Avertest Llc Dba Averhealth

Summary Statement of Deficiencies D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on interview with the complainant, review of the state complaints of patient A's residence, and interview with the laboratory director (LD) and the vice president of operations, the laboratory failed to ensure documentation of all complaints. Findings: 1. Phone interview with patient A on May 1, 2024, at 8:15 AM: patient A stated that he/she had contacted the laboratory multiple times trying to get a copy of the results and was told he/she could not have them. Phone interview with patient A's personal representative on August 22, 2024, at 11:00 AM, stated "Patient A called the laboratory and requested access to the test reports four times and the laboratory refused to provide the test reports." Complainant (patient A) was not provided with the process to file a complaint against laboratory. 2. Review of complaints from patient A's resident state from January 2024 to date August 19, 2024 and interview with the vice president of operations showed, "After a search, we did not find any client complaints from the state of patient A in the last year. This search included all customers in patient A, not just the Drug Courts." 3. Interview with the LD on August 19, 2024 at 2:00 PM confirmed the laboratory failed to ensure it documented all complaints. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, 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 -- 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 D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on observation of urine specimens and interview with the general supervisor (GS) #1, the laboratory failed to ensure confidentiality of patient information through all phases of the testing process. Findings: 1. Observation of multiple boxes of urine specimens located in the receiving area of the facility showed patient identification information visible on the urine containers. 2. Interview with the general supervisor (GS) #1 on July 19, 2023 at 9:00 AM, the general supervisor (GS) #1 stated that "those urine specimens are discarded in the dumpster outside as is." 3. Interview with the general supervisor (GS) #1 on July 19, 2023 at 9:00 AM confirmed the laboratory failed to maintain patient confidentiality through all phases of the testing process by discarding urine specimens in a public dumpster where patient information would be visible to the public. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory procedures, "Thermometer Logs", and interview with the general supervisor (GS) #1, the laboratory failed to follow the established procedure for specimen storage for 6 of 19 days in July 2023. Findings: 1. Review of the laboratory's procedure "Temperature-Sensitive Equipment", states "Acceptable operating ranges are -2 to 10 C for refrigerators and below 0 C for freezers. If temperature exceed these ranges,

Summary Statement of Deficiencies D0000 A complaint investigation (MO00181535) was conducted on May 4, 2021 under 42 CFR part 493, the requirements for the Clinical Laboratory Improvements Amendments (CLIA). The complaint was found to be unsubstantiated with unrelated definciencies. 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: Review of verification procedures revealed and interview with Laboratory Director, the laboratory failed to verify precision for one of ten analytes on the AU5400. Findings: 1. The laboratory provided the acceptable criteria in the validation report labeled Valid ation Report AU 5400 Wonder Woman as" %CV less than or equal to 25% or 1 ng/mL" for precision. Review of OPI low revealed that the %CV was greater than 25%, the laboratory obtained a %CV of 31.77%. Review of the OPI revealed a greater than 1 ng/mL value difference between target value of 5 ng/mL and laboratory result of 6.63.ng/mL. The laboratory failed to meet established acceptable criteria for precision. 2. Interview with Laboratory Director on May 4, 2021 at 1:45 P. M. confirmed, the laboratory failed to address the unacceptable criteria for precision for OPI low. D5807 TEST REPORT 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 -- CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the Immunoassay Testing procedure, review of patient test report for oral fluids and interview with the general supervisor (GS) #2, the laboratory failed to ensure the procedure cut off value for Benzodiazepines- SI 20 matched the cut off value on the patient test report. Findings: 1. Review of the Immunoassay Testing procedure showed the cut-off value for Benzodiazepines- SI 20 as 5 ng/mL. 2. Review of the patient test report for oral fluids showed the cut-off value for Benzodiazepines- SI 20 as 20 ng/mL. 3. Interview with GS #2 on May 4, 2021 at 11:30 AM confirmed that the Immunoassay Testing procedure cut off value for Benzodiazepines- SI 20 did not match the cut off value on the patient test report for oral fluids. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of procedure manual, personnel documentation and interview with the technical supervisors, the laboratory failed to perform semi-annual competency evaluations in years 2019 and 2020 for seven of twenty two testing personnel. Findings: 1. Review of the procedure manual revealed the laboratory requires an initial, semi-annual and yearly evaluation of employee competencies. 2. The laboratory failed to perform seven semi-annual competency evaluations for testing personnel #11, #13, #14, #16, #17, #18 and #22. 3. Interview with the technical supervisors #1 and #2 on December 08, 2020 at 2:30 PM confirmed the laboratory failed to perform seven semi-annual competency evaluations in the years 2019 and 2020. 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. 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 the manufacturer's product insert and interview with technical supervisor (TS) #1, the laboratory failed to monitor and document the humidity of the laboratory for proper operation for eleven of eleven AB Sciex 4000 LC/MS analyzers located in two separate rooms. 1. Review of the manufacturer's product insert for performance specifications revealed the analyzer requires relative humidity of 20-80 percent. 2. The lack of the relative humidity logs showed the laboratory failed to document humidity for the AB Sciex 4000 LC/MS analyzers in the two rooms. 3. Interview with the technical supervisor on December 8, 2020 at 2:00 PM confirmed the laboratory failed to document the relative humidity in two locations of the laboratory where the AB Sciex 4000 analyzers were in operation. 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: Based on review of performance evaluations for years 2019 and 2020 and interview with the technical supervisor (TS) #1, the TS failed to perform the semiannual performance reviews for seven of twenty two testing personnel. Finding: 1. Review of 2019, 2020 performance evaluations showed the TS failed to perform semi-annual competency evaluations for testing personnel #11, #13, #14, #16, #17, #18 and #22. 2. Interview with TS #1 on December 08, 2020 at 2:30 PM confirmed the laboratory failed to perform seven performance evaluations semiannually during the first year the individual tests patient specimens. -- 2 of 2 --

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Review of personnel records revealed and interview with the technical supervisor confirmed, one of eleven testing personnel did not have academic qualifications required to perform high complexity testing. (Refer to #6171) D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical 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 -- laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of academic credentials and interview with the technical supervisor, the laboratory failed to provide academic credentials to qualify one of eleven testing personnel. Findings: 1. The laboratory could not provide documentation (academic credentials) to show testing person #4 was qualified to perform high complexity testing. 2. Interview with the technical supervisor on November 28, 2018 at 1:30 PM confirmed the documents needed to qualify the testing person #4 were not available for review. -- 2 of 2 --