Acies Tx, Llc

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted January 21, 2026 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. A Standard level deficiency was cited. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor observations, review of laboratory policy, review of laboratory function check records, and interview with laboratory personnel, the laboratory failed to verify centrifugation function checks for two of two years in 2024 and 2025. The findings included: 1. Surveyor observation at 10:50 hours on 1/21/2026 in the laboratory, the lab utilized a ThermoScientific ST-4 centrifuge for spinning plates. A note stuck to the side of the centrifuge stated "cal done 9/19/2025, due 9/19/2026". 2. A review of the laboratory policy, "General Laboratory Maintenance", effective 01/01 /2021, Version 1, under F. Centrifuges, item 4, the policy stated "Centrifuges must be calibrated annually to ensure they are in proper working order. A third party can be hired to perform this service. Documentation of calibration must be kept for a minimum of two years." 3. In an interview at 11:06 hours on 1/21/2026 in the board room, the surveyor requested documentation of the laboratory's centrifuge function checks from 2024 and 2025. The Technical Supervisor stated the laboratory checked the centrifuge themselves with a tachometer, but the last records the lab had available for review were from 2023. 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of patient test records from December 2023 to January 2024, and staff interview, the laboratory failed: A) to ensure 1 of 9 patient samples were tested within the required time, and B) have a mechanism in place to ensure samples were maintained at the required temperature during transport. The findings include: A) 1. A review of the laboratory's policy titled "Laboratory Operations Manual for DNA/RNA Based Pathogen Testing" (approved by the laboratory director on 09/15/2023) under the section titled "Stability of Samples and Storage" determined: "Specimens are to be held at room temperature at 20-25C and processed within 3 days." 2. A review of the laboratory's policy titled "Client Manual - Pre-analytical" (approved by the laboratory director on 09/15/2023) determined: "Specimens should be refrigerated at 4-8C or stored at room temperature at 20-25C and processed within 72 hours." 3. A review of patient test records from December 2023 to January 2024 identified 1 of 9 patient samples tested more than 72 hours after collection. The patient was: Report ID: ACLTX-004 Collection date: 1/13 /2024 Received date: 1/17/2024 Resulted date: 1/18/2024 4. Testing personnel number 2 (as listed on Form CMS 209) confirmed the findings in an interview conducted 2/13/2024 at 1330 hours in the conference room. B) 1. A review of the laboratory's policy titled "Laboratory Operations Manual for DNA/RNA Based Pathogen Testing" (approved by the laboratory director on 09/15/2023) under the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- section titled "Stability of Samples and Storage" determined: "Specimens are to be held at room temperature at 20-25C and processed within 3 days." 2. A review of the laboratory's policy titled "Client Manual - Pre-analytical" (approved by the laboratory director on 09/15/2023) determined: "Specimens should be refrigerated at 4-8C or stored at room temperature at 20-25C and processed within 72 hours." 3. The laboratory was asked to provide documentation of how it ensured samples were maintained at the required temperature during transport. No method was in place. 4. A review of patient test records from November 2023 to January 2024 identified 9 patient samples were sent to the facility. They were: Report ID: ACLTX-001 ACLTX- 002 ACLTX-003 ACLTX-004 ACLTX-005 ACLTX-003030 ACLTX-003027 ACLTX-003029 ACLTX-003011 5. Testing personnel number 2 (as listed on Form CMS 209) confirmed the findings in an interview conducted 2/13/2024 at 1000 hours in the conference room. 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 review of the laboratory's policies, and staff interview, the laboratory failed to have documentation of performing monthly wipe tests for 2 of 2 months. The findings include: 1. The laboratory's policy titled "Laboratory Operations Manual for DNA/RNA Based Pathology Testing" (approved by the laboratory director on 09/15 /2023) under the section titled "Wipe Test" stated: "Once every month, take a patient sample swab and swab the area where sample preparation is performed... Record the test and any