Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted September 13, 2021 through September 14, 2021 and offsite on September 17, 2021, FMC Dialysis Services - Graduate, was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted September 13, 2021 through September 14, 2021 and offsite on September 17, 2021, FMC Dialysis Services - Graduate, 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:
494.40(a) STANDARD
CARBON ADSORP-MONITOR, TEST FREQUENCY
Name - Component - 00
6.2.5 Carbon adsorption: monitoring, testing freq
Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours.
Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet.
Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L].
Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly.
Observations:
Based on reviews of chlorine testing logs, facility policy, and an interview with the facility administrator, the facility failed to ensure free chlorine, chloramine, or total chlorine testing was performed at the beginning of each treatment day prior to patients initiating treatment and every 4 hours for five entries on chlorine testing logs, (Log #1 and Log #2).
Findings include:
A review of facility policy titled "Carbon Filtration Monitoring for Incenter Water Systems Policy" was conducted on September 14, 2021 at approximately 10:00 am. Policy states "What to test: Worker Carbon Filter. When to test: Prior to the initiation of the first patient treatment of the day and at a minimum of every four hours..."
FKC Log Readings Report Logs were reviewed on September 13, 2021 at approximately 1:00 pm revealed the following:
Log #1 review for Month of July 2021:
On 7/9/2021, first test time was entered at 8:10 am. The first patient treatment of the day was initiated at 5:20 am.
On 7/28/2021, first test time was entered at 8:09 am. The first patient treatment of the day was initiated at 5:14 am.
Log #2 review for Month of August 2021:
On 8/11/2021, test time was entered at 8:55 am. Next test time was entered at 1:25 pm. (30 minutes late).
On 8/24/2021, first test time was entered at 6:06 am. The first patient treatment of the day was initiated at 6:15 am.
On 8/27/2021, test time was entered at 4:00 am. Next text time was entered at 9:20 am. (1 hour and 20 minutes late).
An interview with the facility administrator on September 14, 2021 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:The Clinic Manager (CM) or Area Technical Operations Manager (ATOM) will re-educate all the DPC staff on:
- Carbon Filtration Monitoring for Incenter Water Systems Policy
Emphasis will be placed ensuring that free chlorine, chloramine, or total chlorine testing is performed at the beginning of each treatment day prior to patients initiating treatment and every 4 hours thereafter.
The in servicing will be completed November1, 2021, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if one hundred percent (100%) compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment Inmprovement (QAI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
494.40(a) STANDARD
DIALYS PROPORT-MONITOR PH/CONDUCTIVITY
Name - Component - 00
5.6 Dialysate proportioning: monitor pH/conductivity
It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.
Observations:
Based on review of agency policy, testing logs and staff interviews, the facility failed to ensure the Myron L D-6 Conductivity meters were re-calibrated for conductivity, TDS, and pH per facility policy for two (2) of two (2) months of meter testing logs reviewed.
Findings included:
Review of the facility procedure titled "Myron L D-6 Calibration Form" on September 14, 2021 at approximately 10:20 am states, "1. Enter date that calibration is performed. 2. Enter time (24-hour format) that calibration is performed. 3. Measure a sample of 14.00 mS Conductivity solution in accordance with manufacturer's IFU. Document the calibrated reading.5. Measure a sample of 3000 ppm 442 standard solution in accordance with manufacturer IFU and document un-calibrated results. 6. Using 3000 ppm 442 standard solution, calibrate TDS per manufacturer's IFU. Document the calibrated reading. 7. Measure a sample of 7.0 pH buffer solution, calibrate the meter in accordance with manufacturer IFU and document uncalibrated results. 8. Using 7.0 pH buffer solution, calibrate the meter in accordance with manufacturer IFU and document calibrated results. 9. Measure a sample of 4.00 pH buffer solution, calibrate the meter in accordance with manufacturer IFU and document the uncalibrated results. 10. Using 4.00 pH buffer solution, calibrate the meter in accordance with manufacturer IFU and document calibrated results. 11. Measure a sample of 10.00 pH buffer solution, calibrate the meter in accordance with manufacturer IFU and document the uncalibrated results. 12. Using 10.00 pH buffer solution, calibrate the meter in accordance with manufacturer IFU and document calibrated results. 13. Fill pH sensor well with storage solution..."
Review of "Myron L D-6 Meter Verification" logs conducted on September 13, 2021 at approximately 1:00 pm revealed the following:
July 2021 log for Meter Serial #D606931:
7/15/2021 10.0 pH verficiation | Range is 9.96 - 10.04 reading states "10.2"
Was verification within range? entry states "Yes" and no recalibration was completed.
August 2021 log for Meter Serial #D606931:
8/11/2021 7.0 pH verification | Range is 6.96 - 7.04 reading states "7.1".
Was verification within range? entry states "Yes".
8/14/2021 10.0 pH verficiation | Range is 9.96 - 10.04 reading states "19"
Was verification within range? entry states "Yes" and no recalibration was completed.
8/17/2021 7.0 pH verification | Range is 6.96 - 7.04 reading states "7.10".
Was verification within range? entry states "Yes".
8/19/2021 7.0 pH verification | Range is 6.96 - 7.04 reading states "7.1".
Was verification within range? entry states "Yes".
10.0 pH verficiation | Range is 9.96 - 10.04 reading states "97.9"
Was verification within range? entry states "Yes".
