Summary:
Summary Statement of Deficiencies 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: Based on the surveyors' observation, examination of laboratory reagents, and interview with the laboratory director (LD), it was determined that the laboratory failed to not use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, 09/11/2020 at approximately 1:00 p.m., the examiner found the following Mycology reagents currently being used beyond its expiration date : Reagent Lot # Exp. Date Manufacturer 10% KOH 1730603 11/02 /2018 Health Link DTM 445885 02/25/2020 Hardy 2. The LD affirmed on 09/11 /2020 at approximately 2:00 p.m. using the reagents listed in (1) beyond its expiration date. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tests and reports approximately 44 Mycology tests annually. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: Based on surveyor observation, lack of maintenance protocol, and interview with the laboratory director (LD); it was determined that the laboratory failed to establish and follow a maintenance protocol for the Olympus H-2 microscope that ensures its continued performance necessary for accurate and reliable test results. The findings included: 1. Based on the surveyor observation on 09/11/2020, 2020 at approximately 1:15 p.m. there was no evidence or records found on the microscope maintenance or calibration since 2018. 2. During the surveyor document review on the laboratory's microscope records it was determined that the laboratory had no evidence of maintenance protocol or calibration policy. 3. The LD confirmed on an interview on 09/11/2020, 2020 at approximately 1:15 p.m. that the laboratory failed to establish and follow a maintenance protocol for the Olympus H-2 microscope used for mycology, parasitology and histopathology examinations. 4. Based on the laboratory's yearly testing declaration submitted at the time of the survey, the laboratory analyzed and reported approximately 448 samples. -- 2 of 2 --