Fkc Wilkes Barre

“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, observational tour, and interview with the clinical manager (Employee #5), the facility failed to ensure the disinfection process for three (3) of three (3) hemodialysis (HD) machines included disinfection of the sharps container (container utilized for disposing contaminated needles and syringes) which is mounted on the HD machine. (HD Machines at Stations #7, #27 and #30) Findings include: On September 12, 2024 at approximately 9:02 AM, review of the facility policy titled “Cleaning and Disinfection the Dialysis Station” revealed the following: Definitions...Dialysis Station...Area including the dialysis machine...Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments... General Cleaning...The dialysis station could become contaminated with blood and other body fluids during treatment... Cleaning the Dialysis Machine....Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment. During observational tour conducted between September 9, 2024 and September 10, 2024 revealed the following: 09/09/2024 at approximately 10:45 AM: Hemodialysis staff failed to disinfect the sharps container mounted on the HD machine after completion of the HD treatment at station #27. 09/10/2024 at approximately 9:58 AM: Hemodialysis staff failed to disinfect the sharps container mounted on the HD machine after completion of the HD treatment at station #30. 09/10/2024 at approximately 10:55 AM: Hemodialysis staff failed to disinfect the sharps container mounted on the HD machine after completion of the HD treatment at station #7. During interview on September 12, 2024 at 4:34 PM, the clinical manager confirmed HD staff members failed to disinfect the sharps container which was mounted on the HD machines at the above referenced HD stations.”

“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 manufacturer’s recommendations, documentation, and interview with the technical technician (Employee #6), a patient care technician (PCT-Employee #8), and the clinical manager (Employee #5), 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 one (1) of six (6) months between March and August 2024. (July 2024) Findings include: On September 17, 2024 at approximately 3:59 PM, review of manufacturer’s recommendations, which was forwarded via email by the clinical manager, revealed the following: Chapter 6: Cleaning, disinfection, preservation...6.2 Precautions... 6.2.1 Patient Safety...Test for the absence of residual disinfectant. When using disinfectants, an appropriate test for the absences of residual disinfectant must be performed... On September 11, 2024 between the approximate times of 9:24 AM and 10:50 AM, review of water treatment system disinfection documentation revealed chemical disinfection of the water treatment system was performed on July 11, 2024. There was no documentation which provided evidence that testing for absence of the chemical disinfectant was performed after disinfection of the water treatment system on 07/11/2024. During interview conducted on September 11, 2024 at approximately 10:55 AM, the technical technician (Employee #6) reported hemodialysis (HD) staff complete testing for absence of the chemical disinfectant the morning after disinfection of the water treatment system is completed. During interview conducted on September 12, 2024 at approximately 4:13 PM, the PCT (Employee #8) reported testing for absence of the chemical disinfectant would have been performed on 07/12/2024 prior to the initiation of HD treatments. During interview conducted on September 12, 2024 at approximately 4:34 PM, the clinical manager confirmed there was no documentation which provided evidence that testing for absence of the chemical disinfectant after water treatment system disinfection had been performed on 07/12/2024.”

“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: 19122 Based on review of facility policies/procedures, observational tour, and interview with the clinical manager (Employee #5), the facility failed to ensure vascular access sites (opening into a blood vessel which allows blood to travel through soft tubes to the dialysis machine) and patient faces were visible during the hemodialysis (HD) treatment for the patients receiving hemodialysis at twelve (10) of twenty-four (24) hemodialysis stations. (Stations #1, #2, #9, #12, #13, #14, #22, #26, #28 and #32) Findings include: On September 12, 2024 at approximately 9:00 AM, review of the facility policy titled “Patient Assessment and Monitoring” revealed the following: General Observation/Mental Status...Ensure each patient’s face is visible and uncovered. Access...Ensure access remains uncovered throughout the treatment... During observational tour conducted between September 9, 2024 and September 10, 2024 revealed the following: 09/09/2024 between the approximate times of 10:25 AM and 12:45 PM: Access sites were covered with a blanket for the patients receiving HD treatments at stations #1, #2, #9, #12, #13, #22, #26 and #28. At station #28, the patient’s face was also noted to be covered with a blanket. 09/10/2024 at approximately 11:00 AM: Access sites were covered with a blanket for the patients receiving HD treatments at stations #1, #12, #14 and #32. At station #14, the patient’s face was covered with a blanket. During interview conducted on September 12, 2024 at approximately 4:34 PM, the clinical manager confirmed HD staff failed to ensure patient access sites and patient faces were visible during the HD treatment for the patients receiving hemodialysis at the above referenced HD stations.”

