Initial Comments:
Based on the findings of an onsite unannounced complaint investigation completed May 1, 2024, Ara Dialysis Unit At Ohio Valley Hospital LLC was found 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:
494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[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.
Observations:
Based on review of facility policy, manufacturer's directions for use, observation, and staff (EMP) interview, the facility failed to follow written protocols for the cleaning and disinfection of contaminated surfaces, medical devices, and equipment for one (1) of one (1) bleach mixture (bleach 1).
Findings include:
Review of facility policy on May 1, 2024, at 12:30 p.m. showed, "G45 Cleaning and Disinfection of Equipment, Supplies & Treatment Area ... POLICY: 1. Unless equipment manufacturer's specify use of another agent, equipment will be disinfected using 1:100 bleach/water solution."
Review of "pHoenix XL User Guide Rev. F" that was available for review where the meter's where stored on treatment floor on April 30, 2024, at 11 a.m. showed, "Disinfecting Recommendations ... we recommend that you follow these steps daily before the first use of the meter: 1. Draw 1% bleach solution (one-part bleach to ninety-nine parts dialysis quality water) mixed fresh daily, into the meter to the 10 ml line. ... Let the solution sit in the meter for approximately for approximately 10 minutes. ... CAUTION: ... Dwell times longer than 10 minutes will cause premature deterioration of the Measurement Module."
Observation on the treatment floor on May 1, 2024, at 10 a.m. revealed three pHoenix meters (used to test dialysate conductivity) located on counter next to the sink. Also at the counter were two small bins of a water/bleach mixture used to wipe surfaces and to dwell inside equipment such as the pHoenix meter.
During interview with EMP3 on May 1, 2024, at 10:10 a.m. he/she confirmed the two bins observed on the sink's counter contained a mixture of bleach and water. EMP3 confirmed the bleach is used for disinfecting surfaces, and that it was used inside the pHoenix meters today before the treatment day started, where it dwelled for 10 minutes. Surveyor asked EMP3 to describe the process for making the bleach water mixture. EMP3 showed surveyor a 5-liter (5000 milliliter) pitcher that the bleach and water are mixed in. The pitcher had two lines drawn on it with a felt-tip marker. One line was loosely drawn at the pitcher's 3000-milliliter mark, and another was loosely drawn over the pitcher's 2900-liter mark. EMP3 noted that he/she fills the pitcher with 2900 liters of RO (dialysate quality) water and then adds full strength bleach (100 ml) until the total volume of bleach and water is 3000 milliliters.
Interview with EMP1 (clinic manager) on May 1, 2024, at 12 p.m. confirmed above findings and that the above mixture is not 100:1 bleach but actually 29:1.
Plan of Correction:V 000
The governing body and management staff of this facility takes this deficiency statement very seriously and will ensure that these citations are corrected and that they remain in compliance. The governing body met on 5/16/24 to review and approve the plan of correction and the tools that will keep approved plan in compliance. The in-services and tools are available for review in the facility.
V 122
An in-service was initiated to all Direct Patient Care (DPC) staff on 5/20/24 by the Clinic Manager (CM) reinforcing the policy for preparing the bleach mixture used for disinfection of the treatment area and equipment. Per G 45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area Also per policy "1. Unless equipment manufacturers specify use of another agent, equipment, treatment area and work surfaces will be disinfected using a 1:100 bleach/water solution using 5.25% - 6% bleach (with the exception of concentrate containers, which is addressed separately in this policy). Mixing instructions are included at the end of this policy. 1:10 Bleach/water solution should be used for blood spills >10cc." The policy and instructions for mixing the bleach solution were reviewed during the in-services. Emphasis was placed on ensuring all items, including the phoenix meters, are disinfected properly including ensuring the bleach water for disinfecting is mixed properly. This item is on the monthly Infection Control (IC) Audit which will be done weekly for 8 weeks by an assigned Direct Patient Care (DPC) staff member. All breaks in Infection Control will be immediately addressed by the Clinic Manager. Additionally, The CM will spot check the treatment floor, weekly for 8 weeks, to observe staff mixing the bleach water solution, to ensure it is mixed properly. A CM monitoring tool is developed to monitor this action. The Clinic Manager will ensure compliance through direct observation and review of the Infection Control Audits at least monthly prior to the Quality Assessment and Performance Improvement (QAPI) meeting. All findings from the IC audit tool and CM monitoring tool will be addressed at the monthly QAPI meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly audits or if trends are identified, disciplinary action.
