Aids Monitoring Lab

Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 21, 2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard-level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's written policies and procedures, and interview with the Technical Supervisors (TS) #1 and #2 according to the Form Centers for Medicare and Medicaid Services (CMS) 209, the laboratory failed to establish and follow written policies and procedures for specimen transportation condition (temperature) for 2 of 2 years (2025 and 2026). Findings Included: 1) Review of the laboratory's written policy titled 'AIDS Monitoring Laboratory Procedure for Specimen Collection and Data Handling' stated the following on page 5 of 9: "5.2 Specimen Rejection: Specimens must be rejected and a new specimen obtained in the following instances ...5.2.3 Specimens received improperly shipped (excessive heat or cold)". The policy failed to include specimen transportation requirements (i.e. temperature), for patients (self-collection), outside clinics, and couriers. 2) In an interview with staff at 11:30 AM, TSs #1 and #2 confirmed the laboratory failed to have written policies and procedures for specimen transportation requirements, such as temperatures, and could not define exact temperature parameters which would be considered excessive heat or cold. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, the laboratory's refrigerator temperature settings, and interview with Technical Supervisors (TS) #1 and #2 according to the Form Centers for Medicare and Medicaid Services (CMS) 209, the laboratory failed to define refrigerator temperature ranges in accordance with manufacturer instructions for 30 of 30 Quality Control (QC) reagents and beads of various manufacturers. Findings Included: 1) During a laboratory tour at 11:01 AM, the following refrigerators and nodes were observed, with reagents stored within: a. Refrigerator Node 11, Probe 2, 27, S099947: i. 2 Status Flow Cytometry Controls, Lot # FC076, Manufacturer storage temperature requirements 2 to 8 degrees Celsius. ii. 2 Status Flow Cytometry Controls, Lot #FC0726-4L, Manufacturer storage temperature requirements 2 to 8 degrees Celsius. iii. 12 Sysmex XN-L Check Controls, Lot #6121, Manufacturer storage temperature requirements 2 to 8 degrees Celsius. b. Refrigerator 2 (Flow Cytometry), Thermo Scientific TSG NIH#C141478: Node 11, Alarm PT: 0004: i. Becton Dickinson (BD) Cytometer Setup and Tracking (CST) beads Ref # 662414, Lot # 514003 - 3 vials, and Lot # 515375 - 6 vials, Manufacturer storage temperature requirements 2 to 8 degrees Celsius. ii. Becton Dickinson (BD) Flow Cytometry (FC) beads Ref # 662961, Lot# 5181469 - 2 boxes, Lot #5363702 - 1 box, Lot #6030036 -2 boxes, Manufacturer storage temperature requirements 2 to 8 degrees Celsius. 2) Review of the refrigerators alarm ranges revealed a range of 1 to 7 degrees Celsius. 3) In an interview at 11:05 AM, TS #1 and 2 confirmed the refrigerators' lower threshold of the acceptable temperature alarm range was outside of manufacturer requirements. -- 2 of 2 --

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)