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: Based on surveyor observation and confirmed in interview of facility personnel, the laboratory failed to ensure 1 of 1 aliquot container of Cytostat Red was labeled with the lot number and expiration date. The findings included: 1. Surveyor observation made on November 30, 2021 at 12:20 hours found one of one aliquot containers of Cytostat Red labeled without the lot number and expiration of the original container. 2. Interview with the histotechnologist on November 30, 2021 at 12:20 hours confirmed the findings. She explained that she did not remove the original labels and said that in the future she could place the pump in the original container. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: 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 -- Based on surveyor observation and confirmed in interview of facility personnel, the laboratory failed to ensure expired items were not available for testing. The findings included: 1. Surveyor observation made on November 30, 2021 at 12:15 hours during the initial tour of the laboratory found the following expired items: a. Methanol (1 gallon) Lot 54887 Expiration date: 10-31-2021 b. Isopropyl Alcohol (1 gallon) Lot 067176 Expiration date: 06-30-2020 2. An interview with the histotechnologist on November 30, 2021 at 12:15 hours in the laboratory confirmed the findings. -- 2 of 2 --