Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 11, 2024, through March 13, 2024, Fresenius Medical Care Olney 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 on March 11, 2024, through March 13, 2024, Fresenius Medical Care Olney 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:
494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on review of facility policy, observation (OBS) of the treatment area, and an interview with the Facility Administrator, the facility did not follow its policy regarding teammate fingernails for four (4) observations, (OBS #2, 4, 6, and 10).
Findings include:
A review of facility policy on March 13, 2024, at approximately 1:00 P.M. revealed the following:
Policy titled "Hand Hygiene" stated, "Caution regarding fingernails: Do not wear artificial fingernails, extenders or nail wraps when having direct contact with patients. Natural fingernail length shall be kept to 1/4 inch or less..."
Observation of the treatment area was conducted on March 11, 2024, from approximately 9:00 A.M. to 11:30 A.M. revealed the following:
OBS #2, at station #6, PCT# 1 was observed to have artificial nails.
OBS #4, at station #4, PCT# 5 was observed to have lengthy artificial nails.
OBS #6, at station #15, RN# 1 was observed to have artificial nails.
OBS #10, at station #10, PCT #3 was observed to have artificial nails.
An interview with the Facility Administrator on March 13, 2024, at approximately 1:30 P.M. confirmed the above findings.
Plan of Correction:V 113
To ensure compliance the Facility Administrator (FA) or designee will in-service all direct patient care (DPC) staff on:
- Hand Hygiene
The meeting will focus on the staff ensuring that no artificial nails are to be worn when providing direct care to patients. The meeting will re-educate that nails must be kept at the length of one-quarter (1/4) inch or less.
Inservicing will be completed by March 29, 2024. All training documentation is on file at the facility.
The FA or designee will perform daily audits for two (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 Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (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 FA will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 30, 2024
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 Facility Phoenix Meter - All Models Log for the Months of January, 2024 and February, 2024, Facility policy, and an interview with the Facility Administrator and Facility BioMed Technician, it was determined, that the facility failed to ensure that a calibration of the meter was completed when a reading is outside the manufacturer's specifications for nineteen (19) entries.
Findings include:
A review of Facility policy titled "pHoenix Meter, pHoenix XL and Tri-Station Care and Maintenance" on March 13, 2024 at approximately 10:30 am states, "Verification: Note: If the reading is outside the manufacturer's specifications, calibration is needed..."
For the Month of January, 2024, on the following dates, mS verification range is stated to be within 49 mS - 51 mS, readings were reported as "Greater than 51 mS" and no Post-Calibration Value was completed:
January 2
January 3
Janaury 11
January 12
January 13
January 15
January 17
January 26
January 27
January 29
For the Month of February, 2024, on the following dates, mS verification range is stated to be within 49 mS - 51 mS, readings were reported as "Greater than 51 mS" and no Post-Calibration Value was completed:
February 9
February 10
February 12
February 14
February 21
February 23
February 26
February 27
February 28
An interview conducted with the Facility Administrator and Facility BioMed Technician on March 13, 2024 at approximately 1:30 PM confirmed the above findings.
Plan of Correction:V 250
To ensure compliance the FA, Bio-medical Technician (BMT) or designee will in-service all DPC staff on:
- pHoenix Meter, pHoenix XL and Tri-Station Care and Maintenance
The meeting will focus on the staff ensuring that the pHoenix meter is calibrated per policy. The in-service will re-educate the staff that if the reading of the meter is outside the manufacture's specifications, a calibration must be completed.
Inservicing will be completed by March 29, 2024. All training documentation is on file at the facility.
The FA 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 QAPI 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 FA will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 30, 2024
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
Observations:
Based on review of facility policies/procedure, medical records (MR), and an interview with the facility manager, the facility failed to ensure the blood flow rate (BFR) and/or the dialysate flow rate (DFR) was administered per physician order for five (5) of seven (7) incenter hemodialysis patient MR's reviewed. (MR #3, 4, 5, 6, and 7).
Findings include:
A review of facility policy titled "Unable to Achieve Prescribed Blood Flow Rate" was conducted on March 13, 2024 at approximately 11:00 am. The policy reads in part, "Policy: staff, patient and/or care partner will recognize and report to the nurse in charge the inability to achieve prescribed blood flow rate .... Actions To Achieve Prescribed Blood Flow Rate: staff, patient and/or care partner should take the following actions to reduce the possibility of poor access blood flow: projection bloodlines in a way that keeps them from restricting flow kinking, ensure access and bloodline clamps have been appropriately opened/removed, properly cannulate access, avoid the flipping needles, administer heparin as ordered. staff should review the following: ensure needle size is appropriate for prescribed the blood flow rate, monitor KECN, perform access flow testing per physician order, ensure adequate heparin to minimize dialyzer clotting .... Notification: notify physician/extender if unable to achieve prescribed the blood flow rate. Documentation: document in patient's treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders..."
A review of patient medical records (MR) was conducted on March 12, 2024 starting from approximately 9:00 AM through 2:30 PM.
