Initial Comments:
Based on the findings of an unannounced, onsite Medicare complaint investigation survey conducted on October 12, 2023, BMA of Wilkes-Barre 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 for End-Stage Renal Disease Facilities.
Plan of Correction:
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 review of agency policies/procedures and medical records and based on interview with the charge nurse (Employee #1) and administrator (Employee #2), the facility failed to ensure assessment of blood pressure and pulse during the hemodialysis treatment was completed per facility policy/procedure for two (2) of two (2) in-center hemodialysis patients. (Patients #1 and #2)
Findings include:
On October 12, 2023 at approximately 4:07 PM, review of the facility policy titled "Patient Assessment and Monitoring" revealed the following:
Definitions: Data Collection: Gathering of objective and subjective information related to the patient's health status...
During treatment...Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes...Follow the steps below for monitoring patient...
1. Blood pressure...Record blood pressure...Recheck blood pressure after a drop that requires interventions such as administering normal saline...Pulse...Record pulse...General Observation...Observe the patient's overall condition during the treatment...
4. Document any findings and interventions in the medical record...
On October 12, 2023 at approximately 4:10 PM, review of the facility policy titled "Intradialytic Hypotension" (low blood pressure which occurs during the HD treatment) revealed the following:
Treating Hypotension on Hemodialysis...
1. If BP (blood pressure) is verified low, administer 100-200 fluid bolus as ordered by the physician and recheck BP post bolus...
On October 12, 2023 at approximately 3:52 PM, review of the facility policy titled "Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer" revealed the following:
Documentation...Document the time dialysis started and all required patient and machine data in the patient's hemodialysis treatment sheet or electronic medical record...
Patient #1: On October 12, 2023 at approximately 10:20 AM, review of the medical record revealed a three (3) hour dialysis treatment is to be administered three (3) times a week and that normal saline solution (NSS) could be administered times 5 for hypotension as documented under the hemodialysis (HD) treatment or ancillary order tabs.
Review of treatment sheet documentation revealed the following:
-08/24/2023: HD treatment was initiated at 6:16 AM with the following patient assessment findings documented at 8:17 AM: Blood pressure (BP) of 140/57 millimeters of mercury (mmHG) and a pulse of 81. At 7:01 AM, the BP was 104/48 mmHg with a pulse of 72. A total of 200 milliliters of NSS was administered at 7:01 AM. The next patient assessment was completed at 7:24 AM, which was 23 minutes after the administration of the NSS bolus, revealed the BP was 93/44 mmHg with a pulse of 71. At 7:44 AM, the BP was 88/46 mmHg and the pulse was 77 at which time HD staff administered 200 ml of NSS and placed the patient in Trendelenburg position (reclined in chair with head placement lower than the feet). The next assessment of BP and pulse occurred at 8:08 PM, which was 24 minutes after the implementation of the interventions at 7:44 AM. At 8:09 AM, the patient is documented as being restless, perspiring and the patient complained of the feeling the need to vomit at which time treatment was ended at the patient's request.
-09/07/2023: The BP and pulse was assessed at 8:24 AM with the next assessment of BP and pulse being documented at 9:21 AM which was 57 minutes after the previous assessment.
-09/14/2023: At 8:21 AM, the BP was 102/51 mmHg and the pulse was 70. At 8:39 AM, the BP was 99/35 mmHg with a pulse of 42. There was no documentation that an assessment of patient condition was completed at 8:39 AM as there was no data entered under "Comments".
Patient #2: On October 12, 2023 at approximately 1:38 PM, review of the medical record revealed a three (3) hour dialysis treatment is to be administered three (3) times a week as documented under the HD treatment order tab.
Review of treatment sheet documentation revealed the following:
-09/30/2023: The HD treatment was initiated at 7:13 AM. The first assessment of BP and pulse after HD treatment initiation was completed at 7:42 AM which was 29 minutes after the initiation of the HD treatment.
-10/05/2023: The HD treatment was initiated at 7:17 AM. The first assessment of BP and pulse after HD treatment initiation was completed at 8:02 AM which was 45 minutes after the initiation of the HD treatment. BP and pulse were assessed at 9:09 AM with the next assessment of BP and pulse being documented at 11:36 AM which was 2 hours and 27 minutes after the previous assessment.
-10/07/2023: BP and pulse were assessed at 9:28 AM with the next assessment of BP and pulse being documented at 10:22 AM which was 54 minutes after the previous assessment.
During interview conducted on October 12, 2023 at approximately 4:15 PM, the charge nurse and administrator confirmed blood pressure and pulse monitoring during the HD treatment was not completed as per facility policy/procedure for the above identified patients.
Plan of Correction:For ongoing compliance, the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
- Intradialytic Hypotension
The in-service will focus on ensuring that the patient's assessments and vital signs (VS) are obtained per policy. The meeting will reinforce that the VS must be taken and documented during treatment every thirty (30) minutes but not to exceed forty-five (45) minutes. The in-service will stress the importance of documentation of any interventions taken to address hypotension with follow up re-evaluation of the patient.
