Summary:
Summary Statement of Deficiencies D0000 An announced on-site validation survey was performed on 09/01/26. A standard-level deficiency was cited. D5807 TEST REPORT CFR(s): 493.1291(d) (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 review of the laboratory's written procedure, a patient report, and interview with the point-of-care testing (POCT) quality manager, the laboratory failed to have an accurate reference interval on a patient report for 1 of 1 patient report. Findings included: 1. On 09/02/26 at 09:30 am, the POCT quality manager confirmed the laboratory performed arterial blood gas (ABG) testing using 4 portable ABL 90 Flex Plus analyzers in the hospital: a. Operating Room - Serial Number 1393- 092R0460N0028 b. Laboratory - Serial Number 1393-092R0460N001 c. Labor and Delivery - Serial Number 1393-092R0461N005 d. Intensive Care Unit - Serial Number 1393-092R0461N0010 2. A review of the laboratory's written procedure title, "RADIOMETER ABL90 FLEX PLUS ANALYZER" provided a sO2 (oxygen saturation) normal reference range of 95-100% for all ages. 3. A review of 1 patient report (SM1567213 tested on 08/29/26) revealed a "O2 Saturation Arterial" normal reference range of "92 - 99%". 4. An interview on 09/02/26 at 11:43 am with the POCT quality manager confirmed the findings above. 5. The laboratory performs approximately 4,255 ABG tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --