Skin Cancer And Dermatologic Surgery

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the surveyor's review of patient testing records, log sheet, final reports, and an interview with the office manager (OM) on September 9, 2025; it was determined that the laboratory failed to follow established policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. The findings include: 1. Review of patient log for potassium hydroxide (KOH) and scabies revealed the following discrepancies as follows: a. Patient #1335729 and Patient #1545165 were not documented in the final report for the test performed, including the interpretation of the results. b. Patient #1536125 was recorded in the patient log as examined at the abdomen, while the final report indicated preumbilical skin. 2. The OM affirmed by interview on September 9, 2025, at approximately 3:40 p. m. that records were discrepant for the three out of five patients as mentioned in statement #1. 3. No

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the request/lack of documentation of biannual verification for biopsy examinations and interview with office personnel, the laboratory failed to verify the accuracy of their biopsy examinations for 2018. Findings include: a. Upon request, the laboratory was unable to present verification of accuracy for their biopsy examinations for 2018. b. Office personnel confirmed (Personnel E and A, 7/12/2019 at 9:37 A.M.) that the laboratory did not have documentation of biannual verification of accuracy for their 2018 biopsy examinations. c. The laboratory performed approximately 600 patient biopsies in 2018 without documenting biannual verification of accuracy for this test. 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 --