Accutox, Inc/Stat Lab

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on 2/6/2025. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 manufacturers instructions, laboratory records, and confirmed in interview, the laboratory failed to ensure the performance of all necessary main maintenance on the Roche Cobas 6000 for records reviewed in 2023 and 2024. The findings included: 1. Review of the Roche Cobas 6000 manufacturers included the following instrument maintenance to be completed for the c501 module and the e 601 module on the Roche Cobas 6000 chemistry analyzer: Cobas c 501 module Maintenance Log: Every 2 months Replace: ISE measuring cartridges Quarterly: Replace: ISE pinch valve tubing and ISE supper tubing Clean: Ultrasonic mixers Cobas e 601 module Maintenance Log Every 3 Months Replace: Pinch valve tubing 2. Review of the laboratory maintenance checklists for 2023 and 2024 did not include documentation of the following maintenance tasks: 2023 On the C 501 module, of the Roche Cobas 6000, the following quarterly maintenance was not documented for 2023: Replace: ISE pinch valve tubing Replace: ISE sipper tubing Clean: Ultrasonic mixers On the E 601 module, of the Roche Cobas 6000, the following maintenance to be performed every three months was not documented for 2023: Replace: Pinch valve tubing 2024 On the C 501 module of the Roche Cobas 6000, the ISE Measuring cartridges, to be replaced every two months, was last documented replaced on 6/4/2024. No additional documentation that the ISE Measuring cartridges were replaced from July 2024 through December 2024. On the C 501 module of the Roche Cobas 6000, the following quarterly maintenance was not documented in 2024: Replace: ISE pinch 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 -- valve tubing Replace: ISE sipper tubing Clean: Ultrasonic mixers On the E 601 module of the Roche Cobas 6000, the following maintenance to be performed every three months, was not documented in 2024: Replace: Pinch valve tubing 3. In an interview on 1/6/2025 at 10:55 hours, in the laboratory, testing personnel (TP) 1 and TP2 confirmed that the laboratory had not documented and performed all necessary maintenance on the Roche Cobas 6000 chemistry analyzer. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory documentation, and confirmed in interview, the laboratory failed to ensure calibration verification was performed and evaluated every six months on the Cobas Roche 6000 chemistry analyzer in 2024 for 60 of 60 analytes that require calibration verification. The findings included: 1. Review of the laboratory policy titled "Roche Cobas 6000 Calibration Verification Procedure" included the following instruction: "Calibration verification is to be performed on each analyte on the instrument/test system at least every six months or more frequently if specified in the manufacturer's instructions ..." 2. Review of the Roche Cobas 6000 test menu included 60 total analytes with a two-point calibration. Surveyor asked for the calibration verification documentation for 2024 and the evaluation could be provided. 3. In an interview on 2/6/2025 at 11:30 hours, in the office, the laboratory director stated that the calibration verification had not been completed. The missed the first calibration verification of 2024 and had tested the samples at the end of 2024 but no evaluation for acceptability had been completed. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 An onsite survey conducted 03/21/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 surveyor observations, manufacturers instructions, review of the environmental temperature logs from January 2023 to March 2023, and confirmed in interview, the laboratory failed to ensure the proper storage conditions for two of three Biorad controls for the Roche Cobas chemistry analyzer per the manufacturer's instructions. Findings were: 1. Surveyor observations on 03/21/2023 at 1120 hours in the laboratory, freezer #4 contained the following Biorad controls Biorad liquichek specialty Immunoassay Lot 64962, exp 02/28/2025 Biorad liquichek immunology lot 85703, exp 08/31/2024 2. Review of the package inserts for the above controls under Storage and Stability, it stated "this product will be stable until the expiration date when stored unopened at -20 to -70C." Biorad liquichek specialty Immunoassay Lot 64962, exp 02/28/2025 (2023-02, 5450-00S) Biorad liquichek immunology lot 85703, exp 08/31/2024 (2023-02, 3200-00S) 3. The laboratory temperature logs from January to March 2023 had improper acceptable temperature range of -15C to -50 C for the freezer. Based on a random review of the temperature logs from January to March 2023, there were ten of sixty days with temperature higher than -20C. 02/13/2023 -19 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 -- C 02/15/2023 -18C 02/21/2023 -19C 02/28/2023 -19C 03/07/2023 -19C 03/08/2023 -19C 03/10/2023 -18C 03/13/2023 -18C 03/17/2023 -19C 03/20/2023 -18C 4. Based on a review of the laboratory CMS 116, the laboratory performed 419540 chemistry tests annually. 5. An interview with the laboratory director on 3/21/2023 at 1240 hours in his office confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records from 2022 to 2023 and confirmed in interview, the laboratory failed to have documentation of monitoring quality control values over time for Roche quality controls for two of two analytes (Folate and Lipase) reviewed. Findings were: 1. Based on review of the 2022 to 2023 quality controls for Folate and lipase, the laboratory used the following lots of quality control. Folate level 1 - lot 59576300 level 2 - lot 59576500 Lipase level 1 - lot 49417300 level 2 - lot 53571900 2. No documenation was available for review of the laboratory monitoring the above quality controls over time. 3. Based on review of the CMS116, the laboratory performed 419540 chemistry tests annually. 4. An interview with the laboratory director on 3/21/2023 at 1245 hours in his office confirmed the above findings. D5783

