Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed January 29, 2025, Fresenius Medical Care of South Allentown was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed January 29, 2025, 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:
494.80(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 a review of facility policy, a review of medical records, and an interview with the facility Administrator, the facility failed to ensure patient assessments, including but not limited to blood pressure monitoring, were documented every 30 minutes while receiving dialysis treatment, for four (4) of five (5) hemodialysis medical records (MR) reviewed (MR #1, MR #3, MR#4, MR#5).
Findings include:
A review was conducted of facility policy on January 29, 2025 at approximately 10:15 a.m. Policy 'Patient Assessment and Monitoring' 'During Treatment' "Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes ....."
A review of medical records completed on January 29, 2025 at approximately 10:00 a.m. revealed the following:
MR#1, Date of admission 11/01/24:
On 01/17/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 6:10 a.m. The next assessment obtaining vital signs did not occur until 7:10 a.m. (60 minutes between assessments).
On 01/22/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 6:15 a.m. The next assessment obtaining vital signs did not occur until 7:04 a.m. (49 minutes between assessments).
MR#3, Date of admission 06/10/24:
On 01/15/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 10:32 a.m. The next assessment obtaining vital signs did not occur until 11:43 a.m. (71 minutes between assessments).
On 01/20/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 10:32 a.m. The next assessment obtaining vital signs did not occur until 11:36 a.m. (64 minutes between assessments).
On 01/22/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 11:02 a.m. The next assessment obtaining vital signs did not occur until 12:02 a.m. (60 minutes between assessments).
MR#4, Date of admission 01/06/20:
On 01/27/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 6:42 a.m. The next assessment obtaining vital signs did not occur until 7:31 a.m. (49 minutes between assessments).
MR#5, Date of admission 12/16/24:
On 01/13/25 the post treatment flow sheet contained documentation of an assessment obtaining vital signs at 1:33 p.m. The next assessment obtaining vital signs did not occur until 2:57 a.m. (84 minutes between assessments).
An interview with the facility Administrator on January 29, 2025 at approximately 10:15 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the Clinic Manager (CM) or designee will in-service all the direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
The in-service will focus on the staff ensuring that the patient is monitored every thirty (30) to forty-five (45) minutes while on their treatment. The meeting will also review that the documentation of the monitoring is entered at the time the check is completed.
Inservicing will be completed by February 7, 2025. All training documentation will be on file at the facility.
The CM or designee will perform daily audits for two (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, 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 CM will review the audits and report the findings to the QAPI Committee at the monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion date: March 7, 2025
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on a review of facility policy, a review of medical records, and an interview with the facility Administrator; the facility failed to ensure the staff followed facility procedure for early termination of treatment for two (2) out of five (5) medical records (MR) reviewed (MR#2, MR#3).
Findings include:
A review was conducted of facility policy on January 29, 2025 at approximately 10:15 a.m. Policy 'Early Termination or Arriving Late for Treatment' "If a patient insists on terminating treatment early and this has not been previously approved by the patients physician, the patient must take full responsibility for consequences of the missed or shortened treatment. If a patient requests to leave treatment early: Patients requesting early termination of a treatment in an outpatient facility early will be referred to the supervising registered nurse. The registered nurse will evaluate the patient and discuss with the patient their reasons for requesting to terminate their treatment earlier than prescribed. ....The registered nurse who evaluates the patient must document the rationale for early termination ..... The registered nurse is responsible to notify the physician, and document on the "AMA", or 'Against Medical Advice' form. ....." 'Against Medical Advice Forms' "Against Medical Advice Forms are: Signed by the patient ....., Signed with each early termination event and filed in the patients medical record, ...."
A review of medical records completed on January 29, 2025 at approximately 10:00 a.m. revealed the following:
MR #2, Date of admission 09/24/24: Physician orders for Hemodialysis state treatment time ....."4 hours, 0 minutes."
On 01/18/25 patient treatment flow sheet stated 'Hours On' "2:32" (two hours, thirty-two minutes).
