Nea Baptist Clinic - Osceola

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the form CMS 209, laboratory policy and procedure, personnel records, lack of documentation, and interview, the laboratory did not have competency of the Clinical Consultant (CC) and Technical Consultant (TC) on an annual basis. Findings follow: A) Review of the form CMS 209 provided by the laboratory on 2/26/26 revealed that staff members CC and TC as listed on form CMS 209 was identified as Clinical Consultant and Technical Consultant. B) Upon request, the laboratory was unable to provide any competency assessments for the position of CC and TC for the laboratory staff members (CC and TC on form CMS 209) for 2024 and 2025. C) In an interview, at 11:17 a.m. on 2/26/2026, the Laboratory Directory confirmed no competency for the CC and TC listed on the CMS 209 form. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, lack of documentation, and interviews with laboratory staff, the laboratory director failed to approve, sign, and date all the laboratory procedures. Survey findings include: A) During a review of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory procedures, it was determined the laboratory director failed to sign the procedure manual and individual policies (Titled procedures NOT signed by the Laboratory Directory: Testing Personnel (Moderate Complexity), Error Code Policy, and Specimen Rejection Policies.) B) Review of Laboratory Directory Responsibilities Step M states, "Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and ...". Three policies tilted above were not approved by the Laboratory Directory. C) In an interview at 11:17 am on 2/26/2026, Technical Consultant (TC) as listed on the 209 form, confirmed the laboratory director's written approval of the laboratory procedures was not available. -- 2 of 2 --

Summary Statement of Deficiencies D2044 MYCOLOGY CFR(s): 493.827(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Through a review of API (American Proficiency Institute) proficiency test documentation for 2017, a review of the technical consultant reports for 2017, lack of documentation, and interviews with staff, it was determined the laboratory failed to take remedial actions for unsatisfactory testing event scores on Vaginal Wet Prep Examinations. Survey findings follow: A. Through a review of the API Comparative Evaluation forms for the three events in 2017 it was determined the laboratory had unsatisfactory testing event scores on one of three testing events. The laboratory received a 0% score for Wet Prep Examinations on the 1st Proficiency Event of 2017. B. The technical consultant reports for 2017 failed to include documentation of the 0% Wet Prep score or any