MR #3: Admission Date: 9/28/22. Total treatment records reviewed: 7, Treatment record reviewed between 1/3/2024 to 3/4/2024. Order reads in part the following: Blood Flow Rate (BFR): 500 mL/min; Dialysate Flow Rate (DFR): Autoflow 1.5.
Review of Dialysis Treatment Details Reports revealed the BFR and DFR was not administered at prescribed rates on the following dates:
On 1/31/2024, the entire treatment the BFR was administered at 400 mL/min.
On 2/9/2024, the entire treatment the BFR was administered at 400 mL/min.
On 2/12/2024, between 11:27 AM to 12:04 PM, the BFR was administered at 400 mL/min.
On 2/26/2024, between 2:04 PM to 3:30 PM, the BFR was administered at 450 mL/min.
On 2/21/2024, the entire treatment the BFR was administered at 400 mL/min.
There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR was administered at a rate different from the prescribed amount for any of the above dates.
MR #4: Admission Date: 4/21/2021. Total treatment records reviewed: 7, Treatment record reviewed between 2/19/2024 to 3/11/2024. Order reads in part the following: Blood Flow Rate (BFR): 400 mL/min; Dialysate Flow Rate (DFR): Autoflow 1.5.
Review of Dialysis Treatment Details Reports revealed the BFR was not administered at prescribed rates on the following dates:
On 2/19/2024, between 6:02 AM to 6:30 AM, the BFR was administered at 250 mL/min, between 6:30 AM to 9:24 AM, BFR was administered at 350 mL/min.
On 2/23/2024, between 5:38 AM to 6:03 AM, the BFR was administered at 300 mL/min, and between 6:03 AM to 8:45 AM, the BFR was administered at 350 mL/min.
On 2/28/2024, between 5:23 AM to 6:01 AM, the BFR was administered at 300 mL/min, and between 6:01 AM to 8:08 AM, the BFR was administered at 350 mL/min.
There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR was administered at a rate different from the prescribed amount for any of the above dates.
MR #5, Admission Date: 2/13/2024. Total treatment records reviewed: 7, Treatment record reviewed between 2/24/2024 to 3/9/2024. Order reads in part the following: Blood Flow Rate (BFR): 400 mL/min; Dialysate Flow Rate (DFR): Autoflow 1.5.
Review of Dialysis Treatment Details Reports revealed the BFR was not administered at prescribed rates on the following dates:
On 2/27/2024, between 8:31 AM to 10:06 AM, the BFR was administered at 350 mL/min.
On 3/2/2024, between 8:34 AM to 9:33 AM, the BFR was administered at 300 mL/min.
There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR was administered at a rate different from the prescribed amount for any of the above dates.
MR #6, Admission Date: 1/23/14. Total treatment records reviewed: 7, Treatment record reviewed between 2/24/2024 to 3/9/2024. Order reads in part the following: Blood Flow Rate (BFR): 500 mL/min; Dialysate Flow Rate (DFR): Autoflow 1.5.
Review of Dialysis Treatment Details Reports revealed the BFR was not administered at prescribed rates on the following dates:
On 2/24/2024, between 6:35 AM to 7:03 AM, the BFR was administered at 200 mL/min.
On 3/2/2024, between 8:04 AM to 10:33 AM, the BFR was administered at 400 mL/min.
On 3/9/2024, during the entire treatment, the BFR was administered at 400 mL/min.
There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR was administered at a rate different from the prescribed amount for any of the above dates.
MR #7, Admission Date: 12/26/2023. Total treatment records reviewed: 8, Treatment record reviewed between 2/24/2024 to 3/9/2024. Order reads in part the following: Blood Flow Rate (BFR): 400 mL/min; Dialysate Flow Rate (DFR): Autoflow 1.5.
Review of Dialysis Treatment Details Reports revealed the BFR was not administered at prescribed rates on the following dates:
On 2/24/2024, between 6:12 AM to 6:42 AM, the BFR was administered at 200 mL/min.
On 2/27/2024, between 10:01 AM to 10:34 AM, the BFR was administered at 450 mL/min.
There was no documentation in the medical record that the hemodialysis staff had obtained a physician order to allow the BFR to be administered at a rate different from the prescribed amount for any of the above dates and there was no documentation of a reason why the BFR was administered at a rate different from the prescribed amount for any of the above dates.
An interview with the facility clinical manager was conducted on March 13, 2024, at approximately 1:30 pm confirmed the above findings.
Plan of Correction:V 544
To ensure compliance the FA or designee will in-service all DPC staff on policy:
- Unable to Achieve Prescribed Blood Flow Rate
The meeting will emphasize that any machine parameters not within the physician prescribed limits must be reported to the registered nurse (RN) for evaluation, intervention, and documentation. These parameters include the blood flow rate (BFR). The reason the BFR is not being achieved must be documented as well as interventions taken to address the issue. The staff will be instructed that there must be documentation of the RN notification by the patient care technician (PCT). The RN must also document why the BFR being administered is different than the prescribed rate with physician or extender notification if indicated.
Inservicing will be completed by March 29, 2024. All training documentation will be on file at the facility.
The FA 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 QAPI 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 FA will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 30, 2024
|