Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature in one of one room in which supplies with storage temperature requirements were stored on each day of operation. Findings follow: A) During a tour of the laboratory on 1/24 /23 at 12:20 p.m.one room (histology lab) containing items with a temperature storage requirement was observed. B) During a review of the laboratory's temperature records it was noted that no temperature records were presented for the histology lab room. C) During a tour of the laboratory on 1/24/23 at 12:20 p.m. one container of Eosin - Y stain ( lot # 122869 expiration date 3/2024) and two containers of Hematoxylin Stain (lot 120584 expiration date 12/2023) all with a storage temperature requirement of 15 degrees C. to 30 degrees C were observed in the histology lab room. D) Upon request, the laboratory could not present the temperature records for the histology room in which the supplies identified above were stored,. E) In an interview on 1/24/23 at 12: 30 p.m. the laboratory staff member (# 1 separate staff identification list) stated that the daily temperature of the histology room in which the supplies identified above were stored had not been monitored and recorded.. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --