Phenomics Health Inc

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on observations, record review, and interviews, the laboratory failed to to maintain monitoring policies and procedures to ensure contamination with genomic deoxyribonucleic acid (DNA) or amplicons was minimized (refer to D3003), failed to utilize a uni-directional workflow for its pharmacogenomic testing using molecular amplification procedures (refer to D3005 A), and failed to have separate areas for reagent preparation and amplification (refer to D3005 B). D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- . Based on record review and interview with the Laboratory Director, the laboratory failed to maintain monitoring policies and procedures to ensure contamination with genomic deoxyribonucleic acid (DNA) or amplicons was minimized for 8 (June 2023 to February 2024) of 8 months since the laboratory started molecular testing. Findings include: 1. A review of the laboratory's "Wipe Test Procedure" approved for use by the Laboratory Director on 6/20/23 revealed a section stating, "The purpose of the monthly wipe test is to detect possible sources of contaminations with genomic DNA or amplicons within the PGx workflow workstations, and laboratory equipment." 2. A review of the laboratory's "Wipe Test Log" revealed wipe tests were not performed monthly and had only been performed on the following dates: a. 11/15/23 b. 2/12/24 3. An interview on 2/26/24 at 3:08 pm with the Laboratory Director confirmed the laboratory had not performed wipe tests in accordance with the established procedure. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: A. Based on observation and interview with the Laboratory Director, the laboratory failed to utilize a uni-directional workflow for its pharmacogenomic testing using molecular amplification procedures for 8 (June 2023 to February 2024) of 8 months since the laboratory started testing. Findings include: 1. An interview on 2/26/24 at 9: 19 am with the Laboratory Director revealed the laboratory started its pharmacogenomic testing in June 2023. 2. A verbal walkthrough of the laboratory's molecular workflow on 2/26/24 at 9:46 am with the Laboratory Director and the Manager revealed specimen preparation is performed to the left of the dead air box, then is transported through the reagent preparation area to the King Fisher Flex extraction analyzer for nucleic acid extraction. Once completed, the extracted specimens are brought back to the dead air box to add the reagents prior to loading on the Eppendorf Mastercycler x50h to the left of the dead air box. During the amplification process with the Eppendorf Mastercycler x50h, the plate is taken off and brought back to the dead air box to add additional reagents. 3. The surveyor observed Testing Personnel #5 preparing the master mix reagents for the plate that was running on the Eppendorf Mastercycler x50h and left the dead air box to go to the specimen preparation area to use the vortex, then went back to the dead air box to continue preparing the master mix on 2/26/24 at 9:56 am. 4. An interview on 2/26/24 at 9:46 am with the Laboratory Director and General Supervisor confirmed the workflow was not unidirectional. B. Based on observation and interview with the Laboratory Director, the laboratory failed to have separate areas for reagent preparation and amplification for 8 (June 2023 to February 2024) of 8 months since the laboratory started testing. Findings include: 1. An interview on 2/26/24 at 9:19 am with the Laboratory Director revealed the laboratory started its pharmacogenomic testing in June 2023. 2. An interview on 2/26/24 at 9:46 am with the Laboratory Director revealed the Eppendorf Mastercycler x50h runs three different programs for the amplification process and the plate is taken off in-between to add reagents. 3. The surveyor observed Testing Personnel #5 preparing the master mix reagents for the plate that was running on the Eppendorf Mastercycler x50h in the dead air box where the post-amplification plate is brought for the addition of more reagents before running the next program on 2/26/24 at 9:56 am. The same area is used in both -- 2 of 7 -- reagent preparation and amplification. 4. An interview on 2/26/24 at 10:08 am with the Laboratory Director confirmed the laboratory did not have separate areas for amplification and reagent preparation. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director, the laboratory failed to verify the accuracy of analytes not formally graded for 2 (Toxicology event C-C 2023 and Pharmacogenomics event PGX-B 2023) of 4 events reviewed. Findings include: 1. A review of the laboratory's proficiency testing documentation revealed the Toxicology event C-C 2023 response "was not graded due to insufficient peer group data" and the Pharmacogenomics event PGX-B 2023 was an "educational challenge" with a lack of formal scores. 2. A review of the laboratory's "Proficiency Testing Policy-Ungraded PT Test Results Review" revealed a section stating, "

