Bay Dermatology And Cosmetic Surgery Pa

Summary Statement of Deficiencies 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 Lab Director failed to provide overall management and direction of the laboratory. Findings include: Review of the Allegation of Compliance signed and dated by the Laboratory Director 06/26/2025 revealed a plan to correct all deficiencies cited at the 05/22/2025 recertification survey. Previously cited noncompliance was found uncorrected. (See D6079) D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on record review and interview, the Laboratory Director failed to provide effective operational oversight of the lab, and failed to assure compliance with applicable clinical laboratory regulations. Findings included: 1. Review of the Allegation of Compliance signed and dated by the Laboratory Director 06/26/2025 revealed a plan to correct all deficiencies cited at the 05/22/2025 recertification survey. 2. The noncompliance identified was not corrected. (See D5200, D5209, D5291, D5413 and D5791). 3. A telephone interview was conducted with the Lab Director (LD) on 07/09/2025 at 1:03 p.m. The findings of the revisit were discussed. The LD stated they were not aware the

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 05/22/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5200 493.1230 Condition: General Lab Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of previous survey findings and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 02/21/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager, the laboratory failed to perform competency evaluations in accordance with written policies and procedures for three (Testing Personnel #B, #C, #D) out of four Testing Personnel (Testing Personnel #A - #D) for two out two years reviewed (2021 and 2022). Findings Included: Record review of the laboratory's policy " Testing Personnel Competency Assessment" with "Date Issued:" date of 03/01/21 revealed "Practitioners performing Histology, KOH [fungi], & parasitology (scabies) testing will be evaluated bi-annually to assess their competency in performing these tests." Review of the Laboratory Personnel Report (CMS-209) dated and signed by the Laboratory Director on 2/21/2023 revealed Testing Personnel #B performed high complexity testing for H&E stain interpretation. Review of competency assessment records revealed no documentation of competency being performed for Testing Personnel #B for 2021 and 2022 for H&E stain interpretation. Review of the Laboratory Personnel Report (CMS- 209) revealed Testing Personnel #C performed moderate complexity testing of KOH and parasitology (scabies) testing. Review of competency assessment records revealed that Testing Personnel #C did not have any evidence of bi-annual documentation of KOH competency for 2021 and 2022. Additionally, Testing Personnel #C had only Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- one out of two competency records for each year in 2021 and 2022 (10/14/21 and 11/9 /22). Review of the Laboratory Personnel Report (CMS-209) revealed Testing Personnel #D performed moderate complexity testing of KOH and parasitology (scabies) testing. Review of competency records revealed that Testing Personnel #D had KOH competency performed only one time in 2021 and 2022 (12/6/21) and parasitology competency performed only one time in 2021 and 2022 (11/10/22). On 02 /21/2023 at 11:55 AM, the Office Manager confirmed that the laboratory had not performed competency evaluations correctly. 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 mycology (fungi) and parasitology (scabies) testing for three Testing Personnel ( #B, #C, and #D) out of four Testing Personnel (#A, #B, #C, and #D) for two out of two (2021-2023 ) years reviewed. Findings included: Record review of the laboratory's policy titled "Quality Assurance of KOH [sic potassium hydroxide, fungi] and Ectoparasite" revealed "A program has been set-up to review 1% of the results semi-annually by a dermatologist...All cases that are reviewed are documented on the appropriate review sheet and are signed by the reviewing dermatologist." Record review of the "KOH & Ectoparasite Lab Testing Log" revealed that "EVERY 5th TEST" was marked for review without consideration for who performed the test. Record review of the "KOH & Ectoparasite Lab Testing Log" revealed that Testing Personnel #B, #C, and #D performed KOH lab testing. Closer review revealed Testing Personnel #B did not have records for twice annual verification of fungi (KOH) testing for 2022, Testing Personnel #C did not have twice annual verification of fungi testing records for 2021, and only one (12/15/22) twice annual verification of fungi testing in 2022, and Testing Personnel #D did not have twice annual verification of fungi testing records for 2021 and 2022. Record review of the "KOH & Ectoparasite Lab Testing Log" log for Ectoparasite (scabies) showed that Testing Personnel #B, #C, and #D performed scabies testing. Closer review of the logs for Testing Personnel #B had two (10/12/21 and 12/6/22) twice annual verification of scabies testing records, Testing Personnel #C had one (11/9/22) twice annul verification of scabies testing record, and Testing Personnel #D had one (11/10 /22) twice annual verification of scabies testing record. On 02/21/23 at 11:50 AM, the Office Manager confirmed that there was missing semi-annual verification of fungi and scabies testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bay Dermatology and Cosmetic Surgery PA on 02/11/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory director failed to have a personnel competency procedure to evaluate staff competency of those performing high complexity testing for two of two years reviewed (2019-2020). Findings Included: Review of the CMS 209 Laboratory Personnel Report revealed Personnel #A was the Laboratory Director, the Clinical Consultant, Technical Consultant, Technical Supervisor, General Supervisor, and high complexity Testing Personnel. Testing Personnel #B performed high complexity testing. Review of employee files revealed that Personnel #B did not have any competency evaluations for histopathology for two out of two years (2019-2020). Interview on 02/11/21 at 12: 00 PM with the Office Manager revealed she did not know that competency evaluations for histopathology needed to be performed and the laboratory did not have a competency procedure for those that performed high complexity 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of employee competency records and interview with the Office Manager, the laboratory failed to perform competency evaluations on 3 of 3 Testing Personnel (#B, C, and D) who perform KOH and Scabies testing in the subspecialties of Mycology and Parasitology for 2 of 2 (2016-2018) years reviewed and to perform competency assessment on the Technical Supervisor for Histology and the Technical Consultant (who is also Testing Personnel #B) for Mycology and Parasitology for 2 of 2 years (2016 - 2018). Findings Included: 1. Review of employee competency records found no competency evaluations performed on Testing Personnel #B, #C, and #D who perform KOH and Scabies testing, on Technical Consultant for Mycology and Parasitology and Technical Supervisor for Histology 2. Interview on 09/26/2018 at 11: 45 AM confirmed that there was no documented competency evaluations for Testing Person #B, #C and #D. 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 --