Bay Dermatology & Cosmetic Surgery Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 10/08/2025-10/09/2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. A Standard deficiency was cited as follows: D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a record system that included the identify of the Testing Personnel (TP) that performed the grossing component of Histopathology testing for two of two years reviewed (2024- 2025). Findings included: 1) Review of the CMS-209 Personnel form, signed by the Laboratory Director on 10/8/2025, listed two qualified grossing testing persons, TP#A and TP#B. 2) Review of the laboratory's "WindSURG Daily Accession Log" for 10/8 /2025, failed to show documentation of the grossing testing person for 119 of 119 patients listed. 3) Interview with TP#A on 10/8/2025 at 2:50 PM confirmed the laboratory does not have a record system to identify if TP#A or TP#B performed the grossing component of patient specimens for Histopathology 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 04/30/19. The laboratory is 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 Office Manager, the laboratory failed to ensure the accuracy for twice a year testing for histopathology for 3 (#A, #C, #D) out of 6 Testing Personnel (TP) for 2018 and for parasitology (scabies) testing for 5 (#A, #C, #D, #E, and #F) out of 6 TP for 2017 and 2 TP out of 6 for 2018 out of 2 years reviewed (2017- 2018). Findings included: Record review of the "Proficiency Testing Quality Assurance Tracking Log" for peer review revealed that one peer review was performed for histopathology accuracy in 2018 for TP #A, C, and #D (03 /18). Record review of the Quality Assurance (QA) Peer Review for Ectoparasites (scabies) for the subspecialty showed that TP #A, #C, #D, #E, and #F did not perform the peer review in 2017 and TP #A and #C did not test twice in 2018. Interview with the Office Manager on 04/30/2019 at approximately 11:50 a.m. confirmed that there was missing QA peer reviews for histopathology for 3 out of 6 TP (#A,#C, and #D) for 2018 and for 5 out of 6 TP (#A #C, #D, E, and #F) for scabies for 2017 and 2 out 6 TP (#A and #C) for scabies for 2018. 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 --