Fkc Fogelsville

“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: 36372 Based on a review of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the facility was secured against unauthorized individuals for one (1) of one (1) observations (Observation #1). Findings: A review was conducted of facility policy/procedure on July 30, 2024, at approximately 2:00 p.m. Policy ‘Physical Security and Facility Access’ (Setting: IC, HT) ‘Physical Security’ states “.... All secondary external entrances (employee entrance doors, delivery doors) to the facility are to be kept closed and locked when not in use ....” Observations conducted in the facility on 07/29/24 at approximately 8:55 a.m. revealed the following: Observation #1: The exterior door exiting the bio-waste hazard room was observed to be not completely closed/latched (There is a swing type latch on the door and the door could still be opened from the exterior of the building). The facility Biomed Technician (employee #8) was made aware. Employee #8 opened the door completely and let the door swing close. The door did not completely close/latch. With the exterior door not being completely closed/latched securely, access was available to the treatment supply area, utility room which houses the water tanks, and the patient treatment area. An interview with the facility Administrator on July 31, 2024 at approximately 9:30 a.m. confirmed the above findings.”

“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: 36372 Based on a request of facility policy/procedure, observations, and an interview with the facility Administrator, the facility failed to ensure the building was free from hazards to ensure safety of the patients, the staff and the public for one (1) of one (1) observations (Observation #1). Findings: A request was made for facility policy/procedure related to general safety on July 30, 2024, at approximately 2:00 p.m. No specific policy/procedure was provided. Observations conducted in the facility on 07/29/24 at approximately 9:05 a.m. revealed the following: Observation #1: The facility utility room which houses two (2) 100 gallon gas hot water tanks was inspected. The room was approximatley 4’ x 8’ in size. Inside the room, directly in front of the gas water tanks, included but not limited to the following items on the floor: Five (5) one gallon paint cans, two (2) five gallon paint cans, one (1) container of ‘Sheetrock’ Joint Compound, one (1) 4 gallon pail of ‘Modular Pressure Sensitive Adhesive’, and one (1) gallon can of ‘Devguard 4309’ ‘Rust Preventive Gloss Enamel’ ‘Devo High Performance Coatings’ ‘Safety Yellow’ (The pail was approximately a third full and was labeled “Danger: Combustible Liquid and Vapor”). An interview with the facility Administrator on July 31, 2024 at approximately 9:30 a.m. confirmed the above findings.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 36372 Based on a review of facility policy/procedure, a review of facility water logs, and an interview with the Administrator, it was determined the facility failed to ensure facility water logs were completed per policy/procedure, for two (2) of two (2) water logs reviewed (Log Review #1, Log Review #2) and the facility failed to ensure medication was administered as prescribed by physician for one (1) of five (5) in-center hemodialysis patient medical records (MR) reviewed (MR#5). Findings include: A review was conducted of facility policy/procedure on July 30, 2024, at approximately 2:00 p.m. Policy ‘Carbon Filtration Monitoring for Incenter Central Water Systems Policy’ (Setting: IC) ‘Clinical Oversight’ states “The Clinical Manager (CM) or the nurse in charge is responsible for oversight of daily testing and documentation of total chlorine testing. The CM or the nurse in charge must do the following: “..... Complete from the TMS clinical application the “TCL CM Weekly Review Log”.....” A review of the facility water logs was conducted on July 30, 2024 at approximately 9:00 a.m. Log Review #1: The ‘TCL-CM Weekly Review Log -58397’ was reviewed for the months of June/July 2024. Documentation of a review on June 7, 2024. No review documented for the