Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Cenla Family Medicine Associates, CLIA ID 19D0866304, on January 13, 2026. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation by surveyor and interview with personnel, the laboratory failed to ensure laboratory supplies had not exceeded their expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on January 13, 2026 at 9:50 am revealed the following expired items: a) Located in third drawer beneath centrifuges: * Fisherbrand Transport Swab - Lot 3L24A; Expiration Date 11/24/25; Quantity (3) of (20) * Safe-T-Fill Micro Capillary Blood Collection Tubes - Lot 22H4015; Expiration Date 08/31/24; Quantity (32) of (32) b) Located in cabinet beneath the urinalysis instrument: * Health Track Thick Swab One PCR Infection Collection Device - Lot 7422021125; Expiration Date 01/01/26; Quantity (8) of (21) 2. In interview on January 13, 2026 at 10:01 am, Testing Personnel 1 stated that the expired supplies were sent from CPL reference laboratories and were not used for patient testing only for collection purposes to send out for reference testing. Testing Personnel 1 confirmed the identified supplies were expired. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of the laboratory's maintenance logs and interrview with personnel, the laboratory failed to perform weekly and monthly maintenance on the Cobas Integra 400 chemistry analyzer as required by the manufacturer for one (1) of twenty four (24) months reviewed in 2024 and 2025. Findings: 1. Observation by surveyor during the laboratory tour on January 13, 2026 at 10:05 am revealed the laboratory utilizes the Cobas Integra 400 analyzer for chemistry testing. 2. Review of the laboratory's" Cobas Integra 400 plus analyzer" maintenance logs revealed the following maintenance: a) Weekly: * System Power Off /Power On * Clean ISE tower automatically * Backup database * Clean probes and splash guard * Clean wash station * Clean insturment b) Monthly: * Clean waste box fitting * Clean ISE tower manually 3. Further review of the laboratory's "Cobas Integra 400 plus analyzer" maintenance logs revealed the weekly and monthly maintenance was not performed for one (1) of twenty four (24) in 2024 and 2025: a) September 2025 4. In interview on January 13, 2026 at 2:35 pm, Testing Personnel 1 stated the maintenance was performed but not documented on the maintenance logs. Testing Personnel 1 confirmed the maintenance was not documented as required by the manufacturer for the identified dates. II. Based on observation by surveyor, review of maintenance logs and interview with personnel, the laboratory failed to perform daily maintenance for the Tosoh HPLC G8 analyzer as required by the manufacturer for three (3) of twenty four (24) months reviewed in 2024 and 2025. Findings: 1. Observation by surveyor during the laboratory tour on January 13, 2026 at 10:05 am revealed the laboratory utilizes the Tosoh HPLC G8 analyzer for Hemoglobin A1C testing. 2. Review of the laboratory's "Tosoh HPLC G8 analyzer HbA1c Variant Mode" maintenance logs revealed the following daily maintenance: a) Daily: * Check waste container. Empty as needed and add bleach. * Check for leaks during warmup. Tighten fittings as needed. * Record pump pressure. * Check filter count and record. * Check column count and record. * Check buffer lots, volumes, and expiration date. * Check hemolysis and wash volume and expiration date. * Check printer paper supply. * Check card storage space. * Check control recovery and quality of chromatograms. 3. Further review of the "Tosoh HPLC G8 analyzer HbA1c Variant Mode" maintenance logs revealed the laboratory did not perform the daily maintenance for the following three (3) of twenty four (24) months reviewed in 2024 and 2025: a) March 2024: * March 11, 2024 - March 14, 2024 * March 18, 2024 - March 21, 2024 * March 25, 2024 - March 28, 2024 b) April 2024: * April 15, 2024 - April 18, 2024 * April 22, 2024 - April 23, 2024 * April 27, 2024 * April 29, 2024 - April 30, 2024 c) November 2025: * November 3, 2025 - November 6, 2025 * November 12, 2025 - November 13, 2025 * November 19, 2025 - November 21, 2025 * November 24, 2025 - November 26, 2025 4. In interview on January 13, 2025 at 3:37 pm, Testing Personnel 1 stated that personnel did not document maintenance as performed for the identified dates as required by the manufacturer. Testing Personnel 1 confirmed the maintenance was not performed as required. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory records, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to ensure laboratory supplies had not exceeded their expiration dates. Refer to D5417. 2. The laboratory failed to perform weekly and monthly maintenance on the Cobas Integra 400 chemistry analyzer as required by the manufacturer for one (1) of twenty four (24) months reviewed in 2024 and 2025. Refer to D5429 I. 3. The laboratory failed to perform daily maintenance for the Tosoh HPLC G8 analyzer as required by the manufacturer for three (3) of twenty four (24) months reviewed in 2024 and 2025. Refer to D5429 II. -- 3 of 3 --