Initial Comments:
Based on the findings of an unannounced complaint investigation conducted onsite January 7, 2026 and off site January 8, 2026 and January 12, 2026, Dialysis Clinic, Inc. was identified to have the following standard level deficiency that was 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 observations of the incenter hemodialysis (ICHD) treatment area, a review of dialysis clinic (clinic) policies and documents, governing body meeting minutes, quality assurance performance improvement (QAPI) meeting minutes, interviews with employees, the area operations director, nurse manager and education coordinator, the clinic failed to provide dialysis patients, staff and the public a safe, functional and comfortable treatment environment.
Findings include:
The Facility's Procedure No. 300: Routine Disinfection in the Hemodialysis Unit, reviewed on January 7, 2025 at approximately 12:00 PM reads in part, "Proper cleaning and disinfection of environmental surfaces (including patient chairs or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces must be performed between patient uses to prevent transmission of dangerous pathogens."
The Facility's Procedure No. 500: Use of Multiple Dose Vials Procedure, reviewed on January 7, 2026 at approximately 12:20 PM reads in part, "When a multi-dose vial has been opened (e.g., needle-puncture or vial cap removed), the vial should be dated, initialed and discarded with 28 days."
Observations of the ICHD Treatment Area and Isolation Room STN 32 were conducted on 01/07/2026 from 8:55 AM to 10:55 AM. The observations revealed the following:
HD Station (STN) 13 had 2 blue pads on the floor in front of the HD machine which were soaked with water/fluid. The floor was wet and noted to be slippery.
HD STN 18 had 1 blue pad on the floor partially covered with cardboard next to the patient chair. Both the blue pad and the cardboard were wet. The STN was occupied with a patient.
HD STN 24 had wet blue pads on the floor next to the HD machine. The STN was occupied with a patient.
HD STN 27 had wet cardboard on the floor next to the HD machine and a plastic container next to the HD machine with its opening angled towards the bottom of the HD machine in an attempt to capture the leaking water/fluid. The STN was unoccupied.
HD STN 29 had a significant amount of water/fluid on the floor next to and around the HD machines on either side of the patient chair and under the patient chair. Blue pads were being used and exchanged several times to sop up the water. The STN was occupied with a patient. At approximately 10:45 AM on 01/07/2026, PF#2 was asked by the surveyor if the biomedical technician had been notified of the leakage. PF#2 stated that the biomedical technician was unavailable. PF#2 was asked about the frequency of water/fluid leaks to which the employee stated that it happens frequently.
In several areas throughout the treatment floor, the floor was damp from the remnants of wiping up the water/fluid, causing this surveyor to slip twice. There were no " wet floor " signs present. In all cases, the source of the leak was unclear. There did not appear to be any leakage from the wall connections.
HD STN 29 was initially observed while unoccupied but prepared for the next patient. The table attached to the right side of the patient chair contained what appeared to be a small amount of faint blood stains, and the table to the left of the chair contained food crumbs. At 10:30 AM, STN 29 became occupied. The surveyor returned to the area and noted that the faint blood stains were still present on the right sided table. The surveyor was unable to ascertain if the crumbs had been cleaned up as the patient placed his/her belongings on the left sided table.
HD STN 10 was observed while unoccupied but prepared for the next patient. The table attached to the right side of the patient chair contained what appeared to be a small amount of faint blood stains.
In the area next to STN 6 and dirty sink area, there was a jug labeled RO (reverse osmosis) water. The container had a label for date and time, but there was no date nor time written on the label/container to indicate when the water had been placed in the container. Four (4), twenty (20) ml (milliliter) syringes found in the same area were expired. Each syringe had a use by date of 11/01/2025, lot # 201201. A plastic bottle containing 700 ml of a 1% bleach solution was neither dated nor timed. The same area had a round, plastic, Tupperware-like container with a red lid. The red lid had 8 holes/slits punctured through the lid. The lid was corroded with a while crystallized substance and contained a light blue solution. The container was not labeled with the contents, nor was a date or time present on the container. PF#1 was asked is s/he was aware of the contents of the contained. PF#1 was unaware of the container ' s contents, and stated that it may be something that housekeeping uses.
A review of the medication refrigerator found one, open 1 ml (milliliter) multidose vial of Retacrit (Epoetin), 20,000 units per ml (used to help increase hemoglobin levels). The vial had been opened and used. Approximately one-half ml remained in the vial. There was no date or time on the vial noting when it was opened.
The medication refrigerator contained 4 sets of two, 3ml syringes. Each set of 2 syringes was housed together in an open 3ml syringe wrapper. The eight syringes each contained 3 ml of a clear solution. None of the syringes were labeled with the contents, nor dated or timed.
The Facility's Procedure No. 310: General Facility Infection Control Procedure, reviewed on January 7, 2025 at approximately 12:10 PM states in part, " Infection Control and patient safety issues should be continuously reported and discussed in QAPI meetings, and the response taken to address these issues should be documented."