8/24/2021 Verify 3000 TDS (442 Solution) | Range is 2970 - 3030 reading states "NA". Was the verification within range? entry states "No" and no recalibration was completed.
8/26/2021 Verify 3000 TDS (442 Solution) | Range is 2970 - 3030 reading states "NA". Was the verification within range? entry states "No" and no recalibration was completed.
8/27/2021 Verify 3000 TDS (442 Solution) | Range is 2970 - 3030 reading states "NA". Was the verification within range? entry states "No" and no recalibration was completed.
8/30/2021 Verify 3000 TDS (442 Solution) | Range is 2970 - 3030 reading states "NA". Was the verification within range? entry states "No" and no recalibration was completed.
July 2021 log for Meter Serial #D606992:
The following entries were noted on all days 7/1/2021 through 7/31/2021 when testing was completed except for 7/27/2021:
"Verify 50 mS conductivity | Expected reading is 49mS to 51mS" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
"Verify 3000 TDS (442 Solution) | Range is 2970 - 3030" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
Additionally, the following was noted:
7/6/2021 10.0 pH verficiation | Range is 9.96 - 10.04 reading states "10.1"
Was verification within range? entry states "Yes" and no recalibration was completed.
7/9/2021 7.0 pH verification | Range is 6.96 - 7.04 reading states "7.08".
Was verification within range? entry states "Yes" and no recalibration was completed.
7/16/2021 7.0 pH verification | Range is 6.96 - 7.04 reading states "7.10".
Was verification within range? entry states "Yes" and no recalibration was completed.
August 2021 log for Meter Serial #D606992:
The following entries were noted on all days 8/1/2021 through 8/31/2021 when testing was completed except for 8/17/2021; 8/24/2021; 8/25/201; 8/25/2021; 8/28/2021; and 8/31/2021:
"Verify 50 mS conductivity | Expected reading is 49mS to 51mS" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
"Verify 3000 TDS (442 Solution) | Range is 2970 - 3030" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
Additionally, the following was noted:
8/4/2021, 8/5/2021, and 8/30/2021, no readings were documented for these days.
July 2021 log for Meter Serial #D606991:
The following entries were noted on all days 7/1/2021 through 7/31/2021 when testing was completed except for 7/17/2021 and 7/27/2021:
"Verify 50 mS conductivity | Expected reading is 49mS to 51mS" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
"Verify 3000 TDS (442 Solution) | Range is 2970 - 3030" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
Additionally, the following was noted:
7/9/2021 "Verify 14.0 mS conductivity | Range is 13.86 - 14.14" reading was "14.2". "Was the verification within range?" reading was "Yes" and no recalibration was completed.
"4.0 pH verficiation | Range is 3.96 - 4.0" reading was "4.10". "Was verficiation within range?" reading was "Yes" and no recalibration was completed.
August 2021 log for Meter Serial #D606991:
The following entries were noted on all days 8/1/2021 through 8/31/2021 when testing was completed except for 8/7/2021; 8/17/2021; 8/24/201; 8/25/201; 8/26/2021; 8/28/2021; 8/30/2021; and 8/31/2021:
"Verify 50 mS conductivity | Expected reading is 49mS to 51mS" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
"Verify 3000 TDS (442 Solution) | Range is 2970 - 3030" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
Additionally, the following was noted:
8/4/2021, and 8/5/2021, no readings were documented for these days.
July 2021 log for Meter Serial #D606990:
The following entries were noted on all days 7/1/2021 through 7/31/2021 when testing was completed except for 7/27/2021:
"Verify 50 mS conductivity | Expected reading is 49mS to 51mS" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
"Verify 3000 TDS (442 Solution) | Range is 2970 - 3030" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
Additionally, the following was noted:
7/6/2021 and 7/8/2021 "4.0 pH verfication | Range is 3.96 - 4.14" reading was "4.1". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
August 2021 log for Meter Serial #D606990:
The following entries were noted on all days 8/1/2021 through 8/31/2021 when testing was completed except for 8/17/2021; 8/24/201; 8/25/201; 8/26/2021; 8/28/2021; 8/30/2021; and 8/31/2021:
"Verify 50 mS conductivity | Expected reading is 49mS to 51mS" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
"Verify 3000 TDS (442 Solution) | Range is 2970 - 3030" reading states "NA". "Was the verification within range?" entry states "Yes" and no recalibration was completed.
Additionally, the following was noted:
8/4/2021, and 8/5/2021, no readings were documented for these days.
An interview with the regional biomed supervisor on September 14, 2021 at approximately 10:00 am confirmed entries where a numeric entry is specified should have numeric entries and not listed as "NA" (not applicable).
An interview with the facility administrator on September 14, 2021 at approximately 1:30 pm confirmed the above findings.
Plan of Correction:To ensure compliance the CM or ATOM will in-service all DPC staff on the proper completion of the following procedure:
- Myron L D-6 Calibration Form
The meeting reviewed the importance of completion of the calibration of the Myron L D-6 Meter log every day and also the need for recalibration of the metere if the results are out of the acceptable range. The meeting also reinforced that entries where a numeric entry is specified should have numeric entry and is not to be listed as "NA".
The in servicing will be completed by November 1, 2021, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly QAI schedule. A POC audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results with the DO. The CM will report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
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