Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at DERMATOLOGY CONSULTANTS PA on September 22, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited was as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of Histopathology testing at least twice annually for 1 (2025) out of 2 years (2025-2026) reviewed. Findings included: 1. Personnel records reviewed revealed that in the Histopathology section there was one testing personnel TP1 (Laboratory Director, LD) as per CMS 209 Form signed by the LD on September 22, 2026. 2. Review of Subpart I, 42 CFR Part 493.901 through 493.959 revealed that there were no approved proficiency testing programs for the interpretation of stained tissues. 3. Review of the laboratory procedure signed by the LD on 01/05/2026, QUALITY ASSURANCE PROFICIENCY TESTING / PEER REVIEW stated "This laboratory has instituted its own Quality Control program. Every 6 months, (License # ) will do the review." 4. Review of the Quality Assurance (QA) peer review found that peer review for Histopathology was done on 4/17/2026. Peer review records for 2025 were requested but not provided. 5. During an interview on 09/22/2026 at 11:40 AM, the Risk Management/QA consultant admitted to not having twice annually QA peer review for 2025 because the laboratory did not perform any patient testing. 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 --