Summary:
Summary Statement of Deficiencies D0000 Federal Surveyors from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted a recertification survey. The following condition level 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: I. Based on direct observation, manufacturer's instructions and interview with the Technical Supervisor (TS), the laboratory failed to define, monitor and document the room temperature where temperature dependent reagents and supplies were located for 1 of 3 rooms. Findings Included: 1) During a laboratory tour on 7/18/2025 at 9:19 AM, the following reagents and supplies were observed in the supply/storage room without room temperature monitoring or documentation: a. 3 Siemens QuikLYTE Sample Diluent bottles, Lot #4KV635, Manufacturer storage temperature specifications 2 to 30 degrees C. b. 3 DCL Cellpack Boxes, Lot #A5095, Manufacturer storage temperature specifications 2 to 35 degrees C. c. 3 packs of 100 BD Vacutainer SST Tubes, Lot #5063109, Manufacturer storage temperature specifications 4 to 25 degrees C. d. 2 boxes of BD Veritor System for Rapid Detection of Flue A+B, Lot #256045, Manufacturer storage temperature specifications 2 to 30 degrees C. 2) In an interview on 7/18/2025 at 9:20 AM, the TS corroborated 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 4 -- findings that the supply/storage room did not have room temperature monitoring or documentation, where reagents and supplies were stored. II. Based on direct observation, manufacturer's instructions and interview with the Technical Supervisor (Ts), the laboratory failed to define temperature ranges consistent with the manufacturer's instructions, for the freezer temperature where 3 of 3 temperature dependent reagents and supplies were stored. Findings Included: 1) In direct observation on 7/18/2025 at 2:05 PM in the laboratory, 3 boxes of Quidel Triage Total 5 Control reagents, Lot #C4083AN, were found with manufacturer storage requirements of -20 degrees C or colder. 2) Review of the freezer temperature range revealed the range to be set at -30 degrees C to -15 degrees C. 3) In an interview on 7 /18/2025 at 2:10 PM in the laboratory, the TS corroborated the improper temperature range settings for the freezer in use. 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 review of manufacturer's instructions, laboratory's procedures, review of Rubella quality control (QC) testing records, and interview with technical consultant #1, the laboratory failed to document the daily rotator speed 3 of 3 months (April through June 2025) reviewed. Findings Included: 1.In review of the manufacturer's instructions for ASI rubella testing states, "rotate at 100 +/- RPM for 5 minutes." 2.In review of the laboratory procedure titled Rubajet Rubella states under 5.5, "place to test card on a flatbed rotator for 100 RPM for 5 minutes ..." 3. In review of the laboratory QC testing records titled Rubella Testing log for April through June 2025, the laboratory did not document the rotator speed for each day of use. 4. In an interview with technical consultant #1 at 1113, she confirmed that they were not documenting rotator speed before testing. 5. The laboratory performed 23 rubella tests between April through June 2025. D5783