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
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.
Observations:
Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to operate pHoenix XL meters (dialysis equipment for verifying conductivity) in accordance with the manufacturer's directions for use for three (3) of three (3) Phoenix meters (PXH23501, PXH23499, & PXH27265).
Findings included:
Observation of treatment floor during a non-treatment day on April 30, 2024, at 10:20 a.m. revealed the facility's three pHoenix XL meters (PXH23501, PXH23499, & PXH27265) were stored with 8-9 milliliters (ml) of liquid inside the meter's control syringe (20 ml syringe for holding sample to be tested). Interview with EMP2 (technical manager) at 10:42 a.m. confirmed the meter's syringes contained Neocare and have been stored this way since end-of-treatment day on 4/29/2024. See below for manufacturer's recommendations on storage-- meters are not to be stored with Neocare.
Review of maintenance logs "ARA Dialysis Ohio Valley Phoenix Meter XL Verification and Calibration Log" on April 30, 2024, at 10:53 a.m. showed that the meters required calibration on 4/8, 4/10, and 4/12/2024. On 4/8, the meter's (PXH23501) verified conductivity was 14.2 with no recalibration. On 4/10, the meter's (PXH23501) verified pH was 7.2 with no recalibration. On 4/12, the meter's (PXH27265) verified conductivity was 14.2 with no recalibration. Per directions on the maintenance log, conductivity must be 14.0 +/- 0.1 or 13.9-14.1, and pH must be 7.0 +/- 0.1 or 6.9-7.1.
Review of "pHoenix XL User Guide Rev. F" that was available for review where the meter's were stored on treatment floor on April 30, 2024, at 11 a.m. showed, "B. Safety Cautions Verify accurate function of your pHoenix Meter before taking measurements or whenever inaccurate readings are suspected. ... Disinfecting Recommendations ... we recommend that you follow these steps daily before the first use of the meter: 1. Draw 1% bleach solution (one-part bleach to ninety-nine parts dialysis quality water) mixed fresh daily, into the meter to the 10 ml line. ... Let the solution sit in the meter for approximately for approximately 10 minutes. ... CAUTION: ... Dwell times longer than 10 minutes will cause premature deterioration of the Measurement Module. ... Storage Recommendations ... Mesa Laboratories NEO-CARE Cleaning Solution is ideal for pHoenix XL Meter. For storing meters overnight ot long, follow these steps: 1. Flush the meter with ... NEO-CARE ... 2. Disconnect the meter from the solution. Purge remaining fluid by rapidly pumping the syringe several times into waste receptacle. 3. Seal the Measurement module with an air-tight cap. 4. The measurement module is to be damp only during storage, never full of fluid. Always seal the measurement module to prevent residual NEO-CARE in the cell and syringe from drying out." Note: facility used a stronger concentration of bleach in their meters. See V122 for more information.
An interview with EMP2 on April 30, 2024, at approximately 1 p.m. confirmed above findings concerning calibration and that the pHoenix meters are not to be stored with Neocare inside the syringe (to be expelled leaving residual only to maintain dampness).
Plan of Correction:V 403
An in-service was initiated to all Direct Patient Care (DPC) staff, including the Facility Technical Manager (FTM) on 5/20/24 regarding ensuring the manufacturer guidelines are followed when using and storing the pHoenix XL meters. To ensure proper readings of the conductivity and pH of dialysate all manufacturer guidelines when using and storing the pHoenix XL meters must be followed. During the in-service the manufacturer guidelines were reviewed in entirety with emphasis on:
- NEO-CARE must not be left in the meter when the meter is being stored.
- Immediately after the meter is flushed with NEO-CARE the solution must be purged from the meter by "rapidly pumping the syringe several times into a waste receptacle."
- If disinfecting with a bleach water solution, the solution must be mixed properly, and the solution should only sit for 10 minutes and then discarded. If the solution is allowed to sit for >10 minutes, it could damage the measurement module of the meter.
- To ensure proper readings the meter should be calibrated daily or when inaccurate readings are suspected.The clinic manager will spot check the treatment floor and meter maintenance logs weekly, for 8 weeks, to ensure staff are calibrating and storing the meters per manufacturer guidelines. A CM monitoring tool was developed to monitor this action. The CM will ensure compliance through direct observation and use of the CM monitoring tool. The CM monitoring tool will be brought to the monthly Quality Assessment Performance Improvement (QAPI) meeting, of which the medical director is a member, where findings will be discussed and additional action taken as deemed appropriate such as continued staff education, continued monitoring or if trends identified, disciplinary action.
