Vitruvian Health

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the general supervisor, the laboratory failed to follow its urine specimen labeling policy for one of one specimen collection observed. Findings include: 1. The surveyor observed the urine specimen collection area on 11/10/25 at 9:10 am and saw one urine specimen labeled with the first initial, last name, and date of birth handwritten on the urine collection cup. 2. A review of the laboratory's "Urine Collection" policy revealed a section stating, "Specimens are labeled to assure appropriate identification throughout the pre-analytic (pre-testing) and analytical phases of testing. Containers containing patient specimens for testing are labeled as follows: Patient name and laboratory identification number (e.g. DOB, or other unique patient identifier such as medical record or chart number) Sex and age, where appropriate Source/type of specimen (e.g. anatomical site, urine) Time and date of collection." 3. An interview on 11/10/25 at 9:10 am with the general supervisor confirmed the specimen was labeled only with the first initial, last name, and date of birth handwritten on the urine collection cup. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not 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 -- limited to-- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: . Based on record review and interview with the general supervisor, the technical supervisor failed to perform direct observations of routine patient test performance for two (4/30/25 and 11/7/25) of two competency assessments performed for testing personnel #1. Findings include: 1. A review of competency assessments for testing personnel #1 revealed the initial competency assessment for urine toxicology testing was performed on 4/30/25 and the six-month competency assessment was performed on 11/7/25. Both assessments included electronic signatures for the technical supervisor. 2. An interview on 11/10/25 at 12:05 pm with the general supervisor confirmed the technical supervisor had not performed direct observations of patient test performance as part of the competency assessments for testing personnel #1. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced complaint investigation was completed on October 14, 2024 at Vitruvian Health by the State of Michigan Licensing and Regulatory Affairs Department. During the investigation, it was determined the laboratory was out of compliance with the following condition-level deficiencies: 493.1230 Condition: General laboratory systems 493.1250 Condition: Analytic systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493. 1447 Condition: Laboratories performing high complexity testing; technical supervisor D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to establish competency assessment policies (refer to D5209) and failed to verify the accuracy of its Thermo Scientific Indiko Plus analyzer and Applied Biosystems MDS Sciex analyzer (refer to D5217). 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical supervisor, the laboratory failed to establish competency assessment policies for 13 (September 2023 to October 2024) of 13 months reviewed. Findings include: 1. A review of the laboratory's Form CMS-209 revealed the laboratory employed one testing personnel. 2. A review of the competency assessment documentation for the testing personnel performed on 9/16/23 revealed it had been performed as a self-assessment. 3. The surveyor requested the laboratory's competency assessment policy on 10/14/24 and it was not made available. 4. An interview on 10/14/24 at 1:45 pm with the technical supervisor confirmed the laboratory had not established competency assessment policies. 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 record review and interview with the technical supervisor, the laboratory failed to verify the accuracy of its Thermo Scientific Indiko Plus analyzer and Applied Biosystems MDS Sciex analyzer for 13 (September 2023 to October 2024) of 13 months reviewed. Findings include: 1. A review of the laboratory's test menu revealed it tests the following analytes not listed under Subpart I: a. Oxycodone b. Fentanyl c. Opioids d. Benzodiazepine e. Barbiturates f. Amphetamine g. Benzoylecogonine h. Methadone i. 6-MAM j. 7-Aminoclonazepam k. Alphahydroxyalprazolam l. Alprazolam m. Amphetamine n. Butalbital o. Carisoprodol p. Codeine q. Diazepam r. EDDP s. Ethyl sulfate t. Gabapentin u. Hydrocodone v. Hydromorphone w. Ketamine x. Meprobamate y. Methamphetamine z. Mitragynine aa. Morphine bb. Naloxone cc. Norbuprenorphine dd. Nordiazepam ee. Norfentanyl ff. Norhydrocodone gg. Norketamine hh. Noroxycodone ii. Oxymorphone jj. Pregabalin kk. Tapentadol ll. Tramadol mm. Urine specific gravity nn. Urine pH oo. Urine creatinine 2. A review of the laboratory's twice annual verification of accuracy documentation revealed a lack of records between September 2023 to October 2024 to verify accuracy of its Thermo Scientific Indiko Plus toxicology testing and Applied Biosystems MDS Sciex toxicology testing. 3. An interview on 10/14/24 at 2:35 pm with the technical supervisor confirmed the laboratory had not verified the accuracy of its Thermo Scientific Indiko Plus toxicology testing and Applied Biosystems MDS Sciex toxicology testing. 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 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. -- 2 of 17 -- This CONDITION is not met as evidenced by: . Based on observation, record review, and interviews, the laboratory failed to have a procedure manual to include specimen collection, labeling, acceptability, rejection criteria, and control procedures (refer to D5403), failed to monitor and document temperatures of its laboratory, specimen and reagent refrigerator, and reagent freezer (refer to D5413), failed to label its reagents, solutions, control materials, and calibration materials with the identity, preparation and expiration dates (refer to D5415), failed to ensure reagents, control materials, and calibration materials were not used beyond expiration dates (refer to D5417), failed to verify performance specifications for its Thermo Scientific Indiko Plus analyzer prior to using it for patient testing (refer to D5421), and failed to perform and document instrument maintenance for its Thermo Scientific Indiko Plus analyzer (refer to D5433). 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, 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 D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to have a documented electronic request for patient testing from an authorized person for 1 (patient 9667) of 14 patient charts reviewed. Findings include: 1. A review of patient charts revealed for 1 (patient 9667) of 14 patient charts reviewed there was no electronic order for the urine drug screen that was performed and resulted on 5/11/2022 in the patients electronic medical record (EMR). 2. An interview on 7/18/2022 at 12:20 pm, the TC confirmed there were no orders documented in the patients EMR for the urine drug screen performed and resulted on 5 /11/2022. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to include the results of testing performed for 1 (Patient 11911) of 14 patient test reports reviewed in the electronic medical record (EMR) . Findings include: 1. A review of patient test reports revealed for 1 (Patient 11911) of 14 patient charts reviewed, the final test report for the urine drug screen (UDS) was not in the 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 -- patient's electronic medical record (EMR). 2. When queried on 7/18/2022 at 12:10 pm, the TC was unable to provide the surveyor test results in the patient's EMR system. 3. An interview on 7/18/2022 at 12:10 pm, the TC confirmed the testing was performed and no final report was available in the patient's EMR record. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure 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 and interview with Testing Personnel #1, the laboratory failed to ensure patient urine aliquots were labeled for 1 of 6 patient samples observed. Findings include: 1. An observation at 10:16 am on 12/9/20 revealed Testing Personnel #1 at 10:16 am on 12/9/20 preparing patient urine toxicology specimens to be tested and 1 aliquot did not have identifying information when loaded into the analyzer. 2. An interview with Testing Personnel #1 on 12/9/20 at 10:16 am confirmed the urine toxicology specimen aliquot did not have identifying information. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. 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 record review and interview with the Technical Consultant, the laboratory failed to ensure quality control successfully passed for 1 (12/23/19) of 8 patient testing days reviewed. Findings include: 1. A review of the laboratory's quality control records revealed the negative control level for cocaine tested positive on 12/23 /19. 2. A review of patient testing logs revealed 32 patients had toxicology testing performed on 12/13/19 when the cocaine control was out of range. 3. An interview on 12/9/20 at 11:50 am with the Technical Consultant confirmed the quality control testing for cocaine had not passed on 12/23/19. -- 2 of 2 --