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)
V0132 IC-TRAINING & EDUCATION
CFR(s): 494.30(a)(1)(i)

Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices.


This STANDARD is not met as evidenced by:
Based on personnel file review, ESRD (End Stage Renal Disease) Core Survey Facility Worksheet: Personnel File, facility policy, and interview, it was determined the facility failed to ensure staff completed annual infection control training 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.... 1. During observations of care on 4/19/23 from 8:25 AM until 9:10 AM, the surveyor observed EI # 7, CCHT providing care for in-center patients including care of the hepatitis B positive patient dialyzing in the isolation room. 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 the Infection Control Training date was 11/17/2020. On 4/20/23 at 8:50 AM after additional training documentation was provided by EI # 13, Administrative Assistant, a review of EI # 7's Education Transcript dated 4/18/2020-4/18/23 revealed the Infection Control Fundamentals Training completion date was 11/17/2020. Further review of training documentation revealed EI # 7's Direct Patient Care-Annual Skills Validation Checklist was last completed 6/30/21 and included direct observation of seven infection control skill components including hepatitis B precautions and isolation techniques. EI # 7's Infection Control training and Infection Control Skills Validation was not completed annually per facility policy. An interview was conducted on 4/20/23 at 10:40 AM with EI # 1, Director of Operations who confirmed there was no documentation EI #7 completed annual Infection Control training and annual skills validation for infection control were demonstrated.