Summary:
Summary Statement of Deficiencies 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 review of i-STAT validation records, the absence of proficiency testing records, and interview with the practice manager 4/16/24, the laboratory failed to enroll in proficiency testing for the i-STAT testing performed. Review of i-STAT validation records revealed the laboratory performed patient testing on the i-STAT for the following analytes: sodium, potassium, chloride, ionized calcium, carbon dioxide, glucose, blood urea nitrogen, creatinine, hemoglobin, hematocrit, and anion gap. Review of i-STAT validation records revealed the laboratory validated the instrument for patient testing in April 2022. There were no records available to document that the laboratory was enrolled in proficiency testing, and there were no proficiency testing records available for review during the survey. During interview at approximately 8: 15 a.m., the practice manager confirmed the laboratory had not enrolled in proficiency testing for the i-STAT testing performed. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2022, 2023, and 2024 i-STAT quality control records and interview with TP (testing personnel) #1 on 4/16/24, the laboratory failed to retain the Value Assignment Sheets (VAS) for at least two years for 6/6 lot numbers of quality control material. Findings: Review of 2022, 2023, and 2024 i-STAT quality control records revealed the laboratory had not retained the VAS for the following lot numbers of quality control material: 1. lot #229H220800181 and lot #229H222640181 for CLEW A43 and CLEW A44; 2. lot #229H222640181 for CLEW A45; 3. lot #229H223492181 and lot #229H230580181 for CLEW A45 and CLEW A46; 4. lot #229H231880181 and lot #229H232760181 for CLEW A47. During interview at approximately 9:55 a.m., TP #1 confirmed that the laboratory had not saved the VAS for each lot number of control material. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)