On 01/23/25 patient treatment flow sheet stated 'Hours On' "3:32" (three hours, thirty-two minutes).
No documentation of the physician being notified, the AMA form being signed, and/or documentation by the registered nurse documenting patient refusal to sign.
MR #3, Date of admission 06/10/24: Physician orders for Hemodialysis state treatment time ....."4 hours, 15 minutes."
On 01/15/25 patient treatment flow sheet stated 'Hours On' "3:55" (three hours, fifty-five minutes).
No documentation of the physician being notified, the AMA form being signed, and/or documentation by the registered nurse documenting patient refusal to sign.
An interview with the facility Administrator on January 29, 2025 at approximately 10:15 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all the DPC staff on the following policies:
- Early Termination or Arriving Late for Treatment
- Against Medical Advise (AMA) Form
The meeting will focus on ensuring that the registered nurse (RN) is notified when a patient is requesting to discontinue treatment early with documentation of the RN notification. The meeting will review that the RN must evaluate the patient and document the reason for the early termination of treatment. The staff meeting will also reinforce that the patient must sign an Against Medical Advise
(AMA) form. The meeting will reinforce that the physician is notified with documentation of the physician notification.
In servicing will be completed by February 7, 2025. 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 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 CM 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: March 7, 2025
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on a review of facility policy, observations, and an interview with the facility Administrator; the facility failed to ensure the staff followed facility policy for aseptic medication preparation for one (1) out of one (1) patient heparin preparations observed (Observation #1) and failed to ensure the staff followed facility policy for portable communication devices for one (1) out of one (1) treatment floor observations (Observation #2).
Findings include:
A review was conducted of facility policy on January 29, 2025 at approximately 10:15 a.m. Policy 'Medication Preparation and Administration' 'Infection Control' "The following steps must be taken to ensure infection control: "..... Aseptic technique will be used to prepare and administer IV medications."
Policy 'Use of Portable Electronic Communication Devices' 'Introduction' ".... This policy covers devices used for mobile communication, including, but not limited to,: "Cell phones, ...." 'Portable Communication Devices- Clinical Environments' "Employees in clinical settings ...: Devices must be kept out of sight from patients and clients, and used only in a break room or other non-public location..... " 'Important:' Patient care employees are prohibited from carrying cell phones and portable communication devices into patient care areas. ..."
Treatment area observations conducted on January 27, 2025 between approximately 9:00 a.m. - 12:40 p.m. revealed the following:
Observation #1: On January 27, 2025 at approximately 10:45 a.m., employee (EF#1) was observed at the medication preparation area preparing a heparin dose for a patient (MR#6). EF#1 did not follow aseptic technique and remove her used PPE (personal protective equipment) gown prior to preparing the patients medication. A interview was conducted with the treatment area staff nurse (EF#5) on 01/27/25 at approximately 10:50 a.m. EF#5 stated normal procedure is staff to remove gown prior to preparing/administering medications.
Observation #2: On January 27, 2025 at approximately 11:30 a.m. a cell phone was observed lying on the desk at the nursing station. EF#5 stated the cell phone was hers and she utilizes it to communicate with physicians when needed.
The cell phone was not identified as a Fresenius Medical Care device.
An interview with the facility Administrator on January 29, 2025 at approximately 10:15 a.m. confirmed the above findings.
Plan of Correction:By February 7, 2025, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policies:
- Medication Preparation and Administration
- Use of Portable Electronic Communication Devices
The Medical Director will be informed at the meeting with the DO and CM that the staff will be re-educated on the above policies. The Medical Director will be informed that the focus of the staff meeting will be on ensuring that aseptic technique will be used when medications are being prepared and administered. This means that the RN is not to wear a gown while preparing medications. The meeting will also with all staff that cell phones are not permitted in the treatment care area.
The in-service will be completed by February 7, 2025. Documentation of the meeting will be on site 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/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 CM will review the audit results and report the findings to the Medical Director prior to the QAPI meetings. The audit results will also be reviewed at the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion date: March 7, 2025
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