Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 08/25-08/26/2026. The facility was found to be out of compliance with CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.1409 Technical Consultant D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: Based on review of ABL90 Flex Plus blood gas analyzer operator's guide, room temperature logs, and confirmed in staff interview, the laboratory failed to ensure the defined room humidity range did not exceed the operator's specifications for 2 of 2 ABL90 Flex Plus blood gas analyzers. Findings included: 1. Review of the ABL90 Flex Plus blood gas analyzer operator's guide stated: "Chapter 13 Specifications Specification Value Relative Humidity 10-80%" 2. Review of the laboratory's "Room Temperature Log" revealed an acceptable room humidity range of 5% to 85%. The laboratory's defined acceptable humidity range of 5% to 85% exceeded the manufacturer's acceptable humidity range of 10-80% for the two ABL90 Flex Plus blood gas analyzers. 3. During an interview in the office on 07/21/2026 at 2:32 PM, 08 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- /25/2026 at 2:00 PM, the respiratory supervisor, after a review of the records, confirmed the laboratory failed to ensure the defined room humidity range did not exceed the operator's specifications for 2 of 2 ABL90 Flex Plus blood gas analyzers. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of laboratory policies, verification studies for the ABL90 Flex Plus blood gas analyzer, laboratory reference ranges, laboratory test records, and confirmed in interview, the laboratory failed to ensure the normal range for 14 of 14 blood gas parameters were verified by the laboratory's verification studies in 2026 (February) for 2 of 2 ABL90 Flex Plus blood gas analyzers. Findings included: 1. Review of the laboratory's policy "# HPLAB.1.0070" titled "LABORATORY METHOD VALIDATION" stated: "I. INTENDED USE: To perform validation /verification of each non-waived test/method/instrument system before use in patient testing. This verification includes accuracy, precision, analytic sensitivity, reportable range of patient test results, and establishment of reference ranges before methods are implemented. The methodperformance [sic] specifications are validated or verified in the location in which the patient testing will be performed ... II. POLICY ... I. Reference Ranges: Developed or verified according to Policy Lab 1.0100." Review of laboratory's policy "# LAB.1.0100" titled "LABORATORY REFERENCE RANGES" stated: "I. PURPOSE: The laboratory must provide useful clinical data. Reference intervals (normal ranges) are important to allow a clinician to assess patient results against an appropriate population. II. POLICY/PROCEDURE: A. The reference range must be established or verified for each analyte and specimen source (blood, urine, cerebrospinal fluid), when appropriate. 1. The reference range will be established during validation of a new procedure or instrument, and the range must be approved by the appropriate medical director." 2. According to verification studies, the laboratory added two ABL90 Flex Plus blood gas analyzers to their test menu on 03 /2026. The laboratory's "Method Instrument Validation Summary" for one ABL90 Flex Plus blood gas analyzers stated: I have reviewed the validation data for accuracy, precision, linearity, and reportable range for the ABL90 Flex Plus-SN: 09R0665N024, and the performance of the method is considered acceptable for patient testing." The laboratory's "Method Instrument Validation Summary" for the second ABL90 Flex Plus blood gas analyzers stated: I have reviewed the validation data for accuracy, precision, linearity, and reportable range for the ABL90 Flex Plus-SN: 092R0665N025, and the performance of the method is considered acceptable for patient testing." Further review of the verification studies for the ABL90 Flex Plus blood gas analyzers revealed the laboratory did NOT perform a normal range (reference range) study as required. 3. Review of the laboratory's policy # "POC. 8.400" titled "RT-ABG ABNORMAL VALUES" listed the normal ranges for the parameters tested on the ABL90 Flex Plus analyzer as follows: Adult ABG Normal Range pH 7.35 - 745 [sic] PCO2 35 - 45 mmHg PO2 80 - 100 mmHg HCO3 19 25 - -- 2 of 6 -- mmol/L THB 12 - 16 g/dL COHB 0 - 1.5% CO OXY HGB 95 - 100% METHB 0.0 - 1.5 Adult VBG Normal Range pH 7.326 - 7.426 PCO2 41 - 51 mmHg PO2 30 - 50 mmHg Adult Electrolytes Normal Range Sodium 136 - 145 mmol/L Potassium 3.5 - 5.1 mmol/L Lactate 0.4 - 1.9 mEq/L Calcium Ionized 1.17 - 1.32 (12Y - 59 Y) Glucose 70 - 110 mg/dL The laboratory was asked to provide the studies used to obtain these normal ranges, and none were provided. 4. Review of laboratory test records identified 514 patients who had a blood gas analysis performed from March 1, 2026, through June 11, 2026, on the ABL90 Flex Plus blood gas analyzers. 5. During an interview on 08/25/2026 at 1:13 PM, the laboratory representatives, after a review of records, confirmed the laboratory failed to ensure the normal range for 14 of 14 blood gas parameters were verified by the laboratory's verification studies in 2026 (February) for 2 of 2 ABL90 Flex Plus blood gas analyzers. ABG - arterial blood gas pH - potential of hydrogen PCO2 - partial pressure of carbon dioxide PO2 - partial pressure of oxygen THB - total hydrogen C0HB - carboxyhemoglobin CO OXY HGB - oxyhemoglobin METHB - methomoglobin mmHg - millimeters of mercury mmol/L - millimole per liter g/dL - grams per deciliter VBG- venous blood gas mEq/L - milliequivalents per liter Y - years mg/dL - milligrams per deciliter D5781