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on record review of the CMS database and the College of American Pathologists' proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the toxicology analyte valproic acid. Findings include: 1. The laboratory failed to achieve satisfactory performance in proficiency testing for the toxicology analyte valproic acid. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review of the CMS database and the College of American Pathologists' proficiency testing reports, the laboratory failed to achieve satisfactory performance in proficiency testing for the toxicology analyte valproic acid for 3 (3rd event of 2022 and 1st event of 2023, and 2nd event of 2023) of 3 consecutive testing events reviewed. Findings include: 1. A record review of the College of American Pathologists' proficiency testing records revealed the laboratory had not provided its results to the proficiency testing company, resulting in a score of 0 for valproic acid. 2. A record review of the CMS database revealed the laboratory failed to achieve satisfactory performance for three consecutive proficiency testing events: Valproic Acid PT Event Score 3rd event 2022 0% 1st event 2023 0% 2nd event 2023 0% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on review of the CMS database and review of the College of American Pathologists (CAP) proficiency testing reports, the Laboratory Director failed to provide overall management and direction. Findings include: 1. Laboratory Director failed to ensure that the laboratory successfully participated in a proficiency testing program as required under subpart H. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the College of American Pathologists (CAP) proficiency testing reports, the Laboratory Director failed to ensure that the laboratory successfully participated in a proficiency testing program as required under subpart H. Findings include: The laboratory failed to achieve satisfactory performance for valproic acid. Refer to D2016 and D2118. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on record review of the CMS database, the College of American Pathologists' proficiency testing reports, and interview with the Laboratory Director, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the toxicology analyte valproic acid. Findings include: 1. The laboratory failed to achieve satisfactory performance in proficiency testing for the toxicology analyte valproic acid. Refer to D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on record review of the CMS database, the College of American Pathologists' proficiency testing reports, and interview with the Laboratory Director, the laboratory failed to achieve satisfactory performance in proficiency testing for the toxicology analyte valproic acid for 2 (3rd event of 2022 and 1st event of 2023) of 2 consecutive testing events reviewed. Findings include: 1. A record review of the College of American Pathologists' proficiency testing records revealed the laboratory had not provided its results to the proficiency testing company. 2. A record review of the CMS database revealed the laboratory failed to achieve satisfactory performance for two consecutive proficiency testing events: Valproic Acid PT Event Score 3rd event 2022 0% 1st event 2023 0% 3. A phone interview on 6/8/23 at 4:01 pm with the Laboratory Director confirmed the laboratory received the score of 0% for the proficiency testing events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director and Testing Personnel #2, the laboratory failed to treat proficiency testing samples in the same manner as it tests patient samples for 4 (ZE-A, T-A, C-A, and C-B) of 4 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' Proficiency Testing documentation revealed a lack of test reports for the proficiency testing samples showing the results going through the laboratory's laboratory information management system for the following testing events: a. 2022 ZE-A b. 2022 T-A c. 2022 C-A d. 2022 C-B 2. An interview on 10/10 /22 at 1:57 pm with Testing Personnel #2 and the Laboratory Director revealed the data from the proficiency testing samples are not exported back through the laboratory's information management system, like a patient would have been, but are instead immediately entered into the proficiency testing website. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 Laboratory Director, the laboratory failed to document the evaluation of ungraded proficiency testing results for 3 (ZE-A, T-A, and C-A of 4 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' Proficiency Testing documentation revealed the following events had ungraded results from the proficiency testing provider and a lack of a documented evaluation of the laboratory's results to verify its accuracy of testing: a. 2022 ZE-A b. 2022 T-A c. 2022 C-A 2. An interview on 10/10/22 at 2:10 pm with the Laboratory Director confirmed the laboratory had not performed and documented the ungraded results from the proficiency testing provider for the events listed above. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of