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 a review of Gem Premier 3500 Blood Gas analyzer user manual, manufacturer's instruction, observations made during a tour, lack of documentation, as well as interviews with staff, it was determined the Respiratory laboratory failed to document temperature ranges and humidity conditions that are essential for the proper storage of reagents and the operation of the Gem Premier 3500 analyzer. As evidenced by: A. A review of the user manual ( Section 11.3 "Specifications") for the Gem Premier 3500 Blood Gas analyzer revealed the Ambient Environmental and storage requirements for the analyzer operations: Relative Humidity 5% to 90%; External Ambient Temperatures 15 to 35 degrees Celsius: Gem Premier 300 Pak cartridges 15 to 25 degrees Celsius. B. A review of the manufacturer's instructions of GEM CVP 1 (Calibration Valuation Product) ( Lot # 1834 expiration date 03/2019) and CVP 2 (lot #2834 expiration date 03/2019) revealed the storage and stability requirements: " Unopened ampoules are stable until the expiration date shown on the label when stored at 2-8 degrees Celsius, or up to 12 months at room temperature (20- 28 degrees Celsius)." C. A review of the manufacturer's instructions for BIORAD Liquichek Blood Gas Quality Control ( lot #28710 expiration date 07/31/2020) revealed the storage and stability requirements: " This product will be stable until the expiration date when stored unopened at 18 to 25 degrees Celsius." D. During a tour Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- of the Respiratory laboratory on 7/25/2018 at 1300, the following was observed stored and in use at room temperature: Gem Premier 3500 Blood Gas Analyzer, 4 of 4 boxes of Critical Care Quality Control 7 ( storage requirements 15-25 degrees Celsius); 3 of 3 boxes of Gem CVP 1 (storage requirements 20-28 degrees Celsius); 3 boxes of Gem CVP 2 (storage requirements 20-28 degrees Celsius); 1 of 1 box of Level 1 Liquichek Controls (storage requirements 18-25 degrees Celsius); 2 of 2 boxes of Level 2 Liquichek Controls (storage requirements 18-25 degrees Celsius) and 2 of 2 boxes of Gem Premier 3500 cartridges (storage requirements 15-25 degrees Celsius). The quality controls and reagents did not contain an opened date. E. The surveyor requested documentation of temperature requirements and humidity conditions. None was provided. F. In an interview on 7/25/2018 at 1330, laboratory employee #14 (as listed on form CMS 209) confirmed the Respiratory laboratory has no documentation of temperature or humidity conditions. 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: Through observations made during a tour of the laboratory and through interviews with staff, it was determined the laboratory had culture media available for use when it had exceeded it's expiration date. Survey findings follow: A. During a tour of the laboratory, at 1:25 p.m. on 7/25/2018, the surveyor observed two of six blood agar slants (lot #8011991 expiration 7/5/18) in the microbiology refrigerator, available for use, when they had exceeded their expiration dates. B. In an interview, at the time of the laboratory tour, laboratory employee #14 (as listed on the form CMS-209) confirmed the blood agar slants were available for use after they had exceeded their expiration. D5783