager (Employee #8) and the Administrator (Employee #9), the facility failed to ensure documentation was maintained which provided evidence that testing for absence of the chemical disinfectant was performed after disinfection of the water treatment system for eight (8) of twenty-seven (27) disinfection cycles performed between December 2024 and June 2025. (2 Cycles in December 2024, February, March and April 2025) Findings include: On June 5, 2025 at approximately 12:55 PM, review of the facility policy/procedure titled “CWP 100 Inservice Unit Operation and Monitoring” revealed the following under “Start (After Chemical Disinfection)”: Do not operate the system without first verifying the water is free from disinfectant. On June 5, 2025 at approximately 9:15 AM, review of CWP (Central Water Platform) system disinfection start log documentation revealed chemical disinfection of the water treatment system was performed 27 times between December 2024 and June 2025. There was no documentation on the CWP disinfection end logs which provided evidence absence of chemical disinfectant had been verified after 8 of 27 disinfection cycles performed between December 2024 and June 2025. (12/01 and 12/15/2024, 02/02 and 02/16/2025, 03/02 and 03/09/2025, 04/20 and 04/27/2025). During interview conducted on June 4, 2025 at approximately 2:55 PM, the RN (Employee #10) reported due to internet connectivity issues, electronic documentation of water testing results may be delayed until internet connectivity is re-established. During interview conducted on June 5, 2025 at approximately 1:45 PM, the Biomedical Technician (Employee #1) and the ATOM (Employee #11) reported hemodialysis staff complete testing for absence of the chemical disinfectant the morning after disinfection of the water treatment system is completed but confirmed there was no documentation which provided evidence absence of chemical disinfectant had been verified after 8 of 27 disinfection cycles performed between December 2024 and June 2025. During interview conducted on June 6, 2025 at approximately 4:00 PM, the covering clinic manager and the Administrator confirmed there was no documentation which provided evidence that testing for absence of the chemical disinfectant after water treatment system disinfection had been verified after 8 of 27 disinfection cycles performed between December 2024 and June 2025.”

“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: 19122 Based on review of facility policies/procedures and medical records, and based on interview with the covering clinic manager (Employee #8) and the Administrator (Employee #9), the facility failed to ensure the medical record included documentation that patient assessments were conducted in in accordance with facility policy/procedure for three (3) of seven (7) patients. (Patients #2, #4 and #6) Findings include: On June 6, 2025 at approximately 2:39 PM, review of the facility policy titled “Patient Assessment and Monitoring” revealed the following: Data Collection...Direct patient care staff may collect data such as blood pressure (BP), pulse...general observations... During Treatment: -.Obtain blood pressure and pulse every 30 minutes...but not to exceed 45 minutes... -General Observation... -3. Machine parameters...Check arterial pressure... -4. Document any findings and interventions in the medical record... During interview conducted on June 6, 2025 at approximately 4:00 PM, the covering clinic manager and the Administrator confirmed patient assessments should not exceed 60 minutes during the hemodialysis treatment. Patient #2: On June 6, 2025 at approximately 10:00 AM, review of hemodialysis (HD) treatment sheet documentation revealed the following: -05/26/2025: Assessment of the arterial pressure (AP) was completed at 5:21 AM and the next AP assessment was documented as having been completed at 6:25 AM which was more than 60 minutes after the previous assessment. Patient #4: On June 6, 2025 at approximately 11:42 AM, review of HD treatment sheet documentation revealed the following: -06/03/2025: Assessment of the arterial pressure (AP) was completed at 9:42 AM and the treatment end time was 11:24 AM. There was no documentation in the medical record which provided evidence the AP was assessed within 60 minutes of the 09:42 AM assessment. -06/05/2025: Assessment of the arterial pressure (AP) was completed at 9:41 AM and the next AP assessment was documented as having been completed at 10:43 AM which was more than 60 minutes after the previous assessment. Patient #6 (Discharge): On June 6, 2025 at approximately 1:35 PM, review of HD treatment sheet documentation revealed the following: -03/31/2025: General observation assessment findings were not documented during the assessments performed at 1:05 PM and 2:42 PM. -04/02/2025: Assessment of BP and pulse was completed at 2:31 PM and the next assessment of BP and pulse was documented as having been completed at 3:25 PM which was more than 45 minutes after the previous assessment. General observation assessment findings were not documented during the assessments performed at 2:21 PM, 2:47/2:48 PM; 3:25 PM, 3:52 PM and 4:03 PM. During interview on June 6, 2025 at 4:00 PM, the covering clinic manager reported data transfer issues from the HD machine may have resulted in the above referenced findings. The covering clinic manager and the Administrator confirmed assessment of BP, pulse, AP and general observations had been documented in accordance with facility policy/procedure for the above identified patients on the aforementioned dates and times.”