Shapiro And Borenstein Dermatology Llp D/B/A

Summary Statement of Deficiencies D0000 A recertification survey was conducted on January 9, 2024. Shapiro and Borenstein Dermatology LLP dba Gardens Dermatology and Cosmetic Surgery Center clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 10/4/21 at Shapiro and Borenstein Dermatology LLP dba Gardens Dermatology and Cosmetic Surgery Center, a clinical laboratory in Palm Beach Gardens, Florida. Shapiro and Borenstein Dermatology LLP dba Gardens Dermatology and Cosmetic Surgery Center is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. 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 Testing Personnel #B, the Laboratory Director failed to ensure that the laboratory had a competency procedure that was all inclusive and failed to perform competency evaluations on 8 (Testing Personnel (TP) #C - #D, and TP # F - #K) out 10 ( TP #A - #D and #F - #K) Testing Personnel for 2 (2020 - 2021) out of 2 years(2020 - 2021). The findings included: Record review of the laboratory's policy and procedure revealed a procedure titled 'Evaluation of Technologist/Technician/Laboratory Staff Competency' which stated, "All histology technologists and technicians are evaluated for their skills in the handling of specimens, embedding, cutting permanent sections, safety procedures, quality control, special stains, and routine staining". This procedure did not include histopathology slide interpretation testing or identification of fungi (mycology subspecialty), scabies 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 -- (parasitology subspecialty), and the Tzanck (for chicken pox or herpes) (virology subspecialty) testing. Review of 4 Testing Personnel records (TP# C-#D, #F, and #G) revealed that the hematoxylin and eosin, and Periodoci Acid Schiff (histopathology subspecialty) high complexity competency evaluations had not been completed for 2 (2020 - 2021) out 2 years (2020 - 2021). Record review of 4 Testing Personnel records ( TP #H - #K) revealed that the fungi (mycology subspecialty), scabies (parasitology subspecialty), and the Tzanck (for chicken pox or herpes) (virology subspecialty) moderate complexity competency evaluations had not been completed for 2 out of 2 years reviewed (2020-2021). Interview on 10/4/19 at 3:10 p.m., Testing Personnel #B stated she talked to Testing Personnel #D who stated they thought the semi - annual performance verification was the competency evaluation. -- 2 of 2 --