Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct inspection of CG8+ test cartridges for the i-Stat analyzer and interview with the technical consultant (TC) on 6/25/26 at 2:00 PM, the laboratory failed to label three out of three CG8+ test cartridges with the expiration date when storing at room temperature. Findings include: 1. The laboratory began patient testing using the CG8+ and CG4+ test cartridges on the i-Stat analyzer on 8/01/25. 2. Review of the laboratory's established policy and test manufacturer's package insert indicates CG8+ test cartridges may be stored at room temperature (64-86 degrees Fahrenheit) for 2 months. Test cartridges expire at 2 months kept at room temperature or the cartridge expiration date, whichever date comes first. 3. Direct inspection of three CG8+ test cartridges (lot# W25348, expiration date 8/13/26) stored at room temperature on the laboratory counter revealed the test cartridges failed to include the date in which the cartridges were placed on the counter for storage at room temperature and failed to include the 2-month expiration date. 4. TC interviewed on 6 /25/26 at 2:00 PM confirmed that the laboratory failed to document the open expiration date on three CG8+ test cartridges that were stored at room temperature on the laboratory counter and in use at the time of the survey. 5. The laboratory's reported annual test volume is 3,375. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports maintained in the electronic medical record (EMR), review of instrument results from the i-Stat analyzer and interview with the technical consultant (TC-1) on 6/25/26 at 1:45 PM, one out of one test reports failed to indicate the correct testing date. Findings include: 1. The laboratory began patient testing using the CG8+ and CG4+ test cartridges on the i-Stat analyzer on 8/01/25, with a reported annual test volume of 3,375. 2. It is the practice of the laboratory to utilize a "Laboratory Report Form" to record test results, which includes the i-Stat instrument printout and hand written information regarding patient identification, collection date and time and other pertinent information related to a Blood Gas sample and testing. The Laboratory Report Form is scanned into the patient's EMR once testing is complete. 3. One out of one test reports reviewed during the survey (Patient #1) failed to indicate the correct testing date. The i-Stat instrument printout indicated the test was performed on 11/19/25 at 1712, and the Laboratory Report Form listed the collection date and time as 11/20/25 at 0505. The Laboratory Report Form indicated critical test values were reported to the ordering physician on 11/20/25 at 0522. 4. TC-1 interviewed on 6/25/26 at 1:45 PM confirmed that the Laboratory Report Form containing the i-Stat instrument printout for Patient #1 failed to include the correct testing date. 5. The laboratory performed 1 patient test on the i-Stat analyzer from 11/19/25 through 11/20/25. -- 2 of 2 --