Summary:
Summary Statement of Deficiencies D0000 An announced initial survey of the laboratory was conducted from 08/26/2025 to 08 /27/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. Standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's patient requisitions, review of the laboratory's policy, and staff interviews, the laboratory failed to ensure specimens were maintained at an appropriate temperature during transport from referring locations to the laboratory for 14 of 14 specimens in August 2025 (random review). Findings include: 1. A review of patient final reports determined patient specimens were received from referring locations: Accession #: a) NAIL25-1142 Collected: 08/15 /2025 - 12:00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto b) NAIL25-1141 Collected: 08/15/2025 - 12:00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto c) NAIL25-1140 Collected: 08/15/2025 - 12:00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto d) NAIL25-1138 Collected: 08/14/2025 - 9:00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Irving e) NAIL25-1137 Collected: 08/14/2025 - 10: 00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle 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 -- Center - Irving f) NAIL25-1135 Collected: 08/14/2025 - 10:00 AM Received: 08/19 /2025 - no received time Location: Southwest Foot & Ankle Center - Desoto g) NAIL25-1134 Collected: 08/15/2025 - 12:00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto h) NAIL25-1133 Collected: 08/14/2025 - 9:25 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto i) NAIL25-1132 Collected: 08/14/2025 - 11:00 AM Received: 08/19/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto j) NAIL25-1131 Collected: 08/13/2025 - 12:00 AM Received: 08/14/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto k) NAIL25-1130 Collected: 08/13/2025 - 12:00 AM Received: 08/14/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto l) NAIL25-1129 Collected: 08/12/2025 - 12: 00 AM Received: 08/14/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto m) NAIL25-1128 Collected: 08/12/2025 - 12:00 AM Received: 08/14 /2025 - no received time Location: Southwest Foot & Ankle Center - Desoto n) NAIL25-1127 Collected: 08/12/2025 - 12:00 AM Received: 08/14/2025 - no received time Location: Southwest Foot & Ankle Center - Desoto 2. Review of the laboratory's policy titled "MOL GEN 12 SFAC SPAC: Specimen Rejection Criteria", approved by the laboratory director on 11/24/2024 stated: "2. Scope Any specimen that is submitted to the laboratory for testing must properly identify the patient and must be collected and transported in a way that does not compromise the integrity of the specimen ... 3. Specimen Rejection Criteria: 3.1 Specimens may be rejected for the following reasons: ...Sample stored or shipped improperly ..." 3. The surveyor asked testing person-1 (as listed on the CMS-209 form) if specimens were collected, transported, and received from the referring locations for patient testing on 08/26 /2025 at 1210 hours in the office. Testing person-1 (TP-1) confirmed specimens are collected at referring locations and transported to the laboratory for testing via an external courier service. The surveyor asked TP-1 how specimens are received from referring locations. TP-1 stated the specimens are received in a cooler with ice packs. The surveyor asked TP-1 if the specimens received in the cooler are documented for acceptable temperature upon receipt. TP-1 denied documenting the temperature of the patient specimens upon arrival from referring locations. The laboratory was asked to provide documentation of verification that specimens maintained the required temperature during transport from the referring location to the laboratory. No documentation was provided. 4. The Technical Supervisor (as listed on the CMS-209 form) confirmed the laboratory failed to ensure patient specimens were maintained at an appropriate temperature from collection to receipt for specimens collected from referring locations to receipt to the laboratory during an interview conducted on 08/26 /2025 at 1216 hours in the office. Key: CMS - Centers for Medicare and Medicaid -- 2 of 2 --