The results of a monthly Internal Facility Safety Inspection that took place on 02/29/25, reviewed on January 7, 2026 at approximately 1:15 PM, contained an observation that that water was present on the floor and a comment stating, "machine leaks due to RO.
The results of a General Compliance Audit completed 4/3/25, 4/10/25, and 4/22.25 (reviewed on January 7, 2026 at approximately 12:50 PM), noted noncompliance with dry floors due to " 11-year-old leaking BBrauns " (Dialog Hemodialysis Machines manufactured by BBraun, a medical device company).
The results of an In-Center HD Internal Audit completed on 8/4/25 and 8/7/25 (reviewed on January 7, 2026 at approximately 1:00 PM) contained several areas to be observed as part of the audit. One observation noted on either 8/4 or 8/7 that "Station 27 had an acid leak. Staff aware. Floor wet. Cardboard was on floor to absorb moisture. "
A review of Governing Body/Executive Committee (GB) Meeting Minutes, on January 7, 2026 at 11:30 AM found the following:
February 20, 2025: Equipment Maintenance - Discussion mentioned that a work order was placed for a "leaking station."
March 20, 2025: Equipment Maintenance - Discussion mentioned that a work order was placed for a leak from the water line at Station #28 connected to Machine #27.
April 24, 2025: Discussion mentioned that there was water on the treatment floor during audit rounds due to the old BBraun machines leaking, and that the biomedical technician was handling the physical plant issues with the Area Director of Operations.
May 22, 2025: Equipment Maintenance: Discussion mentioned that a work order was placed for station leak acid connector.
There was no specific discussion ascertained from a review of the GB meeting minutes after May 2025 concerning water leaks and/or associated actions plans to mitigate the leaks though it appeared that water/fluid leaks/wet floors continued to be a persistent problem.
A review of the Quality Assurance/Performance Improvement (QAPI) Meeting Minutes on January 7, 2026 at 2:00 PM found the following:
QAPI Meeting dated February 20, 2025: The annual OSHA report noted that 3 work-related incidents pertained to employee falls secondary to wet floors: 7/18/24: Employee slipped on leaking acid; 09/24/2024: Employee reported that s/he fell on the floor due to water leaking from a machine; 11/20/24: Employee was cleaning up water at Station 1 then proceeded to Station 3 to clean up more water under the chair and behind the HD machine when s/he slipped on some items placed behind the chair and machine to absorb the water.
In addition, QAPI meeting minutes on 2/20/25, 3/20/25, 4/24/25, and 5/22/25 contained the same discussion as noted in the above Governing Body Meeting minutes pertaining to water and/or acid leaks. There was no specific discussion ascertained from a review of the QAPI meeting minutes after May 2025 concerning water leaks and/or associated actions plans to mitigate the leaks, though it appeared that water/fluid leaks/wet floors continued to be a persistent problem.
A phone interview conducted with the Area Operations Director, Nurse Manager, and Education Coordinator on January 8, 2026 starting at 9:30 AM confirmed the above findings.
Plan of Correction:Deficiency: Water on Treatment Floor is Unsafe
A BBraun Senior Water Treatment System Specialist says that cold incoming water drops product water pressure and flow rate below normal operating ranges. Leaking from the machines can result when water temperature goes too low or high. Dialog machines lose pressure and the tank at the bottom of the machine overflows making the water flow out of the machines onto the floor.
The hot water tank is scheduled to be replaced with a larger one and storage tank by a local plumber, estimated date for the replacement is Friday February 6th.
The blending valve was also replaced. (1/27/26)
All BBraun Dialog machines are scheduled to have BBraun replace the internal tanks with newer-style tanks.
But per the Senior Customer Engineer of BBraun, they must have all the parts and technicians available before they provide Nurse Manager with a date for the repair.
If water leaks onto the floor for any reason, mop/bucket and water vacuum will be used rather than cardboard or blue pads. "Wet Floor" signs will be used to alert people of possible danger of slipping. BBraun technicians will be consulted for their expertise concerning the cause of a machine's leak.
Daily assessments by patient shift will be made by the Charge Nurse and Bio-Medical Technician and reported to the Nurse Manager and monthly QAPI/Governing Body.
This item is checked annually with completion of the General compliance audit to check for continued compliance.
Deficiency: Blood noted on 2 Chairs, Food Crumbs noted on chair side table
The Nurse Manager met with the in-center nurses and CCHTs on 1/19, 1/20/26 to review (1) the PA DOH Deficiency Listing and (2) Clinical Policy 300 "Routine Disinfection in the Hemodialysis Unit" in its entirety which includes the policy directive that for visible blood, the intermediate-level disinfection protocol must be followed, which requires the area be immediately cleaned with a cloth soaked with tuberculocidal disinfectant or 1:100 dilution of bleach (300-600 mg/L free chlorine), following the manufacturer's direction for contact time. Gloves must be worn, and the cloth placed into a leak proof container. After cleaning up all visible blood, a disinfectant must be applied a second time using a new cloth or towel." and (2).
