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. 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 the surveyor's direct observation, patient records from 3/1/23 to 3/24/23, and confirmed in an interview found the laboratory failed to monitor the expiration date for one of five reagents observed available for use. The findings were: 1. The surveyor's director observation on 3/24/2023 at 10:15 am in the lab revealed one of five reagents observed available for use was expired. STATLAB Polarstat Frozen Embedding Media Catalog: CRYO-4 Lot: 114880 Exp: 2023-01-31 2. An interview with the medical assistant on 3/24/2023 at 10:16 am in the lab confirmed the above reagent was put in use in March 2023. 3. Review of the patient records from 3/1/2023 to 3/24/2023 revealed 27 patients had the slides made with the reagent. 3/1/2023 Case# 104 3/2/2023 Case# 105 3/2/2023 Case# 106 3/2/2023 Case# 107 3/2/2023 Case# 108 3/3/2023 Case# 109 3/3/2023 Case# 110 3/7/2023 Case# 111 3/7/2023 Case# 112 3/7/2023 Case# 113 3/8/2023 Case# 114 3/9/2023 Case# 115 3/9/2023 Case# 116 3/13/2023 Case# 117 3/13/2023 Case# 118 3/13/2023 Case# 119 3/14 /2023 Case# 120 3/14/2023 Case# 121 3/14/2023 Case# 122 3/14/2023 Case# 123 3 /15/2023 Case# 124 3/15/2023 Case# 125 3/21/2023 Case# 126 3/22/2023 Case# 128 3/23/2023 Case# 129 3/23/2023 Case# 130 3/24/2023 Case# 131 4. An interview with the medical assistant on 3/24/2023 at 10:17 am in the lab confirmed the above finding. The medical assistant did acknowledge the 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 --