Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and an interview, the laboratory failed to retain patient test records documenting analytic systems activities for at least two years. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of test reports found that neither electronic, nor hard copies were made from instrument printouts, on thermal paper that fades over time, to ensure that they are retrievable and legible for at least two years. 2. An interview with a lab manager, on 2 /26/18 at 9:44 am, confirmed that neither electronic, nor hard copies were made from instrument printouts, on thermal paper that fades over time, to ensure that they are retrievable and legible for at least two years. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on record review, the laboratory failed to report the correct reference interval for the partial pressure of oxygen (pO2) chemistry test, for three out of three patients, as determined by the laboratory and approved by the Laboratory Director. Findings 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 -- Include: 1. Review of the laboratory's established "Reference Ranges" policy listed the pO2 reference range: "PO2 80-105 mm/Hg." 2. Review of three of the laboratory's patient test reports, found the following reported reference interval: Patient #1: "pO2 113 mm/Hg (75-100)" Patient #2: "pO2 64 mm/Hg (75-100)" Patient #3: "pO2 47 mm /Hg (75-100)." -- 2 of 2 --