Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 012515 (X3) Date Survey Completed 04/20/2023
Name of Provider or Supplier Fresenius Medical Care Opelika Street Address, City, State 2609 Village Professional Drive, Suite 2, Opelika, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
V0681 PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY
CFR(s): 494.140

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.


This STANDARD is not met as evidenced by:
Based on review of the ESRD (End Stage Renal Disease) Core Survey Facility Worksheet: Personnel File, employee personnel file, facility policy, and interview, it was determined the facility failed to ensure staff completed annual competencies for one of three CCHT (Certified Clinical Hemodialysis Technician) files reviewed, including EI (Employee Identifier) # 7, CCHT. This had the potential to affect all patients served by the facility. Findings include: Facility Policy: Knowledge, Skills and Competency for Clinical Staff Published: 10/12/2021 Version: 3 Purpose ...FKC (Fresenius Kidney Care) provides all clinical field employees with initial and ongoing development and evaluation of the knowledge and skills essential for a highly functional and well-trained workforce. Background The following are...required clinical topics covered during training... -Initial, Annual, and One-time Role Specific Training -Initial, Annual, and One-time Role Specific Knowledge Evaluation -Initial, Annual, and One-time Role Specific Skills Evaluation ...Policy Employees are required to pass all exams, including an initial and annual exam. Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given timeframe. Employees without current documented competency within the past 365 days may be removed from performing independent direct patient care (DPC) until competency is demonstrated and documented. ...Documentation Completion dates are entered...for ... annual exam and skills validation...Annual Skills Validation.... A review of the 'ESRD Core Survey Facility Worksheet: Personnel File' dated 4/19/23 revealed EI # 7's, date of hire was 2/26/01 and Competencies Documented Dates were 12/23/23. On 4/20/23 at 8:50 AM a review of EI # 7's Education Transcript dated 4/18/2020 to 4/18/23 revealed the last Clinical Annual Competency Exam-Direct Patient Care completion date was 4/29/2020, the Annual Clinical Skills Validation and Exam for PCT (Patient Care Technician) completion date was 12/23/2020 . Further personnel documentation review revealed an Annual Direct Patient Care Skills Validation Checklist, Outpatient Hemodialysis, revealed EI # 7's last completed competency validation was 6/30/21, which was greater than 365 days. In addition, no Clinical Manager and Medical Director signature/date was documented on the 6/30/21 Annual Skills Validation Checklist. An interview was conducted on 4/20/23 at 10:40 AM with EI # 1, Director of Operations who confirmed staff failed to complete the competency skills evaluation within 365 days, per policy.