Stone Dermatology

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to have written procedures for Potassium Hydroxide (KOH) and Dermatophyte Test Medium (DTM) testing. The laboratory performs approximately 20 KOH and DTM tests annually. Findings include: 1. The laboratory failed to have written procedures for KOH and DTM testing. 2. Lead Medical Assistant not listed on the Laboratory Personnel Report (CMS-209) confirmed during an interview on 09/21/2022 at approximately 12:10 p.m., the laboratory did not have written procedures for KOH and DTM testing. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 lack of documentation and interview with staff, the Laboratory Director failed to ensure a quality assessment plan was established to assure quality of laboratory services through the pre-analytical, analytical, and post-analytical phases. The laboratory performs approximately 4,000 histopathology and 20 mycology tests annually. Findings include: 1. The procedure manual failed to include a written Quality Assessment (QA) plan. 2. Laboratory Director confirmed during an interview on 09/21/2022 at approximately 12:00 p.m., the laboratory did not have a written QA plan. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation of Potassium Hydroxide (KOH) reagent and confirmation by staff the laboratory failed to ensure KOH reagent was not used past its expiration date for two of eight KOH preparation tests reviewed. Findings include: 1. Potassium hydroxide reagent observed expired 06/2017. 2. Patient testing performed after the KOH reagent expiration date were performed on 09/20/2017 for patient date of birth (DOB) 09/29/1992 and on 12/20/2017 for patient DOB 03/04/1979. 3. Staff confirmed the lab used only one container for KOH testing and it had expired 06 /2017. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory technical consultant failed to evaluate 1 of 2 testing personnel annually for 2 years of Dermatophyte Test Media culture (DTM). The test person performed from 1 to 5 culture results per year for two years of testing reviewed (2016 and 2017). Findings 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 -- include: 1. The laboratory failed to document competency evaluations for DTM tests performed annually in 2016 and 2017. 2. In an interview with staff on 01/11/2018 staff stated the testing person performed fewer than 5 of approximately 50 DTM tests performed per year. -- 2 of 2 --