Rxtox Inc

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of Pennsylvania Department of Health (PADOH) proficiency testing (PT) records and interview with Technical Supervisor (TS) #2 (CMS 209 Personnel #3, dated 03/06/2026) the Laboratory Director failed to ensure review and evaluation of the results obtained for 1 of 3 PADOH Toxicology PT events performed in 2025. Findings: 1. The PA Regulation 5.22(d) states, "The owner and director shall, if different persons, be jointly and severally responsible for the operation of the clinical laboratory in compliance with this section and with other pertinent regulatory and statutory requirements. They shall be responsible for the employment of personnel meeting qualifications specified in this chapter. They shall submit to the Department, on forms provided by the Department, an annual report of the number and types of laboratory examinations performed during the preceding year." 2. The laboratory's Proficiency Testing Procedure stated, "All of the results are reviewed by a technical supervisor to ensure a passing grade (100%)." 3. On the day of survey 03/11/2026 at 9: 40 am, review of PADOH PT records revealed the technical supervisor failed to review the following 1 of 3 PA DOH PT events to ensure a passing grade was obtained for toxicology testing performed in 2025: - Event #3 in 2025, Drugs in Urine 2025-III, 11-15. 4. TS #2 confirmed the findings above on 03/11/2026 at 11:40am. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or 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 -- scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) policy, College of American Pathologist (CAP) PT records and interview with Technical Supervisor (TS) #2 (CMS 209 Personnel #3, dated 03/06/2026), the laboratory failed to verify the accuracy of the PT results obtained for 3 of 4 CAP Toxicology PT testing events performed in 2024 and 2025. Findings Include: 1. The laboratory's Proficiency Testing Procedure stated, "If an exception code exists, the technical supervisor must follow through with reviewing it and documenting if the results were acceptable. This must then be signed off on by the director." 2. The CAP's actions laboratories should take when a PT result is not graded document stated, "the laboratory is required to review participant summary for comparative results and document performance accordingly. Evaluation criteria is not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self-evaluation." 3. On the day of survey, 03/11/2026 at 09:40 am review of the laboratory's CAP PT records revealed the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agency for 3 of 4 CAP Toxicology PT testing events performed in 2024 and 2025: - 2nd event 2024 DAI B - DAI 04, DAI 05, and DAI 06 (Creatinine qual, pH qual, Specific Gravity qual) - 1st event 2025 DAI A - DAI 01, DAI 02, and DAI 03 (Creatinine qual, pH qual, Specific Gravity qual) - 2nd event 2025 DAI B - DAI 04, DAI 05, and DAI 06 (Creatinine qual, pH qual, Specific Gravity qual) 4. TS #2 confirmed the findings above on 03/11/2026 at 11:40 am. 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 review of the laboratory's temperature logs, lack of documentation and interview with technical supervisor (TS) #2 (CMS 209 Personnel #3, dated 03/06 /2026), the laboratory failed to monitor and document humidity as required to ensure reliable test system operation and test result reporting for 7 of 7 instruments used to perform Chemistry testing from 05/22/2024 to date of survey. Findings include: 1. On the date of the survey, 03/11/2026 at 10:55 am, the laboratory could not provide documentation for monitoring room humidity (manufacturer's acceptable range 40- 80% RH) to ensure operating conditions were met for the following 7 of 7 instruments used to perform Chemistry testing from 05/22/2024 to 03/11/2026: - 1 of 1 Beckman AU680 - 2 of 2 Agilent GC/MS - 4 of 4 Agilent 6430 TripleQuad LC/MS/MS 2. The laboratory performed 300,000 Chemistry tests in 2025. (CMS-116 estimated annual volume, dated 03/06/2026). 3. TS #2 confirmed the findings above on 03/11/2026 at 11:30 am. