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, review of temperature records, lack of documentation and interview the laboratory failed to monitor the temperature on each day of operation in one of two rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 5/14/26 at 09:45 a.m. the surveyor observed two rooms (core laboratory, and phlebotomy area) separated by closable doors. Each room contained laboratory items with a temperature storage requirement . B) A review of the laboratory's temperature records revealed that no room temperatures were presented for the phlebotomy area for the year 2025. C) During a tour of the laboratory on 5/14/26 at 11:46 a.m. the surveyor observed 9 Vacuette 2ml Na Citrate Blue Top blood collection tubes lot # 2507339 expiration date 2026-07-01 with a storage temperature requirement of 4- 25 degrees C and 48 BD 8.5 ml Heparin Green Top blood collection tubes lot # 6013826 expiration date 2027-01-31 with a storage temperature requirement of 4 - 25 degrees C in the Phlebotomy area. D) Upon request, the laboratory could not present the temperature records for the phlebotomy area in which the supplies identified above were stored. E) 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 -- In an interview on 5/14/26 at 11:45 a..m., the laboratory staff member (# 2 on form CMS 209) confirmed that temperature records for the Phlebotomy room or small storage room were not recorded. -- 2 of 2 --