Tox Testing Inc

Summary Statement of Deficiencies D0000 The Tox Testing, INC laboratory survey was conducted for complaint MI000120992 in conjunction with the recertification survey. The allegation was found to be unsubstantiated. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) for the following Condition: D5022: Toxicology D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to maintain test requisitions used to order toxicology testing for at least 2 years for 3 (October-December 2019) of 24 months reviewed. Findings include: 1. The surveyor requested test requisitions from October 2019 to October 2021 on 10/19/21 at 10:15 am and requisitions from October-December 2019 were not made available. 2. A review of the laboratory's "Laboratory Record Policy" revealed a section stating, "All requisition forms will be kept in the laboratory for three years or as mandated by the State." 3. An interview on 10/19/21 at 10:15 am with TP1 confirmed the laboratory did not have test requisitions available prior to January 2020. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to retain all proficiency testing records for at least 2 years for 3 (Events 1 and 2 in 2020 and Event 1 in 2021) of 3 testing events reviewed. Findings include: 1. A review of the laboratories American Proficiency Institute (API) proficiency testing records revealed a lack of documentation of results obtained from the test system for each of the proficiency testing samples for the following testing events: a. Chemistry Miscellaneous Event 1 2020 b. Chemsitry Miscellaneous Event 2 2020 c. Chemistry Miscellaneous Event 1 2021 2. A review of the laboratory's "Preservation of Records, Reports, and Specimens" revealed a lack of policy regarding proficiency testing records. 3. An interview on 10/19/21 at 11:36 am with TP1 confirmed the results of the proficiency testing samples from the test system were not available. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to maintain test reports of patient toxicology testing for at least 2 years for 3 (October-December 2019) of 24 months reviewed. Findings include: 1. The surveyor requested test reports from October 2019 to October 2021 on 10/19/21 at 10:15 am and requisitions from October-December 2019 were not made available. 2. A review of the laboratory's "Laboratory Record Policy" revealed a section stating, "All laboratory reports are stored in Laboratory computer. These reports will be kept in the laboratory computer for a period of two years or as mandated by State." 3. An interview on 10/19/21 at 10:15 am with TP1 confirmed the laboratory did not have test reports available prior to January 2020. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to perform quality control testing each day of patient testing. Refer to D5445. 2. The laboratory failed to follow

Summary Statement of Deficiencies 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 record review and interview with Testing Personnel #1 (TP1), the laboratory failed to attest that proficiency testing samples were tested in the same manner as patient specimens for 1 (2nd event of 2019) of 1 proficiency testing event reviewed. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) proficiency testing data revealed a lack of attestation statement signed by testing personnel and the laboratory director. 2. An interview on 3/17/2020 at 10: 35 am with TP1 confirmed the laboratory did not have a signed attestation statement available for the testing event above. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: . Based on the number and severity of the deficiencies cited herein, the Condition: Toxicology was not met. Findings include: 1. The laboratory failed to verify the performance specifications for cocaine toxicology testing. Refer to D5421. 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 record review and interview with Testing Personnel #1 (TP1), the laboratory failed to follow quality assessement policies for 5 (October 2019 to March 2020) of 5 months. Findings include: 1. A review of the laboratory's established "Quality Assurance" policy, approved by the laboratory director on 10/10/19 revealed a section titled "Quarterly" stating, "As part of the quality assurance policy, the Technical Supervisor and/or Technical Consultant or Laboratory Director will review Proficiency Testing results and will convene for quality assurance meetings: Proficiency Testing- must be performed according to the policy and procedures set forth in this manual. After results are returned to the lab, the Operator will review them and perform and document any