Arlington County Fire Department

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Arlington County Fire Department on March 7, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited is as follows: D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel (TP) records, procedures, and an interview, the technical consultant (TC) failed to document performance of semi- annual competency assessments for one (1) of 1 new TP in calendar year 2022 and two (2) of 2 new TP in calendar year 2023. The findings include: 1. Review of the laboratory's CMS 209 personnel form revealed the laboratory director (LD) identified two (2) TC and nine (9) TP as responsible for patient testing from April 2022 to the date of the survey on March 7, 2024. 2. Review of personnel records revealed three new testing personnel. TP A was initially trained and began performing patient testing on 3/28/2022. TP B and TP C were each initially trained and began performing patient testing on 11/30/2022. Further record review revealed a lack of semi-annual competency assessment for TP A in 2022 and semi-annual competency assessments for TP B and TP C in 2023. (See Personnel Code Sheet.) The surveyor requested to review the semi-annual competency assessments for the 3 TP listed above. The laboratory provided no semi-annual competency assessments to review. 3. Review of the laboratory's procedures revealed a policy, "EPOC Manual", with the following statements, "Competency-Initial Competency-All new Advanced Paramedic Officers 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 -- will have an initial training...Competency will be assessed again at six months and then annually thereafter." 4. In an exit interview with the TC A and TC B at approximately 12:00 PM on March 7, 2024, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced off-site CLIA recertification survey was conducted for Arlington County Fire Department on April 28, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on April 7, 2022 and virtual record review conducted on April 27, 2022. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (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 proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to maintain PT documents for six (6) of 6 PT events in the twenty-five (25) months reviewed (April 2020 to April 28, 2022). Findings include: 1. Review of the laboratory's 2020, 2021 and 2022 American Proficiency Institute (API) Chemistry Core PT documentation, a total of 6 events (2020 Events 2 & 3, 2021 Events 1-3, 2022 Event 1), revealed the following: API Chemistry Core 2020 Events 2 & 3-lack of attestation signature by testing personnel and laboratory director, lack of chemistry result documents, and lack of PT evaluation documents; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- API Chemistry Core 2021 Events 1-lack of attestation signature by testing personnel and laboratory director, lack of chemistry result documents, and lack of PT evaluation documents; API Chemistry Core 2021 Events 2-lack of attestation signature by laboratory director, lack of PT evaluation documents, and lack of

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Arlington County Fire Department on March 10, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Arlington County Fire Department is in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. 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 An announced CLIA initial survey was conducted at Virginia Hospital Center, Department of Pathology on August 30, 2018 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: : D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, Individual Quality Control Plan (IQCP), quality control records, ePOC manufacturer's instructions, verification records of the ePOC Test System, temperature logs, patient test logs and interviews, the laboratory failed monitor and evaluate the analytic quality by: 1. failure to follow manufacturer's storage requirements for the BGEM Test Cards for sixty-one (61) of one hundred and seventeen (117) days (Cross Reference D5413), 2. failure to verify the performance specifications of the ePOC test system (serial numbers 19772, 20209 and 20208) in the environment where testing is performed (Cross Reference D5421), 3. failure to include on-site testing data for the ePOC test system in determining the frequency of quality control (Cross Reference D5445), 4. failure to document