week of June 9, 2024 - June 15, 2024. Documentation of a review on June 17, 2024. No review documented for the week of June 23, 2024 - June 29, 2024. Documentation of a review on July 5, 2024. No review documented for the week of July 7, 2024 - July 13, 2024. Documentation of a review on July 15, 2024, July 22, 2024, and July 29, 2024. Policy ‘Bicarbonate Concentrate Mixing’ (Setting: IC, IPS) ‘Quality Assurance’ states “Bicarbonate concentrate quality assurance will include verification of the following: ...... The final fill volume of the bicarbonate concentrate is correct in relation to the number of bicarbonate bags prepared. For example: If two bags of Naturalyte 4000, #08-4112-2 were mixed, then the total volume of solution should be 192 liters. .....” Log Review #2: The ‘Bicarb Mixer (Initial Batch) v2 - 57064’ log was reviewed for the months of April/May/June 2024. Documentation of utilizing ‘Isopure Medical Solutions, 282 liters- 3bags’ on April 10, 2024, April 26, 2024, April 29, 2024, May 1, 2024, May 3, 2024, May 22, 2024, June 21, 2024, and June 24, 2024. (Note: The facility utilizes ‘Naturalyte Dry Bicarbonate Concentrate, 96 liter mix Rx-12....270 liters - 3 bags’. The facility does not currently utilize ‘Isopure’. Per the ATOM (area biomed Manager, employee #9) on July 30, 2024, “The staff is checking the wrong drop down box (Isopure) when documenting.” Policy ‘Heparin Free Dialysis’ ‘Purpose’ (Setting: IC) “The purpose of this policy is to provide guidelines for performing heparin free dialysis treatments.’ ‘Policy’ “A physician order is required for heparin free dialysis.” ‘Recommended Options for Preventing Clotting in Heaprin Free’ “The following treatment options are available to prevent clotting in heparin free dialysis. Saline Flushes: Periodic flushes of normal saline .... Saline flushes of 50ml-200ml or more may be indicated ....” ‘Documentation’ “Document normal saline flushes and clotting noted in extracorporeal circuit.” A review of patient medical records conducted on July 31, 2024 at approximately 8:00 a.m. revealed the following: MR#5 Date of admission 04/05/21: Physician orders for this patient include but are not limited to the following: ‘Dialysis Info: Outpatient Dialysis Treatment Medication. Outpatient Dialysis Anticoagulation. “Special Attention: Heparin free flush every 1 hour with 200cc’s normal sterile saline, every treatment, ....” ‘Start Date: “03/06/2024.” Patient treatment flowsheet dated 07/12/24, treatment initiated 7:32 a.m. At 9:00 a.m. ‘Treatment Data’ ‘Comments’ section “...200 flush...” At 10:31 a.m. ‘Treatment Data’ ‘Comments’ section “...200 nss flush...” Treatment discontinued at 11:34 a.m. Saline flush every one hour was not administered as per physician orders. Patient treatment flowsheet dated 07/15/24, treatment initiated 7:28 a.m. At 9:00 a.m. ‘Treatment Data’ ‘Comments’ section “...200 flush...” At 9:58 a.m. ‘Treatment Data’ ‘Comments’ section “...200 ccs nss flush...” No other flushes documented. Treatment discontinued at 11:26 a.m. Saline flush every one hour was not administered as per physician orders. Patient treatment flowsheet dated 07/19/24, treatment initiated 7:24 a.m. At 10:02 a.m. ‘Treatment Data’ ‘Comments’ section “...200 ccs nss flush...” No other flushes documented. Treatment discontinued at 11:25 a.m. Saline flush every one hour was not administered as per physician orders. Patient treatment flowsheet dated 07/17/24, treatment initiated 7:25 a.m. At 10:01 a.m. ‘Treatment Data’ ‘Comments’ section “...200 flush...” No other flushes documented. Treatment discontinued at 11:32 a.m. Saline flush every one hour was not administered as per physician orders. Patient treatment flowsheet dated 07/29/24, treatment initiated 7:24 a.m. At 9:39 a.m. ‘Treatment Data’ ‘Comments’ section “...200 flush...” At 9:58 a.m. ‘Treatment Data’ ‘Comments’ section “...200 flush per special orders...” No other flushes documented. Treatment discontinued at 11:32 a.m. Saline flush every one hour was not administered as per physician orders. An interview with the facility Administrator on July 31, 2024 at approximately 9:30 a.m. confirmed the above findings.”