Cosmetic And Dermatologic

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 surveyor observation of Mohs reagents and interview with the Office Manager (OM), the laboratory failed to discard an expired Mohs reagent from 1/15/ 2020 to the date of survey. The findings include: 1. On the date of the survey the laboratory had an expired reagent as follows: Platinum Line Eosin Y Stain Solution, 1 % (w/v) in Alcohol. Lot number 1901114, Expiration 1/15/2021 2. Approximately 40 patients were tested with the expired reagent. 3. The OM confirmed on 3/9/2021 at 10: 00 am that the laboratory used an expired reagent. 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 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 surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to have an accurate procedure for biannual assessment from 6/27/16 to the date of survey. The findings include: 1.CLIA regulation states "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." (D5217) 2. The PM stated, "proficiency testing is done annually". 3 The TP confirmed on 8/7 /18 at 1:00 pm that the laboratory did have an accurate procedure for BA. 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 --