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) proficiency testing (PT) records and interview with testing personnel (TP) #3 and #4 (CMS 209), the laboratory failed to verify the accuracy of the PT results obtained for 2 of 4 CAP Toxicology testing events in 2023 and 2024. Findings Include: 1. On the day of survey, 05/22/2024 at 09:46 am, review of the laboratory's CAP PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agency in 2023 and 2024: - 1st event 2023 DAI A - DAI 01, DAI 02, and DAI 03 - 1st event 2024 DAI A - DAI 01, DAI 02, and DAI 03 2. The CAP's actions laboratories should take when a PT result is not graded document states, "the laboratory is required to review participant summary for comparative results and document performance accordingly. Evaluation criteria is not established for educational challenges. Laboratories should determine their own evaluation criteria approved by their laboratory director for self-evaluation." 3. The laboratory failed to provide a procedure manual for PT testing. 4. TP #3 and TP #4 confirmed the findings above on 05/22/2024 at 11:00 am. *Repeat Deficiency. 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 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) proficiency testing (PT) records and interview with the Technical Supervisor (TS)#2, the laboratory failed to verify the accuracy for 1 of 3 Toxicology samples in 2021. Findings Include: 1. On the day of survey, 09/13/2022 at 09:30 am, review of 2021 CAP PT records revealed, the laboratory did not verify the accuracy for the following analytes that were not graded by the proficiency testing agency due to non consensus: - Clonazepam - Opiate Group - Buprenorphine - Norbuprenorphine - Fentanyl 2. The TS #2 confirmed the finding above on 09/13/2022 around 11:30 am. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Supervisor (TS)#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 -- the laboratory failed to establish a quality assurance policy from 03/12/2020 to the date of survey. Findings Include: 1. On the day of survey, 09/13/2022 at 11:55 am, the laboratory could not provide a policy for monitoring its pre-analytical, analytical, and post analytic programs from 03/12/2020 to the date of survey. 2. The TS#2 confirmed the finding above on 09/13/2022 at 11:30 am. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Supervisor (TS)#2 , the laboratory failed to evaluate twice a year the relationship between test results for 4 of 4 Liquid Chromatography Mass Spectrometry (LCMS) from 03/12/2020 to 09/13 /2022. Findings include: 1. On the day of survey 09/13/2022 at 10:43 am, The TS#2 could not provide comparison of test results between the following instruments from 03/12/2020 to 09/13/2022: - 2 of 2 Agilent 6430 - 2 of 2 Agilent 6460 2. The TS#2 confirmed the finding above on 09/13/2022 at 11:30 am. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, interview with the laboratory Testing Personnel, and review of the toxicology maintenance records on the date of the survey, the laboratory failed to document maintenance with at least the frequency specified by the manufacturer's frequency for 4 of 4 Kewaunee fume hoods & 2 of 2 Thermo Fisher Scientific Sorval ST40 centrifuges. Findings include: 1. The surveyor observed service stickers dated 06 /08/2016 on 2 of 2 Thermo Fisher Scientific Sorval ST40 centrifuges, no other centrifuge service stickers were observed required by the manufacture, 2. Thermo Fisher Scientific specifies annual tachometer checks for the Sorval ST40 centrifuges. 3. The surveyor observed service stickers dated 08/07/2017 on 4 of 4 Kewaunee fume hoods, no other fume hood service stickers were observed. 4. Kewaunee specifies annual maintenance checks for Kewaunee fume hoods. 5. During the survey at 3 pm 03/12/2020), the Toxicology Superviscr confirmed the above findings. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of the competency records and interview of the Toxicology Supervisor on the date of the survey, Technical Supervisor #1 failed to evaluate the competency for 3 of 3 Technical Supervisors and 2 of 2 General Supervisors responsible for high complexity testing, from February 2018 to the date of survey. Findings include: 1. On the date of the survey (02/26/2019), Technical Supervisor #1 failed to produce annual competency documentation for 3 of 3 Technical Supervisors and 2 of 2 General Supervisors responsible for high complexity testing, from 02/15 /2018 to the date of survey. 2. During the survey at 3:30 pm, the Toxicology Supervisor confirmed above finding. -- 2 of 2 --