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Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on November 11, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: A tour of the laboratory revealed that testing personnel failed to label, in use reagents, with an opened date and/ or expiration date. THE FINDINGS INCLUDE: 1. A tour of the laboratory confirmed that controls and reagents, in use for testing, were not dated with an opened date and/ or an expiration date as required. 2. An exit interview, with the Testing Personnel, Office Manager and the Laboratory Director via phone conference, on November 11, 2025, at 2:30pm, confirmed that the laboratory had multiple reagents in use without labeled opened and/or expiration date. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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: A tour of the laboratory revealed that the laboratory had multiple expired reagents in use for clinical laboratory testing. THE FINDINGS INCLUDE: 1. A tour of the laboratory revealed the following expired reagents: a. 3 boxes of ThermoFisher Scientific MGC Clinical DAU Control Set. 1 box expired on 06/30/2024 and 2 boxes expired on 09/30/2025; b. BD EDTA Vacutainer Tubes that expired 08/31/2020; c. BD Urinalysis Urine Vacutainer Tubes that expired on 08/31/2020; d. Grainer Bio- One GmbH Vacuette Tubes that expired on 09/13/2025; and e. 1 vial of ThermoFischer Scientific Washing Solution 4.5% that expired on 06/20/2024. 2. An exit interview with Testing Personal and Office Manager, as well as the Laboratory Director via phone conference, on November 11, 2025, at 2:30pm confirmed that the laboratory had multiple expired reagents and supplies, on site, in use for clinical laboratory testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 29, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of College of American Pathologist (CAP) proficiency testing (PT) documents and testing personnel interview, the lab failed to participate in PT 2 of 3 events of 2022. Findings: 1. Review of the CAP PT documents available revealed the lab failed to participate in the 2022 events #1 and #2. 2. Interview with testing personnel #1 (CMS 209) on 3/29/23 in the office of the practice manager at 11:35 am confirmed the aforementioned findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure 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 -- positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation during the lab tour, policy and procedure (SOP) review, and testing personnel interview, the laboratory failed to follow the labeling of specimens per the procedure titled "SAMPLE accessioning and follow up LOGIN in HORIZON LIS". Findings: 1. Observation during the tour of the laboratory at 10:17 am, revealed 2 of 2 urine specimens were labeled on the urine cup lid not the sample cup as out lined in the above mentioned procedure. 2. Review of the "SAMPLE accessioning and follow up LOGIN in HORIZON LIS" procedure revealed on page 3 of 4 "each specimen must have 2 unique identifiers on the specimen cup that matches the paperwork". 3. Interview with testing personnel #1 (CMS 209) on 3/29/23 at 10:19 am in the lab confirmed the aforementioned findings. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) documents and an interview with the testing personnel, the lab director (LD) failed to document initial training on 1 of 1 TP for the Indiko Plus analyzer used for toxicology testing. Findings: 1. Review of TP documents revealed the LD failed to ensure 1 of 1 TP had documented initial training for the Indiko Plus analyzer used for toxicology testing. 2. Interview with the TP in the practice manager's office on 3/29/23 at 10:30 am confirmed the aforementioned finding. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual (SOP) and lab director (LD) interview, the laboratory director failed to specify, in writing the duties and responsibilities of each required Clinical Laboratory Improvement Amendments (CLIA) position. Findings : 1. SOP review revealed the LD failed to specify in writing the duties and responsibilities of the Technical Consultant (TC), the Clinical Consultant (CC), and the LD. 2. Interview with the LD (CMS 209) in the practice manager's office at 10:30 am confirmed the SOP did not contain a duties and responsibilities policy and procedure for the aforementioned positions. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) initial survey was completed on August 21, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. An immediate jeopardy situation was identified due to the laboratory's inability to demonstrate compliance in the speciality of Toxicology for a moderate complexity laboratory. Specifically, the labs inability to validate the analytical system prior to patient testing that began 1/15/19 and the lab director's inability to provide overall management and direction in accordance with 493.1407. The following deficiencies were cited: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of lab documents provided and staff interview, the lab failed to verify the accuracy of the test or procedure twice annually for all assays performed by the lab on the Indiko Plus analyzer. Findings include: 1. Review of Proficiency Testing (PT) binder and enrollment letter (dated 8/12/19) revealed the lack of participation in PT or verification of accuracy twice annually to date. 2. Interview on 8 /21/19 with staff #1 (CMS 209 form) on the phone at approximately 11:00 AM confirmed the lack of participation in PT or verification of accuracy twice annually. 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 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 -- 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 laboratory records provided and interviews with the Lab Director (LD) and testing personnel (TP) the lab failed to validate the overall quality of the analytical system used for urine drug testing before performing patient analysis in accordance with 493.1289 resulting in Immediate Jeopardy (IJ). This Condition level deficiency contributed to the Immediate Jeopardy. Findings include: For details refer to: D5401, D5411, D5421 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the lab procedure manual (SOP) and staff interview, the lab failed to have written procedures for all assays performed by the lab on the Indiko Plus analyzer. Findings include: 1. Review of SOP revealed the lack of procedure for the THC (tetrahydrocannabinol) and EDDP (2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine) assays. 2. Interview on 8/21/19 with staff #1 (CMS 209 form) on the phone at approximately 11:15 AM confirmed the lack of the aforementioned procedure assays. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the lab procedure manual (SOP) and staff interview, the lab failed to have package inserts/ manufacturer procedures for all assays performed by the lab on the Indiko Plus analyzer. Findings include: 1. Review of SOP revealed the lack of package inserts/manufacturer procedures for the THC (tetrahydrocannabinol) and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) assays. 2. Interview on 8 /21/19 with staff #1 (CMS 209 form) on the phone at approximately 11:15 AM confirmed the lack of the aforementioned assay package inserts/ manufacturer procedures. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 5 -- 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: Based on review of laboratory records provided and interview with the Lab Director (LD), the lab failed to validate the overall quality of the analytical system used for urine drug testing before performing patient analysis Findings include: 1. Review of calibration and EP Evaluator documents presented revealed the lab failed to validate the overall quality of the Indiko Plus analyzer by performing accuracy, precision, linearity, sensitivity, specificity, and reference intervals on the analyzer at the facility's lab location. 2. Interview on 8/21/19 with staff #1 (CMS 209 form) on the phone at approximately 4:45 PM confirmed the lab documentation did not indicate the analyzer was validated at the facility's lab location. D5781