In-servicing will be completed by October 26, 2023, and the 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 one hundred percent (100%) compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) specific auditing 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: November 11, 2023
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 a review of facility policies/procedures and medical records and based on interview with the charge nurse (Employee #1) and the administrator (Employee #2), the facility failed to ensure the plan of care included the signature of the patient's or patient's designee for one (1) of two (2) in-center hemodialysis (HD) patients. (Patient #1)
Findings include:
On October 12, 2023 at approximately 3:53 PM, review of the facility policy titled "Comprehensive Interdisciplinary Assessment and Plan of Care" revealed the following:
General Policy for Patient Assessment and Plan of Care...
The...Plan of Care must be developed and implemented by the interdisciplinary team (IDT) consisting of at minimum, the patient or patient's designee...
The...Plan of Care (adult patient) must be completed electronically in the medical record. The Plan of Care should be signed at the time the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDP (IDT) member within 30 days of the completion of the interdisciplinary meeting...
Role of the Interdisciplinary Team: POC (Plan of Care)...Each patient's plan of care must be signed by all members of the IDT...
Patient #1: On October 12, 2023 at approximately 10:20 AM, review of the medical record revealed the admission date was 02/18/2023 and that a POC meeting was conducted on 06/06/2023 as documented on the "Plan of Care".
There was no documentation in the medical record which provided evidence that the patient or the patient's designee had signed the "Plan of Care" dated 06/06/2023.
During interview conducted on October 12, 2023 at approximately 4:15 PM, the charge nurse and administrator confirmed there was no documentation in the medical record which provided evidence that the patient or the patient's designee had signed the "Plan of Care" dated 06/06/2023 for the above identified patient.
Plan of Correction:The 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, this includes the patient. The in-service will also review that if not attending in person the care plan must be signed by the IDT members, including the patient, within thirty (30) days of the IDT meeting.
The in-servicing will be completed by October 26, 2023, with documentation of the training on file at the facility.
The CM or designee will perform monthly audits of all 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 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: November 11, 2023
494.180(e) STANDARD
GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED
Name - Component - 00
The facility's internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services.
The grievance process must include-
(1) A clearly explained procedure for the submission of grievances.
(2) Timeframes for reviewing the grievance.
(3) A description of how the patient or the patient's designated representative will be informed of steps taken to resolve the grievance.
Observations:
Based on review of facility policies/procedures, documentation and medical records, and based on interview with the charge nurse (Employee #1) and the administrator (Employee #2), the facility failed to ensure grievance documentation and follow-up procedures were completed as per facility policy and procedure for one (1) of one (1) complaints/concerns. (Patient #1)
Findings include:
On October 12, 2023 at approximately 4:07 PM, review of the facility policy titled "Patient Grievance" revealed the following:
Position and Responsibility:
-All facility staff: Promptly acknowledging the patient/family member's concern and reporting any patient grievances to the Nurse in Charge or the Team Leader...
-Nurse in Charge or Team Leader: Meeting with the patient/representative within 72 hours of being notified of a grievance. Assisting in accessing and resolving patient grievances as appropriate. Completing as many fields as possible on the Patient Grievance Status Report.
-Clinical Manager: Reviewing the Patient Grievance Status report daily. Meeting with the patient representative within 5 business days to discuss the grievance, resolve it as quickly as possible, and provide specific updates to the patient. Documenting actions taken on the Patient Grievance Status Report...
Definition...Grievance is any complaint or concern raised by the patient or the patient's representative...
On October 12, 2023 at approximately 11:40 AM, review of the "Patient Grievance Report" form revealed the following statement was included on the form: "No data available from past 12 months".
Patient #1: On October 12, 2023 at approximately 10:20 AM, review of the medical record revealed the following clinical note was entered by a certified registered nurse practitioner (CRNP) on 09/19/2023: Family member expressed concerns regarding laboratory results, failure of facility staff to obtain laboratory specimen at the beginning of the hemodialysis treatment, professionalism of facility staff (facility staff talking about each other) and inability of facility to provide the family member with a copy of a patient incident report. Clinical manager (CM) notified "about same".
There was no documentation which provided evidence the above referenced concerns were documented on a "Patient Grievance Status Report" nor was documentation present which provided evidence the CM (Employee #3) completed the above listed procedures included in the "Patient Grievance" policy.
During interview conducted on October 12, 2023 at approximately 4:15 PM, the charge nurse and administrator confirmed grievance documentation and follow-up procedures were not completed as per facility policy/procedure for the above identified patient.
Plan of Correction:The Director of Operations (DO) will meet with the CM to review the grievance process and the importance of following up with any patient issues and/or complaints within the timeframe per policy. The DO will also review the importance of documentation of the grievance investigation with the patient within five (5) days and follow up with the patient of the findings.
For ongoing compliance, the CM or designee will in-service all staff on policies:
- Patient Grievance
- Patient Grievance Log
The in-service will review the time frame outlined in the policy for acknowledging, investigating, documenting, and addressing grievances. The meeting will also emphasize the importance of ensuring:
- Completion of the Patient Grievance Status Report
- Review of the grievance logs at the monthly QAPI meetings
The DO, CM or designee will perform monthly audits of all grievances for 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 Do and CM with re-education and counseling.
The DO will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: November 11, 2023
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