Madison County Medical/Surgery Clinic

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 upon a review of the CMS 209 form, review of laboratory documentation of competency assessment, lack of documentation and interview with laboratory staff the laboratory failed to assess technical consultant competency on an annual basis for one of one technical consultant personnel listed on the CMS 209 form. Findings follow: A) Review of the CMS 209 form revealed that the technical consultant (number 2 on the form CMS 209) was employed by the laboratory. B) Review of competency assessment records revealed that the technical consultant (number 2 on the CMS 209 form) had records of competency evaluation in 2020, 2021, 2022, 2023 but no subsequent dates. C) Upon request, the laboratory was unable to provide competency assessments for techical consultant (number 2 on the CMS 209 form) for 2024 and 2025. D) In an interview on 3/3/26 at 01:10 p.m., the laboratory staff member (number 2 on the form CMS 209) confirmed that competency assessments for the techical consultant was not performed in 2024 and 2025 and the technical consultant had been contracted by the laboratory during those years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Through review of laboratory policy and procedure, observation and interview it was determined that the laboratory failed to label eight of forty specimens with patient name and unique patient identifier. Findings follow: A) Review of the laboratory policy and procedure revealed that specimens are to be labeled with the patient's first and last names and a unique patient identifier, patient number or patient's date of birth or specimens would be rejected. B) During a tour of the laboratory on 2/9/22 at 11:45 AM forty specimens were observed in the laboratory refrigerator, of the forty, four blood specimens collected in EDTA for CBC analysis and four blood specimens in 15 ml. red top tubes were labeled with the patient's first and last name only. C) In an interview on 2/9/22 at 11:45 AM , the laboratory staff member, identified as number three on the CMS 209 form, confirmed that the specimens identified above lacked proper patient identification on the container as required by policy and procedure. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --