Inova Laboratories At Fair Oaks

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Inova Laboratories at Fair Oaks on April 2, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The specific deficiency cited is as follows: D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, laboratory policy and procedure manual, lack of documentation, and interview, the technical supervisor failed to follow established policy and perform annual competency assessment evaluations for one (1) of one new testing personnel responsible for performing high complexity testing in Chemistry and Hematology in calendar year 2023. The findings include: 1. Review of the CMS 209 form revealed Testing Personnel (TP) A performed high complexity testing. 2. Review of TP A's personnel file revealed TP A was hired and completed initial training/competency in 12/2022 (See Personnel Code Sheet). Further review revealed TP A's file contained a semi-annual competency performed on 6/23/2023. The personnel file lacked documentation of a 2023 annual competency. The surveyor requested to review documentation of TP A's 2023 annual competency. The laboratory provided no documentation to review. 3. Review of the laboratory's policy and procedure manual revealed a policy, "ILS Personnel Competency Policy", with the statement "The competency of personnel performing 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 -- non-waived testing is assessed prior to the initiation of independently performing testing, semi-annually during the first year of testing-first assessment within 7 months from initiation of testing and second assessment no later than 12 months from the start of testing during the first year an individual tests patient specimens (new employees)..." 4. In an interview with the technical supervisor on April 2, 2024 at approximately 10:00 AM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Inova Laboratories at Fair Oaks on June 15, 2022 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: 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 laboratory's Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, lack of documentation, and an interview, the laboratory failed to rotate 13 of 13 PT events (hematology, coagulation, and chemistry) among testing personnel (TP) in calendar year 2021. Findings include: 1. Review of the CMS 209 laboratory personnel form revealed that the laboratory director identified TP A and TP B as responsible for moderate/high complexity hematology, coagulation, and chemistry patient testing. (See attached Testing Personnel Code Sheet.) 2. Review of the laboratory's 2021 College of American Pathologists (CAP) hematology, chemistry, and coagulation PT documentation, a total of thirteen (13) events, revealed that TP A signed attestation /performed: 2021 WB Prothrombin Time/INR Events WP3-A, B, C; 2021 General Chemistry Events A, B, C; 2021 Reticulocyte Events RT A, B; 2021 Hematology Auto Differential Events FH9 Events A, B, C; 2021 Clinical Microscopy Events CM- A, B; TP A performed 13 of 13 events reviewed in calendar year 2021. The inspector requested to review PT rotation including TP B during calendar year 2021. No documentation was available for review. 3. An exit interview with the technical supervisor on 6/15/22 at approximately 12:30 PM confirmed the above findings. 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 -- D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a tour, review of policies, hematology analyzer performance verification records, lack of documentation, and an interview, the laboratory failed to record an evaluation/verification of precision and reportable range for Sysmex XN-1000 Complete Blood Count (CBC) testing after a physical move/installation to a new suite in February 2022 prior to reporting four thousand four hundred nineteen (4,419) patient test results as of the date of the inspection on June 15, 2022. Findings include: 1. During a tour of the laboratory on 6/15/22 at approximately 10:00 AM, the inspector noted that the laboratory had physically moved from a fourth level downstairs to a first floor suite location. The inspector inquired of the move date. The technical supervisor (TS) stated: "We moved from upstairs earlier this year on February 17, 2022." 2. Review of the laboratory policies revealed a Calibration Verification policy that outlined: "Calibration verification and AMR validation are performed under following circumstances - with every methodology installation, when instructed by the manufacturer, when a major instrument part is changed or after major preventative maintenance, when QC trends or shift necessitating, or if instrument is moved." 3. Review of the Sysmex XN-1000 analyzer's performance verification documentation (serial number 22415) revealed no lab director approved evaluation/verification of CBC precision or reportable for the timeframe of the installation in the new laboratory location (2/17/22) up to the date of the inspection, 6 /15/22. The inspector requested the performance records. No documentation was available for review. 4. Review of the patient test logs revealed that the lab had resulted 4,419 CBC reports during the four months outlined above. 5. An exit interview with the TS on 6/15/22 at approximately 12:30 PM confirmed the above findings -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Inova Laboratories at Fair Oaks on April 26, 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: 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 laboratory's Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, a total of fifteen (15) events, and interviews, the laboratory failed to rotate proficiency testing among the personnel performing patient testing from calendar year 2016 to the date of the survey, on 4/26/18. Findings include: 1. Review of the CMS 209 laboratory personnel form revealed a total of three (3) laboratory testing personnel were listed as performing patient testing. (See attached Testing Personnel Code Sheet) 2. Review of the laboratory's 2016, 2017, and to date 2018 College of American Pathologists (CAP) hematology, chemistry, and coagulation PT documentation revealed that testing personnel A performed fifteen (15) of fifteen (15) events reviewed. 3. In an exit interview with the laboratory director and technical supervisor on 4/26/18 at approximately 4:00 PM , it was confirmed that the laboratory failed to rotate PT among all personnel responsible for performing patient hematology, chemistry, and coagulation testing for the events and timeframe outlined above. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) 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 -- (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) documentation, and an interview, the laboratory failed to retain documentation of the Abbott iSTAT analyzer results for ten (10) of ten (10) PT events reviewed. Findings include: 1. Review of the laboratory's 2016, 2017, and to date 2018 College of American Pathologists (CAP) chemistry and coagulation PT results, a total of ten (10) events, revealed no Abbott iSTAT instrument result print outs were retained for: 2016 WP3 Event C, 2016 AQ3 Event C, 2017 WP3 Event A, 2017 AQ3 Event A, 2017 WP3 Event B, 2017 AQ3 Event B, 2017 WP3 Event C, 2017 AQ3 Event C, 2018 WP3 Event A, 2018 AQ3 Event A. The inspector requested to review the analyzer result print outs for the PT events listed above. No documentation was available for review. 2. In an exit interview with the laboratory director and technical supervisor on 4/26/18 at approximately 4:00 PM , it was confirmed that the laboratory failed to retain the Abbott iSTAT analyzer printed results for the PT events outlined above in calendar years 2016, 2017, and 2018. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of policies, maintenance records, and an interview, the laboratory failed to document maintenance protocols for one (1) variable volume single channel pipette located in the hematology area in calendar years 2016 and 2017. Findings include: 1. During a lab tour on April 26, 2017 at approximately 2:00 PM, the inspector noted the following variable volume single channel pipette in the hematology specimen processing area: Fisherbrand 20-200 ul - Serial Number (SN) 23941. 2. Review of the laboratory's policies revealed a protocol that outlined annual pipette calibration requirements to verify accuracy of the device. 3. Review of the available maintenance records from 2016 to the date of the survey revealed one pipette calibration record for the Fisherbrand SN 23941 (calibration dated 4/6/18). The inspector requested to review the pipette calibration records for 2016 and 2017. -- 2 of 3 -- No other pipette documentation was available for review. 4. In an interview with the laboratory director and technical supervisor on 4/26/18 at approximately 4:00 PM, it was confirmed that the laboratory failed to document maintenance protocols for the hematology pipette as outlined above in calendar years 2016 and 2017. -- 3 of 3 --