Summary Statement of Deficiencies D0000 An onsite recertification survey was performed on 12/15/21 to 12/16/21. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATELY JEOPARDY findings: D5300 493.1240: Pre-Analytic Systems The immediate jeopardy conditions were abated as evidenced by a letter signed by the laboratory director on 12/16/21. See the attached letter. and the following CONDITION LEVEL findings: D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) Micrographs , laboratory policy, and confirmed in interview, the laboratory failed to test PT samples the same number of times that it routinely tests patient samples for four out of six hematology events reviewed for 2020 and 2021. The findings include: 1. Review of the AccuTox, Inc. StatLab Proficiency Testing policy stated the following: "Run the proficiency testing exactly as you would run a patient. It is okay to repeat a questionable result if you would normally repeat a patient, but it is not okay to run all rests in duplicate." 2. Review of the API Hematology events for 2020 and 2021 list the following testing personnel (TP) performing identification (testing) as documented on the micrographs. 2020 - Hematology 2nd Event - Testing performed by TP7 and TP6 Blood Cell Identification (BCI)-08, BCI-10 2020 - Hematology 3rd Event - Testing performed by TP1 and TP7 BCI-11, BCI-12, BCI-13, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- BCI-14, BCI-15 Erythrocyte Cell Identification (ECI)-11, ECI-12, ECI-13, ECI-14, ECI-15 Urine Sediment (US)-05, US-06 Urine Eosinophils (UE)-03 2021 - Hematology 1st Event - Testing performed by TP1 and TP7 BCI-01, BCI-02, BCI-03, BCI-04, BCI-05 ECI-01, ECI-02, ECI-03, ECI-04, ECI-05 US-01, US-02 UE-01 2021 - Hematology 3rd Event - Testing performed by TP1 and TP3 BCI-12, BCI-13, BCI- 14 ECI-11, ECI-12, ECI-13 US-05, US-06 UE-03 3. In an interview on 12/15/2021 at 11:45 hours, in the office, the laboratory director stated that the hematology micrographs should have only been performed by one testing personnel, and that patient slides are not reviewed by more than one testing personnel before resulting. . D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of laboratory policy, American Proficiecny Institute (API) proficiency testing (PT) results, and confirmed in interview, the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified resulting in a score of 0% for the one of six core chemistry PT events reviewed in 2020 and 2021. The findings include: 1. Review of laboratory policy titled "Proficiency Testing" paragraph 6 has the following statement: "Be sure to have all results in by the date on forms. Late results will not be graded." 2. Review of the laboratories PT 'Performance Review and

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: . Based on surveyor observation, review of laboratory quality assesment documentation and staff interview, the laboratory failed to establish procedures for monitoring specimen acceptability and rejection. Findings: 1. In the course of the survey, documentation of rejected specimens was requested. In an interview at the site on 05-07-2019, testing person 1 (CMS form 209) stated specimen rejections were noted in the laboratory information system and that no manual log was maintained. 2. An electronic report of specimen rejections for the previous year was requested. In an interview at the site on 05-07-2019, the laboratory director (CMS form 209) stated that although the data needed was stored in the information system, no one at the site was able to produce such a report. . 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. 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 review of method verification documentation for the Sysmex XS-1000i hematology analyzer and staff interview, the laboratory failed to verify that the manufacturer's reference intervals were appropriate for the facility's patient population. Findings: 1. Method verification documentation for the Sysmex XS-1000i hematology analyzer was reviewed. In studies provided principally by the manufacturer's field service representative, accuracy, precision and reportable range were addressed. 2. No evidence of reference range verification was included. In an interview at the site on 05-07-2019, the laboratory diretor stated he was not aware that the study had not been performed. . D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: . Based on review of laboratory documentation for verification of the accuracy of calculations performed in the laboratory information system and staff interview, the laboratory failed to verify the accuracy of calculations for international normalized ratio (INR) and creatinine clearance performed by the Lab Daq information system. Findings: 1. Laboratory documentation for comparison of instrument printouts to Lab Daq reports was reviewed. The section for INR calculations showed the following: Specimen INR INR reported 636869 4.69 4.89 636886 1.09 1.07 636885 1.32 1.30 636857 3.34 3.43 636864 2.01 2.02 2. The section for creatinine clearance showed the following: Specimen Creat.Clearance Lab Daq results 628817 38.04 39.64 627576 8.98 9.36 632002 21.66 22.85 634041 31.00 32.15 3. In an interview at the site on 05- 07-2019, the laboratory director, who also serves as technical consultant (CMS form 209) stated he believed he had used the wrong calculations in the verification process. -- 2 of 2 --