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 direct observation and interview with general supervisor and technical supervisor, reagents, control materials, and calibration materials were in use past their expiration dates. The laboratory performs approximately 1.9 million chemistry tests annually. Findings include: 1. ALT reagent in fridge stated an expiration date of 8/3 /21. 2. HDL reagent in fridge stated an expiration date of 8/9/21. 3. EtG Calibrator in fridge stated an expiration date of 7/31/21. 4. Oxycodone positive control stated an expiration date of 7/28/21. 5. EMIT specialty Multi drug level 3 control stated an expiration date of 7/28/21. 7. In an interview on 8/10/21 at approximately 6:30 pm, the general supervisor and technical supervisor confirmed that reagents, control materials, and calibration materials were located in the in use section of the fridge past their expiration dates. 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 document review, direct observation, and interview with the general supervisor, the laboratory did not perform and document annual calibration of thermometers. Findings include: 1. Standard operating procedure for equipment maintenance stated that thermometers will be calibrated annually using an NIST certified thermometer. 2. Review of thermometers in use in the laboratory did not show evidence of current calibration. 3. Review of equiment maintenance documentation lacked evidence of thermometer calibration in 2020 or 2021. 4. In an interview on 8/10/21 at approximately 4:00 pm, the general supervisor confirmed that thermometer calibration was not documented in 2020. -- 2 of 2 --