Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 2/4/2021, Fresenius Medical Care Altoona 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 completed 2/4/2021, Fresenius Medical Care Altoona 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)(1)(i) STANDARD
IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS
Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.
When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.
Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.
Observations:
Based on review of agency policy, direct observation (OBV) and interview with staff (EMP), it was determined that the facility failed to ensure staff prepared medications in a clean area for one (1) of two (2) observed staff (EMP 3) preparing medication (OBV2)
Findings included:
Review of the agency policy and procedures conducted on 2/4/2021 at approximately 10:00 AM revealed, Policy "Medication Preparation and Administration...Infection Control The following steps must be taken to ensure infection control. Perform hand hygiene prior to accessing supplies, handling vials and IV solutions and preparing or administering medications. Aseptic technique will be used to prepare and administer IV medications. Medications shall be prepared in a clean work area away from dialysis patient stations and delivered separately to each patient. Common medication carts and trays shall not be used to deliver medications from patient station to patient station..."
During treatment floor observations for Parenteral Medications Preparation and Administration on 2/3/2021 at 12:00 PM, surveyor observe medication administration (OBV2) while EMP3 (RN) prepared two intravenous medications Venofer and Mircera. The medication preparation area was a small metal cart (estimated two feet by two feet) next to the nurses station located in designated pod two of the facility. On top of the cart were supplies on the right hand side, and on the left side of the cart was a manilla folder with papers inside. The surveyor did not observe EMP3 cleaning the surface area of the cart prior to medication preparation.
The surveyor observed a similar cart used for medication preparation in the facility designated area pod one. On top of the cart in pod one also had the supplies on the right hand side and manilla folder with papers inside on the left side of the cart. EMP1 confirmed these carts were used for medication preparation.
An exit interview was conducted with the facility administrator, clinical manager on 2/3/2021 at approximately 3:30 PM which confirmed the findings.
Plan of Correction:V 117
For ongoing compliance, the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on the following policy:
- Medication Preparation and Administration Policy
Emphasis will be placed on ensuring that all medications are prepared in a clean work area away from patient stations. The DPC staff were informed at the meeting that all medication carts tops will be cleaned and disinfected at the beginning of the day. The medication areas will also be cleaned and disinfected before the beginning of the next shift medications are prepared and at the end of the day.
The inservice will be completed by 3/2/2021 and the education records will be on file in the facility.
The CM or designee will perform daily audits on the DPC staff for two (2) weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment Improvement (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 counseled.
The CM will review the audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion date: 3/12/2021
494.40(a) STANDARD
MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ
Name - Component - 00
7.2 Microbial monitoring methods:
7.2.1 General: Dialysate: monthly dialysate sample/collection/freq
Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution.
Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1.
7.2.2 Sample collection
Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers.
Observations:
Based on review of agency policy, bacteriological testing log and staff (EMP) interview the facility failed to ensure corrective measures were promptly taken to complete bacteria and endotoxin repeat sample timely.
Findings included:
Review of the agency policy and procedures conducted on 2/4/2021 at approximately 10:00AM revealed, policy "Microbiological Monitoring of Dialysate...General This policy defines the minimum microbiological monitoring of dialysate. Staff may elect to perform additional testing as needed to assure their systems are maintained in accordance with these policies and the manufacturer instruction for use...Sample Cancellations (Agency) Laboratories policy directs that samples will automatically be cancelled and a test cancellation notice sent for any of the following: Greater than 48 hours from the collection date, improperly packaged, received frozen If you receive a test cancellation notice from (Agency) Laboratories, you must: Notify the Clinical Manager and local Technical Manager of Cancellation notice. Perform a repeat sample (both bacteria and endotoxin test) within 72 hours of notification..."
Review of the agency bacteriological testing logs on 1/29/2021 at approximately 1:15 PM revealed, specimen lab reports with a collection date of 12/21/2020, for the following "Sample ID Hd Machine's 34a...35a...36a...37a...38a...39a...40a..." Documented under the "TEST NAME Statue...Colony Count, Dialysate...1 Specimen too old to process: delayed in transit...Endotoxin, Dialysate...2 Specimen to old to process; delayed in transit" for cancelled specimens. The specimen lab reports confirms the "Received Date: 12/26/2020" and the "Reported Date: 12/27/2020."
A log for water and dialysate collection "Environmental CQI Date Range: 1/1/2021 to 1/9/2021" was reviewed. All samples listed provided a collection date of 1/5/2021. EMP8 confirmed no additional specimens were collected between 12/28/2020 and 1/4/2021 for the cancelled water and dialysate samples. The samples were collected outside the time frame of the agency policy.
An exit interview was conducted with the facility administrator, clinical manager on 2/3/2021 at approximately 3:30 PM which confirmed the findings.
