Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on February 26, 2021, Fresenius Medical Care South Hills 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 completed on February 26, 2021, Fresenius Medical Care South Hills 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 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.
Observations:
Based on observation (OBS), review of facility policy and interview with the Clinical Manager, it was determined that the facility failed to ensure the removal of expired medication for one (1) of one (1) observation. OBS #1.
Findings included:
Review of facility policy completed on 2/26/21 at approximately 10:00 a.m. revealed: "Policy Medication Preparation and Administration: Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Medical Services off-site program or in accordance with local and/or state law."
OBS #1 conducted on 2/26/21 from approximately 8:35 a.m. to 9:30 a.m. revealed the medication storage refrigerator containing a bottle of Prevnar 13 (vaccine for the prevention of pneumonia) with an expiration date of 6/2020.
During an interview on 2/26/21 at approximately 9:05 a.m. the Clinical Manager confirmed the above findings.
Plan of Correction:V 111
To ensure immediate compliance, on 2/26/2021, the Clinic Manager (CM) disposed of the expired pneumonia vaccine identified during the survey. All medications were inspected at the same time to ensure that they were not over their expiration dates.
For ongoing compliance, the CM or designee will in-service all direct patient care (DPC) staff on the following policy:
- Medication Preparation and Administration Policy
Emphasis will be placed on ensuring that all medications, including Prevnar 13, that are used in the facility are current and not past their expiration dates. The stocking of supplies will also be reviewed at the meeting reinforcing with the staff that stock needs to be rotated on a regular basis according to expiration dates. The use of a monthly log will be implemented for recording the expiration dates of all stocked medications and lab supplies stored on the treatment floor.
In-servicing will be completed by 3/3/2021.
All training documentation will be on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. If evidence of improved compliance is observed the audits will then be completed monthly following the Quality Assessment Improvement (QAI) program. The CM will also review the monthly expiration log for compliance monthly. A Plan of Correction (POC) specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audits and the expiration log and report the findings monthly at the QAI Committee meeting for further guidance and ongoing oversight.
Completion Date: 4/2/2021
494.140 STANDARD
PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY
Name - Component - 00
All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility's staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility's staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions.
Observations:
Based on review of Personnel Files (PF), facility policies and procedures, and interview with the Clinical Manager, it was determined the facility failed to ensure personnel received baseline tuberculosis screening, per policy, for one (1) of seven (7) PFs reviewed. PF #5.
Findings include:
Review of facility policy completed on 2/25/21 at approximately 9:50 a.m. revealed: Policy "Employee Tuberculin Skin Testing Mantoux, TB (tuberculosis) skin test is required upon hire using the two-step tuberculin test (TST) method. If first step TST result is negative, administer second TST in 1-3 weeks."
Review of personnel files (PF) conducted on 2/25/21 at approximately 8:30 a.m. to 9:45 a.m., revealed the following:
PF5 hire date: 6/1/2020. Documentation of initial TST administered on 6/3/2020 with a read date of 6/5/2020 with a negative result. Documenation of second step TST administered on 6/5/2020, same day as first step read date.
An interview with the Clinical Manager and the Director of Operations on 2/25/21 at approximately 9:45 a.m. confirmed the above findings.
Plan of Correction:V 681
To ensure compliance, the Director of Operations (DO) met with the CM to review:
- Employee Tuberculin Skin Testing Mantoux Policy
Emphasis will be placed on ensuring that all new hires receive a two-step Tuberculin Skin Test (TST) upon hire. The meeting also reinforced that the second TST is to be one (1) to three (3) weeks apart.
In-servicing will be completed by 3/3/2021.
All training documentation will be on file at the facility.
The DO will audit all new hires 2-step TST for the next six (6) months for completeness and accuracy. At that time, if one hundred percent (100%) compliance is observed the audits will then be completed following the QAI program. A POC specific auditing tool will be used for the audits.
The DO will address issues of non-compliance with re-education and counseling.
The DO will review the audits findings with the CM who will report the findings monthly at the QAI Committee meeting for further guidance and ongoing oversight.
Completion Date: 4/2/2021
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 medical records (MR), review of facility policies and procedures, and interview with the Clinical Manager, it was determined the facility failed to ensure the nurse performed an assessment prior to the patient starting treatment for one(1) of five (5) MRs reviewed. (MR1)
Findings included:
Review of facility policy completed on 2/23/21 at approximately 3:00 p.m. revealed: Policy "Comprehensive Interdisciplinary Assessment and Plan of Care: A registered nurse (RN) must perform an assessment on patients new to dialysis before initiation of their first treatment to determine immediate needs. The RN must document the assessment."
Review of medical records (MR) conducted on 2/23/21 at approximately 9:45 a.m. to 3:00 p.m., revealed the following:
MR 1: Medical Record 1 revealed admission date of 7/24/18. Initial dialysis treatment was conducted on 7/24/18 at 7:35 a.m. The initial RN assessment was conducted on 7/24/18 at 9:52 a.m., 137 minutes after start of treatment.
An interview with the Clinical Manager on 2/23/21 at approximately 2:30 p.m. confirmed the above findings.
Plan of Correction:V 715
On, 3/9/2021, the 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 Medical Staff Bylaws and policies:
- Comprehensive Interdisciplinary Assessment and Plan of Care
The meeting will focus on the importance of the staff always following Fresenius Medical Care (FMC) policies. The meeting reviewed that a pre-assessment must be performed by a Registered Nurse (RN) on any patient new to dialysis prior to the initiation of the patient's first treatment. The Medical Director was informed that the CM or designee will be completing audits on all new patients for the next three (3) months.
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 and the staff will receive education on the above policies by the CM or designee by 3/10/2021. The staff meeting will emphasize that all patients, new to dialysis, must have a pre-assessment completed by a Registered Nurse (RN) prior to the initiation of the patient's first treatment.
All training documentation will be on file at the facility.
To ensure ongoing compliance the CM will meet with the Medical Director weekly for the next 3 months to review the audits. After 3 months, if 100% compliance is observed, the audits will be completed following the QAI calendar.
Staff found to be non-compliant will be re-educated and counseled.
Completion date: 4/2/2021
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