“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: 19122 Based on review of facility policies/procedures and medical records, and based on interview with the medical director (Employee #9) and the clinical manager (Employee #5), the facility failed to ensure interventions and/or assessments related to fluid volume management had been completed per facility policy/procedure/protocol and/or physician orders for five (5) of ten (10) patients. (Patients #1, #2, #6, #8 and #9) Findings include: On September 12, 2024 at approximately 4:27 AM, review of the facility policy titled Volume Management in ESRD (End Stage Renal Disease) Patients on Hemodialysis:: Definitions...Estimated Dry Weight (EDW): Lowest tolerated post-dialysis weight with minimal signs or symptoms of hypovolemia (a condition of low fluid volume in your body) or hypervolemia (higher fluid volume in your body). EDW is used to calculate the target weight removal for each dialysis treatment... Fluid Assessment...At minimum, fluid assessment will include review of the following indicators...EDW...Pre/post weight... Fluid Interventions...If any of the following patient clinical conditions occur, refer to the volume algorithm or consult with provider for the appropriate fluid interventions...Pre-treatment weight is less than or equal to EDW...Treatment adjustments based on fluid assessment, symptoms and blood pressure are critical to improve patient’s volume status. EDW order should be updated post treatment to reflect treatment adjustments and patient fluid status. On September 12, 2024 at approximately 9:00 AM, review of the facility policy titled “Patient Assessment and Monitoring” revealed the following: Blood Pressure...Recheck blood pressure after a drop that requires interventions such as administering of normal saline... Ultrafiltration Rate (UF-amount of fluid removal)...Monitor UF rate. NOTE: Ultrafiltration rates greater than 13 ml/kg/hr (milliliter per kilogram per hour) should be avoided if possible... On September 12, 2024 at approximately 4:28 PM, review of the facility policy titled “Intradialytic Hypotension” (low blood pressure which occurs during the dialysis treatment) revealed the following: Definition: Patient pre-treatment sitting blood pressure (BP) equal to or greater than 110 and then drops below 90 during treatment OR... Patient pre-treatment sitting blood pressure equal to or greater than 101 but equal to or less than 109 and has a drop of 20 during treatment... Signs and Symptoms...Dizziness...lightheadedness...nausea or emesis... Treating Hypotension on Hemodialysis... 1. If BP is low or patient is symptomatic, administer 100-200 ml (milliliters) of fluid bolus as ordered by the provider... 5. Monitor and record the BP every five minutes until any symptoms resolved... During interview conducted on September 12, 2024 at approximately 4:34 PM, the medical director reported BP should be monitored approximately every 5-15 minutes after administration of normal saline (NSS) for treatment of asymptomatic hypotension. Patient #1 (Discharged): On September 11, 2024 at approximately 9:14 AM, review of the medical record revealed the following as documented on the “Current Orders Report”: -An EDW of 65 kg (kilograms) was prescribed on 10/17/2023. -If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD. Review of “Treatment Sheet for Facility” documentation revealed the following: -On between 03/02/2024 and 03/12/2024, the patient’s pre-dialysis weight as more than 1.5 kg lower than the prescribed EDW. The pre and post-dialysis weights were as follows: -03/02/2024: Pre-dialysis weight: 63.4 kg; post dialysis weight: 62.4 kg. -03/05/2024: Pre-dialysis weight: 61.7 kg; post dialysis weight: 62 kg. -03/072024: Pre-dialysis weight: 61.2 kg; post dialysis weight: 60.7 kg. -03/09/2024: Pre-dialysis weight: 61.1 kg; post dialysis weight: 60.3 kg. -03/12/2024: Pre-dialysis weight: 61.9 kg; post dialysis weight: was not obtained due to change in medical condition. -03/12/2024: 200 ml of NSS was administered at 11:44 AM due to low BP reading of 90/43. The next BP assessment was completed at 12:05 PM which was 21 minutes after the administration of NSS. There was no documentation in the medical record which provided evidence HD staff had obtained an order to adjust the prescribed EDW between 03/05/2024 and 03/12/2024 nor was documentation present which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on 03/12/2024. Patient #2: Between September 11, 2024 at approximately 11:21 AM and September 12, 2024 at approximately 9:17 AM, review of the medical record revealed the following as documented on the “Current Orders Report”: -If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD; and -Do not UF greater than 13 ml of fluid per kilogram of estimated dry weight per treatment unless otherwise noted. Review of “Treatment Sheet for Facility” documentation revealed the following: -08/28/2024: The UF exceeded 13 ml/kg between 5:51 AM and 7:05 AM. At 8:43 AM, the patient complained of cramping. -08/30/2024: 200 ml of NSS was administered at 9:02 AM (BP 86/51). The next BP assessment was completed at 9:19 AM which was 17 minutes after the administration of NSS. -09/06/2024: The UF exceeded 13 ml/kg between 7:00 AM and 7:21 AM. -09/11/2024: The UF exceeded 13 ml/kg between 6:03 AM and 6:40 AM. At 7:36 AM, the UF was turned off and fluid removal goal was decreased due to a low BP. There was no documentation in the medical record which provided evidence UF rate and reassessment of BP after administration of NSS were administered or completed in accordance with the above referenced policies/procedures or protocol on the aforementioned dates. Patient #6: On September 12, 2024 at approximately 11:34 AM, review of the medical record revealed the following as documented on the “Clinical Record Review Report”: -If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD. Review of “Treatment Sheet for Facility” documentation revealed the following: -09/04/2024: 200 ml of NSS was administered at 8:06 AM for BP of 80/55. The next BP assessment was completed at 8:25 AM which was 19 minutes after the administration of NSS. There was no documentation in the medical record which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on 09/04/2024. Patient #8: On September 12, 2024 at approximately 1:07 PM, review of the medical record revealed the following as documented on the “Current Orders Report”: -If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD. Review of “Treatment Sheet for Facility” documentation revealed the following: -09/11/2024: 200 ml of NSS was administered at 2:57 PM for a BP of 82/56. The next BP assessment was completed at 3:22 PM which was 25 minutes after the administration of NSS. There was no documentation in the medical record which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on 09/11/2024. Patient #9: Between September 12, 2024 at approximately 2:08 PM and September 13, 2024 at approximately 2:25 PM review of the medical record revealed the following as documented on the “Treatment Sheet for Facility”: -09/05/2024: NSS was administered at 12:24 PM for a BP of 77/57. The next BP assessment was completed at 12:41 PM which was 17 minutes after the administration of NSS. -09/10/2024: 200 ml of NSS was administered at 11:46 AM for a BP of 93/52. The next BP assessment was completed at 12:10 PM which was 26 minutes after the administration of NSS. There was no documentation in the medical record which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on the aforementioned dates. During interview conducted on September 12, 2024 at approximately 4:34 PM, the clinical manager confirmed interventions and/or assessments related to fluid volume management were not completed in accordance with facility policies/procedures or protocol for the above referenced patients.”