Old Dominion University Student Health Services

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Old Dominion University Student Health Services on March 27, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel form (CMS 209), proficiency testing (PT) records and interviews, the laboratory failed to rotate PT among personnel performing Complete Blood Count (CBC) patient testing for three (3) of 3 PT events in calendar year 2023. Findings include: 1. Review of the CMS Form 209 revealed the laboratory director (LD) identified five testing personnel qualified/responsible for performing patient CBC testing during the review timeframe of 3/16/22 to 3/27/24. 2. Review of the laboratory's Washington State Laboratory of Hygiene (WSLH) 2023 PT documentation, a total of 3 events, revealed that TP #1 signed attestations and performed the following CBC PT: 2023 WSLH Hematology Event 1; 2023 WSLH Hematology Event 2; 2023 WSLH Hematology Event 3. TP #1 performed 3 of 3 PT events in 2023. (See Personnel Code Sheet.) 3. An exit interview with the LD and general supervisor on 3/27/24 at 1:00 PM confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Old Dominion University Student Health Services on March 15, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a tour/review of laboratory equipment, interviews, maintenance logs, and lack of documentation, the laboratory failed to document function checks for centrifuge revolutions per minute (RPM) for their urinalysis centrifuge during the twenty-six (26) months reviewed. Findings include: 1. During an entrance interview with the laboratory's lead tech on 3/15/22 at approximately 1:30 PM, the inspector noted a Unico Power Spin LX C858 centrifuge serial number (SN 1802432) in use for urine microscopy specimen processing. The inspector inquired of the lead tech to describe the laboratory's urine sediment examination protocol. The lead tech stated at approximately 1:40 PM: "We use the Power Spin. We centrifuge urine in the Unico dialed at the urinalysis setting of 1,500 to 2,000 RPM selection for 5 -10 minutes". 2. 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 -- Review of the Unico Power Spin user manual revealed the following instructions: "Rotate the speed control knob slowly to the appropriate speed (Blood at 3,400 RPM, Urine at 2,000 RPM mark)". 3. Review of the laboratory's maintenance documentation revealed no records of RPM verifications for the Unico centrifuge urine setting of 2,000. The laboratory supervisor logged into Merico Biomedical Services record site and printed the following two documents: 8/10/20 SN 1802432 centrifuge speed verified by tachometer 4000 RPM. 8/13/21 SN 1802432 centrifuge speed verified by tachometer 3000 RPM. The inspector requested to review the laboratory's centrifuge calibration protocol and centrifuge verification records for the urinalysis RPM range during the review timeframe (January 2020 to the date of the inspection). No documentation was available. 4. An exit interview with the laboratory supervisor on 3/15/22 at approximately 4:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Old Dominion University Student Health Services on February 27, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 the laboratory's 2016 and 2107 American Academy of Family Physicians (AAFP) proficiency testing (PT) records and an interview with the laboratory director and primary testing personnel at approximately 3:30 PM on 2/27 /18, it was confirmed that the laboratory failed to enroll in a PT module for blood cell identification for two (2) of two (2) calendar years reviewed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedures, American Academy of Family Physicians (AAFP) proficiency testing (PT) records, patient test logs, and an interview, the laboratory failed to document the accuracy, at least twice a year, for Wright Stain White Blood Cell (WBC) manual count and differential identification tests in 2016 and 2017 while reporting fifty-three (53) patient results. Findings include: 1. Review of the laboratory's policy manual revealed a Wright Stain Manual Differential procedure which included the statement: "Classify 100 leukocytes. Examine red blood cell (RBC) morphology, and platelets. Tech may identify common atypical or immature blood cells such as lymphs, bands, and polychromatophilic RBC's. References to abnormalities should be made to cell line". 2. Review of the 2016 and 2017 AAFP hematology proficiency testing records, a total of six (6) events, revealed no PT documentation for manual blood cell identification for leukocytes (lymphocytes, monocytes, neutrophils), RBC, or platelet morphology. The inspector requested to review accuracy checks for the Wright Stain manual differential. No records were available for review. 3. Review of the patient test logs revealed thirty- one (31) patient manual differentials were reported in 2016 and twenty-two (22) were reported in 2017. 4. In an interview with the lab director and primary testing personnel at approximately 3:30 PM on 2/27/18, it was confirmed that the laboratory failed to perform accuracy checks for their Wright Stain Manual Differential testing in two (2) of two (2) years reviewed, while reporting fifty-three (53) patient results. -- 2 of 2 --