Bradenton Dermatology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bradenton Dermatology PA on 09/02/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 interview with the Laboratory Director, the laboratory failed to verify the accuracy of testing twice a year for 2 of 2 years (2019-2021) reviewed for the subspecialties of Mycology, Parasitology, and Virology. Findings Included: Review of quality assurance peer review revealed no peer reviews were completed for two out of two years (2019 - 2021) for fungi testing with Potassium hydroxide (KOH) in Mycology, Scabies testing in Parasitology, and Tzanck testing in Virology. Review of the "KOH/Tzanck/Scabies (K/T/S) " patient log revealed the statement "No longer reading KOH/Tzanck slides as of June 2019". On 09/02/21 at 09: 15 AM, the Laboratory Director stated he wanted to keep his subspecialties of mycology, parasitology, and virology and reported that he had performed microscopic (KOH, Scabies, and Tzanck) testing but had not logged the patients. He also confirmed he had not performed peer review for two out of two years (2019 -2021) This is a repeat deficiency. 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 D0000 An announced CLIA recertification survey was conducted at Bradenton Dermatology on 07/10/2019. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 interview with the Laboratory Director, the laboratory failed to verify the accuracy of testing twice a year for 2 of 2 years (2017-2018) reviewed for Mycology, Parasitology, and Virology. Findings Included: Review of quality assurance peer review revealed no peer reviews were completed in 2017 for KOH (Potassium hydroxide) testing in Mycology, Scabies testing in Parasitology, and Tzanck testing in Virology. In addition, in 2018 peer review was only conducted one time for Scabies (01/18/18) and Tzanck testing (11/15/18). On 07/10/2019 at 3:30 PM, the Laboratory Director stated he thought the peer reviews for KOH, Scabies, and Tzanck had been performed in 2017. For 2018 the Laboratory Director stated, the laboratory only had 1 positive patient for the Scabies and the Tzanck 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 --