Aids Monitoring Lab

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the review of approved reference ranges in the laboratory procedure manual, two of two patient reports, and an interview with the technical supervisor (TC) #2, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Three of the nine complete blood cell count (CBC) parameters listed on the laboratory information system (LIS) patient report differed from those in the procedure manual. Findings: 1. Review of two of two patient reports from the LIS system revealed three of the nine CBC parameters listed on the laboratory information system (LIS) patient report differed from those in the procedure manual. LIS Patient Report Total Lymphs/uL 1.012.03-2871.49 Bands % 0.00-0.00 Atyp % 0.00-2.00 Procedure Manual Total Lymphs/uL 0.94-3.04 Bands % no value Atyp % no value 2. Interview with the TC #2 on April 23, 2024, at 1:15 PM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. 3. The laboratory reports approximately 3,892 CBC tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The Centers for Medicare and Medicaid Services (CMS) Philadelphia Regional Office CLIA Surveyors conducted an announced routine CLIA recertification survey at AIDS MONITORING LAB- LEIDOS BIOMEDICAL RESEARCH, INC on January 13, 2021. The laboratory is on compliance with 42 CFR part 493, Requirement for Laboratories with Standard level deficiencies. 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)