Initial Comments:
Based on the findings of an unannounced, Medicare complaint investigation survey initiated onsite August 23, 2024 and completed offsite , Fresenius Kidney Care of Reading was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the 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(d)(2) STANDARD
PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO
Name - Component - 00
In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted-
At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.
Observations:
Based on review of policy/procedure, medical record (MR) and interview with clinic staff the clinic failed to conduct a monthly reassessment of the patient to revise the plan of care for one (1) of one (1) record reviewed. MR #1.
Findings include:
Review of policies/procedures completed on 8/29/2024 between approximately 12:47PM and 2:00PM showed the following:
Comprehensive Interdisciplinary Assessment and Plan of Care; Policy: " The comprehensive Interdisciplinary assessment and plan of care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the patient or patient ' s designee, a registered nurse, the patients attending physician (or physician extender where allowed by state regulations), qualified master ' s degree level social worker and qualified registered dietician. Patient stability must be reviewed monthly ... " .
An onsite unannounced complaint investigation was completed on August 23, 2024, between approximately 9:00AM and 2:00PM
review of medical records revealed:
MR#1, start of care: 3/6/2024, contained documentation of a plan of care meeting completed 7/12/24 listing the patient as unstable with a scheduled meeting for 8/12/24. No doucmentation the scheduled meeting took place.
Interviews with staff completed on 8/23/24 between approximately 9:00 AM and 12:00 PM confirmed the above findings.
Plan of Correction:The Clinic Manager (CM) or designee will re-educate the Interdisciplinary Team (IDT) staff on:
- Comprehensive Interdisciplinary Assessment and Plan of Care
Emphasis will be placed on ensuring that all patients deemed unstable have monthly care plans completed, signed and dated per policy by all the IDT members, including the patient.
The in-servicing will be completed by September 20, 2024, with documentation of the training on file at the facility.
The CM or designee will perform monthly audits of all unstable patients care plans for the next three (3) months. At that time, if 100% compliance is observed, the audits will then be completed following the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) specific audit tool will be used for the audits.
Issues of non-compliance will be addressed by the CM with re-education and counseling.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: October 25, 2024
494.90(b)(1) STANDARD
POC-COMPLETED/SIGNED BY IDT & PT
Name - Component - 00
The patient's plan of care must-
(i) Be completed by the interdisciplinary team, including the patient if the patient desires; and
(ii) Be signed by the team members, including the patient or the patient's designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided.
Observations:
Based on review of policy/procedures, medical records (MR) and interview with staff the clinic failed to ensure the plan of care was signed by the physician within thirty (30) days of the meeting date per policy for one (1) of one (1) record reviewed. MR #1.
Findings include:
Review of policies/procedures completed on 8/29/2024 between approximately 12:47PM and 2:00PM showed the following:
Comprehensive Interdisciplinary Assessment and Plan of Care; Policy: " The comprehensive assessment and plan of care must be completed electronically in the patient's medical record. The plan of care must be signed at the time of the interdisciplinary team meeting for those attending in person or if attending remotely within thirty (30) days of the interdisciplinary team meeting".
An onsite unannounced complaint investigation was completed on August 23, 2024, between approximately 9:00AM and 2:00PM.
review of medical records revealed:
MR#1, SOC: 3/6/2024 contained documentation of a plan of care meeting held on 7/12/24 signed by the physician (attended remotely) on 8/19/24, thirty seven (37) days after the date of the meeting.
Interviews with staff completed on 8/23/24 between approximately 9:00 AM and 12:00 PM confirmed the above findings.
Plan of Correction:The Clinic Manager (CM) or designee will re-educate the Interdisciplinary Team (IDT) staff on:
- Comprehensive Interdisciplinary Assessment and Plan of Care
Emphasis will be placed on ensuring that all care plans are completed, signed and dated per policy by all the IDT members, including the physician. The in-service will also
review that if not attending in person the care plan must be signed by the IDT members, including the physician, within thirty (30) days of the IDT meeting.
The in-servicing will be completed by September 20, 2024, with documentation of the training on file at the facility.
The CM or designee will perform monthly audits of all care plans to ensure timely IDT signatures for the next 3 months. At that time, if 100% compliance is observed, the audits will then be completed following the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Issues of non-compliance will be addressed by the CM with re-education and counseling.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: October 25, 2024
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 review of policy/procedure, medical records (MR) and interview with staff the clinic failed to ensure the nurse obtained a physician order to remove the sutures from the central venous catheter CVC for one (1) of one (1) record reviewed. MR #1.
Finding include:
review of policy/procedure IC, HT; Suture removal completed 9/6/24 at approximately 3:10PM showed: section: responsibility, registered nurses (based on job description, licensure, certification, Federal/State regulations), section: Policy; "Removal of surgical sutures may be performed by the nurse in the dialysis facility when ordered by the attending physician".
An onsite unannounced complaint investigation was completed on August 23, 2024, between approximately 9:00AM and 2:00PM
review of medical records revealed:
MR#1, start of care: 3/6/2024, contained documentation on 04/26/24, "As a side note to address the stitches, at the patients last treatment, his catheter entry site presented as slightly red and irritated. the skin was red and irritated, the patient was complaining repeatedly that the stitch site hurt therefore it was explained to him that the stitch could come out since the access site was mature. Patient was agreeable to this. which was also said in the presence of tech. It was explained to the patient at the time that he would need to keep a close eye on any further discomfort, irritation, chills, or fever since the skin was mildly broken at the stitch prior to removal. 1-2 days later the patients catheter dislodged and came completely out. Returning to this current situation...".
Interviews with staff completed on 8/23/24 between approximately 9:00 AM and 12:00 PM confirmed the above findings. "the patient insisted the stitch be removed because it was bothering him".
Plan of Correction:By September 20, 2024, 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 policy:
- Removal of Surgical Sutures
The meeting will focus on the importance of the nurse removing any surgical sutures in the facility when ordered by the attending physician.
The Medical Director will be informed that the CM will instruct the nursing staff that a physician order must be obtained prior to the removal of any stitches. The nursing staff will also be informed that the CM and/or charge nurse is to be notified prior to the removal of any stitches and verify the physician order. The CM or designee will audit the medical records of any patient having stitches removed for the next four (4) patients having sutures removed. At that time, if 100% compliance is observed, the audits will then be completed following the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
The Medical Director will be informed that staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: October 25, 2024
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