Summary:
Summary Statement of Deficiencies D0000 The initial survey was performed on 05/06,07,08/2026. Standard-level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of policy and procedure and interview with the director of operations and general supervisor, the written policy for assessing the clinical consultant and general supervisor based on the position responsibilities did not define the frequency of assessments to be performed. Findings include: (1) On 05/06/2026, a review of the competency assessment policy for assessing the clinical consultant and general supervisor titled, "Laboratory Policy - Personnel" identified it did not define the frequency of assessments; (2) Interview with the director of operations and general supervisor on 05/06/2026 at 01:22 pm confirmed that although the competencies based on the position responsibilities for the clinical consultant and the general supervisor had been performed annually, the policy did not define the frequency of assessments. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the policy and procedure manuals and interview with the general supervisor, the laboratory failed to have written procedures that explained the current practices and procedures being performed in the laboratory for three of three policies reviewed. Findings include: I. Standard Operating Procedures (1) On 5/7/2026 at 1:00 pm, the general supervisor stated urine Beta-hydroxybutyrate, Creatinine, Glucose, Hemoglobin, Microalbumin, Nitrate, pH, Specific Gravity, Total Bilirubin, Urobilinogen, and Leukocyte esterase testing were performed on the Diazyme c270 DZ-Lite analyzer; (2) The procedure titled, "Standard Operating Procedures" indicated that the laboratory performed urine drug screen testing and not urine chemistry testing; (3) The findings were reviewed with the general supervisor who stated on 05/7/2026 at 1:00 pm the laboratory did not perform urine drug screen testing and the procedure in the manual did not reflect the laboratory's current method of urine chemistries. II. Instruments (1) On 5/7/2026 at 1:00 pm, the general supervisor stated urine Beta-hydroxybutyrate, Creatinine, Glucose, Hemoglobin, Microalbumin, Nitrate, pH, Specific Gravity, Total Bilirubin, Urobilinogen, and Leukocyte esterase testing were performed on the Diazyme c270 DZ-Lite analyzer; (2) The procedure titled, "Instruments" indicated that the laboratory performed testing on the Indiko IA and Diazyme c270 DZ-Lite analyzers; (3) The general supervisor stated on 05/7/2026 at 1:00 pm the procedure manual did not reflect the laboratory's current sample stability for urine chemistry testing. III. Specimen Transport (1) On 5/7 /2026 at 1:00 pm, the general supervisor stated urine chemistry testing on the Diazyme c270 DZ-Lite analyzer was performed on fresh samples within 4 hours of collection or within 24 hours if refrigerated; (2) The procedure titled, "Specimen Transport" indicated that the laboratory performed urine chemistry testing as follows: (i) Room Temperature - 0-12 hours; (ii) Refrigerated - 12 hours-10 days; (iii) Frozen - 10-180 days. (3) The findings were reviewed with the general supervisor who stated on 05/7/2026 at 1:00 pm the laboratory did not perform urine drug screen as stated in the procedure manual and it did not reflect the laboratory's current procedure for urine chemistry testing. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (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)