Paducah Dermatology

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 07/16/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on document review and confirmed in staff interview, the laboratory failed to perform semiannual competency evaluation during the first year for 1 of 5 staff who held the position of Testing Personnel (TP). Findings included: Review of the "Laboratory Personnel Report," signed by the Laboratory Director (LD) and dated 07 /10/2024, revealed the laboratory had five individuals who held the position of TP. TP #4's competency assessment revealed the initial assessment was conducted on 10/11 /2023. There was no documentation provided by the laboratory to indicate TP #4 had a semiannual competency assessment. During an interview on 07/16/2024 at 11:15 AM, the Clinical Manager (CM) stated TP #4 was hired in October 2023. The CM stated TP #4's initial evaluation was conducted in October 2023, but a six-month competency was not conducted as it was an oversight. During an interview at 07/16 /2024 at 1:15 PM, the LD stated he was responsible for oversight over all laboratory activities to include employee competency. The LD acknowledged there should have been a semiannual evaluation of TP #4. 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 A Recertification Survey was initiated on 05/03/2022 and concluded on 05/03/2022. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493.1252(d) with deficiencies cited. 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 observation, staff interview and record review, it was determined the laboratory failed to ensure Potassium Hydroxide (KOH) reagent currently in use had not exceeded the manufacturer's expiration date. Findings include: Review of the laboratory's procedures, on 05/03/2022 at 11:45 AM, revealed there was no documented evidence the laboratory had a system in place to monitor for expired KOH reagents. Observation during a tour of the laboratory, on 05/03/2022 at 11:10 AM, revealed the KOH reagent currently in use had expired on 03/23/2022. Interview with the Technical Consultant, on 05/03/2022 at 11:45 AM, revealed the laboratory did not have a system in place to ensure that reagents exceeding the expiration date were not in use. 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 --