Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on the review of the laboratory's twice annual accuracy check records from 2021 to 2022, CMS 116 application, and confirmed in an interview found the laboratory failed to have documentation of two of two performing twice annual accuracy assessment for MOHS surgical procedures in 2021. The findings were: 1. Review of the laboratory's twice annual accuracy check records from 2021 to 2022 revealed the laboratory failed to have have documentation of two of two performing twice annual accuracy assessment for MOHS surgical procedures in 2021. 2. Review of CMS 116 application signed by the laboratory director on 1/19/2023 revealed the annual volume was 150. 3. An interview with the histotechnologist on 1/19/2023 at 12: 15 pm in the breakroom confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Services 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's direct observation and confirmed in an interview found the laboratory failed to monitor the expiration dates for one of five reagents available for use. The findings were: 1. The surveyor's director observation on 1/19/2023 at 9:00 am in the lab revealed one of five reagents available for use was expired. STATLAB RapidFix Lot: 107314 Exp: 2022-10-31 2. Requested the facility to provide patient case logs and no documentation was provided. 3. An interview with the histotechnologist on 1/19/2023 at 9:00 am in the lab confirmed the above finding. The histotechnologist achknoweledged using STATLAB Rapidfix on paitent slides past the expiratrion date. -- 2 of 2 --