Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 01/19/2025. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D2000 - 42 C. F.R. 493.801 Enrollment And Testing Of Samples 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 a review of laboratory's submitted test menu, laboratory's records, policies /procedures and staff interview, the laboratory failed to enroll and participate in an approved proficiency testing program for General Chemistry and Hematology for nine of nine regulated analytes included in the Abbott iStat Chem8+ cartridge used by the laboratory in patient testing in January 2023 and January 2024. Findings included: 1. Review of laboratory's test menu revealed the laboratory performed testing using the Abbott iStat Chem8+ cartridge, that tested for the following regulated analytes: Sodium Potassium Chloride Total carbon dioxide Glucose Urea nitrogen Creatinine Hematocrit Hemoglobin 2. Review of laboratory's records revealed the laboratory did not have records for proficiency testing (PT) or documentation of enrollment in an approved PT program. 3. Review of laboratory's policies/procedures revealed there were no protocols/requirements in place for enrollment and performance of 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 -- proficiency testing. 4. In an interview on 01/19/2025 at 0720 hours in the field hospital's laboratory testing area, Testing Person number one (as indicated on submitted Form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid -- 2 of 2 --