Summary:
Summary Statement of Deficiencies D0000 A validation survey was conducted on 3/31/2026 and standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions, and interview with testing person-1 (TP-1, as listed in the Form CMS-209), the laboratory failed to monitor and document the storage room temperature where 13 of 13 packages (100 tubes per package) of blood collection tubes were stored. Findings included: 1. During a tour of the storage room on 3/31/2026 at 10:30 am, the following BD Vacutainer blood collection tubes were observed: 100 of Buffered Sodium Citrate (lot #5260120, expiration date 6-30-2026) 100 of SST yellow top (lot #5255593, expiration date 8-31- 2026) 600 of K2E (Dipotassium Ethylenediamine-tetraacetic acid) 7.2 mg (lot #5169896, expiration date 10-31-2026) 300 of SST (serum separator tube) tiger top (lot #5105206, expiration date 3-31-2026) Manufacturer's storage requirements stated, "Store tubes at 4-25C (39-77F), unless otherwise noted on the package label." 2. During an interview on 3/31/2026 at 10:30 am, TP-1 confirmed the storage room was not monitored and documented for room temperature. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 direct observation, interview with TP-1, and review of patient results, the laboratory failed to ensure expired Access Sensitive Estradiol Calibrator S0 was not used when diluting 2 of 2 patient samples in 2026. Findings included: 1. During a tour of the storage room on 3/31/2026 at 10:28 am, two boxes of expired Access Sensitive Estradiol Calibrator S0 boxes were observed in the refrigerator (lot #588801, expiration date 11-08-2025). 2. During an interview on 3/31/2026 at 10:28 am, TP-1 confirmed the (expired) Access Sensitive Estradiol Calibrator S0 was in-use to dilute patients when their results exceed a certain concentration (>4,935 pg/mL). 3. Review of electronic patient results included when the expired Access Sensitive Estradiol Calibrator S0 was used to dilute patient Estradiol results: patient #1276 on 1/15/2026 and patient #35839 on 2/13/2026. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of