Summary:
Summary Statement of Deficiencies 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 upon observation, manufacturer's temperature requirements for Biorad IH Card AHG, Biorad IH Card ABO, and Vacuette blood collection tubes, the manufacturer's operating humidity requirement for Vitek 2 Compact microbiology analyzer, lack of documentation and interview with laboratory staff, the laboratory failed to monitor the room temperature in two of four rooms in which items with a storage temperature requirement were stored and room humidity in one of two rooms in which instruments with a required operatng humidity level were operated. Findings follow: 1. The laboratory failed to monitor humidity in one of two rooms in which instruments with an operating humidity level were used. A) During a tour of the laboratory on 9/23/25 at 09:00 a.m., a Vitek 2 Compact microbiology analyzer was observed in a room separated from the main laboratory area by a closed door. B) Review of the user's manual for the Vitek 2 Compact microbiology analyzer revealed a operating requirement of a non-condensing humidity level of 20 to 80 percent. C) Review of the laboratory records for environmental monitoring revealed that no humidity levels were presented for the room in which the Vitek 2 Compact microbiology analyzer was operated. D) In an interview on 9/24/25 at 10:40 a.m., the laboratory staff members ( numbers 2 and 3 on the form CMS 209) confirmed that humidity was not recorded in 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 -- the room in which the Vitek 2 Compact analyzer was used in microbiological analysis. 2. The laboratory failed to monitor the room temperature in two of four rooms in which supplies with a storage temperature requirement were stored. A) During a tour of the laboratory on 9/23/25 at 09:00 a.m., four separate rooms (main laboratory, blood bank, phlebotomy room, and microbiology laboratory) were observed containing items with a temperature storage requirement. B) During a tour of the laboratory on 9/24/25 at 10:00 a.m. 450 Biorad IH Card AHG cassettes lot # 9506010 expiration date 2026-06-03 temperature storage requirement 18 degrees Centigrade (C) to 25 degrees (C)., and 642 Biorad IH Card ABO cassettes lot # 9079020 expiration date 2026-09-07 temperature storage requirement 18 degrees (C) to 25 degrees (C) were observed in the blood bank room. C) During a tour of the laboratory on 9/24/25 at 10:00 a.m. 500 Vacutette 3 ml Na Citrate Blue Top blood collection tubes lot # B250133u expiration date 2026-01-01 with a storage temperature requirement of 4 degrees (C) to 25 degrees (C), and 700 Vacutette 3 ml Na Citrate Blue Top blood collection tubes lot # B250233g expiration date 2026-02- 14 and a storage temperature requirement of 4 degress (C) to 25 degrees C were observed in the phlebotomy room. D) Review of the laboratory records for environmental monitoring revealed that no temperatures were presented for the blood bank and phlebotomy rooms. E) In an interview on 9/24/25 at 10:40 a.m., the laboratory staff members ( numbers 2 and 3 on the form CMS 209) confirmed that room temperature was not recorded in the blood bank or phlebotomy rooms. D5779