Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 31, 2024, Fresenius Medical Care Fogelsville was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 31, 2024, Fresenius Medical Care Fogelsville was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
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.
Observations:
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.
Plan of Correction:For immediate compliance on July 29, 2024, the Biomedical technician (BMT) fixed the exterior door exiting the bio-hazard room to ensure that the door closed and latched properly.
The clinic manager (CM) or designee will educate all the staff on:
· Physical security and Facility Access
The meeting will review that all secondary external entrances to the facility must be kept completely closed and locked at all times when not in use. This includes the bio-hazard room door.
In-servicing will be completed by August 8, 2024. Documentation of the training will be on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time, if compliance is observed the audits will then be completed 2 times/week for 2 weeks. If one hundred percent (100%) compliance is maintained after 2 weeks, the audits will be completed monthly following the Quality Assessment and Performance Improvement (QAPI) program. A plan of correction (POC) specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion Date: September 13, 2024
494.60(a) STANDARD
PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY
Name - Component - 00
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.
Observations:
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.
Plan of Correction:For immediate compliance on July 29, 2024, the Biomedical technician (BMT) and the Director of Operations (DO) removed the paint cans, the Gloss Enamel, the High-Performance Coatings, the sheetrock joint compound and the Modular Pressure Sensitive Adhesive being stored in front of the hot water heater.
The CM or designee will educate all the staff on:
· OSHA Facility Checklist
The meeting will review that a safe work environment is to be provided and combustible materials such as paint should not be stored near the hot water heater.
In-servicing will be completed by August 8, 2024. Documentation of the training will be on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time, if compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed following the QAPI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion Date: September 13, 2024
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
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;
Observations:
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.
Plan of Correction:By August 8, 2024, the DO and CM will meet with the facility Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting will also review the following:
· Carbon Filtration Monitoring for Incenter Central Water Systems
· Bicarbonate Concentrate Mixing
· Bicarb mixing Log
· Heparin Free Dialysis
The Medical Director will be informed at the meeting with the DO and CM that the direct patient care (DPC) staff will be in-serviced by August 8, 2024. The DPC staff in-service will include a review of the above policies with staff understanding that the policies are always followed. This includes ensuring:
· The CM or charge nurse provides clinical oversight for the daily testing and documentation of chlorine testing with completion of the weekly review log
· That the verification of the bicarbonate being used at the facility is correctly documented when the concentrate is mixed
· The physician's orders for the patient's treatment are always followed. This includes the administration of normal saline solution (NSS) flushes when the patient is not receiving any heparin during treatment.
All training documentation will be on file at the facility. As well as meeting minutes with the Medical Director.
The Medical Director will be informed that the CM or designee will perform daily audits for 2 weeks. If compliance is noted at that time, the audits will be completed 2 times/week for 2 weeks. If 100% compliance is sustained at that time, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director weekly. The results and progress of the POC will be reviewed at the QAPI Committee monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
The Medical Director will be informed that staff found to be non-compliant will be re-educated and counseled.
Completion Date: September 13, 2024
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