Summary:
Summary Statement of Deficiencies D0000 An initial survey was performed on February 17, 2026. The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2000 - 42 C.F.R. 493.801 Condition: Enrollment and Testing of Samples D6108 - 42 C.F.R. 493.1409 Condition: Technical Consultant-Moderate Complexity D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of Proficiency Testing (PT) records for 2024 and 2025, and the 1st Event of 2026, and an interview with the facility personnel, the laboratory failed to enroll in an HHS approved PT program for regulated testing performed in the specialties of Hematology and Chemistry, which are included in subpart I. Findings include: 1. No documentation was presented for review during the survey conducted on 2/17/26 to indicate the laboratory was enrolled during 2024, 2025, and the 1st Event of 2026 in a CMS-approved PT program for regulated analytes included in subpart I in the specialities of Hematology and Chemistry. 2. The laboratory performs testing for the following regulated analytes: Hemoglobin, Hematocrit, Chloride, Glucose, Potassium, Sodium, PCO2 blood gas, pH blood gas, PO2 blood gas, blood urea nitrogen (BUN), and Creatinine. 3. The facility personnel interviewed on 2/17/26 at 8:45 AM confirmed the laboratory was not enrolled in a CMS-approved PT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- program in 2024, 2025, and the 1st Event of 2026 in the specialities of Hematology and Chemistry. 4. This laboratory began patient testing utilizing the I-Stat analyzers in June 2024 under the specialities of Chemistry and Hematology with a reported annual test volume of 14,400. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of analytes not included in subpart I at least twice annually during 2024 and 2025. Findings include: 1. No documentation was presented for review during the survey conducted on 2/17 /26 to indicate the laboratory verified the accuracy of Lactate, Activated Clotting Time (ACT), TCO2, HCO3, BE, SO2, Anion Gap, and Ionized Calcium testing at least twice annually during 2024 and 2025. 2. The facility personnel interviewed on 2 /17/26 at 8:45 AM confirmed the laboratory failed to verify the accuracy of the analytes indicated above at least twice annually during 2024 and 2025. 3. This laboratory began patient testing utilizing the I-Stat analyzers in June 2024 under the specialities of Chemistry and Hematology with a reported annual test volume of 14,400. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. This laboratory began patient testing in June 2024 utilizing the I-Stat analyzer under the specialties of Chemistry and Hematology with a reported annual test volume of 14,400. 2. No QA documentation was provided for review during the survey conducted on 02/17/2026 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236, including but not limited to, Proficiency Testing policies and procedures. 3. The facility personnel interviewed on 2/17/26 at 9:00 AM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 9 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)