Initial Comments:
Based on the findings of an onsite unannounced complaint investigation survey conducted on July 18, 2023 and completed offsite on July 20, 2023, Fresenius Medical Care-Sharon Hill was identified to have the following standard level deficiency that was 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:
494.150(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, medical records (MR), and an interview with the administrator, the medical director did not ensure the facility staff follow its policies for two (2) of two (2) MRs. MR#1 and 2.
Findings include:
A review of facility policy "Patient Assessment and Monitoring" on July 18, 2023 at 3:40 PM states: "Pre Treatment 2. During nursing rounds, the Registered Nurse will review the data collected above and assess the following parameters as needed:Data Collected Above, Assess patient for symptoms Lund sounds...Edema...,Hear Sounds...Document findings and inteventions in the medical record...During Treatment Blood Pressure...Report to the nurse: Systolic blood pressures greater than 180th, Diastolic blood pressure greater 100 mmHg, Blood Pressure less than or equal to 100 mmHg systolic..Post Treatment...The registered nurse will assess/reassess post treatment as indicated...Document findings in the patient's record."
A review of facility policy "Patient Safety and Event Reporting and Documentation"on July 18, 2023 at 3:40 PM states: Serious Safety Event Results in severe to life threatening patient clinical harm, not due to an underlying disease or condition. Requires lifesaving or major medical intervention that may result in Death, Permanent harm or Revere temporary harm...Clinical Staff are required to report all Safety Events and Serious Safety Events to the patient's physician. Serious Safety Events will require immediate additional reporting to their supervisor and Medical Director. Step1. Clinical staff will perform documentation in the : Patient medical record...Medical Devices in use during a patient event shall be sequestered until further review. Additional investigation may be necessary to determine if the medical device may have caused or contributed to the patient event. If...Serious Safety Event occurred, and the medical device may have caused or contributed to the safety event that resulted in serious patient harm, injury, or death...Notify Clinical Services. Med Watch FDA 3500A Form may be required. Clinical Services will provide guidance with completion of MedWatch FDA 3500 Form. Other Patient Events Other Patient Events...Sustained loss of consciousness while maintaining a pulse and respirations and did not require CPR."
A review of medical records including treatment flow sheets and adverse occurrence report was conducted on 7/18/23 10:15AM-1:45 PM.
MR2 admission date 1/2023, DOB 7/19/57 contained an adverse occurrence on 5/25/23 where patient lost consciousness for a period of time at onset of dialysis while maintaining a blood pressure and pulse. Report stated there was air in the extracorporeal circuit (dialyzer and lines)- staff immediately clamped all lines, no air to patient. Machine was pulled for biomedical review and extracorporeal circuit was bagged and saved for review. Patient regained consciousness prior to arrival of EMTs and was admitted to the hospital with no cause found for loss of consciousness.
There was no documentation of notifying the patient's physician/medical director. There was no documentation of notification of clinical services for further direction regarding completion of Med Watch FDA 3500 form.
A Review of treatment flow sheets 7/1-7/13/23 revealed:
7/13/23 treatment initiated at 12:23 PM. Pre treatment nursing assessment completed 1:47 PM.
MR1 admitted 1/10/23. Dialysis orders: Scheduled hours: 0400 hours.
A review of treatment flow sheets 7/4-7/15/23 revealed:
7/4/23: treatment initated at 11:01 AM. Treatment discontinued ten minutes early at 3:51 PM "tx discontinued due to head ache and low b/p. rn aware. (BP 91/49)." No post nursing evaluation documented for patient's low blood pressure and headache.
7/8/23: treatment initiated at 11:20 AM. The pre treatment nursing assessment was done at 12:28 PM.
7/13/23 treatment initiated at 10:50 AM. The pre dialysis nursing assessment done at 12:22 PM.
An interview with the administrator on July 20, 2023 confirmed the above findings.
Plan of Correction:V 715
By July 28, 2023, the Director of Operations (DO) and the Facility Administrator (FA) 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:
· Patient Assessment and Monitoring
· Patient Safety and Event Reporting and Documentation
The meeting will focus on the importance of the staff always adhering to all Fresenius Medical Care (FMC) policies and procedures. The importance of ensuring that there is always physician notification when a patient experiences an abnormal event, such as loss of consciousness. The meeting will also reinforce that all appropriate notification is completed related to the event, this includes clinical services and MedWatch (if indicated), with documentation of event and follow up in the grievance log. The meeting will also review that the registered nurse (RN) treatment assessment is completed and documented timely. The RNs will also be informed to ensure that early termination of treatment is evaluated for the reason with documentation of intervention and findings.
Minutes of the meeting with the Medical Director will be on file at the facility for review.
The Medical Director was informed at the meeting that the CM or designee will hold a DPC staff inservice and will receive education on the above policies by August 2, 2023.
All training documentation will be on file at the facility.
The Medical Director was informed that the FA or designee will perform daily audits for two (2) weeks. If compliance is noted at that time, the audits will be completed 2 times/week for 2 weeks. If one hundred percent (100%) compliance is sustained at that time, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) 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.
To ensure ongoing compliance the FA will review the audit findings with the Medical Director weekly. The results and progress of the POC will be reviewed at the QAPI Committee monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion date: August 25, 2023
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