Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed at Delta Pathology Group, LLC, Lafayette Lourdes, CLIA ID 19D2010173, on July 10, 2026. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, review of maintenance records, and interview with personnel, the laboratory failed to perform monthly maintenance for the Leica CM1850 UV cryostat for six (6) of fourteen (14) months reviewed. Findings: 1. Observation during the laboratory tour on July 10, 2026 at 9:15 am revealed the laboratory utilized a Leica CM 1850 UV cryostat for histopathology testing. 2. Review of the laboratory's "Cryostat Cleaning Disinfection/Fumigation & Maintenance Log" for the Leica CM 1850 UV cryostat revealed the "Chemical Disinfection Frequency: Monthly." 3. Further review of the laboratory's "Cryostat Cleaning Disinfection/Fumigation & Maintenance Log" for May 20025 through June 2026 revealed the laboratory did not perform the monthly maintenance for the following months: a) May 2025: Post-It note attached to log stated "Chemical disinfection needs to be done and marked monthly." b) June 2025: Post-It note attached to log stated "needs to be done monthly" c) July 2025 : Post-It note attached to log stated "The disinfection needs to be marked off monthly. It should be done monthly." d) August 2025 e) September 2025 f) April 2026 4. In interview on July 10, 2026 at 11:00 am, the Lab Manager confirmed monthly maintenance was not performed during the identified months. 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 -- D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure maintenance procedures were followed to ensure acceptable levels of test performance. Refer to D5433. -- 2 of 2 --