Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 5/14/2021, Napoleon Place Dialysis was found to be in compliance with the requirements of 42 CFR, Part 418.113, Subpart D, Conditions of Participation: Hospice Care - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 5/14/2021, Napoleon Place Dialysis was found not to be in compliance with the following requirements of 42 CFR, Part 418, Subparts A, C, and D, Conditions of Participation: Hospice Care.
Plan of Correction:
494.40(a) STANDARD
RO-MEETS AAMI/MONITORED, RECORDED ON LOG
Name - Component - 00
5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log
Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2.
5.2.7 Reverse osmosis
Users should carefully follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters.
6.2.7 Reverse osmosis
All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review.
Observations:
Based on the review of the facilities policy and procedures, daily waterlog sheets and staff (EMP) interviews the agency failed to follow the manufacturer's instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters for one (1) of five (5) water and dialysate logs review.
Findings included:
A review was conducted of facility policy on 5/14/2021 at approximately 12:15 PM which revealed, "Policy 2-04-03 TITLE: DAILY WATER TREATMENT SYSTEM MONITORING...POLICY: 1. All observations and test results must be recorded on the Monthly Water Treatment Log. Biomed teammates who have been trained to perform the observations and testing required to complete the Monthly Water Treatment Log will observe, test and document their findings. 3. All observations and testing are done after the system has been operating for at least 15 minutes as follows: *For direct feed systems, the RO must have been operating for at least 15 minutes *For indirect feed systems (holding tanks), observations and readings will be taken while the RO is operating with stable flows and pressures * For indirect feed systems (holding tanks), pretreatment samples will be collected after the RO has operated for 15 minutes or immediately after the RO stops if RO fills tank in less than 15 minutes 4. Complete the testing and observations included on the Daily water Treatment Log and Daily Water Treatment Log-Routine Total Chlorine Testing Log and compare results to those most recently recorded on these daily logs. If not in agreement, notify the Facility Administrator/designee and provide and document training/inservice as necessary. 5. All observations and test results are to be within the Acceptable Limits specified on the Monthly Water System Monitoring Log. If observations or test results are found outside the Acceptable Limits, notify the Facility Administrator/designee and take and record corrective actions as necessary. 6. The initials and signature of the Biomed teammate performing and recording all observations and test results are entered where indicated on the Monthly Water System Monitoring Log. 7. A BART ticket is to be completed utilizing the batch ticket option for monthly volume and temperature recording..."
Review on 5/11/2021 at approximately 1:25 PM revealed, "DAILY WATER LOG" from 3/1/2021 to 5/2/2021, readings for #18 Loop return Flow Rate. L/min >/= 1L/min. Reading were below parameters for the following dates: 3/9/2021, 3/11/2021, 3/16/2021 through 3/20/2021, 3/22/2021, 3/24/2021 through 3/27/2021, 4/13/2021 through 4/17/202, 4/19/2021 through 4/21/2021.
Review on 5/11/2021 at approximately 1:25 PM revealed, "DAILY WATER LOG" from 3/1/2021 to 5/2/2021, readings for #22 Recovery Rate
No documentation was provided by the agency to confirm the readings were reported as outside the acceptable limits at the time daily readings were conducted or when review of the daily water treatment logs were completed.
An exit interview was conducted on 5/14/2021 at approximately 12:45 PM with the group facility administrator which confirm the above findings.
Plan of Correction:V0199
All clinical teammates to be in-serviced by Facility Administrator (FA) or Clinical Coordinator (CC) on Policy 2-04-02 Daily Water treatment Monitoring and DaVita Daily Water Treatment Log form 2-04-02A by 06/04/2021. If a teammate is not present during in-servicing they will be in-serviced within upon returning to work. Using surveyor observations as examples, education will include but not be limited to: 1) all observations and test results will be within the limits specified on the Daily Water Treatment Log. 2) If observations or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log. 3) Teammates were instructed that any reading outside acceptable parameters will include documentation of all actions taken including contact and time of notification the log. Verification of attendance will be evidenced by teammate signature on in-service form. On 05/14/2021, the Biomedical Service Specialist placed an updated DaVita Daily Water Treatment Log form 2-04-02A into place. This log has updated values on per the manufactures guidelines. The log was reviewed by the Governing Body, which included the Medical Director, Regional Operations Director and FA and approved.
The FA or designee will review the daily water log daily for two (2) weeks, then two (2) times a week for two (2) weeks then weekly for four (4) weeks then monthly during the biomedical audit to verify all follow up on all unacceptable findings documentation of such. Any incidence of non-compliance will be addressed immediately. The results of the audits will be reviewed with the teammates during homeroom meetings and with the Medical Director during Facility Health Meetings (FHR-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
494.60(c)(4) STANDARD
PE-HD PTS IN VIEW DURING TREATMENTS
Name - Component - 00
Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement).
Observations:
Based on review of facility policy, observation of patients (PT) during in-center dialysis treatment and staff (EMP) interview, it was determined the facility failed to ensure the patient's access sites and bloodline connections were visible during in-center hemodialysis treatment for one (1) in-center hemodialysis patient observations (PT6).
Findings Included:
Review of facility policy on 5/14/2021 at approximately 12:15 PM revealed, Policy "TITLE: PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT...2. The nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN). a. There assessment includes the following components...iv. Verification that the patient access is visible and face is not covered...INTRADIALYTIC DATA COLLECTION/ASSESSMENT...c. The vascular access site, blood line connections and the patient's face should be visible throughout the dialysis treatment...13. All findings, interventions and patient response will be documented in the patient's medical record..."
Observation on 5/12/2021 between approximately 9:33 AM and 10:32 AM revealed that patient PT6 at station 2 had access site (left arm) covered with a blanket. Surveyor continued to monitor this patient/station during time documented. No staff members uncovered and visually assessed patient PT6 access site/bloodline connections during the observation time.
An exit interview was conducted on 5/14/2021 at approximately 12:45 PM with the group facility administrator which confirm the above findings.
Plan of Correction:V0407
Staff to be in-serviced by Facility Administrator (FA) or Clinical Coordinator (CCN) on Policy: 1-03-08 Pre-Intra-Post Treatment Data collection, Monitoring and Nursing Assessment, by 06/04/2021, this will be documented on a training/in-service/ Documentation form. If a teammate is not present during in-servicing they will be in-serviced within one week of returning to work.
The staff was instructed that the vascular access site, blood line connections and the patient's face should be visible throughout the dialysis treatment. During the audit it was noted that a patient's vascular access was covered.
Starting 06/02/2019 FA or designee will monitor that patients face, bloodlines and access are visible during treatment. These checks will be done 2 x a day for 2 weeks, then 2 times a day 3 days a week for 2 weeks, then 2 times a day weekly f0r 4 weeks. These checks will be placed in a log and a copy placed in FHR minutes. Any incidence of non-compliance to the POC will be reviewed with teammates. The POC will be modified with new additional training to staff for areas of non-compliance. All audits must by 100% accurate prior to moving on to the next step audits. After completion of POC audits CCN or designee will conduct random audits for compliance.
Staff will also be in-serviced on POC by 6/16/2021. If a teammate is not present during in-servicing they will be in-serviced within one week of returning to work.
FA is in charge of monitoring for compliance. All findings will be documented in the monthly FHR
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