Brian J Williams Dermatology

Summary Statement of 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 office manager, the laboratory failed to verify the accuracy for potassium hydroxide (KOH) twice a year. The laboratory performs approximately 2 mycology tests annually. Finding include: 1. During laboratory record review on 7/26/2023 at 11:40 AM, the laboratory failed to produce records for accuracy verification since the last survey which was conducted on 1/08 /2021. 2. Interview with the office manager on 7/26/2023 at 11:42 AM, confirmed the laboratory failed to verify the accuracy of KOH two times per year. 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 lack of a competency procedure, lack of competency performance documentation for 1 of 1 year (2019), and interview with staff, the laboratory failed to establish and follow written policies and procedures for assess employee competency for 1 of 1 test person performing dermatophyte test media culture and potasssium hydroxide (KOH) testing for the presence or absence of fungi. The laboratory perfomred approximately 3 Dermatophyte test media cultures and 2 KOH preparations over 2 years (2019 and 2020). Findings include: 1. The laboratory failed to establish a policy that included: direct observation of routine patient test performance, monitoring the recording and reporting of test results; direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens; internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2. In an interview conducted on 01/08/2021 at approximately 1:00 P.M. staff confirmed the laboratory did not have a written policy that describes the procedure for competency evaluation. 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 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 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation and confirmation by staff, the laboratory failed to ensure potassium hydroxide regent was not used past it's expiration date. The laboratory performed approximately 2 tests per year. Findings include: 1. The potassium hydroxide reagent with chlorizol black (lot number 8094) available for use on 10/03 /2018 expired on 04/04/2020. 2. The laboratory tested patient (date of birth 11/05 /1989) on 05/13/2020 using lot number 8094. 3. In an interview conducted on 01/08 /2021 at approximately 12:50 P.M., staff confirmed the reagent was expired when used on 05/13/2020 for testing. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and confirmation by staff, the director failed to sign and date the laboratory procedure manual for dermatophyte cultures and potassium hydroxide testing using Chlorizol Black reagent as approved. The laboratory performs approximately 12 to 15 tests per year. Findings include: 1. The laboratory procedure manual failed to include the signature and date the director approved the procedures. 2. In an interview with staff on 08/16/2018 at approximately 12:30 P.M., staff confirmed the procedure manual did not include the director's signature and date of approval. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures 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 lack of documentation and interview with staff, the laboratory failed to check 1 of 1 lot number of Chlorizol Black reagent prior to or concurrent with use. The laboratory performed approximately 1 to 2 potassium hydroxide preparationsper year using Chlorizol Black reagent. Findings include: 1. The laboratory failed to document they checked Chlroizol Black reagent for lot number 6259 expiring 2018/09 /15. 2. In an interview conducted on 08/16/2018 at approximately 12 :00 P.M., staff confirmed they had not recorded they checked each new lot number of reagents in use prior to performing patient tests. -- 2 of 2 --