Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Christopher G Nelson MD PA on 02/26/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D2038 MYCOLOGY CFR(s): 493.827(a) (a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the lab failed to attain at least an 80% on one of five test events for the analyte dermatophyte. Findings include: 1. The test results from the American Proficiency Institute for test event(s) (TE) 2 and 3 of 2024, and TE 1, 2, and 3 of 2025 for the analyte dermatophyte were reviewed. The lab scored a zero for TE 2 in 2024. 2. Interview with the Technical Consultant on 02/26 /2026 at 10 a.m. confirmed the above. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: 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 -- Based on record review and staff interview, the Laboratory Director failed to develop a policy specifying how they would document onsite visits that were performed every 6 months for one of one year reviewed. Findings include: 1. Quality Assurance documents and policies were reviewed. No document could be found reflecting the Laboratory Director documented on-site visits every 6 months in 2025. No policy could be found regarding onsite 6 month visits. 2. Interview with the Laboratory Director on 02/26/2026 at 11:30 a.m. confirmed the above. -- 2 of 2 --