Daily audits x 2 weeks will be performed by NM or her designee to ensure proper cleaning of chairs, side tables, and dialysis station surfaces for all shifts. If audits are found to be 100% in compliance, audit frequency can decrease to weekly x 4 weeks, auditing on all shifts. If continued compliance, audits can decrease to monthly x3, auditing all shifts.
Audits will be discussed in QAPI meetings and frequency will be determined by the QAPI/GB team based on audit results until resolution.
This item is checked annually with completion of the Infection Control audit performed by the educator/research coordinator to ensure continued compliance.
Deficiency: Jug labeled RO water without date & time prepared
The Nurse Manager removed the "RO jug" which is no longer needed since pHoenix meters and MyronL meters are not used in the treatment area.
The Nurse Manager removed the round, plastic, Tupperware-like container with a red lid, holes in the top and a blue solution inside which Housekeeping had used as an air freshener. Housekeeping was told it was not to be used in a treatment area.
Deficiency: Outdated 20 ml syringes
The Nurse Manager disposed of the outdated syringes. At the beginning of each month, the Education Coordinator will send an email to all clinical staff to remind them to check their work areas for supplies or medications that may be expired and discard them.
The Charge Nurse will oversee the collection and disposal of expired items daily during the rounds. The Nurse Manager will report results to monthly QAPI.
Deficiency Labeling the bleach solution with the date and time.
The Nurse Manager met with the in-center nurses and CCHTs to review (1) the PA DOH Deficiency statement and (2) Clinical Policy 314 "Each batch of bleach solution will be labeled with the date and time mixed along with the initials of the person who mixed the solution."
Daily audits x 2 weeks will be performed by NM or her designee, Charge Nurse, to ensure proper labeling of each batch of bleach solution. If audits are found to be 100% in compliance, audit frequency can decrease to weekly x 4 weeks. If continued compliance, audits can decrease to monthly x 3.
Audits will be discussed in QAPI meetings and frequency will be determined by the QAPI/GB team based on audit results.
This item is checked by the educator/research coordinator annually with completion of the General Compliance audit to ensure continued compliance.
Deficiency: Labeling multidose medication vials with date and time and discarding w/I 28 days unless the manufacturer specifies a shorter date for that opened vial.
The Nurse Manager met with the in-center nurses and CCHTs on 1/19, 1/20/26 to review (1) the PA DOH Deficiency statement and (2) Clinical Policy 500 "When a multi-dose vial has been opened (e.g., needle-punctured or vial cap removed), the vial should be dated, initialed and discarded within 28 days (USP 797), unless the manufacturer specifies a shorter date for that opened vial."
Daily audits x 2 weeks will be performed by NM or her designee, to ensure proper labeling of multidose vials with date and time and discarding w/i 28 days (unless the manufacturer specifies a shorter date for that opened vial) including each shift after patients are on machine. If audits are found to be 100% in compliance, audit frequency can decrease to weekly on all shifts x 4 weeks. If continued compliance, audits can decrease to monthly checking all shifts for compliance.
Audits will be discussed in QAPI meetings and frequency will be determined by the QAPI/GB team based on audit results until resolution.
Deficiency: Labeling syringes with patient name, date, time, contents, and initials of person preparing the medication.
The Nurse Manager met with the in-center nurses to review (1) the PA DOH Deficiency statement and (2) Clinical Policy 501 "Label the syringe with patient name, time, contents, date, and initials of person preparing the med."
Daily audits x 2 weeks will be performed by NM or her designee, to ensure proper labeling of medication syringes including: pt name, date, time, contents, and initials of person preparing the medication on each shift. If audits are found to be 100% in compliance, audit frequency can decrease to weekly on all shifts x 4 weeks. If continued compliance, audits can decrease to monthly x3, checking all shifts for compliance.
Audits will be discussed in QAPI meetings and frequency will be determined by the QAPI/GB team until resolution.
This item is checked annually with completion of the Infection Control audit performed by the educator to monitor for continued compliance.
This item is checked annually with completion of the Infection Control audit performed by the educator/research coordinator to monitor for continued compliance.
Deficiency: Reporting Safety Issues in QAPI:
The Nurse Manager met with the clinical staff to review (1) the PA DOH Deficiency statement and (2) Clinical Policy 310, "Infection control and patient safety issues should be continuously reported and discussed in QAPI meetings, and the response taken to address these issues should be documented."
In addition to the reporting of the safety issues to QAPI monthly, the Bio-Medical Technician will report the corrective actions being taken which will be conveyed in QAPI minutes. Actions to mitigate the safety issues will be specified in writing by the Bio-Medical Technician in the QAPI Technical Report.
Discussion of safety issues such as water leaks will be included in QAPI minutes as well as the actions taken by the technical department.
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