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on review of National Kidney Foundation (NKF) Guidelines, observation (OBS), and staff (EMP) interview, the facility failed to ensure one (1) of one (1) patient with an arteriovenous fistula (AVF) washed their access prior to disinfection and initiation of dialysis (AVF1).
Findings included:
According to NKF Guidelines, "Tips for Everyday Care of Your AV Fistula or Graft Prevent Infection ... Wash your access site before every dialysis treatment. Your dialysis center has hand washing sinks and antimicrobial soap." Retreived from https://www.kidney.org/sites/default/files/11-50-0216_va.pdf
Observation (AVF1) on treatment floor during initiation of dialysis on May 1, 2024, a 12 p.m., revealed patient ambulate to station 10 without washing his/her access at the sink. EMP1 wiped patient's access with disinfectant, inserted needles into patient's access, and started dialysis treatment. Interview with EMP1 at 12:05 p.m. confirmed patient did not wash his/her access in sink with soap and water prior to initiation of dialysis. EMP1 noted that he/she wiped AVF1's access with a hand-sanitizing wipe (PDI Sani-Hands Instant Hand Sanitizing Wipes) per facility policy. When EMP1 was asked why the patient did not wash his/her access in sink EMP1 noted that the patient refuses to do so. Surveyor requested that EMP1 provide documentation from patient's clinical record that he/she had been refusing to wash his/her access in the sink. EMP1 was unable to provide prior documentaiton that to show the patient had been refusing to wash his/her access in the sink or that the patient was educated concerning this guideline. EMP1 asserted that he/she did however document that patient refused to wash his/her access in the sink for today's treatment.
Interview with the patient while he/she was on dialysis on May 1, 2024, at 12:25 p.m. did not reveal that he/she refused to wash his/her access in the sink or that he/she was opposed to this practice.
Plan of Correction:V 550
An in-service was initiated to all Direct Patient Care (DPC) staff, including EMP #1 on 8/19/2024 by the Clinic Manager (CM) regarding ensuring patients wash their access prior to cannulation. Per policy IC04A AVF-AVG Cannulation, Treatment Initiation and Termination policy it states "1. The access will be washed with antibacterial soap and water or skin antiseptic wipe, prior to preparing the site for cannulation." Also, per National Kidney Foundation Access Care it states "Tips for everyday care of your AV fistula or graft – Wash your access site every day. Ask your dialysis care team to recommend a good soap to use. Wash your access site before every dialysis treatment." It was stressed during the in-service that to prevent the potential for vascular related infections the patients should wash their accesses with soap and water prior to cannulation. Prior to the DPC staff member initiating dialysis, they should ask the patient if they have washed their access and educate the patient as to why it should be done prior to cannulation. This education is to be documented in the patient's medical record. If the patient refuses to wash their access this should be documented in the patient medical record. Also, if for any reason the patient is unable to wash their access, then the staff should assist the patient with washing their access prior to cannulation. All patients, including patient at station #10 will be educated by 8/19/2024 on the requirement for washing their vascular access with soap and water prior to cannulation. Each DPC staff member will educate their patients, including the patient at station #10, on the requirement for washing their access with soap and water, each treatment for 4 weeks, and observe or assist the patient with washing their hands and dialysis access with soap and water. If patient refuses to wash their access, this will be documented on the patient flow sheet and the CM will meet with the patient to provide further education to the patient. To ensure further compliance, the Clinic Manager will spot check the treatment floor, one day a week for 8 weeks, prior to and during patient initiation, to ensure staff are prompting patients to wash their access with soap and water prior to cannulation or assisting them to wash their access prior to cannulation if they are not able to. A CM monitoring tool was developed to monitor this action. Additionally, to ensure ongoing compliance, staff are to document a Yes or No in the EMR Treatment flow sheet indicating if the patient has washed their access prior to cannulation. The CM as the custodian of medical records will periodically review this documentation on the treatment flowsheet to ensure it is being conducted and will meet with staff and patients who are not in compliance. The Clinic Manager will ensure compliance through direct observation and use of the CM monitoring tool. All findings from the CM monitoring tool will be addressed at the monthly QAPI meeting, of which the medical director is a member, where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly audits or if trends are identified, disciplinary action.
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