Plan of Correction:V 253
For ongoing compliance, the Regional Technical Operations Director (RTOM) will in-service the Area Technical Operation Manager, the Bio-medical Technician (BMT) and the CM on:
- Microbiological Monitoring of Dialysate
The in-service will review the importance of ensuring that all water and dialysate culture samples are collected and reviewed within the correct timeframe. The meeting will reinforce that if a culture is reported as cancelled due to a delay, a repeat sample must be drawn within 72 hours of the notification. The meeting will stress the importance of notifying the CM, ATOM of the cancelled test.
The inservice will be completed by 3/2/2021 and the education records will be on file in the facility.
The ATOM or designee will perform monthly audits of the bacteriological testing logs for the next four (4) months. At that time if compliance is observed 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 counseled.
The ATOM will review the audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion date: 3/12/2021
494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
(2) Evaluation of the appropriateness of the dialysis prescription,
Observations:
Based on a review of facility policies and procedures, medical records and staff (EMP) interviews, the facility failed confirm the dialysis prescription and to communicate with physicians when dialysate flow rate (DFR) required adjustment beyond the current physicians' orders for one (1) of eight (8) in-center hemodialysis medical records (MR) reviewed (MR7).
Findings included:
Review of the agency policy and procedures conducted on 2/4/2021 at approximately 10:00AM revealed, Policy "Patient Assessment and Monitoring...Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations...3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements * Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow *Check dialysate flow rate setting is correct, and the prescribed flow is being delivered. * Check arterial pressure is less than negative 250mmHG. Monitor high venous pressure for infiltration or clotting.
MR #7 was reviewed on 2/2/2021 at approximately 8:45 AM. A review of the patient's hemodialysis flowsheet dated 1/13/2021 through 1/25/2021 revealed the physician ordered a DFR of 800 mL/min.
The DFR was delivered lower than prescribed on 1/18/2021 at 800 ml/min starting at 10:52 AM until 2:20 PM. Five different staff members documented conducting checks/evaluation during the treatment under the "SIGNATURE " column of the treatment sheet.
An exit interview was conducted with the facility administrator, clinical manager on 2/3/2021 at approximately 3:30 PM which confirmed the findings.
Plan of Correction:V 503
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- FMS-CS-IC-I-110-131C Patient Assessment and Monitoring
Emphasis will be placed on ensuring that any machine parameters not within the prescribed limits must be reported to the Registered Nurse (RN) for evaluation, intervention and if not resolved, physician notification. These parameters include the dialysate flow rate (DFR). The reason the DFR are not being achieved must be documented as well as the documentation of the RN notification by the patient care technician (PCT) as well as the RN and physician notification.
Inservicing will be completed by 3/2/2021 All training documentation is 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/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAI schedule. A POC specific 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: 3/12/2021
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on review of facility policy, medical records (MR) and interview with facility staff, the facility failed to assess and notify appropriate staff for one (1) of seven (7) in center hemodialysis medical records reviewed (MR#4).
Findings Included:
Review of the agency policy and procedures conducted on 2/4/2021 at approximately 10:00AM revealed, Policy "Patient Assessment and Monitoring...3. Document Findings and interventions in the medical record. Contact the physician as needed for additional orders based on assessment findings and clinical judgement. Monitoring During Treatment Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Verify pulses manually or automated reading display below 60 or greater that 100 beets per minute. Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular..."
MR4, admission date 7/23/2019, primary diagnosis; Type 2 diabetes mellitus with diabetic chronic kidney disease. A review of seven (7) treatment records from 1/13/2021 to 1/27/2021, was conducted on 2/1/2021 at approximately 3:00 PM.
The following hemodialysis flowsheet dated 1/18/2021 revealed the following:
07:34 PULSE 38
08:01 PULSE 54
08:39 PULSE 54
09:06 PULSE 34
09:32 PULSE 56
10:02 PULSE 30
The following hemodialysis flowsheet dated 1/20/2021 revealed the following:
07:26 PULSE 24
07:36 PULSE 28
08:35 PULSE 58
09:02 PULSE 54
10:02 PULSE 58
10:31 PULSE 49
The following hemodialysis flowsheet dated 1/25/2021 revealed the following:
08:37 PULSE 41
10:05 PULSE 39
10:32 PULSE 55
11:05 PULSE 49
11:41 PULSE 53
The agency staff failed to assess and notify appropriate staff when verifying pulses for above referenced patient whose heartbeats had dropped below 60 beats per minute.
An exit interview was conducted with the facility administrator, clinical manager on 2/3/2021 at approximately 3:30 PM which confirmed the findings.
Plan of Correction:V 504
To ensure compliance the CM or designee will in-service all the DPC staff on policy:
- FMS-CS-IC-I-110-131C Patient Assessment and Monitoring
Emphasis will be placed on ensuring that any pulse not within the acceptable limits must be reported to the RN with the DPC documentation of the RN notification. The meeting also reinforced the need for the RN to complete an assessment with documentation of findings and any interventions taken, including physician notification. There must also be a follow up re-assessment to the intervention with complete documentation.
Inservicing will be completed by 3/2/2021. All training documentation is 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 to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAI schedule. A POC specific 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: 3/12/2021.
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