Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Mark & Kambour, MD, PA on 11/06/2025 - 11/10/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6076 493.1441 Condition: Laboratory Director D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to provide overall management and direction for 2024-2025. See D6080, D6091, D6093, D6102, and D6103. 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: Based on record review and interview, the Laboratory Director failed to develop a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- policy or provide evidence of the required every 6 month onsite visits from 01/2025-11 /2025. Findings Included: 1. Review of records revealed no approved policy regarding the Laboratory Director being onsite every 6 months and no evidence of visits for 01 /2025 to 11/2025. An unapproved policy regarding the required onsite every 6 month visits was presented for review. 2. The Laboratory Director stated via email interview on 11/10/2025 at 12:11 p.m., he had not been able to visit the laboratory from 01 /2025-11/2025. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require